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Imipramine 25mg Tablets

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Imipramine 25mg Tablets


PACKAGE LEAFLET: INFORMATION FOR THE USER


Read all ofthis 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, please ask your doctor or pharmacist or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    WhatlmipramineTabletsareand what they are used for

2.    What you need to know before you take Imipramine Tablets

3.    How to take Imipramine Tablets

4.    Possible side effects

5.    How to store Imipramine Tablets

6.    Contents of the pack and other information

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

Imipramine belongs to a class of antidepressant drugs known as the tricyclics. Imipramine is used to treat depression. It can also be used to treat bed-wetting in children.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMIPRAMINE TABLETS

Do not take Imipramine Tablets

•    If you have previously suffered an allergic reaction to a medicine containing Imipramine orother antidepressant medicines.

•    If you think you are allergic to any of the other ingredients.

•    If you are recovering from a heart attack or have suffered from heart problems including abnormal heart rhythm (abnormal heart beat).

•    If you have had severe liver disease.

•    If you are or have recently taken (within 14 days) any other medicines for depression, particularly monoamine oxidase inhibitors (MAOIs). See: Other medicines and Imipramine Tablets

•    If you suffer from any mental illness such as manic-depression or obsessions.

•    If the patient is a child under 6 years old.

•    If you suffer from glaucoma (increased eye pressure).

•    If you have difficulty passing water.

•    If you have had a heart attack within the past three months.

•    If you suffer with porphyria (a genetic disorder of the red blood cells haemoglobin causing skin blisters, abdominal pain and brain/nervous system disorders).

Warnings and precautions Thoughts ofsuicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts ofharming or killing yourself. These may be increased when 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 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.

Talk to your doctor or pharmacist or nurse before taking Imipramine Tablets:

•    If you have a history of epilepsy or suffered recently from convulsions (fits).

•    If you are taking medicines to treat a thyroid disorder

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•    If you have a tumour of the adrenal gland (e.g phaeochromocytoma or neuroblastoma)

•    If you suffer from constipation.

•    If you have low blood pressure or problems with yourcirculation.

•    If you are due to undergo surgery or receive anaesthetics (even at the dentist) or have electroconvulsive therapy (ECT).

•    If you wear contact lens as Imipramine may decrease tear production in eyes.

•    If you have had severe kidney problems.

•    If you are elderly as the doctor may need to do more check ups.

•    As these tablets may cause a dry mouth and increase tooth decay, therefore ensure regular dental checkups.

During the treatment with Imipramine, your doctor may wish to carry out a number of tests (heart, blood and liver tests). This is quite usual and nothing to be concerned about.

Other medicines and Imipramine Tablets:

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

•    Monoamine oxidase inhibitors (MAOIs) and other medicines use to treat depression e.g clozopine, pimozide.

•    Medicines used to lower blood pressure e.g guanethidine, debrisoquine, bethanidine, methyldopa , clonidine ordiuretics ("watertablets").

•    Barbiturates used to depress the central nervous system by acting as a sedative (e.g Phenobarbital).

•    Bronchodilators which are used to help your breathing.

•    Thyroid hormone therapy.

•    Medicines used to treat Parkinson's disease e.g Apomorphine, Levodopa, entacapone orselegiline.

•    Disulfiram used to treat alcoholism.

•    Cimetidine used to treat stomach ulcers.

•    Sympathomimetic medicines such as adrenaline, ephedrine, isoprenaline, noradreanline, phenylphrine and phenylpropanolamine. These may be present in many medicines for colds and nasal stuffiness. Tell your pharmacist that you are taking Imipramine before buying these products.

•    Medicines used for heart disease e.g Quinidine.

•    Medicines used to thin the blood (anticoagulants e.g warfarin).

•    Oral contraceptives or oestrogens used for hormone replacement.

•    Methylphenidate, a drug used in the treatment of childhood behavioural disorders.

•    Beta blockers, used to treat angina, heart failure and high blood pressure.

•    Apraclonidine and brimonidine (to treat glaucoma).

•    Ritonavir (to treat HIV).

•    Medicines to treat some heart conditions such as diltiazem and verapamil.

•    Nitrates used to treat angina.

•    Appetite suppressants.

•    Painkillers such as nefopam, tramadol, codeine, dihydrocodeine.

•    Baclofen (a muscle relaxant).

Taking Imipramine Tablets with food, drink and alcohol:

Imipramine should not be taken with alcohol as it will increase the sedative effects of this medicine and therefore should be avoided. It is not necessary to take these tablets with food. These tablets are taken with a glass ofwater.

Pregnancy and Breastfeeding:

Imipramine Tablets should not be taken during pregnancy or if breast-feeding.

If Imipramine tablets are taken in the last 3 months the baby may be born with breathing difficulties, lethargy, colic, irritability, changes in blood pressure, tremors, spasm. Imipramine tablets should be withdrawn at least 7 weeks before the expected delivery date.

Driving and using machines:

If you feel dizzy or drowsy when you start taking this medicine do not operate machinery until these effects were off.

