Skip to Content

TEGRETOL LIQUID 100MG/5ML

Active substance: CARBAMAZEPINE

View full screen / Print PDF » Download PDF ⇩
Transcript
(71)

2. Things to consider before you start to take Tegretol Liquid • Do you have any mental illness?
Package Leaflet: Information for the User

TEGRETOL® 100 mg/5 ml Liquid
(carbamazepine)
What you need to know about Tegretol Liquid
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 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
• 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.

• Isotretinoin (a medicine for the treatment of acne).
• Metoclopramide or aprepitant (anti-sickness medications).
Some people MUST NOT take Tegretol Liquid. Talk to your doctor if:
• Acetazolamide (a medicine to treat glaucoma – increased pressure
• you think you may be hypersensitive (allergic) to carbamazepine
in the eye).
or similar drugs such as oxcarbazepine (Trileptal), or to any of a
• Danazol or gestrinone (treatments for endometriosis).
related group of drugs known as tricyclic antidepressants (such as
amitriptyline or imipramine). If you are allergic to carbamazepine
• Theophylline or aminophylline (used in the treatment of asthma).
there is a one in four (25%) chance that you could also have an
• Ciclosporin, tacrolimus or sirolimus (immunosuppressants, used
allergic reaction to oxcarbazepine.
after transplant operations, but also sometimes in the treatment
• you think you may be allergic to any of the other ingredients of
of arthritis or psoriasis).
Tegretol Liquid (these are listed at the end of the leaflet). Signs of
• Drugs to treat schizophrenia (e.g. paliperidone, aripiprazole).
a hypersensitivity reaction include swelling of the face or mouth
• Cancer drugs (e.g. temsirolimus, cyclophasphamide, lapatinib).
(angioedema), breathing problems, runny nose, skin
• The anti-malarial drug, mefloquine.
rash, blistering or peeling.
Are you taking other medicines?
• Drugs to treat HIV.
• you have any heart problems,
Because of the way that Tegretol works, it can affect, and be affected • Levothyroxine (used to treat hypothyroidism).
• you have ever had problems with your bone marrow,
by, lots of other things that you might be eating or medicines that you • Tadalafil (used to treat impotence).
• you have a blood disorder called porphyria,
are taking. It is very important to make sure that your doctor knows all • Albendazole (used to treat worms).
• you have taken drugs called monoamine oxidase inhibitors
about what else you are taking, including anything that you have bought
(MAOIs), used to treat depression, within the last 14 days.
• Bupropion (used to help stop smoking).
from a chemist or health food shop. It may be necessary to change the
• A herbal remedy called St John’s Wort or Hypericum.
A small number of people being treated with anti-epileptics such as dose of some medicines, or stop taking something altogether.
• Drugs or supplements containing Vitamin B (nicotinamide).
carbamazepine have had thoughts of harming or killing themselves. If
Tell the doctor if you are taking:
at any time you have these thoughts, immediately contact your doctor.
• Hormone contraceptives, e.g. pills, patches, injections or implants. Pregnancy and breastfeeding
Serious skin rashes (Stevens- Johnson syndrome, toxic epidermal
Tegretol affects the way the contraceptive works in your body, and You must discuss your epilepsy treatment with your doctor well
necrolysis) have been reported with the use of carbamazepine.
you may get breakthrough bleeding or spotting. It may also make before you become pregnant. If you do get pregnant while you’re
Frequently, the rash can involve ulcers of the mouth, throat, nose,
the contraceptive less effective and there will be a risk of getting
taking Tegretol Liquid you must tell the doctor straightaway. It is
genitals and conjunctivitis (red and swollen eyes). These serious skin
pregnant. Your doctor will be able to advise you about this, and
important that your epilepsy remains well controlled, but, as with
rashes are often preceded by influenza-like symptoms fever, headache,
you should think about using other contraceptives.
other anti-epilepsy treatments, there is a risk of harm to the foetus.
body ache (flu-like symptoms). The rash may progress to widespread
Make sure you are very clear about the risks and the benefits of
• Hormone Replacement Therapy (HRT). Tegretol can make HRT
blistering and peeling of the skin. The highest risk for occurrence of
taking Tegretol Liquid.
less effective.
serious skin reactions is within the first months of treatment.
• Any medicines for depression or anxiety.
Mothers taking Tegretol Liquid can breastfeed their babies, but you
These serious skin reactions can be more common in people from
must tell the doctor as soon as possible if you think that the baby is
some Asian countries. The risk of these reactions in patients of Han • Corticosteroids (‘steroids’). You might be taking these for
inflammatory conditions such as asthma, inflammatory bowel
suffering side effects such as excessive sleepiness, skin reaction or
Chinese or Thai origin may be predicted by testing a blood sample
disease, muscle and joint pains.
yellow skin and eyes, dark urine or pale stools.
of these patients. Your doctor should be able to advise if a blood
• Anticoagulants to stop your blood clotting.
test is necessary before taking carbamazepine.
Will there be any problems with driving or using machinery?
• Antibiotics to treat infections including skin infections and TB
If you develop a rash or these skin symptoms, stop taking
Tegretol Liquid can make you feel dizzy or drowsy, or may cause
(e.g. ciprofloxacillin).
carbamazepine and contact your doctor immediately.
blurred vision, double vision, or you may have a lack of muscular
• Antifungals to treat fungal infections.
coordination, especially at the start of treatment or when the dose is
You should also ask yourself these questions before taking Tegretol
• Painkillers containing paracetamol, dextropropoxyphene,
changed. If you are affected in this way, or if your eyesight is
Liquid. If the answer to any of these questions is YES, discuss
tramadol, methadone or buprenorphine.
affected, you should not drive or operate machinery.
your treatment with your doctor or pharmacist because Tegretol
• Other medicines to treat epilepsy.
Liquid might not be the right medicine for you.
Other special warnings
• Medicines for high blood pressure or heart problems.
• Are you pregnant or planning to become pregnant?
• Tegretol Liquid contains parahydroxybenzoates as preservative.
• Antihistamines (medicines to treat allergy such as hayfever, itch, etc).
• Are you breastfeeding?
These may cause allergic reactions, which may not appear
• Diuretics (water tablets).
• Do you suffer from the sort of epilepsy where you get mixed
immediately.
5032628 GB
seizures which include absences?
• Cimetidine or omeprazole (medicines to treat gastric ulcers).

