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Assessed against UK PIL dated May 2013


Tegretol 100mg/5ml Liquid


The name of your medicine is Tegretol 100mg/5ml Liquid but will be referred
to as Tegretol Liquid throughout this leaflet.
What you need to know about Tegretol Liquid
Your doctor has decided that you need this medicine to help treat your
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 Liquid is and what it’s used for
2. Things to consider before you start to take Tegretol Liquid
3. How to take Tegretol Liquid
4. Possible side effects
5. How to store Tegretol Liquid
6. Further information
Tegretol Liquid is a white suspension tasting of caramel.
Carbamazepine, the active ingredient in Tegretol Liquid, 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 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
Some people MUST NOT take Tegretol Liquid. 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
- you think you may be allergic to any of the other ingredients of Tegretol
Liquid (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
- 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.

By rajeevkumarj at 9:32 am, Oct 01, 2013

You should also ask yourself these questions before taking Tegretol
Liquid. If the answer to any of these questions is YES, discuss your
treatment with your doctor or pharmacist because Tegretol Liquid
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?
- Are you elderly?
- Do you have any eye problems such as glaucoma (increased pressure in
the eye)?
- Do you have an intolerance to some sugars? (Tegretol Liquid contains
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
- 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
- Anticoagulants to stop your blood clotting.
- Antibiotics to treat infections including skin infections and TB (e.g.
- 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
- 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 Liquid
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 Liquid.
Mothers taking Tegretol Liquid 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 Liquid.
Will there be any problems with driving or using machinery?
Tegretol Liquid 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.

Other special warnings
- Tegretol Liquid contains parahydroxybenzoates as preservative. These
may cause allergic reactions, which may not appear immediately.
- 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.
The doctor will tell you how much Tegretol Liquid to take and when to
take it. 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 liquid at the right times. If you are not sure,
ask your doctor or pharmacist. Keep taking your medicine 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 Liquid during, after or between meals. Shake the
bottle before you measure out your dose. You are usually told to take a
dose two or three times a day.
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 up to and over 1 year: Usually 10–20 mg/kg body weight
daily in several divided doses. Your doctor will tell you how much liquid the
child should take.
To treat trigeminal neuralgia the usual dose is: 600–800 mg a day. Once the
pain is controlled your doctor will probably reduce the 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 much liquid?
If you accidentally take too much Tegretol Liquid, tell your doctor or your
nearest hospital casualty department. Take your medicine pack with you so
that people can see what you have taken.
Tegretol Liquid does not usually cause problems, but like all medicines, it
can sometimes cause side effects.
Some side effects can be serious
Stop taking Tegretol Liquid and tell your doctor straight away if you
- 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)
- Many pus-filled spots usually on red skin and often accompanied by fever
- 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
Do not be alarmed by this list. Most people take Tegretol Liquid
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.
Keep out of the sight and reach of children.

Do not store above 25 C. Store in the original container. Protect from heat
and light. Keep container tightly closed.
Do not take Tegretol Liquid after the expiry date which is printed on the
outside of the pack.
If your doctor tells you to stop taking the medicine, please take any left over
back to your pharmacist to be destroyed. Do not throw it away with your
normal household water or waste. This will help to protect the environment.
If your medicine becomes discoloured or shows any other signs of
deterioration, seek the advice of a pharmacist.
Tegretol Liquid contains 100 mg of the active ingredient, carbamazepine, in
each 5 ml. The liquid also contains polyethylene glycol stearate,
microcrystalline cellulose, carmellose sodium, sorbitol solution 70% (noncrystallising), methyl parahydroxybenzoate, propyl hydroxybenzoate,
saccharin sodium, hydroxyethylcellulose, sorbic acid, propylene glycol,
caramel flavour and purified water.
Tegretol Liquid is a white oral suspension in an amber glass bottle with a
child resistant/tamper evident cap. The bottle contains 250ml of liquid.
Tegretol Liquid is manufactured by Novartis Pharma AG, Postfach 4332,
Stein, Switzerland. Procured from within the EU by Product Licence holder:
Tenolol Ltd., 5 Sandridge Close, Harrow HA1 1XD. Repackaged by
Servipharm Ltd.

PL No: 30900/2064

Leaflet revision and issue date (Ref) 26.09.13[11]
Tegretol is a registered trademark of Novartis AG.

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