Lofepramine 70mg Tablets
T00075-01 Malta Zejtun 190x380 PIL
Package Leaflet: Information for the user
Lofepramine 70mg Tablets
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 are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
^ What Lofepramine Tablets are and what they are used for
^ Before you take Lofepramine Tablets ^ How to take Lofepramine Tablets 4| Possible side effects T| How to store Lofepramine Tablets 6| Further information
j What Lofepramine tablets are and what they are used for
Lofepramine belongs to a group of medicines known as antidepressants.
Lofepramine Tablets are used to treat the symptoms of depression. Common symptoms include feelings of worthlessness or deep sadness, difficulty with everyday tasks, sleeping too much or not being able to sleep, and feeling anxious.
^ Before you take Lofepramine tablets
Do not take Lofepramine Tablets if you:
• are allergic (hypersensitive) to lofepramine
• are allergic to any of the other ingredients of Lofepramine Tablets.
• have severe liver and/or kidney problems
• are being treated for heart problems such as an abnormal heart rhythm or heart block
• are recovering from a recent heart attack
• have a mental illness known as "mania"
Take special care with Lofepramine Tablets
Talk to your doctor before taking these tablets if any of the following apply to you:
• if you are elderly
• if you have heart, liver or kidney problems
• if you have been told that you have a rare tumour known as "neuroblastoma" or "phaeochromocytoma"
• if you have a condition called "porphyria"
• if you have ever had epilepsy, fits or convulsions
• if you have any other mental illness
• if you have an overactive thyroid gland
• if you have been told that you have a blood disorder
• if you have increased pressure in the eye (narrow angle glaucoma)
• if you have a history of prostate gland problems
• if you are receiving electroconvulsive therapy for your depression.
If you have any thoughts of suicide or harming yourself whilst taking this medicine, you should contact your doctor immediately (see Section 4 - Possible Side Effects).
Taking other medicines
If taken with some other medicines, the effects of lofepramine or the other medicine may be changed. Please tell your doctor if you are taking any of the following:
• medicines called monoamine oxidase inhibitors (used to treat depression). You should not take lofepramine if you are taking these medicines or you have done so in the last 14 days.
• other antidepressants called serotoin reuptake inhibitors 'SSRIs' (e.g. fluvoxamine, fluoxetine).
• cold remedies, nasal decongestants or other medicines containing adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephedrine or phenylpropanolamine
• medicines which make you feel sleepy or less alert (e.g. sleeping pills, tranquilisers and hypnotics) and alcohol
• medicines to treat thyroid problems
• medicines used to treat high blood pressure (e.g. guanethidine, debrisoquine, clonidine, diuretics, diltiazem, verapamil, sotalol)
• medicines to treat abnormal heart beats (e.g. amiodarone, disopyramide, procainamide, propafenone, quinidine, sotalol, digitalis glycosides)
• medicines to treat epilepsy
• strong painkillers (e.g. nefopam, tramadol, codeine or morphine)
• rifampicin (used for serious bacterial infections such as tuberculosis)
• anti-cholinergics - used to treat Parkinsons disease, irritable bowel syndrome, bladder problems, asthma
• medicines to thin the blood (e.g. warfarin)
• antimalarials (e.g. halofantrine)
• medicines to treat certain mental illnesses (e.g. pimozide, sertindole,clozapine)
• medicines for treating HIV infections (e.g. ritonavir)
• medicines for anxiety (e.g. alprazolam)
• antihistamines (for treating allergies)
• medicines for treating Parkinson's disease (e.g. levodopa, biperiden, entacapone)
• muscle relaxants such as baclofen
• cisapride (for stomach disorders)
• altretamine (for advanced ovarian cancer)
• cimetidine (to treat indigestion or a stomach ulcer)
• certain medicines for angina (e.g. diltiazem, verapamil and "nitrates")
• disulfiram (for treatment of alcohol dependence)
• estrogen (e.g. hormone replacement therapy and oral contraceptives)
Tell your doctor that you are taking Lofepramine tablets if you are going to have an operation. Anaesthetics may react with Lofepramine Tablets.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Lofepramine Tablets with food and drink
Swallow the tablets with a drink of water. You should not drink alcohol whilst taking this medicine.
Pregnancy and breast-feeding
Lofepramine Tablets are not recommended if you are pregnant or breast-feeding.
