1. What Carbamazepine Tablets are and what they are used for

Carbamazepine, the active ingredient in Carbamazepine Tablets, can affect the body in several different ways. It is an anti-convulsant medicine (prevents fits), it can also modify some types of pain and can control mood disorders.

Carbamazepine is used:

• To treat some forms of epilepsy
• To treat a painful condition of the face called trigeminal neuralgia
• To help control serious mood disorders when some other medicines don’t work.

12. What you need to know before you take Carbamazepine Tablets

• If you are allergic to similar kind of drugs as carbamazepine such as oxcarbazepine (Trileptal), or to any of a related group of drugs known as tricyclic antidepressants (such as amitriptyline or imipramine). If you are allergic to carbamazepine there is a one in four (25%) chance that you could also have an allergic reaction to oxcarbazepine.
• If you have any heart problems.
• If you have ever had problems with your bone marrow.
• If you have a blood disorder called porphyria.
• If you have taken drugs called monoamine oxidase inhibitors (MAOIs), used to treat depression, within the last 14 days.

A small number of people being treated with anti-epileptics such as carbamazepine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Serious skin rashes (Stevens- Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of carbamazepine. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza-like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread blistering and 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 develop a rash or these skin symptoms, stop taking carbamazepine and contact your doctor immediately.

Warnings and precautions

Talk to your doctor or pharmacist before taking Carbamazepine Tablets:

• If you are pregnant or planning to become pregnant.
• If you are breastfeeding.
• If you suffer from the sort of epilepsy where you get mixed seizures which include absences.
• If you have any mental illness.
• If you are allergic to an epilepsy medicine called phenytoin.
• If you have liver problems.
• If you have kidney problems associated with low sodium blood level or you have kidney problems and you are taking certain medicines that lower sodium blood levels (diuretics such as hydrochlorothi­azide, furosemide).
• If you are elderly.
• If you have any eye problems such as glaucoma (increased pressure in the eye) or you have difficulty retaining your urine.

Other medicines and Carbamazepine Tablets

Tell your doctor if you are taking, have recently taken or might take any other medicines, including anything that you have bought from a chemist or health food shop. It may be necessary to change the dose of some medicines, or stop taking something altogether.

Tell the doctor if you are taking:

• Hormone contraceptives, e.g. pills, patches, injections or implants. Carbamazepine affects the way the contraceptive works in your body, and you may get breakthrough bleeding or spotting. It may also make the contraceptive less effective and there will be a risk of getting pregnant. Your doctor will be able to advise you about this, and you should think about using other contraceptives.
• Hormone Replacement Therapy (HRT). Carbamazepine can make HRT less effective.
• Any medicines for depression or anxiety.
• Corticosteroids (‘steroids’). You might be taking these for inflammatory conditions such as asthma, inflammatory bowel disease, muscle and joint pains.
• Anticoagulants to stop your blood clotting.
• Antibiotics to treat infections including skin infections and TB (e.g. ciprofloxacillin).
• Antifungals to treat fungal infections.
• Painkillers containing paracetamol, dextropropoxyphene, tramadol, methadone or buprenorphine.
• Other medicines to treat epilepsy
• Medicines for high blood pressure or heart problems
• Antihistamines (medicines to treat allergy such as hayfever, itch, etc)
• Diuretics (water tablets)
• Cimetidine or omeprazole (medicines to treat gastric ulcers).
• Isotretinoin (a medicine for the treatment of acne)
• Metoclopramide or aprepitant (anti-sickness medications).
• Acetazolamide (a medicine to treat glaucoma – increased pressure in the eye)
• Danazol or gestrinone (treatments for endometriosis)
• Theophylline or aminophylline (used in the treatment of asthma)
• Ciclosporin, tacrolimus or sirolimus (immunosuppressants used after transplant operations, but also sometimes in the treatment of arthritis or psoriasis)
• Drugs to treat schizophrenia (e.g. paliperidone, aripiprazole).
• Cancer drugs (e.g. temsirolimus, cyclophasphamide, lapatinib).
• The anti-malarial drug, mefloquine
• Drugs to treat HIV
• Levothyroxine (used to treat hypothyroidism)
• Tadalafil (used to treat impotence)
• Albendazole (used to treat worms)
• Bupropion (used to help stop smoking)
• A herbal remedy called St John’s Wort or Hypericum
• Drugs or supplements containing Vitamin B (nicotinamide)

