Tegretol 100mg/5ml oral suspension

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

CARBAMAZEPINE

Dostępny od:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

Kod ATC:

N03AF01

INN (International Nazwa):

CARBAMAZEPINE 100 mg

Forma farmaceutyczna:

ORAL SUSPENSION

Skład:

CARBAMAZEPINE 100 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTIEPILEPTICS

Status autoryzacji:

Authorised

Data autoryzacji:

2006-07-31

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEGRETOL
® 200MG TABLETS
TEGRETOL
® CR 200 TABLETS
TEGRETOL
® CR 400 TABLETS
TEGRETOL
® 100MG/5ML ORAL SUSPENSION
Carbamazepine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them even if their signs of illness are the same as yours.
-
If you get any side effects, talk to you doctor, pharmacist or
healthcare provider. This
includes any possible side effects not listed in this leaflet. See
section 4.
-
If you have any further questions, ask your doctor, pharmacist or
healthcare provider.
WHAT IS IN THIS LEAFLET
1
What Tegretol is and what it is used for
2
What you need to know before you take Tegretol
3
How to take Tegretol
4
Possible side effects
5
How to store Tegretol
6
Contents of the pack and other information
1
WHAT TEGRETOL IS AND WHAT IT IS USED FOR
WHAT TEGRETOL
®
IS
The name of your medicine is Tegretol. It contains the active
ingredient carbamazepine.
Tegretol belongs to a group of medicines called antiepileptics
(medicine for seizures). Due to its
mode of action it can be used for other diseases too.
WHAT TEGRETOL
®
IS USED FOR
Tegretol is used to treat certain types of seizures (epilepsy). It is
also used to treat some
neurological diseases (such as a painful condition of the face called
‘trigeminal neuralgia’) as
well as certain psychiatric conditions (such as a disorder known as
mania episodes of bipolar
mood disorders and a certain type of depression). It must not be used
for common aches or pains.
Epilepsy is a disorder characterised by two or more seizures (fits).
Seizures occur when
messages from the brain to the muscles are not properly passed on by
the nerve pathways in the
body. Tegretol helps to control the passing-on of these messages.
Tegretol also regulates nerve
functions for the other diseases mentioned above.
2
WHAT

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TEGRETOL
200mg tablets
TEGRETOL
CR 200mg modified-release film-coated tablets
TEGRETOL
CR 400mg modified-release film-coated tablets
TEGRETOL
100mg/5ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: 5H-dibenzo[b,f]azepine-5-carboxamide (carbamazepine)
TABLETS:
200 mg carbamazepine.
CR TABLETS
(modified-release film-coated tablets, divisible)
:
200 mg and 400 mg carbamazepine.
ORAL SUSPENSION:
5 mL (= 1 measure) contain 100 mg carbamazepine.
EXCIPIENT(S) WITH KNOWN EFFECT:
CR 200 MG AND 400 MG:
macrogolglycerol hydroxystearate/castor oil polyoxyl 40 hydrogenated
0.22 mg and 0.44 mg per tablet.
ORAL SUSPENSION:
Sorbitol (E 420) 875 mg per 5 ml, methyl parahydroxybenzoate (E 218)
6.00 mg per 5 ml
propylparahydroxybenzoate (E 216) 1.50 mg per 5 ml and propylene
glycol
(E 1520) 125 mg per 5 ml.
For a full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Tablets
White, round flat tablets with bevelled edges. One side bears the
imprint “CG”, the other
“G/K” and a score.
Modified-release film-coated tablets (CR tablets)
•
CR 200mg: Beige-orange, oval, slightly biconvex. One side debossed
with “H/C”, the
other with “C/G”, both sides are scored.
•
CR 400mg: Brownish-orange, oval, slightly biconvex. One side debossed
with
“ENE/ENE”, the other with “CG/CG”, both sides are scored
Oral suspension (white, viscous suspension)
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Epilepsy
- Complex or simple partial seizures (with or without loss of
consciousness) with or without
secondary generalization.
- Generalized tonic-clonic seizures. Mixed forms of seizures.
Tegretol
®
is suitable for both monotherapy and combination therapy.
Tegretol is usually not effective in absences (petit mal) and
myoclonic seizures (see section 4.4
Special warnings and precautions for use).
•
Acute mania and maintenance treatment of bipolar affective disorders
to prevent or attenuate
recurrenc