Tegretol 100mg/5ml liquid

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carbamazepine

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

N03AF01

INN (International Name):

Carbamazepine

Dosage:

20mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04080100; GTIN: 5010678450309

Patient Information leaflet

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.
2.
THINGS TO CONSIDER BEFORE YOU START TO TAKE TEGRETOL LIQUID
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%) chanc

Summary of Product characteristics

OBJECT 1
TEGRETOL LIQUID 100 MG/5ML
Summary of Product Characteristics Updated 15-Jan-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Tegretol
®
100mg/5ml Liquid
2. Qualitative and quantitative composition
The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide. The
liquid contains 100mg
carbamazepine Ph.Eur. in each 5ml.
3. Pharmaceutical form
Tegretol Liquid is a white oral suspension.
4. Clinical particulars
4.1 Therapeutic indications
Epilepsy - generalised tonic-clonic and partial seizures.
Note:
Tegretol is not usually effective in absences (petit mal) and
myoclonic seizures. Moreover,
anecdotal evidence suggests that seizure exacerbation may occur in
patients with atypical absences.
The paroxysmal pain of trigeminal neuralgia.
For the prophylaxis of manic-depressive psychosis in patients
unresponsive to lithium therapy.
4.2 Posology and method of administration
Tegretol Liquid is given orally, usually in two or three divided
doses.
Tegretol Liquid (the liquid should be shaken before use) may be taken
during, after or between meals.
Since a given dose of Tegretol Liquid will produce higher peak levels
than the same dose in tablet form, it
is advisable to start with low doses of the liquid and to increase
them slowly so as to avoid adverse effects
on the central nervous system such as dizziness and lethargy.
When switching a patient from tablets to liquid the same overall dose
may be used but in smaller, more
frequent, doses.
Before deciding to initiate treatment, patients of Han Chinese and
Thai origin should whenever possible
be screened for HLA-B*1502 as this allele strongly predicts the risk
of severe carbamazepine-associated
Stevens-Johnson syndrome (See information on genetic testings and
cutaneous reactions in section 4.4).
_Epilepsy:_
The dose of carbamazepine should be adjusted to the needs of the
individual patient to achieve adequate
control of seizures. Determination of plasma levels may help in
establishing the optimum dosage. In the
treatment of epilepsy, the dose