5032628_GB.indd 1

13.05.15 15:16

Fabrik Sonntag 4b
D-79183 Waldkirch
Fon +49 76 81/4 93 93-0
novartis@pharma-print-design.de
Live Text:
WO:

X Yes
1393819

Comp. Description:

Leaflet_TEGRETOL_
SYR_2%300ML_GB

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

5032628 GB
5028880 GB
420 x 210 mm
5032628_GB_TS_LFT

Min. Font Size Text:
Font Type:

Version No.: 1

• 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?
• Do you have an intolerance to some sugars? (Tegretol Liquid
contains sorbitol).

No

Both

9 pt

Production Site:
CTM:

France, TPO, Delpharm, Huningue
Kyra Grossmann

Printing Colours:

Pantone 314 C

Technical Colours:

Cutting
Guides
Dimensions

News Gothic MT Pro Bold, Condensed,
Regular

13.05.2015

S. Burger

! PLEASE TURN OVERPRINTING ON !

• 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.

Some side effects can be serious

blood pressure (which may make you feel dizzy, with a flushed face,
headache, fatigue and nervousness); low blood pressure
Stop taking Tegretol Liquid and tell your doctor straight away if
(the symptoms of which are feeling faint, light headed, dizzy,
you notice:
confused, having blurred vision); changes to heart beat; stomach
• Serious skin reactions such as rash, red skin, blistering of the lips,
pain; liver problems including jaundice; symptoms of lupus.
eyes or mouth, or skin peeling accompanied by fever. These
reactions may be more frequent in patients of Chinese or Thai origin Up to 1 in 10,000 people have reported:

• 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 • Yellowing of your skin or the whites of your eyes
to take it. Always follow his/her instructions carefully. The dose will • Swollen ankles, feet or lower legs
be on the pharmacist’s label. Check the label carefully. It is
• Any signs of nervous illness or confusion
important to take the liquid at the right times. If you are not sure, • Pain in your joints and muscles, a rash across the bridge of the
ask your doctor or pharmacist. Keep taking your medicine for as
nose and cheeks and problems with breathing (these may be the
long as you have been told, unless you have any problems. In that
signs of a rare reaction known as lupus erythematosus)
case, check with your doctor.
• Fever, skin rash, joint pain, and abnormalities in blood and liver
function tests (these may be the signs of a multi-organ sensitivity
Your doctor will usually start Tegretol at a fairly low dose which can
disorder)
then be increased to suit you individually. The dose needed varies
between patients. You can take Tegretol Liquid during, after or
• Bronchospasm with wheezing and coughing, difficulty in
between meals. Shake the bottle before you measure out your
breathing, feeling faint, rash, itching or facial swelling (these may
dose. You are usually told to take a dose two or three times a day.
be the signs of a severe allergic reaction)
• Pain in the area near the stomach.
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.

