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TEGRETAL PROLONGED RELEASE 400MG TABLETS

Active substance(s): CARBAMAZEPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TEGRETOL® PROLONGED RELEASE 400mg TABLETS
(carbamazepine)
This medicine is available as the above name but will be referred to as Tegretol Tablets throughout the rest of this
leaflet. Please note that the leaflet also contains information about other strength (Tegretol® Prolonged Release
200mg Tablets).
What you need to know about Tegretol 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 Tablets are and what they are used for
2. Things to consider before you start to take Tegretol Tablets
3. How to take Tegretol Tablets
4. Possible side effects
5. How to store Tegretol Tablets
6. Further information
1. WHAT TEGRETOL TABLETS ARE AND WHAT THEY ARE USED FOR
Tegretol 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 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 TABLETS
Some people MUST NOT take Tegretol 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 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 Tablets. If the answer to any of these
questions is YES, discuss your treatment with your doctor or pharmacist because Tegretol 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 Tablets work, 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, 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 Tablets affect 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 Tablets 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).
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 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 Tablets.
Mothers taking Tegretol 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 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.

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 Tablets and from
time to time during your treatment. This is quite usual and nothing to worry about.
Important information about an ingredient of Tegretol Prolonged Release Tablets
This medicine contains hydrogenated polyoxyl 40 castor oil which may cause stomach upset and diarrhoea.
3. HOW TO TAKE TEGRETOL TABLETS
The doctor will tell you how many Tegretol 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 Tablets at a fairly low dose which can then be increased to suit you
individually. The dose needed varies between patients. You can take Tegretol 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 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.
What if you take too many tablets?
If you accidentally take too many Tegretol 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 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 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 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 Tegretol 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.
5. HOW TO STORE TEGRETOL TABLETS
• Do not store above 25°C. Protect from moisture.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not use Tegretol Tablets after the expiry date, which is stated on the label, carton and on blister strip.
• 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.
• If the tablets become discoloured or show signs of any deterioration, consult your doctor or pharmacist who will
tell you what to do.
6. FURTHER INFORMATION
What Tegretol Tablets contains
Each film-coated tablet contains 400mg carbamazepine in a prolonged release formulation.
Tegretol Tablets also contain the following: colloidal anhydrous silica, ethylcellulose aqueous dispersion,
microcrystalline cellulose 102, Eudragit ED (copolymer based on polyacrylic esters / methacrylic), magnesium
stearate, carboxymethylcellulose sodium and talc. Coating: cellulose HP-M603 (hydroxypropyl methylcellulose),
hydrogenated polyoxyl 40 castor oil (Cremophor RH 40- glyceryl polyoxyethylene glycol stearate), red iron oxide
(E172), yellow iron oxide (E172), talc and titanium dioxide (E171).
What Tegretol Tablets looks like and contents of the pack
The tablet is oval, slightly biconvex and brownish-orange tablet with a breakline on each side and is coded
‘ENE/ENE” on one side and ‘CG/CG’ on the reverse.
Tegretol Tablets are available as blister packs of 30 or 60 tablets.
PL: 15814/0765
Tegretol Prolonged Release 400mg Tablets
POM
Manufactured by Novartis Farma S.p.A., Via Provinciale Schito, 131 80058 Torre Annunziata, Napoli, Italy OR
Novartis Farma – Produtos Farmacêuticos, S.A., Avenida Professor Doutor Cavaco Silva, n.° 10E Taguspark, 2740255 Porto Salvo, Portugal and procured from within the EU and repackaged by the PL holder: O.P.D. Laboratories
Ltd., Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 19.05.2016.
Tegretol is a registered Trade Mark of Novartis AG, Switzerland.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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