Driving and using machines
Lofepramine Tablets may cause dizziness or drowsiness especially when you first start taking this medicine. If you suffer from any of these side effects, do not drive or operate machinery
Important information about some of the ingredients of Lofepramine Tablets
This medicine also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine also contains colouring agents sunset yellow FCF (E110) and carmoisine (E122). These may cause allergic reactions.
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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 sure.
Adults: The usual dose for adults is one tablet to be taken 2 or 3 times a day.
Elderly: Elderly patients may be prescribed lower doses.
Children: Lofepramine Tablets are not recommended for children.
Swallow the tablets with a drink of water.
Keep taking your medicine until your doctor tells you to stop.
If you take more Lofepramine Tablets than you should
If you (or someone else) swallow a lot of the tablets together, or if you think your child has swallowed any of the tablets, tell your doctor or go to the nearest hospital casualty department immediately.
If you forget to take Lofepramine Tablets
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.
If you are unsure, speak to your doctor.
If you stop taking Lofepramine Tablets
Do not suddenly stop taking the tablets as this may cause problems such as sleeplessness, agitation and sweating. When you are feeling better, talk to your doctor before stopping Lofepramine Tablets.
• headache
• pins and needles
• generally feeling unwell
• dry mouth
• constipation
• problems with the eyesight
• problems passing water
• sweating
• shakiness or tremor
• nausea (feeling sick)
• vomiting (being sick)
• changes of blood sugar level
• low salt (sodium) in the blood which may cause weakness, confusion or difficulty thinking. Other symptoms might include loss of appetite, nausea, vomiting or headaches,
• enlargement of one or both breasts in men
• production of breast milk in women who are not pregnant or breast-feeding
• pain in testicles
• effects on sexual function
• mental change called hypomania (feeling elated or emotionally "high")
• uncoordinated movement
• changes in sense of taste
• ringing in the ears.
• increased sensitivity to the sunlight.
An increased risk of bone fractures has been observed in patients taking this type of medicines.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
actavis
Actavis, Barnstaple, EX32 8NS, UK
4| Possible side effects
Like all medicines, Lofepramine Tablets can cause side effects, although not everybody gets them.
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 thoughts 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 young adults (less than 25 years old) 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.
If you have any of the following side effects you should tell your doctor immediately:
• An allergic reaction: signs are swelling of the lips, face and tongue, difficulty in breathing, feeling faint, rash or itching (affecting the whole body)
• Unusual bruising or bleeding of the skin, mouth, nose or vagina
• Feeling feverish, unusually tired or generally unwell, or you have a sore throat or sore tongue (you may have a blood disorder)
• Your skin or eyes start turning yellow or you have severe stomach ache (you may have a liver problem or jaundice)
• You have a "fit" (seizure)
The following side effects have also been reported. Tell your doctor if you get any troublesome symptoms that you think are side effects.
• low blood pressure,
• an irregular or fast heartbeat (pulse)
• dizziness
• sleeping difficulties
• drowsiness
• agitation
• confusion
• hallucinations
How to store Lofepramine tablets
Blister packs: Store below 25°C. Store in the original package.
Plastic containers: Store below 25°C. Keep the bottle tightly closed.
Keep out of the sight and reach of children.
Do not use Lofepramine Tablets after the expiry date which is stated on the carton or container after EXP. The expiry date refers to the last day of that month.
Do not use Lofepramine Tablets if you notice any visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6| Further information
What Lofepramine Tablets contains
• The active substance is lofepramine (as lofepramine hydrochloride). Each tablets contains 70mg lofepramine base (as 76.1mg lofepramine hydrochloride)
• The other ingredients are lactose, maize starch, citric acid, hydrogenated vegetable oil, povidone and glycerol. The coating on the tablets contains hypromellose 6cp (E464), carmoisine (E122), indigo carmine aluminium lake (E132), titanium dioxide (E171), sunset yellow FCF aluminium lake (E110), iron oxide red (E172) and macrogol 400.
What Lofepramine Tablets looks like and contents of the pack
Lofepramine Tablets are violet brown film-coated tablets.
Lofepramine Tablets come in blister packs of 28, 30, 56 and 100 tablets and in a plastic container of 250 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.,
Reykjavikurvegi 76-78, 220 HafnarfjorSur,
Iceland
Manufacturer
Actavis Ltd
BLB 016, Bulebel Industrial Estate, Zejtun, ZTN 3000,
Malta
This leaflet was last revised in October 2015.
If you would like a leaflet with larger text, please contact 01271 385257.
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