Pepcid AC Maximum Strength Tablets

Pronunciation: fa-MOE-tih-deen
Generic Name: Famotidine
Brand Name: Examples include Pepcid AC and Pepcid AC Maximum Strength Tablets

Pepcid AC Maximum Strength Tablets is used for:

Treating heartburn associated with acid indigestion and sour stomach. It is also used for preventing heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.

Pepcid AC Maximum Strength Tablets is an H₂ (histamine) blocker. It works by reducing stomach acid by blocking one of the chemicals (histamine) that stimulates the release of acid into the stomach.

Do NOT use Pepcid AC Maximum Strength Tablets if:

• you are allergic to any ingredient in Pepcid AC Maximum Strength Tablets or to other H₂ blockers (eg, ranitidine)


• you are taking dasatinib

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pepcid AC Maximum Strength Tablets:

Some medical conditions may interact with Pepcid AC Maximum Strength Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney or liver disease


• if you have trouble swallowing, pain swallowing food, vomiting with blood or vomit that looks like coffee grounds, or bloody or black stools


• if you have frequent chest pain, unexplained weight loss, nausea or vomiting, or stomach pain


• if you have had heartburn for longer than 3 months; heartburn associated with light-headedness, sweating, or dizziness; or frequent wheezing, especially with heartburn


• if you have chest, arm, neck, or shoulder pain, especially with shortness of breath; sweating; or light-headedness

Some MEDICINES MAY INTERACT with Pepcid AC Maximum Strength Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following: Dasatinib because its effectiveness may be decreased by Pepcid AC Maximum Strength Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pepcid AC Maximum Strength Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pepcid AC Maximum Strength Tablets:

Use Pepcid AC Maximum Strength Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pepcid AC Maximum Strength Tablets by mouth with or without food.


• To relieve symptoms of heartburn, swallow 1 tablet with a glass of water.


• To prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn.


• Do not take more than 2 tablets in a 24-hour period unless directed by your health care provider.


• If you take atazanavir, erlotinib, itraconazole, ketoconazole, or rilpivirine, ask your doctor or pharmacist how to take it with Pepcid AC Maximum Strength Tablets.


• Ask your doctor before taking antacids or other acid reducers with Pepcid AC Maximum Strength Tablets.


• If you miss a dose of Pepcid AC Maximum Strength Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pepcid AC Maximum Strength Tablets.

Important safety information:

• Pepcid AC Maximum Strength Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Pepcid AC Maximum Strength Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• If your symptoms do not get better or become worse, or if you need to take this product for more than 14 days for heartburn symptoms, stop use and contact your doctor.


• You may need to make significant diet and lifestyle changes to help treat and prevent heartburn, including stress-reduction programs, exercise, and diet changes. Discuss any questions or concerns with your doctor.


• Use Pepcid AC Maximum Strength Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Use of Pepcid AC Maximum Strength Tablets is not recommended in CHILDREN younger than 12 years old without first talking with the child's doctor.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pepcid AC Maximum Strength Tablets while you are pregnant. Pepcid AC Maximum Strength Tablets is found in breast milk. Do not breast-feed while taking Pepcid AC Maximum Strength Tablets.

Possible side effects of Pepcid AC Maximum Strength Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); irregular heartbeat; seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pepcid AC Maximum Strength side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Pepcid AC Maximum Strength Tablets:

Store Pepcid AC Maximum Strength Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pepcid AC Maximum Strength Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Pepcid AC Maximum Strength Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Pepcid AC Maximum Strength Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pepcid AC Maximum Strength Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pepcid AC Maximum Strength resources

• Pepcid AC Maximum Strength Side Effects (in more detail)
• Pepcid AC Maximum Strength Use in Pregnancy & Breastfeeding
• Pepcid AC Maximum Strength Drug Interactions
• 0 Reviews for Pepcid AC Maximum Strength - Add your own review/rating

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Ondemet 4mg Tablets (Beacon Pharmaceuticals)

1. Name Of The Medicinal Product

Ondemet 4mg Tablets

2. Qualitative And Quantitative Composition

Ondemet 4 mg

Each film-coated tablet contains 4 mg ondansetron (as hydrochloride dihydrate).

Excipients:

Each film-coated tablet contains 84.50 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film coated tablet

4 mg: pale yellow, round biconvex, film-coated tablet embossed with 41 on one side, diameter 7.2 mm.

4. Clinical Particulars

4.1 Therapeutic Indications

Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention of post-operative nausea and vomiting (PONV).

4.2 Posology And Method Of Administration

Oral use

For the different dosage regimens appropriate strengths and formulations are available.

Chemotherapy and radiotherapy induced nausea and vomiting

Adults

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of Ondansetron should be flexible and selected as shown below.

Emetogenic chemotherapy and radiotherapy

For patients receiving emetogenic chemotherapy or radiotherapy ondansetron can be given either by oral or intravenous administration.

For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron should initially be administered intravenously immediately before treatment, followed by 8 mg orally twelve hourly.

For oral administration: 8 mg 1-2 hours before treatment, followed by 8 mg 12 hours later.

To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended dose for oral administration is 8 mg twice daily.

Highly emetogenic chemotherapy

For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, ondansetron can be given by intravenous administration.

To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron should be continued for up to 5 days after a course of treatment. The recommended dose for oral administration is 8 mg twice daily.

Children (aged 2 years and over) and adolescents (< 18 years)

Experience in paediatric patients is limited. In children older than two years, ondansetron may be administered as a single intravenous dose of 5 mg/m² over 15 minutes immediately before chemotherapy, followed by 4 mg orally twelve hours later. Oral treatment with a dose according to the body area should be continued for up to 5 days after a course of treatment. Children with a total body area between 0.6 and 1.2 m² should receive a dosage schedule of 4 mg 3 times a day, while children with a body area above 1.2 m² should receive 8 mg 3 times a day.

There is no experience in children younger than 2 years old.

Ondansetron film-coated tablets cannot be used in children with a total body surface below 0.6 m².

