TEGRETOL 125 Milligram Suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CARBAMAZEPINE

Available from:

Novartis Pharmaceuticals UK Ltd

INN (International Name):

CARBAMAZEPINE

Dosage:

125 Milligram

Pharmaceutical form:

Suppositories

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

TEGRETOL
®
 125MG SUPPOSITORIES
TEGRETOL
®
 250MG SUPPOSITORIES
CARBAMAZEPINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS 
MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions please ask your doctor or 
pharmacist.
This medicine has been prescribed only for you. Do not use it 
for any other illness; do not pass it on to others. It may harm 
them, even if their signs of illness are the same as yours.
If any of the side effects affects you severely, or if you notice 
any side effects not listed in this leaflet, please tell your doctor 
or pharmacist.
IN THIS LEAFLET
1  What Tegretol Suppositories is and what it is used for
2  Before you take Tegretol Suppositories
3  How to take Tegretol Suppositories
4  Possible side effects
5  Storing Tegretol Suppositories
6  Further information
The name of your medicine is Tegretol Suppositories. It contains 
the active ingredient carbamazepine. 
Tegretol Suppositories also have inactive ingredients: 
hypromellose and hard fat. 
These suppositories are white or off-white in colour and are 
available in two strengths. The lower dose contains 125mg 
carbamazepine and weighs approximately 1g, and the higher 
dose contains 250mg carbamazepine and weighs 
approximately 2g.
There are five Tegretol Suppositories in each pack.
MARKETING AUTHORISATION HOLDER
Novartis Pharmaceuticals UK Limited, Frimley Business Park, 
Frimley,
 Camberley, Surrey GU16 7SR, United Kingdom.
MANUFACTURER
Novartis Pharmaceuticals UK Limited, Frimley Business Park, 
Frimley,
 Camberley, Surrey GU16 7SR, United Kingdom.
PRODUCT AUTHORISATION NUMBER: 13/81/7-8
1  WHAT TEGRETOL SUPPOSITORIES IS AND WHAT IT IS USED FOR
Tegretol Suppositories 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. Tegretol Suppositories is used 
to treat certain types of seizures (epilepsy). It is also used to 
treat some neurological disea

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tegretol 125mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 125 mg carbamazepine
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Suppository
White to off-white, torpedo shaped suppositories with a fatty odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anticonvulsant in the management of epilepsy (generalised tonic-clonic and partial seizures).
Tegretol suppositories are for short-term use as replacement therapy in patients where oral treatment is temporarily not
possible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tegretol is available in suppositories, for short term use. They are intended as replacement therapy (maximum period
recommended: 7 days) in patients for whom oral treatment is temporarily not possible, for example in post-operative
patients.
When switching from oral formulations of Tegretol to suppositories the dosage should be increased by approximately
25% (the 125mg and 250mg suppositories correspond to the 100 and 200mg tablets respectively).
The final dose adjustment should always depend on the clinical response in the individual patient. Tegretol
suppositories, in appropriate doses, have been shown to provide plasma levels which are well within the therapeutic
range.
The pharmacokinetic properties of the suppositories are such that the maximum daily dose is limited to 1000mg
(250mg four times daily at 6 hourly intervals).
_Use in the elderly_
Due to the potential for drug interactions, the dosage of Tegretol should be selected with caution in elderly patients.
_Use in paediatric patients_
Tegretol suppositories are not recommended for very young children.
SPECIAL POPULATIONS
RENAL IMPAIRMENT / HEPATIC IMPAIRMENT
No data are available on the