3 years.
Not applicable.
Core tablet:
Lactose Monohydrate
Pregelatinized Maize Starch
Microcrystalline Cellulose
Sodium Starch Glycolate (Type A)
Magnesium Stearate
Film-coating:
OPADRY® Yellow1, Carnauba Wax
1OPADRY® contains:
Hypromellose
Macrogol
Polysorbate 80
And as colourants, titanium dioxide E171 and iron oxide yellow E172
In nonclinical studies of fertility, despite maternal and paternal toxicity as low as 8 mg/kg/day, no effects on fertility were observed, in male or female rats with doses up to 100 mg/kg/day.
In preclinical studies, topiramate has been shown to have teratogenic effects in the species studied (mice, rats and rabbits). In mice, fetal weights and skeletal ossification were reduced at 500 mg/kg/day in conjunction with maternal toxicity. Overall numbers of fetal malformations in mice were increased for all drug-treated groups (20, 100 and 500 mg/kg/day).
In rats, dosage-related maternal and embryo/fetal toxicity (reduced fetal weights and/or skeletal ossification) were observed down to 20 mg/kg/day with teratogenic effects (limb and digit defects) at 400 mg/kg/day and above. In rabbits, dosage-related maternal toxicity was noted down to 10 mg/kg/day with embryo/fetal toxicity (increased lethality) down to 35 mg/kg/day, and teratogenic effects (rib and vertebral malformations) at 120 mg/kg/day.
The teratogenic effects seen in rats and rabbits were similar to those seen with carbonic anhydrase inhibitors, which have not been associated with malformations in humans. Effects on growth were also indicated by lower weights at birth and during lactation for pups from female rats treated with 20 or 100 mg/kg/day during gestation and lactation. In rats, topiramate crosses the placental barrier.
In juvenile rats, daily oral administration of topiramate at doses up to 300 mg/kg/day during the period of development corresponding to infancy, childhood, and adolescence resulted in toxicities similar to those in adult animals (decreased food consumption with decreased body weight gain, centrolobullar hepatocellular hypertrophy). There were no relevant effects on long bone (tibia) growth or bone (femur) mineral density, preweaning and reproductive development, neurological development (including assessments on memory and learning), mating and fertility or hysterotomy parameters.
In a battery of in vitro and in vivo mutagenicity assays, topiramate did not show genotoxic potential.
13 December 2017
Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
Do not store above 25°C. Store the tablets in the original package (blister or bottle) to protect from moisture. Keep the bottle tightly closed to protect the tablets from moisture.
Opaque plastic bottle with tamper-evident closure containing 20, 28, 30, 50, 56, 60 or 100 tablets: bundle pack comprising 200 (2 x 100) tablets. In each bottle, there is a desiccant canister which should not be swallowed.
Blister pack of an aluminium/aluminium foil in strips. Pack sizes of 10, 20, 28, 30, 50, 56, 60 or 100 tablets: bundle pack comprising 200 (2 x 100) tablets. Individual (alu/alu) blister strips are packed inside a folding box.
Not all pack sizes may be marketed
PL 00242/0303
No special requirements.
Date of first authorisation: 18 July 1995
Date of last renewal: 30 June 2010