Elderly

Ondansetron is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of administration are required.

Please refer also to ”Special populations”.

Post-operative nausea and vomiting (PONV)

Adults

Prevention of PONV

For the prevention of PONV ondansetron can be administered orally or by intravenous injection.

For oral administration:

16 mg one hour prior to anaesthesia.

Alternatively, 8 mg one hour prior to anaesthesia followed by two further doses of 8 mg at eight hourly intervals.

Treatment of established PONV

For the treatment of established PONV intravenous administration is recommended.

Children (aged 2 years and over) and adolescents (< 18 years)

For the prevention and treatment of PONV slow intravenous injection is recommended.

Elderly

There is limited experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting (PONV) in the elderly, however ondansetron is well tolerated in patients over 65 years receiving chemotherapy.

Please refer also to ”Special populations”.

Special populations

Patients with renal impairment

No alteration of daily dosage or frequency of dosing, or route of administration are required.

Patients with hepatic impairment

Clearance of Ondansetron is significantly reduced and serum half life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg should not be exceeded.

Patients with poor sparteine/debrisoquine metabolism

The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients, repeat dosing will give medicinal product exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing are required.

4.3 Contraindications

Hypersensitivity to ondansetron or to other selective 5-HT3-receptor antagonists (e.g. granisetron, dolasetron) or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

Very rarely and predominantly with intravenous ondansetron, transient ECG changes including QT interval prolongation have been reported. Therefore caution should be exercised in patients with cardiac rhythm or conduction disturbances, in patients treated with anti-arrhythmic agents or beta-adrenergic blocking agents and in patients with significant electrolyte disturbances.

As ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration.

In patients with adenotonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron.

Since there is little experience to date of the use of ondansetron in cardiac patients, caution should be exercised if ondansetron is coadministered with anaesthetics to patients with arrhythmias or cardiac conduction disorders or to patients who are being treated with antiarrhythmic agents or beta-blockers.

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Ondansetron film-coated tablets should not be used in children with a total body surface below 0.6 m².

The medicinal product should not be used for children younger than two years, as for these patients the experience is limited.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There is no evidence that ondansetron either induces or inhibits the metabolism of other medicinal products commonly coadministered with it. Specific studies have shown that ondansetron does not interact with alcohol, temazepam, furosemide, alfentanil, propofol and thiopental.

Ondansetron is metabolised by multiple hepatic cytochrome P-450 enzymes: CYP3A4, CYP2D6 and CYP1A2. Due to the multiplicity of metabolic enzymes capable of metabolising ondansetron, enzyme inhibition or reduced activity of one enzyme (e.g. CYP2D6 genetic deficiency) is normally compensated by other enzymes and should result in little or no significant change in overall ondansetron clearance or dose requirement.

Phenytoin, Carbamazepine and Rifampicin: In patients treated with potent inducers of CYP3A4 (i.e. phenytoin, carbamazepine, and rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased.

Tramadol: Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol.

4.6 Pregnancy And Lactation

Pregnancy

Use in pregnancy has not been established and is not recommended.

To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. If it is absolutely necessary that Ondansetron be given caution should be exercised when prescribing to pregnant women especially in the first trimester. A careful risk/benefit assessment should be performed.

Lactation

Tests have shown that ondansetron passes into the milk of lactating animals (see section 5.3). It is therefore recommended that mothers receiving ondansetron should not breast-feed their babies.

4.7 Effects On Ability To Drive And Use Machines

Ondansetron has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (

The following frequencies are estimated at the standard recommended doses of ondansetron according to indication and formulation.

Immune system disorders

Rare: Immediate hypersensitivity reactions sometimes severe, including anaphylaxis.

Nervous system disorders

Very common: Headache.

Uncommon: Extrapyramidal reactions (such as oculogyric crisis/dystonic reactions) have been observed without definitive evidence of persistent clinical sequelae; seizures.

Eye disorders

Rare: Transient visual disturbances (eg. blurred vision) predominantly during rapid intravenous administration.

Very rare: transient blindness predominantly during intravenous administration.

The majority of the blindness cases reported resolved within 20 minutes. Most patients had received chemotherapeutic agents, which included cisplatin. Some cases of transient blindness were reported as cortical in origin.

Cardiac disorders

Uncommon: Arrhythmias, chest pain with or without ST segment depression, bradycardia.

Very rare: Transient ECG changes including QT interval prolongation.

Vascular disorders

Common: Sensation of warmth or flushing.

Uncommon: Hypotension.

Respiratory, thoracic and mediastinal disorders

Uncommon: Hiccups.

Gastrointestinal disorders

Common: Constipation. Local burning sensation following insertion of suppositories.

Hepatobiliary disorders

Uncommon: Asymptomatic increases in liver function tests.

These events were observed commonly in patients receiving chemotherapy with cisplatin.

4.9 Overdose

Little is known at present about overdosage with ondansetron, however, a limited number of patients received overdoses. Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second degree AV block. In all instances, the events resolved completely. There is no specific antidote for ondansetron, therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antiemetics and antinauseants, Serotonin (5-HT3) antagonists

ATC Code: A04AA01

Ondansetron is a potent, highly selective 5-HT3 receptor-antagonist.

Its precise antiemetic and antinauseal mechanism of action is not known. Chemotherapeutic agents and radiotherapy may cause release of 5-HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5-HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5-HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5-HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

In a pharmaco-psychological study in volunteers ondansetron has not shown a sedative effect.

Ondansetron does not alter plasma prolactin concentrations.

The role of ondansetron in opiate-induced emesis is not yet established.

