Epimaz Tablets 400 Mg
(Carbamazepine)
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By jarmand at 8:55 am, 4/3/06
tablet contains Carbamazepine BP 400mg Also contains Lactose monohydrate For the Pharmacist:
Please tear off and provide a leaflet with each prescription dispensed
Store in a cool dry place
Keep all medicines out of the reach and sight
of children
For oral use
Swallow the tablets whole, with water Dosage as directed by the doctor
MA holder: IVAX Pharmaceuticals UK Royal Docks London E16 2QJ UK
100 tablets
mu
Epimaz
Tablets (Carbamazepine)
Each tablet contains Carbamazepine BP 400mg Also contains Lactose monohydrate For the Pharmacist:
Please tear off and provide a leaflet with each prescription dispensed
Store in a cool dry place
Keep all medicines out of the reach and sight of children
For oral use
Swallow the tablets whole, with water Dosage as directed by the doctor
MA holder: IVAX Pharmaceuticals UK Royal Docks London E16 2QJ UK
100 tablets
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INSTRUCTIONS
Artwork text and content must not be
reset,remade, amended or altered. The only exceptions to this are:
Bleeds, chokes, spreads or other adjustments required for print reproduction purposes only.
If you have any difficulties please contact:
M.Y. Healthcare, Waterford.
Tel. 051-376484 Fax 051-378407
IVAX Ivax Pharmaceuticals Ireland, IDA Industrial Park, Cork Road, Waterford, Ireland.
Product Name: Epimaz TAB 400MG 100 IUK
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Job No: 8220 |
| Date: 26/01/06 |
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Epimaz 400mg Tablets (Carbamazepine) IVAX
Patient information leaflet
Please read this information carefully before you start to take your tablets. It contains important information. If you are not sure about anything, or you want to know more, ask your doctor or pharmacist.
About your tablets
The brand name is Epimaz 400mg Tablets, but will be referred to as 'Epimaz Tablets' in this leaflet. The active ingredient is Carbamazepine.
Epimaz tablets are part of a group of drugs known as antiepileptics.
These tablets are available in three strengths of 100mg, 200mg and 400mg.Your doctor will decide what strength is best for you.
What is in your tablets Each tablet contains:
• Carbamazepine BP 400 milligrams (mg), (active ingredient); and
• Maize starch, lactose monohydrate, croscarmellose sodium, polyvidone and magnesium stearate (inactive ingredients).
Epimaz Tablets 400mg are white coded CBZ 400 and breakline on one side, twin triangle logo or plain on reverse.
The pharmacist will dispense the amount prescribed by the doctor.
Who makes your tablets
Your tablets are made by IVAX Pharmaceuticals I reland, Waterford, Ireland.
The marketing authorisation holder is IVAX Pharmaceuticals UK, Albert Basin, Royal Docks, London E16 2QJ, UK.
What your tablets do
Epimaz Tablets are used to prevent certain types of epileptic seizures. They are also used to control the pain in trigeminal neuralgia (severe pain in the head and the face). Epimaz Tablets are also used to help control mood swings.
