Carbamazepine Norton 100mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
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 any further questions, 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Carbamazepan is and what it is used for
2. Before you take Carbamazepin
3. How to take Carbamazepin
4. Possible side effects
5. How to store Carbamazepin
6. Further information
1. WHAT CARBAMAZEPIN IS AND WHAT IT IS USED FOR
Epimaz tablets belong to a group of drugs known as antiepileptics. Epimaz tablets are also known by the name of the active ingredient, carbamazepine.
Epimaz is used:
• to prevent certain types of epileptic seizures (fits)
• to control the pain of trigeminal neuralgia (severe pain in the head and the face)
• to help control mood swings in patients unresponsive to lithium treatment.
2. BEFORE YOU TAKE CARBAMAZEPIN
DO NOT take Carbamazepin if you:
• are allergic (hypersensitive) to carbamazepine or similar drugs such as oxcarbazepi ne (T ri l eptal) or any of the other ingredients of this medicine. If you are allergic to carbamazepine there is a one in four (25%) chance that you could also have an al lergic reaction to oxcarbazepi ne.
• have ever had an allergic reaction to any of the group of drugs known as tricyclic antidepressants (such as amitriptyline or imipramine)
• have a hereditary metabolic disorder called porphyria which is a deficiency of specific enzymes within the body, causing an increase of substances called porphyrins
• are taking monoamine oxidase inhibitors (MAOIs) or have taken them in the past two weeks
• have a history of bone marrow suppression
• have heart conduction problems and do not have a pacemaker.
Take special care with Carbamazepin
A small number of people being treated with anti-epileptics such as Epimaz have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor
Serious skin side effects can rarely occur during treatment with carbamazepine. This risk can be predicted with a blood sample in people of Chinese and Thai Origin. Discuss this with your doctor before taking carbamazepine if you are of such origin
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Epimaz, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
The highest risk for occurrence of serious skin reactions is within the first months of treatment.
These serious skin reactions can be more common in people from some Asian countries. The risk of these reactions in patients of Han Chinese or Thai origin may be predicted by testing a blood sample of these patients. Your doctor should be able to advise if a blood test is necessary before taking carbamazepine.
If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Epimaz, you must not be re-started on Epimaz at any time.
If you develop a rash or these skin symptoms, stop taking carbamazepine and contact your doctor immediately.
Talk to your doctor before you start to take this medicine if you:
• are pregnant (see the section ‘Pregnancy and breast-feeding’ ), as your doctor will want to monitor the levels of your medicine in your blood
• are taking the contraceptive pill (see section “Taking other medicines”)
• have ever had any problems with your kidneys, liver or heart, including problems with your circulation
• have a low red blood cell or white blood cell or platelet count
• suffer from mixed seizures which include typical absence or atypical seizures also known as petit mal fits
• suffer from glaucoma (an eye condition where the pressure in your eyes is raised)
• have suffered from any mental illness or are elderly.
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.
Patients and their relatives should be made aware of early sign and symptoms of blood problems, skin problems and liver problems that may happen after starting this medicine. The patient should consult a doctor immediately, if the patient suffers from fever, rash, sore throat, mouth ulcers, eye bruising, bleeding and red purple spots on the skin after starting this medicine.
Taking other medicines
DO NOT take Carbamazepin whilst taking:
• The herbal remedy St. John’s Wort (Hypericum perforatum). If you are already taking St. John’s Wort, consult your doctor before you stop taking the St. John’s Wort preparations.
• Monoamine oxidase inhibitors (MAOIs) used for depression.