5.2 Pharmacokinetic Properties

Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first pass metabolism (bioavailability is about 60%). Peak plasma concentrations of about 30 ng/ml are attained approximately 1.5 hours after an 8 mg dose. For doses above 8 mg the increase in ondansetron systemic exposure with dose is greater than proportional; this may reflect some reduction in first pass metabolism at higher oral doses. Bioavailability, following oral administration, is slightly enhanced by the presence of food but unaffected by antacids. Studies in healthy elderly volunteers have shown slight, but clinically insignificant, age-related increases in both oral bioavailability (65%) and half-life (5 hours) of ondansetron. Gender differences were shown in the disposition of ondansetron, with females having a greater rate and extent of absorption following an oral dose and reduced systemic clearance and volume of distribution (adjusted for weight).

The disposition of ondansetron following oral, intramuscular(IM) and intravenous(IV) dosing is similar with a terminal half life of about 3 hours and steady state volume of distribution of about 140 L. Equivalent systemic exposure is achieved after IM and IV administration of ondansetron.

The protein binding of ondansetron is 70-76%. A direct effect of plasma concentration and anti-emetic effect has not been established. Ondansetron is cleared from the systemic circulation predominantly by hepatic metabolism through multiple enzymatic pathways. Less than 5% of the absorbed dose is excreted unchanged in the urine. The absence of the enzyme CYP2D6 has no effect on ondansetron's pharmacokinetics. The pharmacokinetic properties of ondansetron are unchanged on repeat dosing.

Following oral, intravenous or intramuscular dosing in patients with severe hepatic impairment, ondansetron's systemic clearance is markedly reduced with prolonged elimination half-lives (15-32 h) and an oral bioavailability approaching 100% due to reduced pre-systemic metabolism.

5.3 Preclinical Safety Data

Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.

Ondansetron and its metabolites accumulate in the milk of rats, milk/plasma-ratio was 5.2.1.

A study in cloned human cardiac ion channels has shown ondansetron has the potential to affect cardiac repolarisation via blockade of HERG potassium channels. The clinical relevance of this finding is uncertain.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Cellulose, microcrystalline

Lactose monohydrate

Starch, pregelatinised (maize)

Magnesium stearate

Film coating:

Hypromellose

Hydroxypropylcellulose

Propylene glycol

Sorbitan oleate

Sorbic acid

Vanillin

Titanium dioxide (E171)

Quinoline yellow (E 104).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage precautions.

6.5 Nature And Contents Of Container

Blister (PVC/Al)

4 mg: 6, 10, 30, 50 and 100 film coated tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Beacon Pharmaceuticals Ltd

The Regent

The Broadway

Crowborough

East Sussex

TN6 1DA

UK

8. Marketing Authorisation Number(S)

PL 18157/0016

9. Date Of First Authorisation/Renewal Of The Authorisation

08/06/2009

10. Date Of Revision Of The Text

08/06/2009

Zirtek Allergy Relief 10 mg film-coated Tablets

1. Name Of The Medicinal Product

Zirtek Allergy Relief 10 mg film-coated tablets

2. Qualitative And Quantitative Composition

One film-coated tablets contains 10 mg cetirizine dihydrochloride

Excipients: one film-coated tablet contains 66.40 mg lactose-monohydrate

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film-coated tablets

White, oblong, film-coated tablet, with breakline and Y-Y logo

4. Clinical Particulars

4.1 Therapeutic Indications

In adults and children 6 year and above:

- Cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

- Cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.

4.2 Posology And Method Of Administration

Children aged from 6 to 12 years: 5 mg twice daily (a half tablet twice daily).

Adults and adolescents over 12 years of age: 10 mg once daily (1 tablet).

The tablets need to be swallowed with a glass of liquid.

Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal.

Patients with moderate to severe renal impairment: there are no data to document the efficacy/safety ratio in patients with renal impairement. Since cetirizine is mainly excreted via renal route (see section 5.2), in cases no alternative treatment can be used, the dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CL_cr) in mL/min is needed. The CL_cr (mL/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:

Dosing adjustments for adult patients with impaired renal function

Group	Creatinine clearance (mL/min)	Dosage and frequency
Normal		10 mg once daily
Mild	50 – 79	10 mg once daily
Moderate	30 – 49	5 mg once daily
Severe	<30	5 mg once every 2 days
End-stage renal disease - Patients undergoing dialysis	<10	Contra-indicated

In pediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient, his age and his body weight.

Patients with hepatic impairment: no dose adjustment is needed in patients with solely hepatic impairment.

Patients with hepatic impairment and renal impairment: dose adjustment is recommended (see Patients with moderate to severe renal impairment above).

4.3 Contraindications

Hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to any piperazine derivatives.

Patients with severe renal impairment at less than 10 mL/min creatinine clearance.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take cetirizine film-coated tablet.

4.4 Special Warnings And Precautions For Use

At therapeutic doses, no clinically significant interactions have been demonstrated with alcohol (for a blood alcohol level of 0.5 g/L). Nevertheless, precaution is recommended if alcohol is taken concomitantly.

Caution in epileptic patients and patients at risk of convulsions is recommended.

The use of the film-coated tablet formulation is not recommended in children aged less than 6 years since this formulation does not allow for appropriate dose adaptation.

Allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Due to the pharmacokinetic, pharmacodynamic and tolerance profile of cetirizine, no interactions are expected with this antihistamine. Actually, neither pharmacodynamic nor significant pharmacokinetic interaction was reported in drug-drug interactions studies performed, notably with pseudoephedrine or theophylline (400 mg/day).

The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased.

4.6 Pregnancy And Lactation

Pregnancy

For cetirizine very rare clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

Lactation

Cetirizine is excreted in human milk at concentrations representing 0.25 to 0.90 those measured in plasma, depending on sampling time after administration. Therefore, caution should be exercised when prescribing cetirizine to lactating women.

4.7 Effects On Ability To Drive And Use Machines

Objective measurements of driving ability, sleep latency and assembly line performance have not demonstrated any clinically relevant effects at the recommended dose of 10 mg.

Patients intending to drive, engaging in potentially hazardous activities or operating machinery should not exceed the recommended dose and should take their response to the medicinal product into account.

In sensitive patients, concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of performance.

