Imipramine Tablets Bp 10mg
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IMIPRAMINE Tablets lOmg & 25mg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 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 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
Imipramine belongs to a group of drugs known as tricyclic antidepressants. This medicine is used for the treatment of depression in adults and for the treatment of enuresis (bedwetting) in children.
2. Before you take Imipramine Tablets
Do not take these tablets if you:
• are allergic to imipramine, any other tricyclic antidepressants or to any of the ingredients in the tablets (see section 6)
• are currently taking medicines known as monoamine oxidase inhibitors (MAOIs) such as phenelzine, tranylcypromine or moclobemide. Imipramine should not be started until at least 3 weeks after treatment with MAOIs has stopped
• have any form of heart disease or are recovering after a heart attack
• have liver disease, porphyria, glaucoma (raised pressure in the eye) or difficulty in urinating.
Check with your doctor before taking these tablets if you:
• are pregnant, think you may be pregnant or are breast feeding
• have epilepsy
• have diabetes or an overactive thyroid
• have prostate problems
• have manic depression, schizophrenia or any other psychiatric disorder
• have a tumour of the adrenal medulla e.g. phaeochromocytoma
• have low blood pressure or poor circulation
• have kidney disease
• have long term constipation
• have brain damage
• are undergoing alcohol or drug withdrawal
• suffer from panic attacks
• wear contact lenses
• are bedridden.
Taking other medicines
Check with your doctor or pharmacist before taking these tablets if you are taking any other medicines, including any that you can buy without a prescription. This is particularly important if you are taking:
• medicines to treat high blood pressure e.g. guanethidine, debrisoquine, reserpine, clonidine, methyldopa, diuretics (water tablets) or bethanidine
• medicines to treat some heart conditions such as diltiazem, verapamil, labetalol, propranolol, quinidine
• medicines to treat angina that you spray or dissolve under your tongue (e.g. glyceryl trinitrate “GTN”, isosorbide dinitrate)
• medicines called “benzodiazepines” such as diazepam, nitrazepam, oxazepam, alprazolam
• methylphenidate (used to treat attention deficit/hyperactivity disorder (ADHD))
• biperiden, entacapone or selegiline (to treat Parkinson’s disease)
• appetite suppressants
• altretamine (to treat some types of cancer)
• other medicines to treat depression, such as selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine
• medicines to stop your blood clotting (e.g. warfarin)
• painkillers such as nefopam, tramadol, codeine, dihydrocodeine
• medicines to treat some mental illnesses such as thioridazine, chlorpromazine, phenothiazine; and tranquillisers, sedatives or sleeping drugs
• barbiturates e.g. phenobarbital or other medicines used for epilepsy such as phenytoin and carbamazepine
• antihistamines (medicines to treat allergies)
• apraclonidine and brimonidine (to treat glaucoma)
• sympathomimetic medicines such as adrenaline, noradrenaline, isoprenaline, ephedrine, phenylephrine, phenylpropanolamine (some of which may be present in cough and cold medicines)
• steroid hormones e.g. hydrocortisone, prednisone
• oral contraceptives (birth control tablets) or hormone replacement therapy (HRT)
• medicines to treat thyroid problems e.g. carbimazole or thyroxine
• disulfiram (to treat alcohol addiction)
• baclofen (a muscle relaxant)
• atropine (as eye drops or as used for emergency treatment)
• nicotine replacement therapy
• cimetidine (to treat stomach ulcers).
This medicine may interact with anaesthetics. Therefore, it is important to tell the doctor or dentist in charge that you are taking this medicine before you have any kind of surgery.
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.
• 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.
Check-ups:
If you are taking this medicine for a long time, it is important that your doctor checks your progress at regular intervals to allow for dosage adjustments and to help reduce side effects. Your doctor may also check your blood pressure before starting treatment and may take regular blood samples during treatment to check your liver function and blood cells. It is also important to have regular dental check-ups.
Alcohol
Avoid drinking alcohol when you are taking these tablets. Alcohol will increase the drowsiness produced by this medicine. Driving and using machinery This medicine may cause drowsiness, dizziness and blurred vision. Do not drive or operate machinery if this medicine has this effect on you.
Pregnancy and breast-feeding
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.
Important information about some of the ingredients of ImipramineTablets.
Contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Also contains tartrazine (E102) and the 25 mg tablets also contain amaranth (E123) which may cause allergic reactions.
3. How to take Imipramine Tablets
The tablets should be swallowed with a drink of water.
Your doctor will decide the dose that is best for you. The pharmacist’s label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.
Usual dose for depression:
Adults: Initially 75 mg daily in divided doses, increasing gradually to 150-200 mg daily. In severe cases treated in hospital, the dose may be up to a maximum of 100 mg three times a day. For maintenance, the dose is reduced to 50-100 mg daily.
