TEGRETOL RETARD 200 Milligram Tablets Gastro-Resistant
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-06-2024
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Active ingredient:
CARBAMAZEPINE
Available from:
PCO Manufacturing
INN (International Name):
CARBAMAZEPINE
Dosage:
200 Milligram
Pharmaceutical form:
Tablets Gastro-Resistant
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2012-12-28
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tegretol Retard 200mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One Tegretol Retard 200mg Gastro-resistant tablet contains 200mg carbamazepine
Excipients: Each tablet contains Polyethoxylated castor oil
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
_Product imported from _Poland.
Gastro-resistant, film-coated tablets, beige-orange in colour, oval shaped, slightly biconvex with a score on each size
and imprinted with ‘H/C’ on one side and ‘C/G’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. As an anticonvulsant in the management of epilepsy (generalised tonic – clonic and partial seizure types
2. The paroxysmal pain of trigeminal neuralgia and the lancinating component of other forms of differentiation pain,
for example glossopharyngeal neuralgia, peripheral diabetic neuropathy, tabetic lightning pain, superior laryngeal
neuralgia, stump pain, phantom limb pain and post herpetic neuralgia.
3. Management of alcohol withdrawal symptoms.
4. Treatment of mania and prophylaxis of manic-depressive illness, especially in patients unresponsive to lithium.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Tegretol is given orally, usually in two to four divided doses.
Tegretol may be taken during, after or between meals. The tablets should be taken with a little liquid, e.g. a glass of
water.
1. EPILEPSY:
It is advised that a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the
individual patient. It may be helpful to monitor the plasma concentration of carbamazepine to establish the optimum
dose _(see section 4.4 Special warnings and special precautions for use). _Whenever possible, a
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