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OSPOLOT is indicated: • As an anticonvulsant for behavioural disorders associated with epilepsy; hyperkinetic behaviour; temporal lobe epilepsy; myoclonicseizures; grand mal attacks; Jacksonian seizures.


Adverse reactions:

More common reactions: Ataxia, paraesthesia of the face and extremities, hyperpnoea, dyspnoea, anorexia.


Alcohol must not be consumed during treatment. The concomitant use of sulthiame and primidone may lead to severe side-effects, including psychotic reactions. The addition of sulthiame to pre-existing phenytoin therapy has shown to be followed by a rise in the serum levels of phenytoin. It has been suggested that this may be due to either to inhibition by sulthiame of the hydroxylation of phenytoin or to displacement of phenytoin from a storage site by sulthiame. Phenytoin dosage may need to be reduced when sulthiame is added. Sulthiame may also induce a rise in the serum level of phenobarbitone. Sulthiame may interfere with the estimation of barbiturates in laboratory tests on blood.


Suicidal Behaviour and Ideation: Antiepileptic drugs, including sulthiame, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication. Patients treated with any antiepileptic drug (AED) for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, and/ or any unusual changes in mood or behaviour. Use in Pregnancy The risk of a mother with epilepsy giving birth to a baby with an abnormality is about three times that of the normal population. Some of this risk is due to the anticonvulsant drugs taken. Mothers taking more than one anticonvulsant drug might have a higher risk of having a baby with a malformation than mothers taking one drug. There is a lack of data permitting any statement that women taking sulthiame are at any different risk of having a baby with an abnormality from women taking other anticonvulsants. Overall, the risk of having an abnormal child is far outweighed by the dangers to the mother and foetus of uncontrolled convulsions. If administered during pregnancy the dose of sulthiame must be kept as low as possible, particularly between days 20 and 40 of gestation. Use in Lactation It is not known whether sulthiame is excreted in breast milk nor whether it has a harmful effect on the newborn. Therefore, it is not recommended for nursing mothers unless the expected benefits outweigh any potential risk.



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