Elderly: Initially 10 mg daily increasing gradually to 30-50 mg daily.
Children: Not recommended.
Usual dose for night-time bedwetting in children:
To be taken just before bedtime.
Over 11 years: 50-75 mg.
8-11 years: 25-50 mg.
6-7 years: 25 mg.
Under 6 years: Not recommended.
In children a daily dose of 2.5 mg/kg bodyweight should not be exceeded, nor should it exceed 75 mg daily. Treatment should not continue for longer than 3 months (including gradual withdrawal).
If you have taken too many tablets:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
If you forget to take a dose:
Take it as soon as you remember, however if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSES.
If you stop taking these tablets:
Do not stop taking this medicine without first checking with your doctor, as your doctor may want to reduce the dose gradually before stopping completely in order to prevent withdrawal symptoms.
Withdrawal symptoms:
Feeling or being sick, stomach pains, diarrhoea, difficulty sleeping, headache, feeling nervous or anxious and excessive sweating can occur if you are taken off this medicine too quickly.
4. Possible side effects
Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.aov.uk/vellowcard alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday-Friday) or fill in a paper form available from your local pharmacy.
STOP TAKING the tablets and contact a doctor straight away if you experience any of the following effects as these may be signs of an allergic reaction:
• shortness of breath, difficulty breathing, swelling of the face or tongue, collapse
• skin reactions such as rashes, itching, swelling, puffiness, sensitivity to light
• fever, chills, cough, unusual weight loss (signs of pneumonitis).
Tell your doctor if you notice any of the following other side effects that may occur:
Very common (may affect more than 1 in 10 people):
• dry mouth, constipation
• blurred vision or visual disturbances
• fast heartbeat, or dizziness and light headedness when standing up
• increased sweating, hot flushes, weight gain
• trembling.
Common (may affect less than 1 in 10 people):
• drowsiness, tiredness, restlessness, confusion, hallucinations and changes in mental state (particularly in the elderly)
• anxiety, agitation, mood swings, trouble sleeping
• headache, dizziness, a feeling of pins and needles
• irregular heartbeat or feeling your heartbeat
• difficulty passing urine
• feeling or being sick, loss of appetite
• changes in liver enzymes which will be found during blood tests
• disturbances in sexual function.
Uncommon (may affect less than 1 in 100
people):
• epileptic seizures/convulsions (fits)
• triggering of mental disturbances
• problems with liver function (signs include yellowing of the skin and whites of the eyes).
Rare (may affect less than 1 in 1,000
people):
• aggressiveness
• changes in the electrical activity of the brain (EEG)
• muscle twitching, weakness, fever
• problems with speech, movement or balance, ringing in the ears
• increased blood pressure and problems with the heart pumping blood around the body
• poor blood flow which makes the toes and fingers numb, cold and pale
• fluid build up under the skin
• inflammation of the liver (hepatitis), signs include dark urine, pale stools, loss of appetite
• extreme dilation of the pupils and glaucoma (increased pressure inside the eye)
• ulcers or inflammation in the mouth, sores on the tongue or black tongue
• abdominal (stomach) pains or lack of bowel movement due to a blockage
• darkening of the skin, red/purple patches or spots on the skin, hair loss
• changes in blood sugar levels
• changes in weight
• breast swelling in men and women, production of breast milk
• low blood levels of sodium (especially in the elderly) which can cause tiredness, confusion, muscle twitching, fits and coma
• reduced numbers of some blood cells/ platelets (signs include sore throat, fever,
feeling unusually tired, getting infections more often than usual, easier bleeding or bruising)
• over production of anti-diuretic hormone resulting in water retention.
Other effects:
• an increased risk of bone fracture has been observed in patients taking this medicine
• changes in behaviour in children
• delusions (believing things that are not real)
• fainting and very low blood pressure.
5. How to store Imipramine Tablets
Keep the tablets in the pack provided and protect from heat, light and moisture.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information
Ingredients:
Imipramine Tablets are available in two strengths and contain either 10 mg or 25 mg of imipramine hydrochloride as the active ingredient.
The other ingredients are lactose, povidone, magnesium stearate, maize starch, talc, sucrose, kaolin heavy, shellac, titanium dioxide (E171), sodium benzoate (E211), erythrosine (E127), tartrazine (E102). The 10 mg tablets also contain indigo carmine (E132) and the 25 mg tablets also contain amaranth (E123).
What the medicine looks like:
Imipramine Tablets 10 mg are orange in colour and Imipramine Tablets 25 mg are tan in colour. The medicine is available in pack sizes of 28, 42, 50, 56, 84, 100, 112, 250,
500 and 1000 tablets. (Not all pack sizes may be marketed).
Who makes this medicine and holds the product licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED Date leaflet prepared: October 2012 If you would like this leaflet in a different format please contact the licence holder at the above address.
P0105T