Before you take your tablets Do not take your tablets if you:
• Have ever had an allergic reaction to carbamazepine or to any of the group of drugs known as tricyclic antidepressants (such as amitriptyline or imipramine);
• Think that you might be allergic to any of the other ingredients listed in the 'What is in your tablets' section;
• Have ever had any problems with your heart rhythm (palpitations);
• Have a history of bone marrow disease;
• Have a hereditary metabolic disorder called porphyria;
s Are taking monoamine oxidase inhibitors or nave taken them in the past two weeks. Tell your doctor if you:
• Are pregnant, or may become pregnant or are breast feeding;
• Have ever had any problems with your kidneys, liver or heart, including problems with your circulation;
• Have a low white blood cell or platelet count;
• Suffer from mixed seizures which include absences in seizures;
• Suffer from glaucoma (an eye condition where the pressure in your eyes is raised);
• Have suffered from any mental illness;
• Have ever had an allergic reaction to oxcarbazepine, phenytoin, or have ever suffered a reaction to any other medicine which affected your blood;
• Have an intolerance to some sugars e.g. lactose monohydrate;
• Are taking medicines for epilepsy, for example, clobazam, clonazepam, oxcarbazepine, ethosuximide, primidone, valproic acid, phenytoin, lamotrigine, phenobarbitone, tiagabine or topiramate;
• Are taking other drugs, including alprazolam (for anxiety), corticosteroids (used to reduce inflammation and treat allergic diseases such as asthma), ciclosporin (used to prevent rejection of tissue or organ transplant), haloperidot (a tranquilliser!, amitriptyline, nortriptyline, clomipramine or imipramine (for depression), cfozapine, olanzapine or risperidone (for schizophrenia), indinavir, saquinavir or ritonavir (tor HIV treatment), levothyroxine (for hypothyroidism), tibolone (for menopause symptoms), dextropropoxyphene, methadone or tramadol (for pain), theophylline (for breathing problems), warfarin (to prevent blood clots), or paracetamol;
• Are taking antibiotics (for example erythromycin, clarithromycin, doxycycline), isoniazid or rifampicin (for tuberculosis), itraconazole, ketoconazole or fluconazole (antifungals), terfenadine or loratadine (anti-histamines to treat allergy), metoclopramide (for sickness!, cisplatin, doxorubicin or toremifene (for cancer treatment), mefloquine or chforoquine (antimalarial drugs), fluoxetine, fluvoxamine, viloxazine, lithium, thioridazine or nefazodone (for depression), cimetidine (for ulcers), acetazolamide (for glaucoma), danazol or gestrinone (for menstrual disorders and for breast enlargement in men), isotretinoin (for acne) or nicotinamide (Vitamin B supplements);
• Are taking medicines for high blood pressure or heart problems which might be verapamil, diltiazem, digoxin, or other treatments known as dihydropyridines e.g. nifedipine, felodipine, isradipine;
• Are taking contraceptives (the pill, injections or implants) may not work as well and you may notice breakthrough bleeding or spotting). It may be wise to use a different method of contraception;
• Are taking Hormone Replacement Therapy (HRT). Epimaz Tablets can make HRT less effective,
• Are taking diuretics ("water tablets" such as furosemide and hydrochlorothiazide). Please inform your doctor if you are taking or have recently taken, any other medicine, even those without a prescription.
Epimaz Tablets can cause drowisness, dizziness and blurred or double vision, especially when you first start to take them. Do not drive or use machinery if they affect you in this way. Do not drink alcohol while you are taking these tablets.
Before you start to take your tablets you may need to have blood and urine tests and tests to show how well your liver is working. You may then need regular blood tests once you have started to take your tablets. Your doctor will arrange this for you.
The herbal remedy St.John's Wort (Hypericum perforatium) should not be taken at the same time as this medicine. If you are already taking St. John's Wort, consult your doctor before stopping the St. John's Wort preparations.
Grapefruits and grapefruit juice interact with Epimaz Tablets. Do not eat or drink grapefruits or grapefruit juice when you are taxing this medicine.
If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking. Epimaz Tablets may react with some muscle relaxants (for example pancuronium) which could be used during surgery. Tell the doctor or the anaesthetist that you are taking Carbamazepine.
How to take your tablets
You must take your tablets as you doctor has told you. The label will tell you how many to take and how often to take them. The number of tablets you take is called the 'dose'. The most common adult starting dose for epilepsy is lOOmg to 200mg once or twice a day. Your doctor will gradually increase this dose until he or she finds tne best dose for you. This is often between 800mg and 1200mg a day, but can be up to 1600mg to 2000mg a day.