4.8 Undesirable Effects

Clinical studies have shown that cetirizine at the recommended dosage has minor undesirable effects on the CNS, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported.

Although cetirizine is a selective antagonist of peripheral H₁-receptors and is relatively free of anticholinergic activity, isolated cases of micturition difficulty, eye accommodation disorders and dry mouth have been reported.

Instances of abnormal hepatic function with elevated hepatic enzymes accompanied by elevated bilirubin have been reported. Mostly this resolves upon discontinuation of the treatment with cetirizine dihydrochloride.

Clinical trials

Double blind controlled clinical trials comparing cetirizine to placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), of which quantified safety data are available, included more than 3200 subjects exposed to cetirizine.

From this pooling, the following adverse reactions were reported for cetirizine 10 mg in the placebo-controlled trials at rates of 1.0 % or greater:

Adverse reactions (WHO-ART)	Cetirizine 10 mg (n= 3260)	Placebo (n = 3061)
Body as a whole – general disorders Fatigue	1.63 %	0.95 %
Central and peripheral nervous system disorders Dizziness Headache	1.10 % 7.42 %	0.98 % 8.07 %
Gastro-intestinal system disorders Abdominal pain Dry mouth Nausea	0.98 % 2.09 % 1.07 %	1.08 % 0.82 % 1.14 %
Psychiatric disorders Somnolence	9.63 %	5.00 %
Respiratory system disorders Pharyngitis	1.29 %	1.34 %

Although statistically more common than under placebo, somnolence was mild to moderate in the majority of cases. Objective tests as demonstrated by other studies have demonstrated that usual daily activities are unaffected at the recommended daily dose in healthy young volunteers.

Adverse reactions at rates of 1 % or greater in children aged from 6 months to 12 years, included in placebo-controlled clinical trials are:

Adverse reactions (WHO-ART)	Cetirizine (n=1656)	Placebo (n =1294)
Gastro-intestinal system disorders Diarrhoea	1.0 %	0.6 %
Psychiatric disorders Somnolence	1.8 %	1.4 %
Respiratory system disorders Rhinitis	1.4 %	1.1 %
Body as a whole – general disorders Fatigue	1.0 %	0.3 %

Post-marketing experience

In addition to the adverse reactions reported during clinical studies and listed above, the following undesirable effects have been reported in post-marketing experience.

Undesirable effects are described according to MedDRA System Organ Class and by estimated frequency based on post-marketing experience.

Frequencies are defined as follows: Very common (

Blood and lymphatic disorders:
Very rare:	thrombocytopenia
Immune system disorders:
Rare:	hypersensitivity
Very rare:	anaphylactic shoc
Psychiatric disorders:
Uncommon:	agitation
Rare:	aggression, confusion, depression, hallucination, insomnia
Very rare:	tics
Nervous system disorders:
Uncommon:	paraesthesia
Rare:	convulsions
Very rare:	dysgeusia, syncope, tremor, dystonia, dyskinesia
Not known:	amnesia, memory impairment
Eye disorders:
Very rare:	accommodation disorder, blurred vision, oculogyration
Cardiac disorders:
Rare:	tachycardia
Gastro-intestinal disorders:
Uncommon:	diarrhoea
Hepatobiliary disorders:
Rare:	hepatic function abnormal (increased transaminases, alkaline phosphatase, γ-GT and bilirubin)
Skin and subcutaneous tissue disorders:
Uncommon:	pruritus, rash
Rare:	urticaria
Very rare:	angioneurotic oedema, fixed drug eruption
Renal and urinary disorders:
Very rare:	dysuria, enuresis
General disorders and administration site conditions:
Uncommon:	asthenia, malaise
Rare:	oedema
Investigations:
Rare:	weight increased

4.9 Overdose

Symptoms

Symptoms observed after an overdose of cetirizine are mainly associated with CNS effects or with effects that could suggest an anticholinergic effect.

Adverse events reported after an intake of at least 5 times the recommended daily dose are: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and urinary retention.

Management

There is no known specific antidote to cetirizine.

Should overdose occur, symptomatic or supportive treatment is recommended. Gastric lavage should be considered following ingestion of a short occurrence.

Cetirizine is not effectively removed by dialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Piperazine derivatives, ATC code: R06A E07

Cetirizine, a human metabolite of hydroxyzine, is a potent and selective antagonist of peripheral H₁-receptors. In vitro receptor binding studies have shown no measurable affinity for other than H₁-receptors.

In addition to its anti-H₁ effect, cetirizine was shown to display anti-allergic activities: at a dose of 10 mg once or twice daily, it inhibits the late phase recruitment of eosinophils, in the skin and conjunctiva of atopic subjects submitted to allergen challenge.

Studies in healthy volunteers show that cetirizine, at doses of 5 and 10 mg strongly inhibits the wheal and flare reactions induced by very high concentrations of histamine into the skin, but the correlation with efficacy is not established.

In a 35-day study in children aged 5 to 12, no tolerance to the antihistaminic effect (suppression of wheal and flare) of cetirizine was found. When a treatment with cetirizine is stopped after repeated administration, the skin recovers its normal reactivity to histamine within 3 days.

In a six-week, placebo-controlled study of 186 patients with allergic rhinitis and concomitant mild to moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms and did not alter pulmonary function. This study supports the safety of administering cetirizine to allergic patients with mild to moderate asthma.

In a placebo-controlled study, cetirizine given at the high daily dose of 60 mg for seven days did not cause statistically significant prolongation of QT interval.

At the recommended dosage, cetirizine has demonstrated that it improves the quality of life of patients with perennial and seasonal allergic rhinitis.

5.2 Pharmacokinetic Properties

The steady - state peak plasma concentrations is approximately 300 ng/mL and is achieved within 1.0 ± 0.5 h. No accumulation is observed for cetirizine following daily doses of 10 mg for 10 days. The distribution of pharmacokinetic parameters such as peak plasma concentration (C_max) and area under curve (AUC), is unimodal in human volunteers.

