PATIENT INFORMATION LEAFLET

Imipramine Tablets 10mg and 25mg

• Please read this leaflet carefully before you start to take your medicine.
• It gives you important information about your medicine.
• If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.
• Keep the leaflet until you have finished the medicine.

WHAT'S IN YOUR MEDICINE

Imipramine Tablets BP are red (10mg) or tan (25mg) circular, sugar coated tablets which come in two strengths. Each tablet contains either 10mg or 25mg of the active ingredient imipramine hydrochloride.

The tablets also contain: beeswax, colloidal silica, dimethicone, gelatin, lactose, magnesium stearate, maize starch, polyvidone, shellac, stearic acid, sucrose, E170, E171, E172, E211, E322, E414, E460, E553. The 10mg tablets also contain E110, E123 and E127. The 25mg tablets also contain sodium hydroxide, E216 and E218.

Imipramine Tablets BP are available in a pack size of 28.

Imipramine is one of a group of medicines called tricyclic antidepressant drugs. These medicines alter the levels of chemicals in the brain to relieve the symptoms of depression.

ABOUT YOUR MEDICINE

The name of your medicine is Imipramine Tablets BP which is the generic (common) name. Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.

Imipramine may be used:

• to treat the symptoms of depression.
• for the relief of bedwetting at night by children.

BEFORE TAKING YOUR MEDICINE

Do not take Imipramine Tablets BP if

• you are pregnant, plan to become pregnant or are breast feeding.
• you are sensitive to imipramine, any of the ingredients in the product or other tricyclic antidepressants, eg amitriptyline, lofepramine.
• you have heart disease including irregular heart beats, heart block or have had a recent heart attack.
• you have liver disease.
• you have the metabolic disease porphyria.
• you have narrow angle glaucoma (increased pressure in the eye).
• you are not able to pass water or have been told you have an enlarged prostate gland.
• you have any psychiatric disorder or suffer from periods of increased and exaggerated behaviour (mania).
• you are or have been taking other medicines to treat depression, such as mono amine oxidase inhibitors (MAOIs) within the last three weeks eg moclobemide.

This medicine should not be used by children under 6 years old.

Make sure you have told your doctor or pharmacist if your child or you:

• have a history of epilepsy or brain damage, are taking medicines to treat epilepsy (eg barbiturates, phenytoin, carbamazepine) or are withdrawing from medicines used to treat fits.
• are taking a class of medicines called "benzodiazepines" (eg alprazolam, diazepam, nitrazepam, oxazepam).
• are or have been taking other medicines to treat depression, such as selective serotonin reuptake inhibitors (SSRIs) eg citalopram, fluoxetine, fluvoxamine, paroxetine or sertraline.
• are taking alprazolam or disulfiram to treat alcohol addiction.
• are being given electroconvulsive therapy (ECT).
• have kidney disease.
• have a tumour of the adrenal gland (eg phaeochromocytoma or neuroblastoma).
• suffer from panic attacks.
• have a diseased thyroid gland or are taking medicines to treat a thyroid disorder.
• suffer from low blood pressure or have not had your blood pressure checked recently.
• suffer from constant constipation.
• need an operation. Tell your doctor or dentist you are taking imipramine.
• wear contact lenses.
• are a heavy smoker or are taking nicotine replacement therapy.
• are taking other medicines such as cimetidine (used to treat stomach ulcers), methylphenidate (used to treat attention deficit/hyperactivity disorder (ADHD)), any medicines to treat high blood pressure (eg guanethidine, debrisoquine, bethanidine, clonidine, methyldopa or reserpine), medicines to treat psychiatric disorders (eg chlorpromazine, thioridazine), sympathomimetic medicines (such as adrenaline (epinephrine), ephedrine, isoprenaline, noradrenaline (norepinephrine), phenylephrine, phenylpropanolamine and quinidine-type antiarrhythmic agents and may be used in cough and cold remedies or medicines to treat irregular heart beats), medicines to control glaucoma (eg apraclonidine or brimonidine), medicines to stop your blood clotting ("anticoagulants", eg warfarin), medicines used in Parkinson’s disease (eg biperiden, entacapone or selegiline), medicines to treat nausea and vertigo (eg chlorpromazine, prochlorperazine), antihistamines (medicines to treat allergies), oral contraceptives (the "pill") or hormone replacement therapy (HRT), ritonavir (used to treat HIV (human immunodeficiency virus), calcium channel blockers (eg diltiazem, verapamil), beta blockers (eg labetalol, propranolol), diuretics ("water" tablets, eg amiloride, bendroflumethiazide, furosemide), medicines to treat angina that you spray or dissolve under your tongue (eg glyceryl trinitrate "GTN", isosorbide dinitrate), sibutramine (used to suppress appetite), altretamine (used to treat some types of cancers), pain killers (eg nefopam, tramadol, codeine, dihydrocodeine, dextropropoxyphene), baclofen (used to treat severe muscle spasms and spasticity).
• are taking any other tablets or medicines that you may have bought without a prescription.

