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Package Leaflet: Information for the user

Lofepramine 70 mg Tablets

lofepramine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

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

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

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

You might And 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.

Children and adolescents

Lofepramine is not suitable for children and adolescents under 18 years of age.

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What is in this leaflet:

1.    What Lofepramine is and what it is used for

2.    What you need to know before you take Lofepramine

3.    How to take Lofepramine

4.    Possible side effects

5.    How to store Lofepramine

6.    Contents of the pack and other information

1.    What Lofepramine is and what it is used for

Lofepramine belongs to a group of medicines called tricyclic antidepressants.

Lofepramine is used to treat symptoms of depression.

2.    What you need to know before you take Lofepramine

Do not take Lofepramine if you:

•    are allergic to lofepramine or any of the other ingredients of this medicine (listed in section 6)

•    are allergic to other tricyclic antidepressants such as clomipramine and imipramine

•    suffer from any mental illness other than depression (known as mania)

•    have serious liver or kidney problems

•    suffer from any serious heart problems, including irregular heart rhythms or have recently had a heart attack

•    have untreated glaucoma (raised pressure of the fluid inside the eye)

•    suffer from prostate problems with urinary retention

•    suffer from chronic constipation

•    are currently suffering from alcohol or drug poisoning or deliria

•    are taking or have taken any other medicine such as monoamine oxidase inhibitors for your depression within the last 14 days (see "Other medicines and Lofepramine" section).

Warnings and precautions

Talk to your doctor or pharmacist before taking Lofepramine if you:

•    have a history of, or you suffer from any heart, circulation, liver or kidney disorders

•    suffer from blood disorders such as porphyria

•    suffer from an overactive thyroid gland and are taking medicine to treat this condition

•    have a history of epilepsy or recent convulsions (fits)

•    are undergoing alcohol withdrawal

•    suffer from chronic constipation, especially if you are elderly or bed-ridden

•    have suffered from prostate problems

•    have suffered from glaucoma (raised pressure of the fluid inside the eye)

•    have an adrenal tumour for example phaeochromocytoma or neuroblastoma

•    have any other mental illness (including a history of mania)

•    are having electroconvulsive therapy for your depression

•    know that you have high blood pressure (hypertension).

Important:

If you are going to be given a general anaesthetic for an operation or a local anaesthetic for a small operation or dental procedure, tell the anaesthetist or other medical staff that you are taking Lofepramine.

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, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

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

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

Other medicines and Lofepramine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

•    medicines used to treat disturbances of the heart rhythm such as disopyramide, procainamide, propafenone, sotalol, quinidine and amiodarone

•    medicines that may interfere with the electrical conduction of the heart such as certain antibiotics, anti-malarials, anti-histamines (to treat allergies) or neuroleptic drugs (medicines used to treat psychosis)

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

•    medicines used to treat heart problems such as digoxin

•    anti-coagulants such as warfarin used to thin the blood

•    calcium channel blockers such as diltiazem or verapamil or other medicines used to treat high blood pressure

•    diuretics (water tablets)

•    cough and cold remedies or other medicines containing adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine or phenylpropanolamine

•    medicines used to treat epilepsy including barbiturates such as phenobarbital

•    medicines used to treat Parkinson's disease

•    medicines that lower blood potassium levels used to treat high blood pressure (such as guanethidine, betanidine, resperine, clonidine, a-methyl-dopa) or loop diuretics which are mainly used to treat heart failure

•    rifampicin used to treat tuberculosis (TB)

•    cimetidine used to treat stomach acid problems or indigestion

•    disulfiram used in the treatment of alcohol problems

•    nitrates used to treat angina

•    ritonavir used to treat HIV

•    medicines to treat thyroid problems

•    oral contraceptives

•    medicines which make you feel sleepy or less alert (such as sleeping pills, tranquilisers and hypnotics); alcohol and general anaesthetics (such as atropine)

•    painkillers

•    other anti-cholinergics used to treat Parkinson's disease, irritable bowel syndrome, bladder problems and asthma.

Lofepramine with alcohol

Do not drink alcohol whilst taking this medicine as it may affect you more than usual.

Pregnancy and breast-feeding

Lofepramine is not recommended if you are pregnant or breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Lofepramine is known to cause drowsiness, dizziness and visual problems especially at the start of treatment. If you suffer from these side effects, do not drive or operate machinery.

Lofepramine contains lactose and Ponceau 4R Red (E124)

Lofepramine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine also contains Ponceau 4R Red (E124), a colouring agent. This may cause allergic reactions.

3. How to take Lofepramine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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