The extent of absorption of cetirizine is not reduced with food, although the rate of absorption is decreased. The extent of bioavailability is similar when cetirizine is given as solutions, capsules or tablets.

The apparent volume of distribution is 0.50 l/kg. Plasma protein binding of cetirizine is 93 ± 0.3 %. Cetirizine does not modify the protein binding of warfarin.

Cetirizine does not undergo extensive first pass metabolism. About two third of the dose are excreted unchanged in urine. The terminal half-life is approximately 10 hours.

Cetirizine exhibits linear kinetics over the range of 5 to 60 mg.

Special populations

Elderly: Following a single 10 mg oral dose, half-life increased by about 50 % and clearance decreased by 40 % in 16 elderly subjects compared to the normal subjects. The decrease in cetirizine clearance in these elderly volunteers appeared to be related to their decreased renal function.

Children, infants and toddlers: The half-life of cetirizine was about 6 hours in children of 6-12 years and 5 hours in children 2-6 years. In infants and toddlers aged 6 to 24 months, it is reduced to 3.1 hours

Renally impaired patients: The pharmacokinetics of the drug were similar in patients with mild impairment (creatinine clearance higher than 40 mL/min) and healthy volunteers. Patients with moderate renal impairment had a 3-fold increase in half-life and 70 % decrease in clearance compared to healthy volunteers.

Patients on hemodialysis (creatinine clearance less than 7 mL/min) given a single oral 10 mg dose of cetirizine had a 3-fold increase in half-life and a 70 % decrease in clearance compared to normals. Cetirizine was poorly cleared by haemodialysis. Dosing adjustment is necessary in patients with moderate or severe renal impairment (see section 4.2).

Hepatically impaired patients: Patients with chronic liver diseases (hepatocellular, cholestatic, and biliary cirrhosis) given 10 or 20 mg of cetirizine as a single dose had a 50 % increase in half-life along with a 40 % decrease in clearance compared to healthy subjects.

Dosing adjustment is only necessary in hepatically impaired patients if concomitant renal impairment is present.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

6. Pharmaceutical Particulars

6.1 List Of Excipients

- Microcrystalline cellulose

- Lactose

- Colloidal anhydrous silica

- Magnesium stearate

- Opadry Y-1-7000

- Hydroxypropylmethylcellulose (E 464)

- Titanium dioxide (E 171)

- Macrogol 400

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

Thermoformed transparent, colorless, physiologically inert PVC blister strip thermosealed by an aluminium foil covered by suitable lac; in a carton box.

Boxes of 7 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE

8. Marketing Authorisation Number(S)

PL 00039/0561

9. Date Of First Authorisation/Renewal Of The Authorisation

12 December 2005

10. Date Of Revision Of The Text

02 March 2011

Elmiron

Generic Name: Pentosan Polysulfate Sodium
Class: Protective Agents
ATC Class: C05BA
VA Class: GU900
Chemical Name: 4-O-Methyl-α-d-glucurono)-(1→2)-(1→4)-β-d-xylopyran hydrogen sulfate sodium salt
Molecular Formula: [C₅H₆Na₂O₁₀S₂]_n (n = 6 to 12)
CAS Number: 140207-93-8

Introduction

Semisynthetic low molecular weight heparinoid; a uroprotective agent resembling glycosaminoglycans.^{1 4 5 6 8}

Uses for Elmiron

Interstitial Cystitis

Symptomatic relief of bladder pain or discomfort associated with interstitial cystitis;^{1 2 6 7} designated an orphan drug by FDA for this use.³

Elmiron Dosage and Administration

Administration

Administer orally.^{1 2 6}

Oral Administration

Administer with water ≥1 hour before or 2 hours after meals.^{1 9 13}

Dosage

Available as pentosan polysulfate sodium; dosage expressed in terms of salt.¹

Adults

Interstitial Cystitis

Oral

100 mg 3 times daily^{1 2 6 7} for 3 months.^{1 7} If after 3 months no improvement or no dose-limiting adverse effects occur, may continue therapy for another 3 months.¹

Manufacturer states that if no improvement of pain is observed by 6 months, the optimal duration and risks of continued therapy unknown.¹ However, data from a long-term clinical study indicate overall continued symptomatic improvement (e.g., pain, urgency, urinary frequency, nocturia) during 1–2 years of therapy.⁷

Some clinicians recommend a dosage of 200 mg twice daily†; it appears to be effective and promotes greater patient compliance.⁶

Special Populations

Hepatic Impairment

No specific dosage adjustments recommended.¹

Renal Impairment

No specific dosage adjustments recommended.¹

Geriatric Patients

No specific dosage adjustments recommended.¹

Cautions for Elmiron

Contraindications

• 
  

  Known hypersensitivity to pentosan polysulfate, structurally related compounds, or any ingredient in formulation.¹

  
  

Warnings/Precautions

General Precautions

Hematologic Effects

Pentosan polysulfate is weak anticoagulant.^{1 11}

Rectal hemorrhage and bleeding complications of ecchymosis, epistaxis, and gum hemorrhage reported.¹

Evaluate patients at increased risk for hemorrhage including those undergoing invasive procedures, with signs and symptoms of coagulopathy, or receiving concomitant drugs that affect hemostasis.¹ (See Specific Drugs under Interactions.)

