Imipramine 25mg Tablets Bp
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IMIPRAMINE 25MG TABLETS B.P,
THIS LEAFLET PROVIDES A SUMMARY OF THE INFORMATION AVAILABLE ON YOUR MEDICINE.PLEASE READ IT CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE IF YOU HAVE ANY QUESTIONS OR YOU ARE NOT SURE OF ANYTHING ASK YOUR DOCTOR OR PHARMACIST.
• WHAT IS IN THIS MEDICINE Imipramine tablets 25mg are red-brown, circular, sugar coated tablets. Each tablet contains 25mg of Imipramine Hydrochloride. This tablet also contain the inactive ingredients lactose monohydrate, maize starch, povidone, magnesium stearate, stearic acid, polyvinyl acetate phthalate, ethyl acetate, talc, calcium carbonate, acacia, sucrose, shellac, yellow carnauba wax and white beeswax. The tablets contain the colours titanium dioxide (E171), tartrazine aluminium lake (E102), amaranth aluminium lake (E123), erythrosine aluminium lake (E127) and indigo carmine aluminium lake (E132) and the preservative sodium benzoate (E211)
Pack sizes of Imipramine 25mg tablets are “7, 14, 28, 56, 84, 100, 500 and 1000 tablets” in containers.
• WHAT IS IMIPRAMINE?
Imipramine belongs to a class of antidepressant drugs known as the tricyclic antidepressant drugs. These medicines alter the levels of chemicals in the brain to relieve the symptoms of depression.
The Marketing Authorization Holder and Company responsible for manufacture:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444 Fax: 0208 997 5433
To request a copy of this leaflet in large print or audio format, please contact the licence holder at the address (or telephone, fax) above.
• WHAT IS THIS MEDICINE FOR?
Imipramine is used to treat depression..
It can also be used to treat bed-wetting in children.
• WHAT DO YOU NEED TO KNOW BEFORE TAKING THIS MEDICINE?
If the answer to any of the following questions is YES, DO NOT take Imipramine tablet and tell your doctor:
• have you previously suffered an allergic reaction while taking this medicine or any other tricyclics antidepressants?
• are you allergic to any of the other ingredients in this medicine? (see section 6 Further information)
• do you suffer from glaucoma (increased eye pressure)?
• do you suffer from serious heart disease such as irregular heartbeat, heart block?
• have you had a heart attack within the past three months?
• do you suffer from severe liver disease?
• do you suffer from periods of increased and exaggerated behaviour (mania)?
• do you suffer with porphyria? (a genetic disorder of the red blood cells haemoglobin causing skin blisters, abdominal pain and brain/nervous system disorders)
• is the child is under 6 years old?
• do you have difficulty passing water?
• are you taking or have you recently taken i.e., within the previous 14 days for depression, any other medicine to treat depression, particularly monoamine oxidase inhibitors, (MAOIs)?
• are you pregnant, planning to become pregnant or breast feeding?
^ 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 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.
^ Check with your doctor or pharmacist before taking Imipramine tablets if you or your child (if the child is the patient)
• suffer from any mental illness(psychiatric disorder) other than depression? (e.g. schizophrenia or manic depression)
• are withdrawing from alcohol or medicines used to treat fits?
• have ever had glaucoma or an enlarged prostate
gland?
• have had an overactive thyroid gland?
• suffer from epilepsy (fits) or brain damage?
• suffer from constipation?
• have low blood pressure or problems with your circulation?
• have a tumour of the adrenal gland (e.g. phaeochromocytoma or neuroblastoma)?
• suffering from severe kidney disease?
• suffer from panic attacks?
• wear contact lenses as the use of Imipramine may lead to eye problems.
• are being given electroconvulsive therapy (ECT)
• are due to have any surgery, including dentistry that involves an anaesthetic.
^ Having operations and tests
If you are to undergo surgery or medical tests tell your doctor or dentist of your treatment with Imipramine.
♦ ARE YOU TAKING ANY OTHER MEDICINE?
