Imipramine 25mg Tablets
Out of date information, search another180 mm
24 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMIPRAMINE 25mg TABLETS
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your 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 25mg Tablets are and what they are used for
2. Before you take Imipramine 25mg Tablets
3. How to take Imipramine 25mg Tablets
4. Possible side effects
5. How to store Imipramine 25mg Tablets
6. Further information
1. What Imipramine 25 mg Tablets are and what they are used for
The name of your medicine is Imipramine 25mg Tablets. It contains the active ingredient called Imipramine Hydrochloride. Imipramine belongs to a group of medicines called tricyclic antidepressants. It is used to treat symptoms of depression and is also used for the relief of bed-wetting by children.
2. Before you take Imipramine 25 mg Tablets
Do not take Imipramine tablets and tell your doctor if you or your child (if they are the patient)
• are allergic (hypersensitive) to Imipramine, other tricyclic antidepressants of any of the other ingredients (see Section 6).
• Have heart disease (such as irregular heartbeats, heart block or have recently had a heart attack.
• Suffer from periods of increased and exaggerated behaviour (mania).
• Have severe liver disease.
• Suffer with porphyria (a genetic disorder of the red blood cells haemoglobin causing skin blisters, abdominal pain and brain/nervous system disorders).
• Are not able to pass water
• Have increased pressure in the eyes (glaucoma)
• are taking monoamine oxidase inhibitors (MAOI) or you have taken MAOIs within the previous 21 days for depression
• If the child is under 6 years old.
Take Special Care with this medicine:
Check with your doctor or pharmacist before taking Imipramine tablets if you or your child (if they are the patient):
• Have any psychiatric disorder (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 an overactive thyroid gland and are taking medicines to treat a thyroid disorder
• Have a history of epilepsy or brain damage
• Have low blood pressure or poor circulation
• Have severe kidney disease
• Have a tumour of the adrenal gland (e.g. phaeochromocytoma or neuroblastoma)
• Suffer from panic attacks
• Suffer from long term constipation
• Wear contact lenses
• Are being given electronvulsive therapy (ECT)
• Are due to have any surgery, including dental, that involves an anaesthetic
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 And 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.
Taking other Medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, especially:-
• Medicines to treat epilepsy such as barbiturates, phenytoin, carbamazepine and Phenobarbital
• Medicines called “benzodiapines” such as diazepam, nitrazepam, oxazepam and alprazolam
• Medicines to treat depression, such as selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine and fluvoxamine
• Disulfiram to treat alcohol addiction
• Nicotine replacement therapy
• Methylphenidate (used to treat attention deficit/hyperactivity disorder (ADHD))
• Medicines to stop your blood clotting (e.g. warfarin)
• Antihistamines (medicines to treat allergies)
• Altretamine (to treat some types of cancer)
• Apraclonidine and brimonidine (to treat glaucoma)
• Baclofen (a muscle relaxant)
• Painkillers such as nefopam, tramadol, codeine and dihydrocodeine
• Medicines to treat some heart conditions such as diltiazem, verapamil, labetalol, propanolol and quinidine
• Medicines to treat angina that you spray or dissolve under your tongue (e.g. glyceryl trinitrate “GTN”, isosorbide dinitrate)
• Any medicines to treat high blood pressure such as guanethidine, debrisoquine, bethanidine methyldopa, reserpine, cloridine or diuretics (“water” tablets)
• Medicines to treat some mental illnesses such as thioridazine chlorpromazine
• Cimetidine (to treat ulcers)
• Entacapone or selegiline (to treat Parkinson’s disease)
• Oral contraceptives (“the pill”) or hormone replacement therapy (HRT)
• Appetite suppressants
• Sympathomimetic medicines such as adrenaline (epinephrine), ephedrine, isoprenaline, noradrenaline (norepinephrine), phenylephrine and phenylpropanolamine (these may be present in many cough and cold remedies or local anaesthetics)
• Ritonavir (to treat HIV)
• Medicines such as atropine, phenothiazine, biperiden. Pregnancy and breast-feeding
Imipramine tablets should not be taken during pregnancy or if breast-feeding. If Imipramine tablets are taken in the last three months, the baby may be bom with breathing difficulties, lethargy, colic, irritability, changes in blood pressure, tremors or spasm. Imipramine tablets should be withdrawn at least 7 weeks before the expected delivery date.
Taking Imipramine tablets with alcohol
Do not drink alcohol while you are taking this medicine. Alcohol may increase the drowsiness and make you less alert.
Driving and using machines
Imipramine may impair your alertness or cause drowsiness or blurred vision and alcohol can make these symptoms worse, Make sure you are not affected before you drive or operate machinery.
Blood Tests
Whilst taking Imipramine tablets, your doctor may regularly monitor your blood cell levels or liver function.
Dental Check Ups
As Imipramine tablets can cause problems with your teeth, it is advisable to have regular dental checkups.
rVwinn
Imipramine INSERT
24 mm
Other precautions you should take
If you see another doctor, attend hospital for surgery involving an anaesthetic, let them know what medicines you are taking. Important Information about some of the ingredients of this medicine
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains types of sugars called lactose or sucrose.