Carbamazepine Tablets with food, drink and alcohol

• Drinking alcohol may affect you more than usual. Discuss whether you should stop drinking with your doctor.
• Eating grapefruit, or drinking grapefruit juice, may increase your chance of experiencing side effects.
• Your doctor may want you to have a number of blood tests before you start taking Carbamazepine and from time to time during your treatment. This is quite usual and nothing to worry about.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you do get pregnant while you’re taking Carbamazepine Tablets 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 the foetus. Make sure you are very clear about the risks and the benefits of taking Carbamazepine Tablets.

Mothers taking Carbamazepine Tablets 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, skin reaction or yellow skin and eyes, dark urine or pale stools.

Driving and using machines

Carbamazepine Tablets can make you feel dizzy or drowsy, or may cause blurred vision, double vision, or you may have a lack of muscular coordination, 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.

Carbamazepine Tablets contain sodium

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially sodium-free

3. how to take carbamazepine tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The dose will be on the pharmacist’s label. Check the label carefully. It is important to take the tablets at the right times. If you are not sure, ask your doctor or pharmacist. Keep taking your tablets for as long as you have been told, unless you have any problems. In that case, check with your doctor.

Your doctor will usually start Carbamazepine at a fairly low dose which can then be increased to suit you individually. The dose needed varies between patients. You can take Carbamazepine Tablets during, after or between meals. Swallow the tablets with a drink. You are usually told to take a dose two or three times a day. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

To treat epilepsy the usual doses are:

Adults:

800–1,200 mg a day, although higher doses may be necessary.

If you are elderly you might require a lower dose.

Children:

Aged 5–10 years: 400–600 mg a day

Aged 10–15 years: 600–1,000 mg a day.

Carbamazepine Tablets are not recommended for children under 5.

To treat trigeminal neuralgia the usual dose is:

600–800 mg a day. The maximum dose is 1200 mg a day. If you are elderly you might require a lower dose.

To treat mood swings the usual dose is:

400–600 mg a day

If you forget to take Carbamazepine Tablets

If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose though, just take the next dose and forget about the one you missed.

If you take more Carbamazepine Tablets than you should If you accidentally take too many Carbamazepine Tablets, tell your doctor or your nearest hospital casualty department. Take your medicine pack with you so that people can see what you have taken.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Stop taking Carbamazepine Tablets and tell your doctor straight away if you notice:

• Serious skin reactions such as rash, red skin, blistering of the lips, eyes or mouth, or skin peeling accompanied by fever. These reactions may be more frequent in patients of Chinese or Thai origin
• Mouth ulcers or unexplained bruising or bleeding
• Sore throat or high temperature, or both
• Yellowing of your skin or the whites of your eyes
• Swollen ankles, feet or lower legs
• Any signs of nervous illness or confusion
• Pain in your joints and muscles, a rash across the bridge of the nose and cheeks and problems with breathing (these may be the signs of a rare reaction known as lupus erythematosus)
• Fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be the signs of a multi-organ sensitivity disorder)
• Bronchospasm with wheezing and coughing, difficulty in breathing, feeling faint, rash, itching or facial swelling (these may be the signs of a severe allergic reaction)
• Pain in the area near the stomach

The side effects listed below have also been reported.

Very common: may affect more than 1 in 10 people:

Leucopenia (a reduced number of the cells which fight infection making it easier to catch infections); dizziness and tiredness; feeling unsteady or finding it difficult to control movements; feeling or being sick; changes in liver enzyme levels (usually without any symptoms); skin reactions which may be severe.

Common: may affect up to 1 in 10 people:

Changes in the blood including an increased tendency to bruise or bleed; fluid retention and swelling; weight increase; low sodium in the blood which might result in confusion; headache; double or blurred vision; dry mouth.

Uncommon: may affect up to 1 in 100 people:

Abnormal involuntary movements including tremor or tics; abnormal eye movements; diarrhoea; constipation.

