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Lofepramine 70mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lofepramine 70mg Film Coated Tablets

lofepramine hydrochloride

The name of your medicine is Lofepramine 70mg Film Coated Tablets, which will be referred to as Lofepramine Tablets throughout this leaflet.

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

• Keepthisleaflet. Youmayrreedtoreadit

• Ifyou have anyfurtherquestions,askyour doctor or pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,even iftheirsymptomsarethe same

• Ifany ofthe side effects gets serious, or if you noticeany side effects not listed in this leaflet, please tell your doctoror pharmacist.

In this leaflet:

1. What Lofepramine tablets are and what they are used for

2. Before you take Lofepramine tablets

3. How to take Lofepramine tablets

4. Possiblesideeffects

5. How to store Lofepramine tablets

6. Further information

1. WHAT LOFEPRAMINE TABLETS ARE AND WHAT THEY ARE USED FOR

Lofepramine belongs to a group of medicines called tricyclic antidepressants.

Lofepramine is used to treat symptoms of depression.

2. BEFORE YOU TAKE LOFEPRAMINE TABLETS

Do not take Lofepramine tablets and tell your doctor if you

• are allergic to lofepramine, othertricyclic antidepressants such as clomipramine and imipramine or any of the ingredients (see section 6, further information)

• sufferfiomany mental illness other than

• have serious liver or kidney problems

• sufferfiomany serious heart problems,

including irregular heart rhythms or have recently had a heart attack

• have untreated glaucoma (raised pressure ofthefluid insidetheeye)

• sufferfrom prostate problemswith urinary retention

• sufferfrom chronic constipation

• are currently suffering from alcohol ordrug 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 'Taking any other medicines' section)

Take special care with Lofepramine tablets

Tell your doctor if you:

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

• sufferfrom blooddisoiders such as porphyria

• sufferfrom an overactive thyroid

• have a history ofepilepsy or recent convulsions (fits)

• are undergoing alcohol withdrawal

• sufferfrom chronic constipation

• have suffered from prostate problems

• have suffered from glaucoma (raised pressure ofthefluid insidetheeye)

• haveanadrenal tumourforexample phaeochromocytoma or neuroblastoma

Lofepramine tablets are not suitable for children.

Important:

If you need to go to hospital to have an operation, tell the anaesthetist orother medical staffthatyou aretaking 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.

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

Bone fractures: An increased risk of bone fractures has been observed in patients taking these types of medicines.

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

Taking any other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take Lofepramine if you are taking:

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

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

- medicines used to treat disturbances of 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 or neuroleptic drugs

- other medicines used to treat depression including Serotonin Selective Reuptake Inhibitors (SSRIs) suchasfluoxetine and fluvoxamine and othertricyclic 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

- warfarin used to prevent blood clotting

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

- diuretics (watertablets)

- medicines found in cough and cold remedies such as 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 such as diuretics for e.g. loop diuretics which are commonly used to treat high blood pressure or thiazide diuretics which are mainly used to treat heart failure.

- rifampicin used to treat tuberculosis (TB)

- cimetidine - used to treat stomach acid problems

- 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

- painkillers.

Taking Lofepramine tablets with alcohol

While you are taking this medicine avoid drinking alcohol because it may affect you more than usual.

Pregnancy and breast-feeding:

Do not take Lofepramine tablets if you are pregnant, think you might be pregnant, are planning to become pregnant or are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

Lofepramine is known tocausedrowsiness, dizziness and visual problems. Do not drive or operate machinery until you know how it will affect you.

Important information about some of the ingredients of Lofepramine tablets:

Lofepramine tablets also contain Ponceau 4R (E124),whichcancause allergic-type reactions including asthma (the allergy is more common in people who are allergic to aspirin).

This medicine 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.

3. HOW TO TAKE LOFEPRAMINE TABLETS Always take Lofepramine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not

Swallow the tablets whole with a drink of water. Make sure you do not run out of your tablets.

Adults: The usualdoseisonetablet (70mg) twice daily. Your doctor may decide to increase this dose to three times daily.