The side effects listed below have also been 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
More than 1 in 10 people have experienced:
Children aged up to and over 1 year: Usually 10–20 mg/kg body
estimated from the available information:
Leucopenia (a reduced number of the cells which fight infection
weight daily in several divided doses. Your doctor will tell you how
Severe skin reactions, accompanied by feeling unwell and changes
making it easier to catch infections); dizziness and tiredness; feeling
much liquid the child should take.
in blood results. Diarrhoea, abdominal pain, and fever (signs of
unsteady or finding it difficult to control movements; feeling or being
inflammation of the colon), reactivation of herpes virus infection
To treat trigeminal neuralgia the usual dose is: 600–800 mg a day. sick; changes in liver enzyme levels (usually without any
(can be serious when immune system is depressed), complete loss of
The maximum dose is 1200mg a day. If you are elderly you might
symptoms); skin reactions which may be severe.
nails, fracture, decrease in the measure of the bone density, drowsiness,
require a lower dose. Once the pain is controlled your doctor will
Up to 1 in 10 people have experienced:
memory loss, purple or reddish-purple bumps that may be itchy.
probably reduce the dose.
Changes in the blood including an increased tendency to bruise or Do not be alarmed by this list. Most people take Tegretol Liquid
To treat mood swings the usual dose is: 400–600 mg a day
bleed; fluid retention and swelling; weight increase; low sodium in
without any problems.
What if you forget to take a dose?
the blood which might result in confusion; headache; double or
If you forget to take a dose, take one as soon as you remember. If it blurred vision; dry mouth.
If any of the symptoms become troublesome, or if you notice
is nearly time for your next dose, though, just take the next dose
anything else not mentioned here, please go and see your doctor.
Up to 1 in 100 people have reported:
and forget about the one you missed.
He/she may want to give you a different medicine.
Abnormal involuntary movements including tremor or tics; abnormal
What if you take too much liquid?
There have been reports of bone disorders including osteopenia and
eye movements; diarrhoea; constipation.
If you accidentally take too much Tegretol Liquid, tell your doctor or
osteoporosis (thinning of the bone) and fractures. Check with your
your nearest hospital casualty department. Take your medicine pack Up to 1 in 1,000 people have reported:
doctor or pharmacist if you are on long-term antiepileptic
Disease of the lymph glands; folic acid deficiency; a generalised
with you so that people can see what you have taken.
medication, have a history of osteoporosis, or take steroids.
allergic reaction including rash, joint pain, fever, problems with the
4. Possible side effects
kidneys and other organs; hallucinations; depression; loss of appetite; Reporting of side effects
Tegretol Liquid does not usually cause problems, but like all
medicines, it can sometimes cause side effects.

restlessness; aggression; agitation; confusion; speech disorders;
numbness or tingling in the hands and feet; muscle weakness; high

5032628_GB.indd 2

X Yes

No

Both

1393819

Comp. Description:

Leaflet_TEGRETOL_
SYR_2%300ML_GB

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

5032628 GB
5028880 GB
420 x 210 mm
5032628_GB_TS_LFT

Min. Font Size Text:
Font Type:

Version No.: 1

5. How to store Tegretol Liquid
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.
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 April 2015.
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.
TEGRETOL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

5032628 GB

13.05.15 15:16

Fabrik Sonntag 4b
D-79183 Waldkirch
Fon +49 76 81/4 93 93-0
novartis@pharma-print-design.de
Live Text:
WO:

If you get any side effects, talk to your doctor or pharmacist. 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.

9 pt

Production Site:
CTM:

France, TPO, Delpharm, Huningue
Kyra Grossmann

Printing Colours:

Cutting
Guides
Dimensions

News Gothic MT Pro Bold, Condensed,
Regular

13.05.2015

Checking against manuscript according to
SOP-0022667. To be signed by AwOps.

Pantone 314 C

Technical Colours:

Approval Box and Ready for Print Box only to be used
in case ArtBase is not used.

S. Burger

! PLEASE TURN OVERPRINTING ON !

Technical approval. To be signed by Manufacturing Site.

Expand view ⇕

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.

Hide