Lofepramine 70mg Tablets
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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
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. Do not pass it on to others. It may harm them, even if their symptoms
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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.
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. Possible side effects
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, other tricyclic antidepressants such as clomipramine and imipramine or any of the ingredients (see section 6, further information) suffer from any mental illness other than depression 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'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, liver or kidney disorders suffer from blood disorders such as porphyria suffer from an overactive thyroid have a history of epilepsy or recent convulsions (fits) are undergoing alcohol withdrawal suffer from chronic constipation 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
Lofepramine tablets are not suitable for children. Important:
If you need to goto hospital to have an operation, 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
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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.
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 read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if ITieyTreTwofrTed'abourcRahgesTn yourbehavioUrr
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) 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
- warfarin used to prevent blood clotting
- calcium channel blockers such as diltiazem or verapamil or other medicines used to treat high blood pressure
- diuretics (water tablets)
- 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 to cause drowsiness, 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 (El 24), which can cause allergic-type reactions including asthma (the allergy is more common in people who are allergic to aspirin).
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I his medicine contains lactose. It you have been told by /our doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOWTO TAKE LOFEPRAMINE TABLETS
Always-take-Lofepramine-table-ts-exattly-as-yeu-r-doGto^bas-— told you. You should check with your doctor or pharmacist if /ou are not sure.
Swallow the tablets whole with a drink of water.
Make sure you do not run out of your tablets.
Dosage:
Adults:The usual dose is one tablet (70mg) twice daily. Your
doctor may decide to increase this dose to three times daily. Elderly: You may be prescribed a lower dose.
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If you take more Lofepramine tablets than you should
f you take too many tablets, tell your doctor or go to a hospital casualty department straight away.
Take your tablets with you. You may experience drowsiness, estlessness, seizures or heart problems.
If you forget to take Lofepramine tablets
f you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose, then go on as oefore. Never double 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, rritability and excessive perspiration.
f you have any further questions on the use of this product, askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Jke all medicines, Lofepramine tablets can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following side effects:
Skin rash that could be a symptom of an allergic reaction, Worsening of depression; if you have thoughts of harming or killing yourself at any time.(See section 2). Liver problems: an increase in liver enzymes, sometimes progressing to clinical hepatitis and jaundice, (a yellowing of the skin and whites of the eyes).
There have been reports of blood disorders which may be characterised by fever or chills, sore throat, ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding, unexpected bruises or soreness/inflammation of mucosal 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 cold or clammy, confusion and anxiety
interference with heart function such as fast heart rate dizziness, drowsiness, tremor, uncoordinated movements, convulsions (fits), impairment of the sense of taste
disturbed sleep pattern, nightmares, hallucinations agitation, confusion, headache, malaise (feeling of general discomfort or uneasiness) nausea, vomiting and diarrhoea, constipation, dryness of mouth
facial swelling, sweating
increased sensitivity to the effects of the sunlight pins and needles visual disturbances
glaucoma, (raised pressure of the fluid 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 breasts 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. HOWTO STORE LOFEPRAMINE TABLETS
- Keep-outof-the-reach-and- sight of children.---------------
Do not take Lofepramine Tablets after the expiry date which is stated 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
medicines no longer required.These measures will help to 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 El 24, talc, titanium dioxide El 71, Indigotine lake El32
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 blister calendar packs containing 28,56,1008 or 2016 tablets.
• Polypropylene containers containing 56,250, or 1000 tablets.
• Glass bottles containing 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck Serono Ltd,
Bedfont Cross, Stanwell Road, Feltham, Middlesex,
TW14 8NX, United Kingdom.
Manufacturer
Manufactured byTD Packaging Ltd, Unit 6,
Stephenson Road, Groundwell Industrial Estate,
Swindon,Wiltshire, SN25 5AX,UK
This leaflet was last revised in September 2012