Talk to your doctor if you are taking any of the following:
• other medicines for epilepsy, e.g. clobazam, clonazepam, oxcarbazepine, ethosuximide, primidone, progabide, valpromide, phenobarbitone, fosphenytoin, levetiracetam, valproic acid, phenytoin, lamotrigine, phenobarbital, tiagabine, vigabatrin or topiramate
• valnoctamide (sedative)
• isoniazid is used to treat tuberculosis (TB)
• alprazolam (for anxiety)
• amitriptyline, nortriptyline, clomipramine, imipramine, fluoxetine, paroxetine, fluvoxamine, viloxazine, lithium, thioridazine, trazodone, citalopram, mianserin, sertraline or nefazodone (for depression)
• clozapine, olanzapine or risperidone (for schizophrenia)
• quetiapine (for mental illness)
• haloperidol (a tranquilliser),
• corticosteroids e.g. prednislone, dexamethasone (used to reduce inflammation and treat allergic diseases such as asthma)
• ciclosporin (used to prevent rejection of tissue or organ transplant)
• indinavir, saquinavir or ritonavir (for HIV treatment)
• levothyroxine (for hypothyroidism)
• tibolone (for menopause symptoms)
• dextropropoxyphene, methadone, tramadol or paracetamol (for pain),
• theophylline (for breathing problems)
• aminophylline (for asthma)
• warfarin, acenocoumarol (to prevent blood clots)
• antibiotics (e.g. erythromycin, clarithromycin, doxycycline), isoniazid or rifampicin (for tuberculosis), itraconazole, ketoconazole, voriconazole or fluconazole (antifungals)
• terfenadine or loratadine (anti-histamines to treat allergy)
• metoclopramide (for sickness)
• cisplatin, doxorubicin, imatinib or toremifene (for cancer treatment)
• mefloquine or chloroquine (antimalarial drugs)
• cimetidine, omeprazole (for ulcers)
• acetazolamide (for glaucoma)
• isotretinoin (for acne) or nicotinamide (Vitamin B supplements)
• 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
• contraceptives (the pill, injections or implants). These may not work as well and you may notice breakthrough bleeding or spotting. It may be wise to use a different barrier method of contraception such as the diaphragm or condom.
• danazol or gestrinone (for menstrual disorders and for breast enlargement in men)
• Hormone Replacement Therapy (HRT), as Epimaz tablets can make HRT less effective
• diuretics (“water tablets” such as furosemide and hydrochlorothiazide)
• buprenorphine (for pain)
• bupropion (for smoking ceasation)
If you are due to have surgery, make sure that you tell the doctor or the anaesthetist that you are taking carbamazepine. Epimaz tablets may react with some muscle relaxants (for example pancuronium) which could be used during surgery.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Important information about some of the ingredients of Carbamazepin
• Patients who are intolerant to lactose should note that Epimaz tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Taking Carbamazepin with food and drink
• DO NOT drink alcohol while you are taking Epimaz tablets.
• Grapefruits and grapefruit juice interact with Epimaz tablets. DO NOT eat grapefruits or drink grapefruit juice when you are taking this medicine.
Pregnancy and breast-feeding
You must discuss your epilepsy treatment with your doctor well before you become pregnant. If you do get pregnant while you’re taking Epimaz you must tell the doctor straightaway. It is important that your epilepsy remains well controlled, but, as with other anti-epilepsy treatments, there is a risk of harm to your unborn baby. Make sure you are very clear about the risks and the benefits of taking Epimaz.
There have been a few cases of seizures in newborn babies and/or breathing problems associated with maternal Epimaz use and other antiepileptic drugs used at the same time. A few cases of vomiting, diarrhoea and/or decreased feeding have also been reported in newborn babies association with maternal Epimaz use. Similar symptoms may appear if the mother stops taking Epimaz.
Mothers taking Epimaz can breastfeed their babies, but you must tell the doctor as soon as possible if you think that the baby is suffering side effects such as excessive sleepiness or skin reactions because you are taking Epimaz.
Driving and using machines
• Epimaz can make you feel dizzy or drowsy, especially at the start of treatment or when the dose is changed. If you are affected in this way, or if your eyesight is affected, you should not drive or operate machinery.