Delayed immunoallergic thrombocytopenia similar to heparin-induced thrombocytopenia with symptoms of thrombosis and hemorrhage reported with sub-Q, IM, or sublingual administration of a different formulation of pentosan polysulfate.^{1 13}

Use with caution in patients with history of heparin-induced thrombocytopenia.¹ Carefully evaluate patients with thrombocytopenia prior to initiation of therapy.¹

Thrombocytopenia and elevations in PT and partial thromboplastin time (PTT) reported in patients with elevated liver function test results.^{1 10} Such effects not observed in healthy men receiving ≤1.2 g of pentosan polysulfate sodium daily (a dosage greater than the recommended 100 mg 3 times daily) for 8 days.¹

Concomitant Illnesses

Carefully evaluate patients with diseases such as aneurysms, hemophilia, GI ulcerations, polyps, or diverticula prior to initiation of therapy.¹

Hepatic Effects

Mild and usually transient elevations (<2.5 times ULN) of serum aminotransferases, alkaline phosphatase, γ-glutamyl transpeptidase, and LDH concentrations reported in about 1.2% of patients.¹ Such abnormalities usually occur 3–12 months after initiation of therapy and generally not associated with jaundice or other clinical signs and symptoms.¹ These elevations may remain unchanged or rarely progress with continued use.¹

Alopecia

Alopecia, primarily alopecia areata (limited to single area on scalp), reported; may occur within first 4 weeks of initiation of therapy.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether pentosan polysulfate is distributed into milk.¹ Use with caution in nursing women.¹

Pediatric Use

Safety and efficacy in pediatric patients <16 years of age not established.¹

Hepatic Impairment

Use with caution.¹ (See Hepatic Effects under Cautions.)

Common Adverse Effects

Rectal hemorrhage,¹ alopecia,^{1 7 9} diarrhea,^{1 7 9} nausea,^{1 2 7 9} headache,^{5 7 9} blood in stool,⁹ rash,^{1 5 7 9} dyspepsia,^{1 7 9} abdominal pain,^{1 7} abnormal liver function tests,^{1 7 9} dizziness,^{1 7 9} bruising.⁹

Interactions for Elmiron

Drugs That Affect Hemostasis

Potential pharmacodynamic effect (increased risk of hemorrhage) with concurrent use of drugs that affect hemostasis.^{1 12}

Monitor for hemorrhage during concurrent administration.^{1 5}

Specific Drugs

Drug	Interaction	Comments
Anticoagulants, oral	Increased risk of bleeding1	Monitor for hemorrhage1 5
Heparin	Increased risk of bleeding1	Monitor for hemorrhage1
NSAIAs	Increased risk of bleeding with aspirin (high dosages) and other NSAIAs1	Monitor for hemorrhage1
Thrombolytic agents (e.g., alteplase, streptokinase)	Increased risk of bleeding1	Monitor for hemorrhage1

Elmiron Pharmacokinetics

Absorption

Bioavailability

Following oral administration, approximately 3% absorbed.^{1 13}

Onset

Early or mild interstitial cystitis: Pain relief occurs within 6–8 weeks.⁶

Moderate to severe interstitial cystitis: In majority of patients, pain relief occurs in approximately 6 months.^{6 7}

Duration

Pain relief may persist for >29 months (in some patients).⁷

Food

Effect of food on absorption of pentosan polysulfate unknown.^{1 13} In clinical trials, pentosan polysulfate was administered with water 1 hour before or 2 hours after meals.¹

Special Populations

Not known whether bioavailability of parent drug or active metabolites is increased in patients with hepatic impairment or splenic disorders.¹

Distribution

Extent

In animals, distributed into uroepithelium of GU tract, with lower amounts distributed into liver, spleen, lung, skin, periosteum, and bone marrow.¹ Small amounts distributed into RBCs in animals.¹

Not known whether pentosan polysulfate is distributed into milk.¹

Elimination

Metabolism

Following IV administration, 68% of a dose undergoes partial desulfation in liver and spleen; partial depolymerization in kidneys reported.^{1 4}

Elimination Route

Following oral administration, excreted in urine (6.3%; range about 4.8–8%), principally as metabolites, and in feces (84.1%; range about 68–92%) as unabsorbed drug.^{1 4}

Half-life

Following oral administration, 4.8 or 26.5 hours for unchanged drug or unchanged drug and metabolites, respectively.^{1 4}

Stability

Storage

Oral

Capsules

15–30°C.¹

ActionsActions

• 
  

  Semisynthetic low molecular weight heparinoid is a uroprotective agent structurally similar to naturally occurring glycosaminoglycans.^{1 4 5 6 8}

  
  


• 
  

  The main cause of interstitial cystitis appears to be a defective mucous glycosaminoglycans layer of the bladder that may cause increased bladder epithelial permeability.^{6 7 8} Such permeability allows movement of irritating urine solutes into interstitium and causes tissue injury.⁸

  
  


• 
  

  Although the mechanism of action of pentosan polysulfate sodium in the management of interstitial cystitis has not been fully elucidated, the drug appears to replenish the defective mucous (glycosaminoglycans) layer and restore bladder integrity (by adhering to surface of bladder); acts as a buffer to control cell permeability and prevent irritating solutes from reaching epithelial cells.^{1 2 6}

  
  


• 
  

  Weak anticoagulant following oral administration compared with heparin (1/15 activity of heparin); may increase bleeding times.^{1 9 11}

  
  


• 
  

  Given parenterally, inhibits generation of factor X_a.¹¹

  
  


• 
  

  In ex vivo study, inhibits thrombin-induced platelet aggregation.¹

  
  

Advice to Patients

• 
  

  Importance of taking pentosan as prescribed, including not altering frequency of use.^{1 9}

  
  


• 
  

  Importance of taking the drug with water ≥1 hour before or 2 hours after meals.^{1 9}

  
  


• 
  

  Importance of contacting emergency room and/or poison control center immediately if recommended dosage is exceeded.⁹

  
  


• 
  

  Importance of informing patients that the drug is intended for their use only and for the specific condition for which it was prescribed.¹ Do not give this drug to others.^{1 9}

  
  


• 
  

  Importance of informing patients of risk of bleeding.^{1 9}

  
  


• 
  

  Importance of patients undergoing surgery to contact their clinician about discontinuance of therapy.⁹

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{1 9}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., warfarin, heparin) and OTC drugs (e.g., some NSAIAs), as well as any concomitant illnesses (e.g., liver disease, conditions requiring surgery).⁹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pentosan Polysulfate Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	100 mg	Elmiron (with propylene glycol)	Ortho-McNeil

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Elmiron 100MG Capsules (JANSSEN): 90/$405.99 or 270/$1186.03

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Ortho-McNeil. Elmiron (pentosan polysulfate sodium) prescribing information. Raritan, NJ; 2006 Sep.