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines including medicine obtained without a prescription. Especially:
• medicines for epilepsy, e.g. phenytoin, barbiturates, and carbamazepine, phenobarbital
• medicines such as sleeping tablets or tranquillisers including diazepam, nitrazepam, oxazepam and alprazolam
• medicines to treat depression, such as selective serotonin reuptake inhibitors (SSRIs) such as fluxetine, fluvoxamine
• disulfiram, a drug used in the treatment of alcohol abuse.
• nicotine replacement therapy
• methylphenidate, a drug used in the treatment of childhood behavioural disorders
• medicines used to thin the blood (anticoagulants, e.g. warfarin).
• medicines (antihistamines) used for colds, sinuses, hay fever or allergies
• altretamine (to treat some types of cancer)
• alpraclonidine and brimonidine (to treat glaucoma)
• baclofen (a muscle relaxant)
• painkillers such a nefopam, tramadol, codeine, dihydrocodeine.
• medicines used for heart disease, such as dilitiazem, verapamil, labetalol, propranolol and quinidine
• medicines to treat angina that you spray or dissolve under your tongue (e.g.glyceryl trinitrate “GTN”,isosorbide dinitrate)
• medicines used for high blood pressure such as guanethidine, debrisoquine, bethanidine,methyldopa, reserpine,clonidine or diuretics (“water”tablets)
• medicines to treat some mental illnesses such as Phenothiazines (e.g. chlorpromazine, thioridazine) and atropine
• cimetidine, a drug used in the treatment of ulcers
• drugs used to treat Parkinson’s disease (e.g. entacapone, selegiline, orphenadrine, procyclidine, and biperiden)
• oral contraceptives (“the pill”) or oestrogens (e.g. used for hormone replacement therapy)
• appetite suppressants.
• sympathomimetic medicines such as adrenaline (epinephrine), ephedrine, isoprenaline, noradrenaline (nor epinephrine), phenylephrine, phenylpropanolamine (these may be present in many cough and cold remedies or local anaesthetics)
• ritonavir (to treat HIV)
• bronchodilators, which are used to help your breathing
^ 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 of pregnancy, the baby may be born with breathing difficulties, lethargy, colic, irritability, changes in blood pressure, tremors, spasm. You should stop taking Imipramine tablets at least 7 weeks before the expected delivery date.
^ Driving and using machines
Imipramine may impair your alertness or cause drowsiness or blurred vision; alcohol can make these symptoms worse. Make sure you are not affected before you drive or operate machines.
^ Tests
During your treatment with Imipramine tablets, your doctor may wish to carry out a number of tests on your heart, blood and liver. This is quite usual and nothing to be concerned about.
^ Dental check ups
You should have regular dental check-ups whilst taking Imipramine. Imipramine can cause dryness of the mouth, which may increase the risk of tooth decay.
^ Sugar intolerance
If you have been told you have an intolerance to some sugar, contact your doctor before taking this medicine, as it contains a type of sugar, called lactose or sucrose.
• HOW MUCH OF THIS MEDICINE SHOULD YOU TAKE?
You should take your medicines as directed by your doctor.
The pharmacist’s label should tell you how much to take and
how often. If it does not or you are not sure ask your doctor
or pharmacist.
• The tablet should be swallowed with a glass of water.
• Caution is advised when drinking alcohol, as it may affect you more than usual when taking Imipramine.
• Keep taking your medicine until your doctor tells you to stop.
• Do not stop because you do not feel any better.
• This medicine may take up to four weeks to work.
DOSES:
^ Depression:
• Adults: Initially 25mg (one tablet) one to three times daily.
If necessary, your doctor may increase this dose gradually up to 150-200mg per day. In severe cases (treated in hospital) the dose may be increased up to a maximum of 100mg three times a day. The usual maintenance dose is between 50mg and 100mg a day in divided doses.
• Elderly: Lower doses may be used. Initially 10mg at night increasing gradually up to 30 - 50 mg daily in divided doses.
^ Bed wetting: Children only (To be taken at bedtime and for no longer than 3 months):
Under 6 years - not recommended
6-7 years (body weight 44-55lbs): 25mg a day.