Rare: may affect up to 1 in 1,000 people:

Disease of the lymph glands; folic acid deficiency; a generalised allergic reaction including rash, joint pain, fever, problems with the kidneys and other organs; hallucinations; depression; loss of appetite; restlessness; aggression; agitation; confusion; speech disorders; numbness or tingling in the hands and feet; muscle weakness; high blood pressure (which may make you feel dizzy, with a flushed face, headache, fatigue and nervousness); low blood pressure (the symptoms of which are feeling faint, light headed, dizzy, confused, having blurred vision); changes to heart beat; stomach pain; liver problems including jaundice; symptoms of lupus.

Very rare: may affect up to 1 in 10,000:

Changes to the composition of the blood including anaemia; porphyria; meningitis; swelling of the breasts and discharge of milk which may occur in both male and females; abnormal thyroid function tests; osteomalacia (which may be noticed as pain on walking and bowing of the long bones in the legs); osteoporosis; increased blood fat levels; taste disturbances; conjunctivitis; glaucoma; cataracts; hearing disorders; heart and circulatory problems including deep vein thrombosis (DVT), the symptoms of which could include tenderness, pain, swelling, warmth, skin discoloration and prominent superficial veins; lung or breathing problems; severe skin reactions including Stevens- Johnson syndrome (These reactions may be more frequent in patients of Chinese or Thai origin); sore mouth or tongue; liver failure; increased sensitivity of the skin to sunlight; alterations in skin pigmentation; acne; excessive sweating; hair loss; increased hair growth on the body and face; muscle pain or spasm; sexual difficulties which may include reduced male fertility, loss of libido or impotence; kidney failure; blood spots in the urine; increased or decreased desire to pass urine or difficulty in passing urine.

Unknown: frequency cannot be estimated from the available data: Severe skin reactions, accompanied by feeling unwell and changes in blood results. Diarrhoea, abdominal pain, and fever (signs of inflammation of the colon), reactivation of herpes virus infection (can be serious when immune system is depressed), complete loss of nails, fracture, decrease in the measure of the bone density, drowsiness, memory loss, purple or reddish-purple bumps that may be itchy.

Do not be alarmed by this list. Most people take Carbamazepine Tablets without any problems.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store carbamazepine tablets

• Keep this medicine out of the sight and reach of children.
• Do not take this medicine after the expiry date, which is stated on the box and on the blister pack. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationthe active substance is carbamazepine.

100mg: Each uncoated tablet contains 100 mg of carbamazepine. 200mg: Each uncoated tablet contains 200 mg of carbamazepine 400mg: Each uncoated tablet contains 400 mg of carbamazepine The other ingredients are: Microcrystalline cellulose (E460), Povidone (K-30, [E1201]), Croscarmellose sodium (E468), Colloidal anhydrous silica (E551), Magnesium stearate (E572).

What Carbamazepine Tablets look like and contents of the pack

1. What Carbamazepine Tablets are and what they are used for

Carbamazepine, the active ingredient in Carbamazepine Tablets, can affect the body in several different ways. It is an anti-convulsant medicine (prevents fits), it can also modify some types of pain and can control mood disorders.

Carbamazepine is used:

• To treat some forms of epilepsy
• To treat a painful condition of the face called trigeminal neuralgia
• To help control serious mood disorders when some other medicines don’t work.

12. What you need to know before you take Carbamazepine Tablets

• If you are allergic to similar kind of drugs as carbamazepine such as oxcarbazepine (Trileptal), or to any of a related group of drugs known as tricyclic antidepressants (such as amitriptyline or imipramine). If you are allergic to carbamazepine there is a one in four (25%) chance that you could also have an allergic reaction to oxcarbazepine.
• If you have any heart problems.
• If you have ever had problems with your bone marrow.
• If you have a blood disorder called porphyria.
• If you have taken drugs called monoamine oxidase inhibitors (MAOIs), used to treat depression, within the last 14 days.

A small number of people being treated with anti-epileptics such as carbamazepine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Serious skin rashes (Stevens- Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of carbamazepine. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza-like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread blistering and 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 develop a rash or these skin symptoms, stop taking carbamazepine and contact your doctor immediately.

Warnings and precautions

Talk to your doctor or pharmacist before taking Carbamazepine Tablets:

• If you are pregnant or planning to become pregnant.
• If you are breastfeeding.
• If you suffer from the sort of epilepsy where you get mixed seizures which include absences.
• If you have any mental illness.
• If you are allergic to an epilepsy medicine called phenytoin.
• If you have liver problems.
• If you have kidney problems associated with low sodium blood level or you have kidney problems and you are taking certain medicines that lower sodium blood levels (diuretics such as hydrochlorothi­azide, furosemide).
• If you are elderly.
• If you have any eye problems such as glaucoma (increased pressure in the eye) or you have difficulty retaining your urine.

