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