Important information about some of the ingredients of Carbamazepin
• Patients who are intolerant to lactose should note that Epimaz contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE CARBAMAZEPIN
Always take Epimaz exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Epimaz may be taken during, after or between meals. The tablets should be swallowed preferably with a drink of water. The usual dose is:
Epilepsy
• Adults and the elderly
The most common adult starting dose for epilepsy is 100 mg to 200 mg once or twice a day. Your doctor will gradually increase this dose until they find the best dose for you. This is often between 800 mg and 1200 mg a day, but can be up to 1600 mg to 2000 mg a day.
• Children over 5 years of age
Your doctor will calculate the appropriate dose of Epimaz for your child based on the child’s 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 200 mg tablets a day.
Children aged 10 to 15 may take three to five 200 mg tablets a day.
These doses will be spaced evenly throughout the day, as advised by your doctor.
Epimaz tablets are not recommended for use in children under 5 years of age.
Trigeminal neuralgia
• Adults and the elderly
200 mg to 400 mg a day.
If you are elderly the usual starting dose is 100 mg twice a day.
Your doctor will gradually increase this dose until he or she finds the best dose for you. This will usually be 200 mg three to four times a day, although occasionally it may be a high as 1600 mg a day. Once your pain is under control, your doctor may reduce your daily dose.
Mood swings
• Adults and the elderly
The usual starting dose will be 400 mg a day in divided doses.
Your doctor will gradually increase this dose until he or she finds the best dose for you. This will usually be 400 mg to 600 mg a day, although occasionally it can be as high as 1600 mg a day. If you are elderly or have liver problems, your starting dose may be lower.
If you take more Carbamazepin than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause heart, breathing, stomach, kidney and nerve problems such as rapid heart beat, slurred speech, agitation, vomiting, inability to pass urine and low blood sugar levels . Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Carbamazepin
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose.
If you stop taking Carbamazepin
DO NOT stop taking your tablets without talking to your doctor first even if you feel better. It can be dangerous to stop taking your tablets without your doctor’s advice as it can cause you to have more frequent seizures (fits).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Epimaz can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)
• Stevens Johnson Syndrome which is a serious illness with blistering of the skin, mouth, eyes and genitalia
• toxic epidermal necrolysis (TEN), which causes blistering and can affect the mouth and tongue
• neuroleptic malignant syndrome (characterised by muscle stiffness, stupor, unstable blood pressure, fever, excessive sweating and incontinence)
• angioedema which is a serious allergic reaction which causes swelling of the face or throat
• 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).
These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.
If you start to have seizures more frequently, you should tell your doctor straight away.
The following side effects have been reported at the approximate frequencies shown:
Very common (affecting more than one person in 10):
• dizziness, drowsiness, difficulty in controlling movements, tiredness
• feeling sick, being sick
• reduction in number of white blood cells which makes infections more likely
• changes in liver test results
• allergic skin reactions.
Common (affecting fewer than one person in 10 but more than one person in 100):
• double vision, headache, blurred vision
• dry mouth
• water retention, weight increase, low blood levels of sodium which can cause tiredness and
confusion, muscle twitching, fits or coma, water intoxication causing lethargy, vomiting, headache, mental confusion
• blood disorders and reduction in blood platelets, which increases the risk of bleeding or
bruising,
• raised liver enzymes alkaline phosphatase.
Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):
• tremor, abnormal muscle rigidity, tics
• intermittent lapse of posture
• diarrhoea, constipation
• raised liver enzyme transaminases
• skin reaction causing skin peeling, abnormal reddening, flaking and thickening of the skin.