3. How to take Imipramine 25 mg Tablets
Always take Imipramine tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow the tablets with a glass of water
You are advised not to drink alcohol with this medicine.
Doses
Depression
Adults - 25mg three times a day increasing to 150-200mg a day in divided doses. In severe cases (treated in hospital) the dose may be increased up to a maximum of lOOmg three times a day. The usual maintenance dose is between 50mg and lOOmg a day in divided doses.
Elderly (over 60 years) - Initially lOmg a day increasing to 30-50mg a day.
Nightly bedwetting:-
Children only to be taken at bedtime (for no longer than 3 months and up to a maximum of 2.5mg/kg)
Over 11 years (35-54 Kgs) - 50-75mg a day 8-11 years ( 25-35 Kgs) - 25-50mg a day 6-7 years ( 20-25 Kgs) - 25mg a day Under 6 years - not recommended
If you take more than you should
If you or the patient (or someone else) swallows a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department, or tell your 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 the tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time.
If you stop taking the tablets
Talk to your doctor before you stop taking the tablets and follow their advice as you may experience withdrawal symptoms (see Section 4).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Imipramine tablets can cause side effects, although not everybody gets them.
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, feeling sick),
• a skin rash, which may be itchy, sensitivity to the sun or sun lamps,
• puffy, swollen face or tongue, which may be severe causing shortness of breath, shock and collapse.
The most common side effects are:
• dry mouth
• blurred or double vision
• headache
• hot flushes, sweating
• constipation
The above effects are often mild and may disappear during treatment. If they are severe or last for more than a few days, tell your doctor.
You are unlikely to experience any of the following side effects but if you do - see your doctor as soon as possible.
• trembling
• weight gain
• fast or racing heartbeat
• light headedness (especially when getting up from lying or sitting position).
• drowsiness, tiredness
• dizziness
• restlessness, anxiety
• nausea (feeling sick)
• jaundice (yellowing of your skin and/or the whites of your eyes)
• sore throat or fever or mouth ulcers
• glaucoma (increased pressure in the eye)
• difficulty in passing water (urine)
• hair loss
• swelling of the breasts in men and women and production or over-production of breast milk
• dilation of the pupils
• increased sensitivity to sunlight
• disturbances in sexual function or sex drive
• ringing in the ears
• mood changes, aggression
• agitation
• vomiting, loss of appetite, weight loss
• blockage of the small intestine
• diarrhoea
• stomach pain
• any general swelling
• tingling or numbness or pins and needles
• muscle weakness or stiffness, muscle spasm
• difficulty in controlling movements
• difficulty in speaking
• difficulty concentrating
• feeling your heartbeat or irregular heartbeat
• changes in ECG readings
• red or brownish spots on skin
• fits, confusion or delirium or disorientation
• sleep disturbances or difficulty in sleeping
• high or severely low blood pressure
• hallucinations
• increase risk of bone fractures
• change in blood sugar levels
• a condition called ‘syndrome of inappropriate antidiuretic hormone secretion’ which will cause a lowering of salt in your body
• severe reduction in number of white blood cells which makes infections more likely
• reduction in blood platelets, which increases risk of bleeding or bruising
• other blood disorders
• raised levels of enzymes in your liver (as seen in blood tests)
• inflammation of the mouth or sores on the tongue. Withdrawal Symptoms: feeling sick, or being sick, stomach pain, diarrhoea, difficulty sleeping, nervousness, anxiety, headache and irritability.
Children: changes in behaviour
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.
5. How to store Imipramine 25 mg Tablets
• Keep out of the reach and sight of children.
• Do not store the tablets above 25°C.
• Keep the container tightly closed.
• Do not use Imipramine Tablets after the expiry date which is stated on the carton (exp.). The expiry date refers to the last day of that month.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information
What Imipramine tablet contains
The active substance is Imipramine 25mg. The other ingredients are Lactose Monohydrate, Maize Starch, Povidone, Magnesium Stearate, Stearic Acid, Polyvinylacetate Phthalate, Talc, Calcium Carbonate, Acacia, Titanium Dioxide (E171), Sucrose, Tartrazine Aluminium Lake (E102), Amaranth Aluminium Lake (E123), Erythrosine Aluminium Lake (E127), Indigo Carmine Aluminium Lake (E132), Sodium Benzoate (E211), Shellac, Yellow Camuba Wax, White Beeswax.
What Imipramine 25mg Tablets looks like and contents of the pack
Imipramine 25mg Tablets are Red-brown, circular, sugar-coated tablets. They are available in packs of 84, 100, 500 and 1000 tablets.
Not all pack sizes are marketed.
Marketing Authorisation Holder Name and Address:
Bristol Laboratories Ltd
Unit 3, Canalside, Northbridge Road,
Berkhamsted, HP4 1EG
Telephone: 0044 (0) 1442 200922
Fax: 0044 (0) 1442 873717
E-mail: info@bristol-labs.co.uk
Imipramine 25mg Tablets, PL 17907/0341
This leaflet was last revised in September 2011.
340 mm
Imipramine INSERT
SAME SIZE ARTWORK
180 x 340 mm
Back