2. Parsons CL, Benson G, Childs SJ et al. A quantitatively controlled method to study prospectively interstitial cystitis and demonstrate the efficacy of pentosanpolysulfate. J Urol. 1993; 150:845-8. [PubMed 7688432]

3. Food and Drug Administration. List of orphan designations and approvals. Rockville, MD; 2007 Oct 4. From FDA website . Accessed 2008 Jan 31.

4. Simon M, McClanahan RH, Shah JF et al. Metabolism of [³H]pentosan polysulfate sodium (PPS) in healthy human volunteers. Xenobiotica. 2005; 35:775-84. [PubMed 16278190]

5. Modi NB, Kell S, Simon M et al. Pharmacokinetics and pharmacodynamics of warfarin when coadministered with pentosan polysulfate sodium. J Clin Pharmacol. 2005; 45:919-26. [PubMed 16027402]

6. Dell JR, Butrick CW. Multimodal therapy for painful bladder syndrome/interstitial cystitis. J Reprod Med. 2006; 51:253-60. [PubMed 16676920]

7. Hanno PM. Analysis of long-term Elmiron therapy for interstitial cystitis. Urology. 1997; 49 (Suppl 5A):93-9. [PubMed 9146008]

8. Parsons CL. The role of the urinary epithelium in the pathogenesis of interstitial cystitis/prostatitis/urethritis. Urology. 2007; 69 (Suppl 4A):9-16. [PubMed 17462486]

9. Ortho-McNeill. Elmiron (pentosan polysulfate sodium) patient information. Raritan, NJ; 2006 Sep.

10. Rodgers GM. Acquired coagulation disorders. In: Greer JP, Foerster J, Lukens JN et al, eds. Wintrobe’s clinical hematology. 11th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2004:1673-4.

11. Fischer AM, Dautzenberg MD, Aurousseau MH et al. Comparison between the effect of pentosan polysulfate heparin and antithrombin III injections in antithrombin III deficient patients. Thromb Res. 1985; 37:295-307. [PubMed 2579452]

12. Sanofi-Aventis. Lovenox (enoxaparin sodium) injection prescribing information. Bridgewater, NJ; 2007 May.

13. Ortho-McNeil Janssen, Titusville, NJ: Personal communication.

More Elmiron resources

• Elmiron Side Effects (in more detail)
• Elmiron Use in Pregnancy & Breastfeeding
• Drug Images
• Elmiron Drug Interactions
• Elmiron Support Group
• 15 Reviews for Elmiron - Add your own review/rating

• Elmiron Prescribing Information (FDA)


• Elmiron MedFacts Consumer Leaflet (Wolters Kluwer)


• Elmiron Concise Consumer Information (Cerner Multum)


• Elmiron Advanced Consumer (Micromedex) - Includes Dosage Information


• Pentosan Polysulfate Sodium Professional Patient Advice (Wolters Kluwer)

Compare Elmiron with other medications

• Bladder Infection
• Interstitial Cystitis

Lomont 70mg / 5ml Oral Suspension

Lomont 70mg/5ml Oral Suspension

• Read all of this leaflet carefully before you start taking this medicine.


• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or your pharmacist.


• This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

• 1. What is Lomont 70mg/5ml Oral Suspension and what is it used for


• 2. Before you take Lomont 70mg/5ml Oral Suspension


• 3. How to take Lomont 70mg/5ml Oral Suspension


• 4. Possible side effects


• 5. How to store Lomont 70mg/5ml Oral Suspension


• 6. Further information

What is Lomont 70mg/5ml Oral Suspension and what is it used for

The name of your medicine is Lomont 70mg/5ml Oral Suspension. This belongs to a group of medicines called tricyclic antidepressants.

Lofepramine alters the levels of chemicals in your brain to relieve the symptoms of depression.

Lofepramine can be used to treat the symptoms of depression.

Before you take Lomont 70mg/5ml Oral Suspension

Do not take Lomont and tell your doctor if:

• you are allergic (hypersensitive) to lofepramine or any other ingredients in this liquid (see section 6). An allergic reaction can include a rash, itching or shortness of breath


• you are pregnant, likely to become pregnant or breast-feeding


• you have heart problems including unusual heart beats, heart block or if you have recently had a heart attack


• you suffer from periods of increased and exaggerated unusual behaviour (mania)


• you have liver or kidney disease


• you are taking MAOIs, amiodarone or terfenadine (see Section 2)

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking
Lomont.

Take special care with Lomont

Before you take this medicine, tell your doctor if:

• you have epilepsy or you are experiencing withdrawal from alcohol or epileptic drugs


• you have an enlarged prostate gland


• you have increased pressure in your eye (known as narrow-angle glaucoma)


• you have thyroid problems or you are taking medicine to treat a thyroid problem


• you have a mental illness such as manic depression


• you are having electroconvulsive therapy (ECT)


• you have a problem with your blood called porphyria or other blood problems


• you have chronic constipation


• you have tumour of the adrenal gland (phaeochromocytoma or neuroblastoma)


• you have high blood pressure. Your doctor may want to check your blood pressure before starting you on treatment with lofepramine


• you have been told by your doctor that you have low sodium levels.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Lomont.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants. This is because these medicines all take about two weeks but sometimes longer to work properly.

You may be more likely to think like this if:

• you have previously had thoughts about killing or harming yourself.


• you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Having operations and tests

Tell your doctor, anaesthetist or dentist that you are taking lofepramine if you are going to have an anaesthetic for an operation or dental treatment.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines.

Do not take Lomont if you are taking the following medicines:

• medicines to treat depression known as Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine or you have taken MAOIs within the last 14 days


• amiodarone, used to control the way your heart beats


• terfenadine, used to treat allergies.