Other medicines and Carbamazepine Tablets

Tell your doctor if you are taking, have recently taken or might take any other medicines, including anything that you have bought from a chemist or health food shop. It may be necessary to change the dose of some medicines, or stop taking something altogether.

Tell the doctor if you are taking:

• Hormone contraceptives, e.g. pills, patches, injections or implants. Carbamazepine affects the way the contraceptive works in your body, and you may get breakthrough bleeding or spotting. It may also make the contraceptive less effective and there will be a risk of getting pregnant. Your doctor will be able to advise you about this, and you should think about using other contraceptives.
• Hormone Replacement Therapy (HRT). Carbamazepine can make HRT less effective.
• Any medicines for depression or anxiety.
• Corticosteroids (‘steroids’). You might be taking these for inflammatory conditions such as asthma, inflammatory bowel disease, muscle and joint pains.
• Anticoagulants to stop your blood clotting.
• Antibiotics to treat infections including skin infections and TB (e.g. ciprofloxacillin).
• Antifungals to treat fungal infections.
• Painkillers containing paracetamol, dextropropoxyphene, tramadol, methadone or buprenorphine.
• Other medicines to treat epilepsy
• Medicines for high blood pressure or heart problems
• Antihistamines (medicines to treat allergy such as hayfever, itch, etc)
• Diuretics (water tablets)
• Cimetidine or omeprazole (medicines to treat gastric ulcers).
• Isotretinoin (a medicine for the treatment of acne)
• Metoclopramide or aprepitant (anti-sickness medications).
• Acetazolamide (a medicine to treat glaucoma – increased pressure in the eye)
• Danazol or gestrinone (treatments for endometriosis)
• Theophylline or aminophylline (used in the treatment of asthma)
• Ciclosporin, tacrolimus or sirolimus (immunosuppressants used after transplant operations, but also sometimes in the treatment of arthritis or psoriasis)
• Drugs to treat schizophrenia (e.g. paliperidone, aripiprazole).
• Cancer drugs (e.g. temsirolimus, cyclophasphamide, lapatinib).
• The anti-malarial drug, mefloquine
• Drugs to treat HIV
• Levothyroxine (used to treat hypothyroidism)
• Tadalafil (used to treat impotence)
• Albendazole (used to treat worms)
• Bupropion (used to help stop smoking)
• A herbal remedy called St John’s Wort or Hypericum
• Drugs or supplements containing Vitamin B (nicotinamide)

Carbamazepine Tablets with food, drink and alcohol

• Drinking alcohol may affect you more than usual. Discuss whether you should stop drinking with your doctor.
• Eating grapefruit, or drinking grapefruit juice, may increase your chance of experiencing side effects.
• Your doctor may want you to have a number of blood tests before you start taking Carbamazepine and from time to time during your treatment. This is quite usual and nothing to worry about.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you do get pregnant while you’re taking Carbamazepine Tablets 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 the foetus. Make sure you are very clear about the risks and the benefits of taking Carbamazepine Tablets.

Mothers taking Carbamazepine Tablets 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, skin reaction or yellow skin and eyes, dark urine or pale stools.

Driving and using machines

Carbamazepine Tablets can make you feel dizzy or drowsy, or may cause blurred vision, double vision, or you may have a lack of muscular coordination, 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.

Carbamazepine Tablets contain sodium

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially sodium-free

3. how to take carbamazepine tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The dose will be on the pharmacist’s label. Check the label carefully. It is important to take the tablets at the right times. If you are not sure, ask your doctor or pharmacist. Keep taking your tablets for as long as you have been told, unless you have any problems. In that case, check with your doctor.

Your doctor will usually start Carbamazepine at a fairly low dose which can then be increased to suit you individually. The dose needed varies between patients. You can take Carbamazepine Tablets during, after or between meals. Swallow the tablets with a drink. You are usually told to take a dose two or three times a day. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

To treat epilepsy the usual doses are:

Adults:

800–1,200 mg a day, although higher doses may be necessary.