Elderly: You may be prescribed a lower dose.

Children: Not recommended.

El

If you take more Lofepramine tablets than you should

Ifyoutake too manytablets, tell yourdoctoror go to a hospital casualty department straight away.

Take your tablets with you. You may experience

drowsiness, restlessness, seizures or heart problems.

If you forget to take Lofepramine tablets

Ifyou forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose,thengoon as before. Neverdouble up on the next dose to make up for the one missed.

If you stop taking Lofepramine tablets

Do not stop taking your tablets without talking to your doctor first. It may be necessary to stop taking your medicine gradually.

Stopping treatment suddenly may cause insomnia, irritability and excessive perspiration. Ifyou have any further questions on the use of this product, ask yourdoctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lofepramine tablets can cause side effects, although not everybody gets

Contact your doctor immediately if you experience any of the following side effects:

• Skin rashthat could bea symptomofan allergic reaction,

• Worseningofdepression;ifyou have thoughts of harming or killing yourself at any time.(See section 2).

• Liverproblems:an increase in liverenzymes, sometimes progressing to clinical hepatitis andjaundice, (ayellowingofthe skin and whites ofthe eyes).

• There have been reports ofblood disorders which may be characterised by fever or chills, sore throat, ulcers in your mouth or throat, unusual tirednessorweakness, unusual bleeding, unexpected bruisesor soreness/inflammation ofmucosal membranes.

Tell your doctor immediately if you notice any of the following symptoms.

Do not be alarmed, most people take Lofepramine without any problems.

• low blood pressure which may be characterized by dizziness, fainting, nausea, feeling coldor clammy, confusion and anxiety

• interference with heart function such as fast heart rate

• dizziness, drowsiness, tremor, uncoordinated movements,convulsions (fits), impairmentofthe sense oftaste

• disturbed sleep pattern, nightmares, hallucinations

• agitation, confusion, headache, malaise (feeling ofgeneral discomfort or uneasiness)

• nausea, vomiting and diarrhoea, constipation, dryness ofmouth

• facial swelling, sweating

• increased sensitivitytotheeffectsofthe sunlight

• pinsandneedles

• visual disturbances

• glaucoma, (raised pressure ofthefluid inside

the eye)

• difficulty in urinating

• interference with sexual function, discomfort or pain in the testicles, enlargement or tenderness of the breast tissue in men, secretion of milk from the

• mood swings

• tinnitus (where sounds are heard in the ear for no apparent reason)

• low blood sodium levels and changes in blood sugar level.

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

5. HOW TO STORE LOFEPRAMINE TABLETS

Keep out of the reach and sight of children.

Do not take Lofepramine Tablets after the expirydatewhich isstated on the label, carton and bottle after 'EXP'. The expiry date refers to the last day of that month.

Store in the original pack.

Store in a dry place. Protect from light.

Do not use Lofepramine Tablets if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longerrequired.These measureswill helpto protect the environment.

6. FURTHER INFORMATION What Lofepramine Tablets contain

The active substance is Lofepramine Hydrochloride, equivalent to 70mg Lofepramine.

The other ingredients are:

Excipients: Lactose, corn starch, L (+) ascorbic acid, talcum, glycerol, glycerol monostearate, ethylene dinitriletetra acetic acid disodium salt (dihydrate) [titriplex III], dimethicone, silicone dioxide, hydroxypropyl methyl cellulose. Coating: 1,2-Propanediol, hydroxypropyl methyl cellulose, ponceau 4R, aluminium lake E124, talc,titaniumdioxide E171, Indigotine lake E132

What Lofepramine Tablets look like and contents of the pack

Lofepramine tablets are violet brown, round film coated tablets, convex on both sides and with a dividing score on one side only.

They are packed in:

• Foil blistercalendarpackscontaining 28, 56, 1008 or 2016 tablets.

• Polypropylene containers containing 56, 250,or1000tablets.

• Glass bottles containing 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Creo Pharma Ltd Felsted Business Centre Felsted

Essex CM6 3LY