TEGRETOL RETARD 200MG FILM COATED TABLETS

Active substance: CARBAMAZEPINE

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Tegretol® Retard 200mg Film-coated Tablets
Tegretol® CR 200mg Film-coated Tablets
(carbamazepine)
Your medicine is known by one of the above names, but will be referred to
as Tegretol CR Tablets throughout this:
Patient Information Leaflet
What you need to know about Tegretol CR 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 CR Tablets are and what they are used for
2) Things to consider before you start to take Tegretol CR Tablets
3) How to take Tegretol CR Tablets
4) Possible side effects
5) How to store Tegretol CR Tablets
6) Further information

1) What Tegretol CR Tablets are and what they are used for
Tegretol CR 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 CR 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 CR
Tablets
Some people MUST NOT take Tegretol CR 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
CR 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.







Do you have any mental illness?
Are you allergic to an epilepsy medicine called phenytoin?
Do you have liver problems?
Are you elderly?
Do you have any eye problems such as glaucoma (increased pressure
in the eye)?

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, 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 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).
• Muscle relaxant drugs.
• 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 CR
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 CR Tablets.
Mothers taking Tegretol CR 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 or skin reactions
because you are taking Tegretol CR Tablets.

If you develop a rash or these skin symptoms, stop taking carbamazepine
and contact your doctor immediately.

Will there be any problems with driving or using machinery?
Tegretol CR Tablets 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.

You should also ask yourself these questions before taking Tegretol
CR Tablets. If the answer to any of these questions is YES, discuss
your treatment with your doctor or pharmacist because Tegretol CR
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?

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.



Tegretol CR Tablets contain hydrogenated castor oil, which may cause
stomach discomfort and diarrhoea.

3) How to take Tegretol CR Tablets
The doctor will tell you how many Tegretol CR 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 CR 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.

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.

Tegretol CR Tablets are not recommended for children under 5.
To treat trigeminal neuralgia the usual dose is: 600-800 mg a day.
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 CR 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 CR 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 CR 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

Do not be alarmed by this list. Most people take Tegretol CR 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.

5) How to store Tegretol CR Tablets







Do not use after the expiry date printed on the carton, or blister label.
Do not store above 25°C. Protect from moisture. Store in the original
package.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking these tablets, please take it back
to the pharmacist for safe disposal. Only keep it if your doctor tells you
to.
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 shows any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.

6) Further information
What Tegretol CR Tablets contains:
Each film-coated tablet contains 200mg of the active ingredient
carbamazepine in a modified release formulation.
The tablets also contain the following inactive ingredients: colloidal
anhydrous silica, ethylcellulose, cetyl alcohol, sodium laurylsulfate,
microcrystalline
cellulose,
polyacrylate,
magnesium
stearate,
croscarmellose sodium, talc, hypromellose, hydrogenated castor oil,
macrogol, red iron oxide (E172), yellow iron oxide (E172) and titanium
dioxide (E171)
What Tegretol CR Tablets looks like and contents of the pack
Tegretol Retard 200mg Tablets are beige-orange, oval, slightly biconvex,
coated tablets with a score on each side. One side bears the imprint “H/C”,
the other “C/G”.
Tegretol Retard 200mg Tablets are available as blister packs of 50 tablets.
PL 10383/1582

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Novartis Farma SpA, 180058 Torre
Annunziata, Italy. Procured from within the EU and repackaged by Product
Licence Holder Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road,
Northolt, Middlesex, UB5 5QS.
Leaflet date: 11.11.2013
®

Tegretol is a trademark of Novartis AG, Basle, Switzerland.

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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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