If you are elderly you might require a lower dose.

Children:

Aged 5–10 years: 400–600 mg a day

Aged 10–15 years: 600–1,000 mg a day.

Carbamazepine Tablets are not recommended for children under 5.

To treat trigeminal neuralgia the usual dose is:

600–800 mg a day. The maximum dose is 1200 mg a day. If you are elderly you might require a lower dose.

To treat mood swings the usual dose is:

400–600 mg a day

If you forget to take Carbamazepine Tablets

If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose though, just take the next dose and forget about the one you missed.

If you take more Carbamazepine Tablets than you should If you accidentally take too many Carbamazepine Tablets, tell your doctor or your nearest hospital casualty department. Take your medicine pack with you so that people can see what you have taken.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Stop taking Carbamazepine Tablets and tell your doctor straight away if you notice:

• Serious skin reactions such as rash, red skin, blistering of the lips, eyes or mouth, or skin peeling accompanied by fever. These reactions may be more frequent in patients of Chinese or Thai origin
• Mouth ulcers or unexplained bruising or bleeding
• Sore throat or high temperature, or both
• Yellowing of your skin or the whites of your eyes
• Swollen ankles, feet or lower legs
• Any signs of nervous illness or confusion
• Pain in your joints and muscles, a rash across the bridge of the nose and cheeks and problems with breathing (these may be the signs of a rare reaction known as lupus erythematosus)
• Fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be the signs of a multi-organ sensitivity disorder)
• Bronchospasm with wheezing and coughing, difficulty in breathing, feeling faint, rash, itching or facial swelling (these may be the signs of a severe allergic reaction)
• Pain in the area near the stomach

The side effects listed below have also been reported.

Very common: may affect more than 1 in 10 people:

Leucopenia (a reduced number of the cells which fight infection making it easier to catch infections); dizziness and tiredness; feeling unsteady or finding it difficult to control movements; feeling or being sick; changes in liver enzyme levels (usually without any symptoms); skin reactions which may be severe.

Common: may affect up to 1 in 10 people:

Changes in the blood including an increased tendency to bruise or bleed; fluid retention and swelling; weight increase; low sodium in the blood which might result in confusion; headache; double or blurred vision; dry mouth.

Uncommon: may affect up to 1 in 100 people:

Abnormal involuntary movements including tremor or tics; abnormal eye movements; diarrhoea; constipation.

Rare: may affect up to 1 in 1,000 people:

Disease of the lymph glands; folic acid deficiency; a generalised allergic reaction including rash, joint pain, fever, problems with the kidneys and other organs; hallucinations; depression; loss of appetite; restlessness; aggression; agitation; confusion; speech disorders; numbness or tingling in the hands and feet; muscle weakness; high blood pressure (which may make you feel dizzy, with a flushed face, headache, fatigue and nervousness); low blood pressure (the symptoms of which are feeling faint, light headed, dizzy, confused, having blurred vision); changes to heart beat; stomach pain; liver problems including jaundice; symptoms of lupus.

Very rare: may affect up to 1 in 10,000:

Changes to the composition of the blood including anaemia; porphyria; meningitis; swelling of the breasts and discharge of milk which may occur in both male and females; abnormal thyroid function tests; osteomalacia (which may be noticed as pain on walking and bowing of the long bones in the legs); osteoporosis; increased blood fat levels; taste disturbances; conjunctivitis; glaucoma; cataracts; hearing disorders; heart and circulatory problems including deep vein thrombosis (DVT), the symptoms of which could include tenderness, pain, swelling, warmth, skin discoloration and prominent superficial veins; lung or breathing problems; severe skin reactions including Stevens- Johnson syndrome (These reactions may be more frequent in patients of Chinese or Thai origin); sore mouth or tongue; liver failure; increased sensitivity of the skin to sunlight; alterations in skin pigmentation; acne; excessive sweating; hair loss; increased hair growth on the body and face; muscle pain or spasm; sexual difficulties which may include reduced male fertility, loss of libido or impotence; kidney failure; blood spots in the urine; increased or decreased desire to pass urine or difficulty in passing urine.