Rare (affecting fewer than one person in 1,000 but more than one person in 10,000):
• abnormal involuntary muscular movements
• a generalised allergic reaction including rash, joint pain, fever, inflammation of blood vessels,
swollen glands, enlargement of liver and spleen at the same time, abnormal liver function, problems with the kidneys and other organs
• abnormal eye or muscle movements, slurred speech, involuntary repetitive movements of the
mouth and face
• disorder of the nerves which can cause weakness, tingling or numbness
• partial loss of voluntary movement or by impaired movement
• depression, aggressive behaviour, hallucinations, loss of appetite, restlessness, agitation ,
confusion
• abdominal pain
• itchy rash
• blood disorders, swollen glands, folic acid deficiency
• inflammation of the liver, yellowing of the skin or whites of the eyes caused by liver or blood
problems
• irregular heart beat, high or low blood pressure
• symptoms of lupus
Very rare (affecting fewer than one person in 10,000):
• loss of contact with reality
• inflammation of the tongue and mouth, mouth ulcers and cold sores
• inflammation of the pancreas
• enlargement of the breasts in men, abnormal milk secretion
• abnormal thyroid function test, high cholesterol levels
• softening and weakness of the bones, brittle bones
• abnormal condition of the mind
• kidney problems passing urine often or inability to pass urine
• impotence (inability to get or maintain an erection)
• sexual difficulties which may include reduced male fertility
• hair loss, bruise like rash, acne, sweating, excessive hair growth, altered skin pigmentation
• severe reduction in blood cells which can cause weakness, bruising or make infections more
likely
• agranulocytosis (severe reduction in number of white blood cells making infections more
likely)
• aplastic anaemia (severe reduction in blood cells which can cause weakness, bruising or make
infections more likely).Megaloblastic anaemia (inhibition of DNA in red blood cell production). Hemolytic anemia (abnormal breakdown of red blood cells)
• reticulocytosis (condition where there is an increase in reticulocytes, immature red blood cell.
It is commonly seen in Anemia)
• porphyria (a deficiency in specific enzymes within the body, causing an increase of substances
called porphyrins); these deficiencies can cause a wide variety of symptoms, including discolouration of the urine, serious skin disorders, anaemia, abdominal pains and severe mental disorders
• granulomatosis, production of lesions or lumps
• liver problems
• aseptic meningitis (sterile meningitis or inflammation of the brain)
• heart problems and slow pulse rate
• aggravation of coronary artery disease
• inflammation of veins and or blood clot formation
• taste disturbances, blurring of the lens of the eye, conjunctivitis, glaucoma, hearing disorders,
ringing in the ears, sounds seeming louder than usual and which can sometimes be painful if the sound is loud or changes in pitch perception
• reaction to certain drugs for psychiatric condition
• joint pain, muscle pain, cramp
• lung problems, shortness of breath, inflammation of the lungs which causes breathlessness,
cough and raised temperature, pneumonia
• potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported (see section 2).
• increased sensitivity of the skin to sunlight, redness of the skin, red nodules just below the
skin surface
• reduction in all types of gamma globulins (this can be identified from your blood test.)
• severe cutaneous tissue adverse reactions
There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CARBAMAZEPIN
Keep out of the reach and sight of children. You should keep your tablets in a cool, dry place.
Do not use Epimaz after the expiry date that is stated on the outer packaging. 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 Carbamazepin Teva tablets contain:
• The active ingredient is carbamazepine 100 mg, 200 mg, or 400 mg.
• The other ingredients are maize starch, lactose monohydrate, croscarmellose sodium, polyvidone and magnesium stearate
What Carbamazepin Teva tablets look like and contents of the pack:
• Epimaz tablets 100 mg are white coded CBZ 100 and breakline on one side, twin triangle logo or plain on reverse.
• Epimaz tablets 200 mg are white coded CBZ 200 and breakline on one side, twin triangle logo or plain on reverse.
• Epimaz tablets 400 mg are white coded CBZ 400 and breakline on one side, twin triangle logo or plain on reverse.
• They come in packs of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 500 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer: IVAX Pharmaceuticals UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX
This leaflet was last revised: December 2014 PL 00530/0328-0330
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