TEGRETOL LIQUID 100MG/5ML

Active substance: CARBAMAZEPINE

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2. Things to consider before you start to take Tegretol Liquid
Some people MUST NOT take Tegretol Liquid. Talk to your doctor if:

Package Leaflet: Information for the User








TEGRETOL® 100 mg/5 ml Liquid
(carbamazepine)

What you need to know about Tegretol Liquid

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 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
peeling.

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.

• you have any heart problems,
• you have ever had problems with your bone marrow,

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

• 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.

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.

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.

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.

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.

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

1. What Tegretol Liquid is and what it’s used for
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

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
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.

• 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.

• 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
sorbitol).
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.
•  ntibiotics to treat infections including skin infections and TB
A
(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).

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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).
C
 iclosporin, 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 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.

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PANTONE 314 C

5025468 GB
5023695 GB 12 A/H
Leaflet_TEGRETOL INC.CR/XR_SYR_2%
300ML_GB
GB
144

Cutting, Dimensions

Laetuscode

Edge Marks: 5 x 2 mm
N/A

420 x 210 mm

Delpharm

5025468_GB_TS_LFT

02/07/2013
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1. Proof








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9pt
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SGS Number: 450722_0

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Some side effects can be serious

• Eating grapefruit, or drinking grapefruit juice, may increase your
chance of experiencing side effects.

• Mouth ulcers or unexplained bruising or bleeding
• Sore throat or high temperature, or both

3. How to take Tegretol Liquid
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.

Up to 1 in 10,000 people have reported:

• Yellowing of your skin or the whites of your eyes

• 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.

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.

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.

Stop taking Tegretol Liquid 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

• 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)

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.

• 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,

To treat epilepsy the usual doses are:

feeling faint, rash, itching or facial swelling (these may be the signs
of a severe allergic reaction)

Adults: 800-1,200 mg a day, although higher doses may be necessary. If
you are elderly you might require a lower dose.

• Pain in the area near the stomach.
The side effects listed below have also been reported.

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.

More than 1 in 10 people have experienced:

To treat mood swings the usual dose is: 400-600 mg a day

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.

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.

What if you forget to take a dose?

Up to 1 in 10 people have experienced:

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.

Do not be alarmed by this list. Most people take Tegretol Liquid without
any problems.

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.

Keep out of the reach and sight of children.
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.

6. Further information
Tegretol Liquid contains 100 mg of the active ingredient,
carbamazepine, in each 5 ml. The liquid also contains the inactive
ingredients Cremophor S9, Avicel RC581, sorbitol solution, saccharin
sodium, Natrosol 250g, methyl and propyl hydroxybenzoate, sorbic acid,
propylene glycol, caramel flavour (E150) and purified water.
The bottle contains 300 ml of liquid.
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley,
Camberley, Surrey GU16 7SR, England.
Manufacturer
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road, Horsham, West
Sussex, RH12 5AB, England, United Kingdom and Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, England, United Kingdom.
This leaflet was revised in May 2013.

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.

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.

What if you take too much liquid?

Abnormal involuntary movements including tremor or tics; abnormal eye
movements; diarrhoea; constipation.
Up to 1 in 1,000 people have reported:

5. How to store Tegretol Liquid

Tegretol Liquid does not usually cause problems, but like all medicines,
it can sometimes cause side effects.

Disease of the lymph glands; folic acid deficiency; a generalised allergic
reaction including rash, joint pain, fever, problems with the kidneys and

Do not store above 30°C. Keep the bottle tightly closed between doses.
Keep the bottle in the outer carton in order to protect from light.

TEGRETOL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

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.

4. Possible side effects

If you would like any more information, or would like the leaflet in
a different format, please contact Medical Information at Novartis
Pharmaceuticals UK Ltd, telephone number 01276 698370.

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.

Up to 1 in 100 people have reported:

5025468_GB_p1_LFT.indd 2

02/07/2013 10:51

The Maltings

824972 / Hauser, Sascha

PANTONE 314 C

5025468 GB
5023695 GB 12 A/H
Leaflet_TEGRETOL INC.CR/XR_SYR_2%
300ML_GB
GB
144

Cutting, Dimensions

Laetuscode

Edge Marks: 5 x 2 mm
N/A

420 x 210 mm

Delpharm

5025468_GB_TS_LFT

02/07/2013
News Gothic Bold, News Gothic MT, News Gothic MT Bold

1. Proof

5025468 GB

K.Jerrum

9pt
Smallest code font size: 6pt
N/A

SGS Number: 450722_0

Page 2/2

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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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