Unknown: frequency cannot be estimated from the available data: Severe skin reactions, accompanied by feeling unwell and changes in blood results. Diarrhoea, abdominal pain, and fever (signs of inflammation of the colon), reactivation of herpes virus infection (can be serious when immune system is depressed), complete loss of nails, fracture, decrease in the measure of the bone density, drowsiness, memory loss, purple or reddish-purple bumps that may be itchy.

Do not be alarmed by this list. Most people take Carbamazepine Tablets without any problems.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store carbamazepine tablets

• Keep this medicine out of the sight and reach of children.
• Do not take this medicine after the expiry date, which is stated on the box and on the blister pack. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationthe active substance is carbamazepine.

100mg: Each uncoated tablet contains 100 mg of carbamazepine. 200mg: Each uncoated tablet contains 200 mg of carbamazepine 400mg: Each uncoated tablet contains 400 mg of carbamazepine The other ingredients are: Microcrystalline cellulose (E460), Povidone (K-30, [E1201]), Croscarmellose sodium (E468), Colloidal anhydrous silica (E551), Magnesium stearate (E572).

What Carbamazepine Tablets look like and contents of the pack

Carbamazepine Medreich 200mg Tablets: White to off white, round, flat, uncoated tablets with bevelled edges, having one side score line debossed with ‘200’ and plain on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses.

Carbamazepine Medreich 400mg Tablets: White to off white, flat, rod shaped, uncoated tablets with bevelled edges, having score line on both sides. The score line is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses. Carbamazepine Medreich 100mg, 200mg and 400mg Tablets are available in blister packs of 28, 56 and 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK

E-mail :

To listen to or request a copy of this leaflet in Braille, large print or audio please call,

02088311580 (UK only)

Please be ready to give the following information:

Product name

Carbamazepine Medreich 100mg Tablets

Carbamazepine Medreich 200mg Tablets

Carbamazepine Medreich 400mg Tablets

This product is authorized in the Member States of the EEA under the following name(s):

Carbamazepine Medreich 100mg Tablets (United Kingdom, Ireland) Carbamazepine Medreich 200mg Tablets (United Kingdom, Ireland) Carbamazepine Medreich 400mg Tablets (United Kingdom, Ireland)

• 1. What Carbamazepine Tablets are and what they are used for

Carbamazepine, the active ingredient in Carbamazepine Tablets, can affect the body in several different ways. It is an anti-convulsant medicine (prevents fits), it can also modify some types of pain and can control mood disorders.

Carbamazepine is used:

• To treat some forms of epilepsy
• To treat a painful condition of the face called trigeminal neuralgia
• To help control serious mood disorders when some other medicines don’t work.
• If you are allergic to carbamazepine or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include swelling of the face or mouth (angioedema), breathing problems, runny nose, skin rash, blistering or peeling.
• If you are allergic to similar kind of drugs as carbamazepine such as oxcarbazepine (Trileptal), or to any of a related group of drugs known as tricyclic antidepressants (such as amitriptyline or imipramine). If you are allergic to carbamazepine there is a one in four (25%) chance that you could also have an allergic reaction to oxcarbazepine.
• If you have any heart problems.
• If you have ever had problems with your bone marrow.
• If you have a blood disorder called porphyria.
• If you have taken drugs called monoamine oxidase inhibitors (MAOIs), used to treat depression, within the last 14 days.

A small number of people being treated with anti-epileptics such as carbamazepine have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Serious skin rashes (Stevens- Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of carbamazepine. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza-like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread blistering and 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 develop a rash or these skin symptoms, stop taking carbamazepine and contact your doctor immediately.

Warnings and precautions

Talk to your doctor or pharmacist before taking Carbamazepine Tablets:

• If you are pregnant or planning to become pregnant.
• If you are breastfeeding.
• If you suffer from the sort of epilepsy where you get mixed seizures which include absences.
• If you have any mental illness.
• If you are allergic to an epilepsy medicine called phenytoin.
• If you have liver problems.
• If you have kidney problems associated with low sodium blood level or you have kidney problems and you are taking certain medicines that lower sodium blood levels (diuretics such as hydrochlorothi­azide, furosemide).
• If you are elderly.
• If you have any eye problems such as glaucoma (increased pressure in the eye) or you have difficulty retaining your urine.

Other medicines and Carbamazepine Tablets

Tell your doctor if you are taking, have recently taken or might take any other medicines, including anything that you have bought from a chemist or health food shop. It may be necessary to change the dose of some medicines, or stop taking something altogether.