Imipramine Tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    HOW TO TAKE IMIPRAMINE TABLETS

Always take imipramine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

Adults (Fordepression): Initially (one tablet) one to three times daily. If necessary, your doctor may increase this dose gradually up to 200mg per day. Elderly (Fordepression): Lowerdoses may be used. Initially 10mg daily, increasing gradually to 30-50mg daily in divided doses.

Children: (for bed-wetting only)

6-7 years (body weight 20-25kg): 25mg. 8-11 years (body weight 25-35kg): 2550mg.

Over 11 years (body weight 35-54kg): 5075mg.

•    Do not give to children under 6 years of age.

•    Give your child the dose just before bedtime.

•    The duration of treatment should not be longer than three months.

Ifyou take more Imipramine Tablets than you should:

If you swallow too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital. Symptoms of an overdose include hypothermia (very low body temperature which may show as shivering, feeling cold, low energy and cold pale skin), irregular heartbeat, wide pupils, convulsions (fits), stupor (decreased mental alertness and consciousness) or coma.

If you forget to take a dose:

Try to take Imipramine Tablets daily as prescribed. If you forget to take a dose, take the next dose at the usual time. Do not take two doses together.

Ifyou stop taking Imipramine Tablets:

Do not stop taking this medicine suddenly, unless your doctor tells you to, as this may lead to unwanted effects such as feeling sick, being sick, stomach pain, sleeping problems, irritability and sweating.

If you have any further questions on the use of tablets ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are more likely in elderly patients.

If you develop any allergic symptoms, stop taking the tablets and contact the doctor immediately, an allergic reaction may show as a puffy, swollen face, tongue and body which may cause shortness of breath, swelling, shock and collapse. A skin rash and photosensitivity may occur.

If you experience any of the following side effects then contact your doctor IMMEDIATELY.

Very rare (Less than 1 in 10,000 patients)

•    Aggressiveness.

•    Changes in electrocardiogram (ECG) measured by the doctor, rapid and uncontrollable muscle spasms orjerks, muscle weakness, clumsiness and imbalance, speech problems.

•    Dilation of the pupil of the eye, glaucoma (increased pressure in the eye).

•    Tongue and throat ulcers, abdominal disorders, excess fluid retention.

•    Photosensitivity usually causing a rash on skin exposed to sunlight, itching or rash.

•    Hair loss.

•    Inflammation of the lungs causing coughing.

•    Unusual tiredness or weakness.

•    Unusual bleeding or unexplained bruises.

Rare (Between 1 in 1000 and 1 in 10,000 patients)

•    Epileptic fits or convulsions.

If any of the following side effects are severe or last more than a few days, tell your doctor.

Occasional (Between 1in10 and 1 in 100 patients)

•    Fatigue, drowsiness, confusion or dizziness.

•    Dizziness or fainting when you stand up.

•    Headache.

•    Palpitations or unusually rapid heartbeat.

•    Disturbances in passing water.

•    Fever and vomiting.

•    Weight loss.

•    Development of a skin rash or itching.

Frequent (Between 1in10 and 1 in 100 patients)

•    Dry mouth.

•    Blurred vision.


•    Constipation.

•    Hotflushes.

•    Difficulty in passing water.

•    Weightgain.

Other side effects may occur and include:-Effects on the hormone system and metabolism:

Disturbances in sexual function and sex drive, breast swelling in men and women, production of breast milk, increased or decreased sugar levels, low sodium contentofthe blood, inappropriate secretions of the hormone ADH (antidiuretic hormone) which may make you urinate more frequently.

Effects of the brain and central nervous system:

Tiredness or sleepnessness, weakness, difficulty in concentrating, confusion, nightmares, slight hyperactivity, exaggerated behaviour, delusions and hearing, seeing and feeling things that are not there anxiety excitement disorientation, pins and needles lack of co-ordination, tremor, epileptic fits, sweating.

Effects on the ears: Buzzing or ringing in the ears

Effects on the heart: Feeling faint when getting up (posteral hypotension), increased blood pressure, heart attack, irregular or slow heart beats or very low blood pressure.

Effects on the liver: yellowing of the eyes or skin indicating a problem with the liver which may be checked by a blood test.

Effects on the blood: Reduction in some blood cells (you may experience a sore throat, mouth ulcers and recurring infections, bleeding or bruising easily).

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.

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.

5. HOW TO STORE IMIPRAMINE TABLETS


Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original package, in order to protect from light.

Do not use after the expiry date stated on the foil or carton.

Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION


What Imipramine Tablets contain.

The active ingredient is imipramine hydrochloride. Each tablet contains 25mg of imipramine hydrochloride.

The other ingredients are lactose monohydrate, maize starch, povidone, magnesium stearate and stearic acid. The tablet coating is made up of hypromellose, lactose monohydrate, macrogol 4000, macrogol 400, talc, iron oxide red (E172) and titanium dioxide (E171).

What Imipramine Tablets look like

Imipramine Tablets are red brown, circular film coated tablets. These tablets are available in blister packs on 28 tablets.


Marketing Authorisation Holder and Manufacturer

Relonchem Limited,

27 Old Gloucester Street London, WC1 3XX


PL 20395/0018


This leaflet was last revised 11/2014.


POM