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Patient Information Leaflet

Imipramine 10 mg and 25 mg Tablets BP

This medicine will be called Imipramine Tablets in this leaflet.

In this leaflet:

1.    What Imipramine Tablets are and what they are used for

2.    Before you take Imipramine Tablets

3.    How to take Imipramine Tablets

4.    Possible side effects

5.    How to store Imipramine Tablets

6.    Further information

1. What Imipramine Tablets are and what they are used for

These tablets are available in two different strengths containing either 10 mg or 25 mg of the active ingredient, imipramine. Imipramine belongs to a group of medicines called antidepressants.

Imipramine Tablets are used to treat depressive illnesses in adults. They can also be used in children to help treat bed wetting.

2. Before you take Imipramine Tablets

Some people must not take these tablets. Do not take

these tablets if:

•    You know you are allergic to imipramine, or to any other similar antidepressants, or to any of the other ingredients (these are listed in section 6)

•    You have recently had a heart attack, you suffer from heart block or an irregular heartbeat

•    You have periods of mania (feeling elated or over-excited)

•    You have severe liver disease

•    You have glaucoma (increased pressure inside the eye)

•    You have problems passing urine

•    You are pregnant or breastfeeding (unless considered absolutely essential by your doctor)

•    You are taking, or have taken, a monoamine oxidase inhibitor (also used to treat depression) in the last 3 weeks or you are taking a reversible MAO-A inhibitor, such as moclobemide.

Imipramine Tablets should not be taken by children under 6 years of age.

You must be especially careful if:

•    You suffer from epilepsy, have brain damage or are undergoing electro-convulsive therapy (ECT)

•    You suffer from severe kidney disease, acute porphyria, hyperthyroidism (an overactive thyroid gland) or you have a tumour of the adrenal gland

•    You have constipation that has persisted for a long time

•    You suffer from a panic disorder, as anxiety may increase during the first few days of treatment

•    You have ever had glaucoma or problems passing urine

•    You have a mental illness such as schizophrenia

•    You have low or unstable blood pressure

•    You are being weaned off dependency on alcohol and some drugs

•    You wear contact lenses.

If any of the conditions above apply to you, please discuss your

treatment with your doctor before taking this medicine.

Taking other medicines

Imipramine Tablets can affect some other medicines you may be taking.

Make sure your doctor knows if you are taking any of the following:

•    Drugs to control high blood pressure such as betanidine, guanethidine, methyldopa, reserpine and clonidine

•    Propranolol, labetolol, diltiazem and verapamil, used to treat irregular heartbeat, angina or high blood pressure

•    Quinidine for heart problems

•    Sympathomimetic drugs such as adrenaline, noradrenaline, ephedrine, isoprenaline, phenylephrine and phenylpropanolamine. These can be used to treat cold and sinus problems, hay fever or other allergies, and may be present in drugs which you can buy without a prescription

•    Oral contraceptives or other drugs containing oestrogens such as hormone replacement therapy (HRT)

•    Cimetidine, to treat stomach ulcers

•    Methylphenidate (Ritalin), used to treat attention deficit hyperactivity disorder (ADHD) in children

•    Phenytoin or carbamazepine, to treat epilepsy

•    Nicotine. Let your doctor know if you are a heavy smoker or are using nicotine replacement therapy to help you stop smoking

•    CNS depressants such as sleeping tablets, sedatives or tranquillisers

•    Thioridazine or phenothiazines, used to treat psychiatric disorders

•    Alprazolam, to treat anxiety

•    Other drugs to treat depression, including drugs called selective serotonin reuptake inhibitors (SSRIs e.g. fluoxetine or fluvoxamine)

•    Anticoagulants, to prevent blood clotting e.g. warfarin

•    Disulfiram, to treat alcohol dependence

•    Terbinafine, to treat ringworm and some nail infections

•    Drugs to treat thyroid problems

•    Anticholinergic drugs such as biperiden and other drugs for Parkinsonism, antihistamines (for allergies) and atropine to relax intestinal smooth muscle and regulate the heart rate.

Always tell your doctor or pharmacist about all the medicines you are

taking. This means medicines you have bought yourself as well as

those you have on prescription from your doctor.

Other special warnings

•    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 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

•    Your doctor will want to check your blood pressure before you start taking these tablets. He/she might also want to carry out certain tests (e.g. liver, heart or blood tests) while you are taking these tablets

•    If you are going to have a local or general anaesthetic make sure the doctor or dentist knows you are taking imipramine

•    If you are taking this medicine for a long time you must go to the dentist regularly for check-ups as this medicine may cause tooth decay

•    Avoid drinking alcohol while you are taking this medicine.

Driving and using machinery

Imipramine Tablets may make you feel drowsy, dizzy or confused.

They might also affect your eyesight. If you are affected you should

not drive or operate machinery.

Important information about some of the ingredients

•    If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains lactose and sucrose

Continued, please turn over.

•    The tablet colouring contains sunset yellow (E110) which may sometimes cause allergic reactions

•    The 25 mg tablets contain sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).

3. How to take Imipramine Tablets

The tablets should be swallowed with a drink of water.

The doctor will decide what dose of tablets you need to take. Always take the tablets exactly as the doctor has told you. The dose will be on the pharmacist’s label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.

You will be given a low dose to begin with, which will be gradually increased by your doctor. The usual doses are given below.