Children can take Epimaz tablets.The dose will be worked out by your doctor depending on your child's weight. The usual dose is 10mg to 20mg for each kilogram of body weight. The starting dose will be low and gradually increased to get the best result.
As a guide, children aged 5-10 may take two to three 200mg tablets a day.
Children aged 10 to 15 may take three to five 200mg tablets a day.
These doses will be spaced evenly throughout the day, as advised by your doctor. Epimaz Tablets are not recommended for very young children.
To treat the pain associated with trigeminal neuralgia the usual starting dose is 200mg to 400mg a day. If you are elderly the usual starting dose is 100mg twice a day. Your doctor will gradually increase this dose until he or she finds the best dose for you.This
will usually be 200mg three to four times a day, although occasionally it may be a high as 1600mg a day. Once your pain is under control your doctor may reduce your daily dose.
If you are taking Epimaz Tablets to control mood swings your usual starting dose will be 400mg a day. Your doctor will gradually increase this dose until he or she finds the best dose for you. This will usually be 400mg to 600mg a day, although occasionally it can be as high as 1600mg a day.
If you are elderly or have liver problems your starting dose may be lower than those shown above.
For oral use. Swallow the tablets whole with water.
If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses together. If it is almost time to take the next dose, wait until then and then carry on as before. It can be dangerous to stop taking your tablets without your doctor's advice as it can cause you to have more frequent seizures. Your doctor will want you to have regular blood tests and tests to check you liver is working properly while you are taking Epimaz Tablets.
What to do if you take too many tablets It is important not to take too many tablets.
Contact your nearest hospital casualty department if you have swallowed too many tablets or if you think a child has accidentally swallowed any.
Take this leaflet and any tablets that you still have to show the doctor.
After taking your tablets
Like atl medicines, you may experience some side effects when taking Epimaz Tablets. These should disappear within 7-14 days. However, if they persist, please speak to your doctor.
If any of the following happen, tell your doctor immediately or go to the nearest hospital as you may nave a serious allergic reaction:
• Headaches accompanied by dislike of bright lights and stiff neck;
• Swelling of any part of the body, most commonly the face, lips and genitals;
• Itchy, red rash and flushing of the skin, or peeling of the skin;
• Wheezing or sudden difficulty breathing speaking or swallowing due to swelling of the tongue, mouth and airways;
• Sudden feeling of extreme anxiety;
• Lupus erythematosus (a combination of symptoms some or all of which may be present, including a rash across the bridge of the nose and across the cheeks, pain in the joints and muscles and problems with breathing);
• Acute kidney failure (greatly reduced urine volume, drowsiness, headache and back pain);
• Fever, skin rash, joint pain, abnormalities in blood and liver function tests and swollen lymph glands;
• Neuroleptic malignant syndrome (characterised by muscle stiffness, stupor, unstable blood pressure, fever, excessive sweating and incontinence);
• Painful swelling of a limb, usually the lower leg or calf.
Epimaz Tablets may occasionally affect your blood. Tell your doctor immediately if you have a fever or a chill, a sore throat, ulcers in your mouth and throat, inflamed itchy skin or any unusual bruising or bleeding. If you start to have seizures more frequently you should tell your doctor.
Occasionally, other side effects include effects on the:
Nervous System: Effects on the nervous system include dizziness, double vision or blurred vision, fatigue, headache, feeling sleepy, a reduction in co-ordination or unsteadiness, confusion, jerky movements, tremor or unusual muscle movements, e.g. tics or involuntary facial or eye movements. And rarely, muscle weakness, loss of muscle tone, slurred speech or a difficulty in articulating words clearly, pins and needles, confusion and agitation, numbness or tingling in the hands or feet, abnormal jerky movements of the head or neck, depression, aggressive behaviour, hallucinations or restlessness. Very rarely psychotic behaviour (extreme impairment of a person's ability to think clearly, respond emotionally, communicate effectively, understand reality and behave appropriately).