Tell the doctor if you are taking:

• Hormone contraceptives, e.g. pills, patches, injections or implants. Carbamazepine affects the way the contraceptive works in your body, and you may get breakthrough bleeding or spotting. It may also make the contraceptive less effective and there will be a risk of getting pregnant. Your doctor will be able to advise you about this, and you should think about using other contraceptives.
• Hormone Replacement Therapy (HRT). Carbamazepine can make HRT less effective.
• Any medicines for depression or anxiety.
• Corticosteroids (‘steroids’). You might be taking these for inflammatory conditions such as asthma, inflammatory bowel disease, muscle and joint pains.
• Anticoagulants to stop your blood clotting.
• Antibiotics to treat infections including skin infections and TB (e.g. ciprofloxacillin).
• Antifungals to treat fungal infections.
• Painkillers containing paracetamol, dextropropoxyphene, tramadol, methadone or buprenorphine.
• Other medicines to treat epilepsy
• Medicines for high blood pressure or heart problems
• Antihistamines (medicines to treat allergy such as hayfever, itch, etc)
• Diuretics (water tablets)
• Cimetidine or omeprazole (medicines to treat gastric ulcers).
• Isotretinoin (a medicine for the treatment of acne)
• Metoclopramide or aprepitant (anti-sickness medications).
• Acetazolamide (a medicine to treat glaucoma – increased pressure in the eye)
• Danazol or gestrinone (treatments for endometriosis)
• Theophylline or aminophylline (used in the treatment of asthma)
• Ciclosporin, tacrolimus or sirolimus (immunosuppressants used after transplant operations, but also sometimes in the treatment of arthritis or psoriasis)
• Drugs to treat schizophrenia (e.g. paliperidone, aripiprazole).
• Cancer drugs (e.g. temsirolimus, cyclophasphamide, lapatinib).
• The anti-malarial drug, mefloquine
• Drugs to treat HIV
• Levothyroxine (used to treat hypothyroidism)
• Tadalafil (used to treat impotence)
• Albendazole (used to treat worms)
• Bupropion (used to help stop smoking)
• A herbal remedy called St John’s Wort or Hypericum
• Drugs or supplements containing Vitamin B (nicotinamide)

Carbamazepine Tablets with food, drink and alcohol

• Drinking alcohol may affect you more than usual. Discuss whether you should stop drinking with your doctor.
• Eating grapefruit, or drinking grapefruit juice, may increase your chance of experiencing side effects.
• Your doctor may want you to have a number of blood tests before you start taking Carbamazepine and from time to time during your treatment. This is quite usual and nothing to worry about.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you do get pregnant while you’re taking Carbamazepine Tablets 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 the foetus. Make sure you are very clear about the risks and the benefits of taking Carbamazepine Tablets.

Mothers taking Carbamazepine Tablets 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, skin reaction or yellow skin and eyes, dark urine or pale stools.

Driving and using machines

Carbamazepine Tablets can make you feel dizzy or drowsy, or may cause blurred vision, double vision, or you may have a lack of muscular coordination, 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.

Carbamazepine Tablets contain sodium

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially sodium-free

3. how to take carbamazepine tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The dose will be on the pharmacist’s label. Check the label carefully. It is important to take the tablets at the right times. If you are not sure, ask your doctor or pharmacist. Keep taking your tablets for as long as you have been told, unless you have any problems. In that case, check with your doctor.

Your doctor will usually start Carbamazepine at a fairly low dose which can then be increased to suit you individually. The dose needed varies between patients. You can take Carbamazepine Tablets during, after or between meals. Swallow the tablets with a drink. You are usually told to take a dose two or three times a day. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

To treat epilepsy the usual doses are:

Adults:

800–1,200 mg a day, although higher doses may be necessary.

If you are elderly you might require a lower dose.

Children:

Aged 5–10 years: 400–600 mg a day

Aged 10–15 years: 600–1,000 mg a day.

Carbamazepine Tablets are not recommended for children under 5.

To treat trigeminal neuralgia the usual dose is:

600–800 mg a day. The maximum dose is 1200 mg a day. If you are elderly you might require a lower dose.

To treat mood swings the usual dose is:

400–600 mg a day

If you forget to take Carbamazepine Tablets

If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose though, just take the next dose and forget about the one you missed.