You are advised NOT to drink alcohol with this medicine.

As Imipramine may impair your alertness, make you feel sleepy or give you blurred vision, make sure you are not affected before you drive or operate machinery.

If you see another doctor or go into hospital, let them know what medicines you are taking.

TAKING YOUR MEDICINE

Your doctor has decided the dose which is best for you. Always follow your doctor's instructions exactly, and those on the pharmacy label. If you do not understand anything, ask your doctor or pharmacist.

 

The maximum dosage in children should not be more than 75mg and imipramine should not be given for more than 3 months.

These tablets should be taken as instructed swallowed with a glass of water. Continue to take them for as long as your doctor tells you to, it may be dangerous to stop without their advice.

If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. NEVER take two doses at the same time.

If you are elderly, it is particularly important to take this medicine exactly as directed by the doctor.

If you accidentally take more than your prescribed dose, contact your nearest hospital casualty department, or tell your doctor, immediately. Take any remaining tablets and the container with you.

AFTER TAKING YOUR MEDICINE

Like many medicines, Imipramine Tablets BP may occasionally cause side-effects in some patients, particularly when you first start taking it. Elderly patients may be more susceptible to undesirable effects affecting the heart, nervous system, brain and anticholinergic effects. Undesirable effects may include:

• Allergic effects: isolated cases of pneumonitis (fever, chills, cough, difficulty with breathing, unusual weight loss, feeling sick) have been reported. A puffy, swollen face, tongue or body has been reported. These reactions may be severe causing shortness of breath, swelling, shock and collapse. If you develop any allergic symptoms, stop taking the medicine and contact your doctor immediately.
• Effects on the blood: isolated changes in blood cells. If you notice that you are bruising more frequently or have more nosebleeds or infections you should consult your doctor.
• Effects on the endocrine system and metabolism: weight gain has been reported frequently. Disturbances in sexual function have been reported occasionally. Isolated cases of enlarged mammary glands, production or over-production of breast milk, increased or decreased blood sugar levels and weight loss have been reported. Low levels of salts in the blood have been reported, usually in elderly patients, which can be identified by a blood test.
• Effects on the brain and central nervous system: tremor has been reported frequently. Headache, confusion, dizziness (especially on standing), numbness/tingling or pins and needles, agitation, anxiety, tiredness, drowsiness, disturbed sleep, restlessness, mood swings, exaggerated behaviour and delusions and hearing, seeing or feeling things that are not there have been reported occasionally and are more common in the elderly or in patients on high doses. Aggressiveness, weakness, lack of co-ordination, sudden muscle spasms, difficulty speaking have been reported in isolated cases. Epileptic-type fits have been reported rarely.
• This medicine can cause a particular group of side effects known as "Anticholinergic effects". These may include: dry mouth, constipation, blurred or double vision and sweating (frequently reported). Difficulty passing water (urine) has been occasionally reported. Dilation of the pupil of the eye, glaucoma and blockage of the small intestine have been reported in isolated cases.
• Effects on the ears: ringing or buzzing in the ears have been reported.
• Effects on the heart: fast/racing heart and very low blood pressure have been reported frequently. Irregular heart-beats or palpitations have been reported occasionally. Increased blood pressure has been reported in isolated cases.
• Effects on the stomach and intestines: feeling or being sick and loss of appetite have been reported occasionally. Isolated cases of tongue lesions and inflammation of the mucus membranes in the mouth have been reported.
• Effects on the liver: changes in liver function have been reported occasionally. This would be identified by a blood test. Hepatitis and jaundice (yellowing of the skin and/or whites of the eyes) have been reported in isolated cases.
• Effects on the skin: allergic reactions, such as an itchy skin rash, have been reported occasionally. Isolated cases of swelling, sensitivity to the sun or sun lamps, hair loss, small purple red spots and itching have been reported.

You should consult your doctor if these are troublesome or continue.

If your medicine is stopped too quickly you may suffer from feeling or being sick, stomach pains, diarrhoea, headache, sleeplessness, nervousness, anxiety, irritability and increased sweating. Always follow your doctor’s instructions on how you or your child should stop taking this medicine.

If you get any other unusual effects, tell your doctor immediately and seek advice.

STORING YOUR MEDICINE

Do not use the tablets after the expiry date shown on the product packaging. Keep the tablets in a dry place below 25°C, and in the original packaging. KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.