Digestive System: Effects on the digestive system can include feeling sick or vomiting, dry mouth, diarrhoea, constipation or loss of appetite. And rarely, pain in the area near the stomach, pain in your stomach which may spread to your back and is made worse when you move, inflamed tongue or mouth.
Endocrine System and Metabolism: Effects on metabolism can include swelling of your fingers, legs and ankles, fluid retention, weight gain, low blood sodium levels that may cause headache, drowsines, sickness and confusion (usually with higher doses), and water intoxication (drowsiness, vomiting, headache, and confusion).
Very rarely the following side effects can occur milk production, breast enlargement in men and women, abnormal thyroid function tests, osteomalacia (may be noticed as pain on walking and possible bowing of the long bones of the legs) and increases in cholesterol.
Urogenital System: Very rarely the following may occur Interstitial nephritis (which may cause pain in the back, blood in the urine and general feeling of unwell), excretion of protein or blood in the urine, difficulty or increased need to pass urine, toss of libido, reduced fertility or impotence.
Skin: Epimaz Tablets may occasionally cause rash, severe skin reaction (including red, itchy, hives, inflamed or flaking skin).Rarely Epimaz Tablets may cause itchy skin, Stevens-Johnson syndrome [(red or purplish-rash or patches of rash on the body), conjunctivitis (burning pain in the eyes with mucus discharge, and sometimes swelling of tne eye), fever, mouth ulcers and blisters in the nose, mouth, genital and anal canal]. Very rarely Epimaz Tablets can cause increased sensitivity of the skin to sunlight, a pink or red tender rash particularly tender and present on the front of your lowerleg, hair loss or an increase in hair growth, alterations in skin pigmentation, unusual bruising, acne and increased sweating.
Blood: Epimaz Tablets may cause the following: Leucopenia (fever, sore throat, mouth ulcers, blisters on the skin and around the genital and anal canal), thrombocytopenia (bruising, unusual bleeding in the mouth, nosebleeds and a pinpoint rash on the skin), eosinopnilia (skin rash), a decrease in the amount of folic acid in your body, anaemia (tiredness, pale skin and shortness of breath, especially when you have exercised), acute intermittent porphyria (a condition when your urine changes colour and becomes red). Your doctor might find an increase or a decrease in your white blood cells or your platelet (these help blood clot) count or your number of new red blood cells.
Liver: You may feel off colour without any specific complaints, in which case your doctor could carry out a blood test to ascertain the cause.
Rarely Epimaz Tablets can cause hepatitis (inflammation of the liver causing tiredness, poor appetite, nausea, vomiting and stomach pain), and jaundice (where the whites of your eyes and skin turn yellow). Very rarely Epimaz Tablets can cause liver failure. Other: Rarely Epimaz Tablets can cause the following: interference with the electrical conduction or your heart, high blood pressure (which may make your feel dizzy with a flushed face, headache, fatigue and nervousness) and low blood pressure (feeling faint, light-headed, dizzy, confused and blurred vision). Very rarely Epimaz Tablets can cause tne following: irregular or slow heart beat, congestive heart failure (swollen legs or ankles and difficulty in breathing), taste disturbances, cataract (blurred vision), conjunctivitis, ringing in the ears, changes in your hearing, muscle pain, cramp, chills, chesty cough and difficulty in breathing.
If you have congestive heart failure, Epimaz Tablets can in very rare cases make your condition worse.
If you notice any other side effects not mentioned in this leaflet which you think may be caused by this medicine, please inform your doctor as soon as possible.
Looking after your tablets
Keep all medicines out of the reach and sight of children.
You should keep your tablets in a cool dry place. Store in the original package. Do not take the tablets after the expiry date.You should take any tablets that are out of date or which you no longer need back to your pharmacist. These tablets are only for you. Only a doctor can prescribe them for you. Never give them to anyone else.
PL number 0530/0330. This leaflet was rewritten in April 2005. PL0092