If you take more Carbamazepine Tablets than you should If you accidentally take too many Carbamazepine Tablets, tell your doctor or your nearest hospital casualty department. Take your medicine pack with you so that people can see what you have taken.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

Stop taking Carbamazepine Tablets and tell your doctor straight away if you notice:

• Serious skin reactions such as rash, red skin, blistering of the lips, eyes or mouth, or skin peeling accompanied by fever. These reactions may be more frequent in patients of Chinese or Thai origin
• Mouth ulcers or unexplained bruising or bleeding
• Sore throat or high temperature, or both
• Yellowing of your skin or the whites of your eyes
• Swollen ankles, feet or lower legs
• Any signs of nervous illness or confusion
• Pain in your joints and muscles, a rash across the bridge of the nose and cheeks and problems with breathing (these may be the signs of a rare reaction known as lupus erythematosus)
• Fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be the signs of a multi-organ sensitivity disorder)
• Bronchospasm with wheezing and coughing, difficulty in breathing, feeling faint, rash, itching or facial swelling (these may be the signs of a severe allergic reaction)
• Pain in the area near the stomach

The side effects listed below have also been reported.

Very common: may affect more than 1 in 10 people:

Leucopenia (a reduced number of the cells which fight infection making it easier to catch infections); dizziness and tiredness; feeling unsteady or finding it difficult to control movements; feeling or being sick; changes in liver enzyme levels (usually without any symptoms); skin reactions which may be severe.

Common: may affect up to 1 in 10 people:

Changes in the blood including an increased tendency to bruise or bleed; fluid retention and swelling; weight increase; low sodium in the blood which might result in confusion; headache; double or blurred vision; dry mouth.

Uncommon: may affect up to 1 in 100 people:

Abnormal involuntary movements including tremor or tics; abnormal eye movements; diarrhoea; constipation.

Rare: may affect up to 1 in 1,000 people:

Disease of the lymph glands; folic acid deficiency; a generalised allergic reaction including rash, joint pain, fever, problems with the kidneys and other organs; hallucinations; depression; loss of appetite; restlessness; aggression; agitation; confusion; speech disorders; numbness or tingling in the hands and feet; muscle weakness; high blood pressure (which may make you feel dizzy, with a flushed face, headache, fatigue and nervousness); low blood pressure (the symptoms of which are feeling faint, light headed, dizzy, confused, having blurred vision); changes to heart beat; stomach pain; liver problems including jaundice; symptoms of lupus.

Very rare: may affect up to 1 in 10,000:

Changes to the composition of the blood including anaemia; porphyria; meningitis; swelling of the breasts and discharge of milk which may occur in both male and females; abnormal thyroid function tests; osteomalacia (which may be noticed as pain on walking and bowing of the long bones in the legs); osteoporosis; increased blood fat levels; taste disturbances; conjunctivitis; glaucoma; cataracts; hearing disorders; heart and circulatory problems including deep vein thrombosis (DVT), the symptoms of which could include tenderness, pain, swelling, warmth, skin discoloration and prominent superficial veins; lung or breathing problems; severe skin reactions including Stevens- Johnson syndrome (These reactions may be more frequent in patients of Chinese or Thai origin); sore mouth or tongue; liver failure; increased sensitivity of the skin to sunlight; alterations in skin pigmentation; acne; excessive sweating; hair loss; increased hair growth on the body and face; muscle pain or spasm; sexual difficulties which may include reduced male fertility, loss of libido or impotence; kidney failure; blood spots in the urine; increased or decreased desire to pass urine or difficulty in passing urine.

Unknown: frequency cannot be estimated from the available data: Severe skin reactions, accompanied by feeling unwell and changes in blood results. Diarrhoea, abdominal pain, and fever (signs of inflammation of the colon), reactivation of herpes virus infection (can be serious when immune system is depressed), complete loss of nails, fracture, decrease in the measure of the bone density, drowsiness, memory loss, purple or reddish-purple bumps that may be itchy.

Do not be alarmed by this list. Most people take Carbamazepine Tablets without any problems.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store carbamazepine tablets

• Keep this medicine out of the sight and reach of children.
• Do not take this medicine after the expiry date, which is stated on the box and on the blister pack. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.