To treat a depressive illness

Adults: Start on 75 mg a day, in divided doses. This dose will be increased gradually to 150 - 200 mg a day. Once you start to feel better your doctor will gradually reduce the dose. If you are in hospital the doses may be higher than those given above.

Elderly: Patients over 60 years of age will start on 10 mg a day. The dose will be increased gradually to 30 - 50 mg a day, to be taken in divided doses.

To treat bed wetting

Children aged 6 or over: Take 25 - 75 mg a day, at bedtime. The dose depends on the child’s body weight. The doctor will gradually reduce the dose and treatment should not continue for any longer than 3 months.

If you take more tablets than you should

You should contact your doctor or go to your nearest hospital casualty department immediately. Take your tablets or the pack with you so that the doctor knows what you have taken.

If you forget to take a dose of Imipramine Tablets

If you miss a dose don’t worry. Do not take a double dose to make up for the forgotten dose, just carry on with the normal routine.

STOPPING TREATMENT WITH IMIPRAMINE

If the doctor tells you that you no longer need to take the tablets, you should carefully follow his/her advice about how to stop your course of treatment. If you stop taking these tablets suddenly you may get withdrawal symptoms such as stomach pain, diarrhoea, headache, difficulty sleeping, feeling or being sick, nervousness and anxiety. Your doctor may wish to see you more regularly when he starts to reduce your tablets.

4. Possible side effects

Like all medicines Imipramine may sometimes cause side effects, particularly in the elderly. These tablets can affect people in many different ways. Changes in behaviour may occur in children.

Some side effects can be serious. Stop taking Imipramine Tablets and tell your doctor straightaway if you notice the following very rare symptoms:

Rash, feeling faint, difficulty breathing, swelling of the face, lips or tongue, breathlessness, cough and raised temperature. These may be the symptoms of a severe allergic reaction.

The following side effects have also been reported.

More than 1 in 10 people have experienced:

•    Weight gain

•    Shaking

•    Constipation

•    Dry mouth, sweating and hot flushes

•    Problems with eyesight and blurred vision

•    Increased heart rate, dizziness or fainting due to low blood pressure.

Less than 1 in 10 people have experienced:

•    Changes in libido (interest in sex), tiredness, drowsiness, difficulty sleeping, anxiety, hallucinations (seeing or hearing things that are not real), restlessness, confusion, mood changes, over-excitedness, headache, dizziness

•    Palpitations (feeling your heart beating), fast or irregular heartbeat

•    Loss of appetite, feeling or being sick

•    Changes in liver function (usually only detected by blood tests)

•    Skin rash or itching

•    Problems passing urine

•    Numbness or tingling anywhere in the body.

Less than 1 in 1,000 people have experienced:

•    Psychosis (signs of this are personality change, loss of contact with reality, delusions, hallucinations, incoherent speech and agitation)

•    Ringing in the ears

•    Fits.

Less than 1 in 10,000 people have experienced:

•    Blood disorders which can cause fever, tiredness, bruising and sometimes abnormal bleeding or make infections more likely

•    Swelling of, or milk flow from, the breasts

•    Weight loss

•    Difficulty in controlling movements, muscle weakness or stiffness, fever, muscle spasm, difficulty in speaking

•    Raised blood pressure, heart problems

•    Stomach problems, sore mouth or tongue

•    Aggression

•    Changes in blood sugar levels

•    Hepatitis with or without jaundice (yellowing of the skin and whites of the eyes)

•    Oedema (build up of fluid under the skin)

•    Skin sensitivity to sunlight and red spots on the skin, hair loss

•    Increased pressure inside the eye, widening of the pupils

•    Paralytic ileus (symptoms include a swollen abdomen, being sick and difficulty passing a motion).

Other effects which have been reported are:

•    Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma

•    Dark skin patches

•    Enlargement of the testicles

•    Fainting

•    Increased appetite, taste disturbances.

•    An increased risk of bone fractures has been observed in patients taking this type of medicine.

If you notice any unwanted effects, even one not mentioned here, please go and see your doctor.

5. How to store Imipramine Tablets

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed, in order to protect the tablets from moisture.

Do not use the tablets after the expiry date shown on the carton or label.

If your doctor tells you to stop taking the tablets, please take any left over back to your pharmacist to be destroyed.

6. Further Information

Ingredients

Each tablet contains either 10 mg or 25 mg of the active ingredient, imipramine. The other ingredients are lactose, talc, colloidal anhydrous silica, stearic acid, sucrose, titanium dioxide (E171), sunset yellow (E110). In addition the 10 mg tablets contain aluminium hydroxide gel and the 25 mg tablets contain sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), erythrosine (E127), indigo carmine (E132) and maize starch.

What the medicine looks like

The 10 mg tablets are round, orange sugar coated and the 25 mg tablets are round, reddish brown sugar coated.

They are supplied to your pharmacist in packs of 28, 56, 100, 250, 500 or 1000 tablets. Not all pack sizes may be available.

Product licence holder and manufacturer

The product licence holder is Dalkeith Laboratories Ltd.,

2 Park Street, Woburn, Bedfordshire, MK17 9PG, UK.

Manufactured by Surepharm Services Ltd., Bretby, Burton upon Trent, Staffs, DE15 0YZ, UK.

Product Licence Numbers:

PL 17496/0010 PL 17496/0011

Date of revision: May 2010

If you would like the leaflet in a different format, please contact the licence holder at the above address.