Novartis Pharmaceuticals UK Ltd

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml of the oral suspension contains 60 mg oxcarbazepine.

Excipients: Each ml also contains 0.30 mg propylparahydroxybenzoate (E216), 1.20 mg methylparahydroxybenzoate (E218), 250 mg sorbitol 70 % liquid (non crystallising) and 0.9 mg ethanol.

For a full list of excipients, see section 6.1.

6.1.      List of excipients

Propyl parahydroxybenzoate (E 216)

Ssaccharin sodium

Ssorbic acid (E 200)

Mmacrogol stearate 400

Mmethyl parahydroxybenzoate (E 218)

Yyellow-plum-lemon flavour (containing ethanol)

aAscorbic acid (E 300)

Ddispersible cellulose (containing microcrystalline cellulose and carmellose sodium)

Ppropylene glycol

Ssorbitol 70% liquid (non-crystallising)

Wwater purified.

Ethanol is a component of the flavour.

Update to section 4.4:
Hypersensitivity
Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, angioedema and reports of anaphylaxis have been received in the post-marketing period.  Cases of anaphylaxis and angioedema involving the larynx, glottis, lips and eyelids have been reported in patients after taking the first or subsequent doses of Trileptal.  If a patient develops these reactions after treatment with Trileptal, the drug should be discontinued and an alternative treatment started.

Update to section 4.6 - rewording of the sentence:

Determination of changes in MHD plasma concentrations should be considered.

Update to section 4. 8. Additional info listed:

Unknown: decrease in T4 (with unclear clinical significance)

Section 4.4 Special warnings and precautions for use

Addition of the paragraph to the Hypersensitivity section:

Hypersensitivity

Section 4.6 Pregnancy and lactation

Addition of the following paragraph:

Data from a limited number of women indicate that plasma levels of the active metabolite of oxcarbazepine, the 10-monohydroxy derivative (MHD), may gradually decrease throughout pregnancy. It is recommended that clinical response should be monitored carefully in women receiving Trileptal treatment during pregnancy to ensure that adequate seizure control is maintained, and if necessary determination of changes in MHD plasma concentrations should be considered. If dosages have been increased during pregnancy, postpartum MHD plasma levels may also be considered for monitoring.

Section 4.8 Undesirable effects

This section has been updated to include hypertension, hyperthyroidism and anaphylactic reactions.

Section 5.2 Pharmacokinetic properties

Addition of the following paragraph:

Pregnancy

Data from a limited number of women indicate that MHD plasma levels may gradually decrease throughout pregnancy (see section 4.6).

Suicidal behaviour

Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomized placebo controlled trials of antiepileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for oxcarbazepine.