Tegretol 400mg Prolonged-Release Tablets

Document: leaflet MAH BRAND_PLPI 10256-0508 change

TEGRETOL® 400mg PROLONGED RELEASE TABLETS

(carbamazepine)

PATIENT INFORMATION LEAFLET

The name of your medicine is Tegretol 400mg Prolonged Release tablets. Your medicine will

be referred to as Tegretol Prolonged Release tablets throughout the rest of this leaflet.

What you need to know about Tegretol Prolonged Release Tablets

Your doctor has decided that you need this medicine to help treat your condition.

• Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

• If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

• This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be 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 Tegretol Prolonged Release Tablets are and what they are used for

2. Things to consider before you start to take Tegretol Prolonged Release Tablets

3. How to take Tegretol Prolonged Release Tablets

4. Possible side effects

5. How to store Tegretol Prolonged Release Tablets

6. Further information

1. What Tegretol Prolonged Release Tablets are and what they are

used for

Tegretol Prolonged Release Tablets are specially formulated to release the active ingredient gradually. Carbamazepine, the active ingredient, 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.

Tegretol Prolonged Release Tablets are 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.

2. Things to consider before you start to take Tegretol Prolonged

Release Tablets

Some people MUST NOT take Tegretol Prolonged Release Tablets. Talk to your doctor if:

• you think you may be hypersensitive (allergic) to carbamazepine or similar drugs 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.

• you think you may be allergic to any of the other ingredients of Tegretol Prolonged Release Tablets (these are listed at the end of the leaflet). Signs of a hypersensitivity reaction include swelling of the face or mouth (angioedema), breathing problems, runny nose, skin rash, blistering or peeling.

• you have any heart problems,

• you have ever had problems with your bone marrow,

• you have a blood disorder called porphyria,

• 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.

You should also ask yourself these questions before taking Tegretol Prolonged Release Tablets. If the answer to any of these questions is YES, discuss your treatment with your doctor or pharmacist because Tegretol Prolonged Release Tablets might not be the right medicine for you.

• Are you pregnant or planning to become pregnant?

• Are you breastfeeding?

• Do you suffer from the sort of epilepsy where you get mixed seizures which include absences?

• Do you have any mental illness?

• Are you allergic to an epilepsy medicine called phenytoin?

• Do you have liver problems?

• Do you have kidney problems associated with low sodium blood level or do you have kidney problems and you are taking certain medicines that lower sodium blood levels (diuretics such as hydrochlorothiazide, furosemide?)

• Are you elderly?

• Do you have any eye problems such as glaucoma (increased pressure in the eye) or do you have difficulty retaining your urine?

Are you taking other medicines?

Because of the way that Tegretol works, it can affect, and be affected by, lots of other things that you might be eating or medicines that you are taking. It is very important to make sure that your doctor knows all about what else you are taking. It is very important to make sure your doctor know all about what else you are taking, 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. Tegretol 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). Tegretol 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 medication).

• 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, tracolimus 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).

• Albendozole (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).

Pregnancy and breastfeeding

You must discuss your epilepsy treatment with your doctor well before you become pregnant. If you do get pregnant while you’re taking Tegretol Prolonged Release 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 Tegretol Prolonged Release Tablets.

Mothers taking Tegretol Prolonged Release 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.

Will there be any problems with driving or using machinery?

Tegretol Prolonged Release Tablets can make you feel dizzy or drowsy, or may cause blurred vision, double vision, or you may have a lack of muscular co-ordination, 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.

Other special warnings

• 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 Tegretol and from time to time during your treatment. This is quite usual and nothing to worry about.

3. How to take Tegretol Prolonged Release Tablets

The doctor will tell you how many Tegretol Prolonged Release Tablets to take and when to take them. Always follow his/her instructions carefully. 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 Tegretol at a fairly low dose which can then be increased to suit you individually. The dose needed varies between patients. You can take Tegretol Prolonged Release Tablets during, after or between meals. Swallow the tablets with a drink. Do not chew them. You are usually told to take a dose two or three times a day. If necessary you may break the tablets in half along the scored line.

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.

Tegretol Prolonged Release 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 1200mg 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 What if you forget to take a dose?

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.

POM

What if you take too many tablets?

If you accidentally take too many Tegretol Prolonged Release 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

Tegretol Prolonged Release Tablets do not usually cause problems, but like all medicines, they can sometimes cause side effects.

Some side effects can be serious

Stop taking Tegretol Prolonged Release 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.

More than 1 in 10 people have experienced:

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.

Up to 1 in 10 people have experienced:

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.

Up to 1 in 100 people have reported:

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

Up to 1 in 1,000 people have reported:

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.

Up to 1 in 10,000 people have reported:

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.

The following have also been reported, but the frequency cannot be estimated from the available information.

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 bone density, drowsiness, memory loss, purple or reddish-purple bumps that may be itchy.

Do not be alarmed by this list. Most people take Tegretol Prolonged Release 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: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

Do not take Tegretol Prolonged Release Tablets after the expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking the tablets, please take any unused tablets back to your pharmacist to be destroyed. Do not throw them away with your normal household water or waste. This will help to protect the environment.

6. Further information

Active ingredient:

Each tablet contains 400mg of the active ingredient carbamazepine in a controlled release formulation.

Inactive ingredients:

Carmellose sodium, microcrystalline cellulose, methacrylic acid copolymer, ethylcellulose aqueous dispersion, magnesium stearate, talc, hydroxypropylmethylcellulose, silicon dioxide, polyethoxylated hydrogenated castor oil, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).

Pack size and presentation:

Tegretol Prolonged Release 400mg tablets are available in packs of 30 controlled release tablets (3 blister strips of 10), or in packs of 60 controlled release tablets (6 blister strips of 10 tablets). The tablets are beige-orange in colour, capsule-shaped, with deep score lines on both sides. They are impressed ‘CG’ on one side and ‘ENE’ on the reverse.

This medicine is manufactured by Novartis Pharma AG, CH 4332 Stein, Switzerland and procured within the EU and repackaged by the Product Licence holder Stephar (UK) Limited, 3 Waveney Park, Hewett Road, Great Yarmouth, Norfolk, NR31 0NN

® Tegretol is the trademark of Novartis Pharmaceuticals UK Ltd.

PRODUCT LICENCE NUMBER: -

Tegretol 400mg Prolonged Release tablets - PL 10256/0508

Print Date: xx/xx/xxxx

5. How to store Tegretol Prolonged Release Tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Tegretol Prolonged Release Tablets should be stored in a dry place below 25° C. Protect from moisture.

If your doctor decides to stop treatment, return any remaining tablets to your pharmacist to be destroyed.