or humans based on conventional studies of single and repeated dose toxicity, local tolerance, genotoxicity and carcinogenic potential. Reproductive toxicity studies in animals were insufficient to rule out a teratogenic effect of carbamazepine in humans.
Carcinogenicity
In rats treated with carbamazepine for two years, there was an increased incidence of hepatocellular tumours in females and benign testicular tumours in males. However, there is no evidence to date that these observations are of any relevance to the therapeutic use of carbamazepine in humans.
Reproductive toxicity
In animals studies in mice, rats and rabbits oral administration of carbamazepine during organogenesis led to increased embryo-fetal mortality and fetal growth retardation at daily doses which were associated with maternal toxicity (above 200mg/kg/day). Carbamazepine was teratogenic in a number of studies, particularly in mice, however showed no or only minor teratogenic potential at doses relevant to humans. In a reproduction study in rats, nursing offspring demonstrated a reduced weight gain at a maternal dosage level of 192 mg/kg/day.
Fertility
In chronic toxicity studies dose related testicular atrophy and aspermatogenesis occurred in rats receiving carbamazepine. The safety margin for this effect is not known.
6. Pharmaceutical particulars
6.1 List of excipients
Tegretol Tablets :
Each uncoated tablet contains aerosil 200 standard, microcrystalline cellulose, nymcel ZSB-10 and magnesium stearate.
6.2 Incompatibilities
None known
6.3 Shelf life
24 months
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package in order to protect from moisture.
6.5 Nature and contents of container
Tegretol 100mg come in PVC/PE/PVDC blister packs of 84 and 100 tablets.
Tegretol 200mg come in PVC/PE/PVDC blister packs of 84 and 100 tablets.
Tegretol 400mg come in PVC/PE/PVDC blister packs of 56.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
None
7. Marketing authorisation holder
Novartis Pharmaceuticals UK Limited
Trading as Geigy Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
England
8. Marketing authorisation number(s)
Tegretol 100mg Tablets :
Tegretol 200mg Tablets :
Tegretol 400mg Tablets :
PL 00101/0461
PL 00101/0462
PL 00101/0463
9. Date of first authorisation/renewal of the authorisation
4 July 1997 / 8 December 2008
10. Date of revision of the text
14 July 2015
Legal category
POM