8-11 years (body weight 55-77lbs): 25-50mg a day. Over 11 years (body weight 77-119lbs): 50-75mg a day.
^ If you take more tablets than you should
If you or anyone else has swallowed a lot of the tablets all together, contact your nearest hospital casualty department or doctor immediately. Symptoms of an overdose include fast or irregular heartbeat, low blood pressure, drowsiness, fits, coma, agitation, muscle rigidity, being sick or fever.
^ If you forget to take a dose
If you forget to take a tablet, leave out until the next dose is due. Do not take two doses together. If you see another doctor or go into hospital, let the doctor or the hospital staff know what medicines you are taking.
^ If you stop taking the medicine
If you need to stop taking your medicine, your doctor will advise you about reducing the dose gradually to avoid unwanted effects.
You may experience withdrawal symptoms if you stop the treatment too quickly. These may include sleeping problems, irritability and sweating.
• WHAT UNWANTED EFFECTS CAN THIS MEDICINE HAVE?
This medicine, like most other medicines may cause side effects in some people, particularly the elderly.
^ STOP TAKING the tablets and contact a doctor at once if you have the following allergic reaction;
pneumonitis (fever, chills, cough, difficulty breathing, unusual weight loss, and feeling sick), skin rash or itching; sore throat; shortness of breath; shock and collapse; increased sensitivity to sunlight; swollen face, or tongue.
^ Tell your doctor if you notice any of the following side effects or notice any other effects not listed
• Blood: reduction in some blood cells (you may experience a sore throat, mouth ulcers and recurring infections, bleeding or bruising easily)
• Endocrine system and metabolism: disturbances in sexual function or sex drive, breast swelling in men and women, production or over-production of breast milk, changes in blood sugar levels , trembling and weight gain or loss, SIADH (syndrome of inappropriate antidiuretic hormone secretion)
• Brain and central nervous system: disorientation, light-headedness (especially when standing up), dizziness, tiredness or sleepiness, weakness, headache, muscle spasm difficulty concentrating, agitation, mood changes, delirium (confusion), tremor, aggressiveness, difficulty in sleeping, delusions, hallucinations (seeing things that are not there), restlessness, pins and needles, or lack of muscle control, difficulty in speaking, fits. Anticholinergic effects (dry mouth, constipation, blurred or double vision, sweating, hot flushes, difficulty passing water (urine), dilation of the pupil of the eye, glaucoma and Intestinal obstruction)
• Heart: feeling faint when getting up (postural hypotension), high or severely low blood pressure, fast/racing heart, palpitations, irregular heart-beats, changes in ECG readings
• Stomach and intestines: feeling or being sick, anorexia (loss of appetite), inflammation of the mucous membranes in the mouth, tongue lesions.
• Liver: impaired liver function, hepatitis, including changes in liver function (as seen in blood tests), jaundice (yellowing of the skin and/or whites of the eyes)
• Other: drowsiness; eye pain; loss of balance; muscle weakness or stiffness; brownish spots on skin; hair loss, ringing in the ears, small purple red spots. An increase risk of bone fractures has been observed in patients taking this type of medicine.
• Withdrawal symptoms: nausea (vomiting); feeling or being sick, stomach pain, diarrhoea, nervousness, anxiety, irritability
• Children: changes in behaviour.
• Imipramine may also increase your feelings of anxiety at the start of treatment.
Tell your doctor if you notice any of the above side effects
or any other effects not listed.
• HOW SHOULD YOU STORE THIS MEDICINE?
• This medicine should not be used after the expiry date
stated on the pack. The expiry date refers to the last date of
that month.
• Imipramine Tablets should be stored at room temperature
below 25°C, in a dry place and protected from light.
• Keep the container tightly closed.
• Store in the original container.
Keep all the medicines out of the reach and sight of children.
Remember: This medicine has been prescribed for you. Do not give it to anybody else even if their symptoms appear to be the same as yours, since it may be harmful to them. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
Date leaflet last revised: January 2014 PL 04556 / 0043 Reference: 00430114/01