In particular tell your doctor if you are taking any of the following medicines:

• other medicines used to treat depression including Serotonin Selective Reuptake Inhibitors (SSRIs) such as fluoxetine and fluvoxamine or drugs that control your moods or alprazolam which makes you feel less anxious


• medicines used to treat heart problems such as:
  
  
  • clonidine, calcium channel blockers such as diltiazem or verapamil or other medicines used to treat high blood pressure
  
  
  • digoxin
  
  
  • nitrates used to treat angina
  
  
  • medicines that control the heart beat such as sotalol, disopyramide, procainamide, propafenone and quinidine
  
  



• warfarin used to prevent your blood clotting. Your doctor may want to perform some tests


• diuretics (water tablets).

Also:

• medicines found in cough and cold remedies such as phenylephrine or phenylpropanolamine. Tell your pharmacist that you are taking lofepramine before buying these medicines


• medicines used to treat epilepsy including barbiturates such as phenobarbital


• disulfiram - used to treat patients with alcohol problems


• medicines used to treat Parkinson’s disease


• ritonavir - used to treat HIV


• cimetidine - used to treat stomach acid problems


• medicines to treat thyroid problems


• altretamine used to treat ovarian cancer


• rifampicin used to treat tuberculosis (TB)


• oral contraceptives


• painkillers.

Taking Lomont with food and drink

Do not drink alcohol whilst taking Lomont.

Pregnancy and Breast-feeding

Talk to your doctor before taking this medicine if you are pregnant or planning to become pregnant or breast-feeding. Do not take Lomont during pregnancy.

Babies born to mothers who have taken tricyclic antidepressants may suffer from withdrawal symptoms, difficulty in breathing and agitation.

Driving and using machines

Lomont may make you feel drowsy. If you experience this, do not drive or use machinery. The amount of alcohol in Lomont may also affect your ability to drive or use machines.

Important information about what is in Lomont:

This medicine contains:

• methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine



• liquid maltitol and sorbitol solution (types of sugar). If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine



• ethanol (alcohol). Each 5ml spoonful contains 10%v/v ethanol which is equal to 10ml of beer or 4ml of wine. Speak to your doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, brain injury or disease, you are pregnant or if this medicine has been prescribed for a child.

How to take Lomont 70mg/5ml Oral Suspension

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

Taking this medicine

• this medicine contains 70mg of lofepramine in each 5ml


• take this medicine by mouth


• shake the bottle well before using.

The usual doses are given below. These may be changed by your doctor:

Adults

The usual dose is 70mg (5ml of suspension) two to three times a day.

Older people

Your doctor will start you on a lower dose and gradually increase it as you may be more sensitive to the medicine.

Children

This medicine should not be used in children.

If you take more Lomont than you should

If you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you.

If you forget to take Lomont

• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose


• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Lomont

Do not stop taking the medicine unless your doctor tells you to. If you stop taking the medicine abruptly, you may get withdrawal effects such as feeling irritable, unable to sleep and sweating more than usual.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Lomont can cause side effects although not everybody gets them.

Stop taking Lomont and see a doctor straight away if you have:

• an allergic reaction. Signs may include swelling of your face, lips, tongue or throat or difficulty breathing or swallowing severe itching of your skin with raised lumps


• a serious effect on your blood, such as low sodium levels. Signs may include fever or chills, sore throat, ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises. These may also be signs of other blood disorders. If you notice any of these, tell your doctor straight away.

Serious side effects: tell a doctor straight away

• If you feel more depressed, including thinking about suicide

If you get any of the following side effects, see your doctor as soon as possible:

• Effects on your heart: feeling faint and dizzy when standing up, change in blood pressure, fast or unusual heart beats, heart failure becoming worse



• Effects on your brain and nervous system: feeling confused, feeling agitated, feeling disorientated (not knowing where you are), delusions and hearing or seeing things that are not there (hallucinations), difficulty sleeping, nightmares, feeling slightly hyperactive, numbness or tingling or pins and needles (particularly in the hands and
  feet), difficulty in co-ordinating movements, fits



• Effects on your liver: hepatitis including changes in liver function that would be identified by a blood test, yellowing of the skin and the whites of your eyes (jaundice)



• Effects on your hormones: change in sexual function and sex drive, breast swelling in men and women, production of breast milk, pain in the testicles, increased or decreased blood sugar levels, inappropriate secretion of the hormone ADH (antidiuretic hormone) that may make you pass water (urinate) more frequently.

Tell your doctor if you get any of these side effects:

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Effects on your ears: buzzing or ringing in the ears


• Effects on your stomach and intestines: feeling or being sick, nasty taste in your mouth, dry mouth, constipation


• Effects on the skin: skin rashes, skin rash due to sunlight, swollen face, bleeding from the skin, swelling of the moist areas of the body such as the nose


• Effects on your eyesight: blurred or double vision, changes in eyesight, glaucoma


• General effects: headache, dizziness, tiredness, increased sweating, difficulty passing water, shaking

How to store Lomont 70mg/5ml Oral Suspension

• Keep out of the reach and sight of children


• Store between 4°C and 25°C. Store away from direct light.


• Do not use after the expiry date (month, year) stated on the label and carton


• If it is out of date or you no longer want it, take it back to the pharmacy


• Do not use Lomont 70mg/5ml Oral Suspension if you notice anything wrong with the medicine. Talk to your pharmacist


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.

Further information

What Lomont 70mg/5ml Oral Suspension contains

• The active ingredient is lofepramine hydrochloride


• The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), sodium ascorbate (E301), sorbitol solution 70% non-crystallising (E420), liquid maltitol (E965), ethanol, colloidal silicon dioxide, cherry flavour and purified water.

What Lomont 70mg/5ml Oral Suspension looks like and contents of the pack

A white to pale yellow/orange suspension with a cherry odour.

It comes in a brown glass bottle holding 150ml of suspension.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

This leaflet was last approved in June 2008.

P0408