What is it and how is it used?
Diacomit belongs to a group of medicines called antiepileptics.
It is used in conjunction with clobazam and valproate to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravet’s syndrome), which affects children. Your child’s doctor has prescribed this medicine to help treat your child’s epilepsy. It should always be taken in combination with other prescribed antiepileptic medicines under the direction of a doctor.
What do you have to consider before using it?
Your child must NOT take Diacomit
• if your child is allergic (hypersensitive) to stiripentol or to any of the other ingredients of Diacomit.
• if your child has ever experienced attacks of delirium.
Using other medicines
If your child needs to use other medicines, please see above “Take special care with Diacomit”.
Please tell your child’s doctor or pharmacist if your child is using or has recently used any other medicines, including medicines obtained without a prescription.
Taking Diacomit with food and drink
Your child should take Diacomit with food, it should NOT be taken on an empty stomach. Do NOT take Diacomit with milk or dairy products (yoghurt, soft cream cheeses, etc), fruit juice, fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks).
Pregnancy
During pregnancy, effective antiepileptic treatment must NOT be stopped. If your child may be or is pregnant, please ask your child’s doctor for advice.
Ask your child’s doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Breast-feeding is not recommended during treatment with this medicine.
Ask your child’s doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may make your child feel sleepy.
Your child should not use any tools, machines, ride or drive if affected in this way. Check with your child’s doctor.
How is it used?
Your child should always take these capsules exactly as your child’s doctor has told you. You should check with your child’s doctor or pharmacist if you are not sure.
Dosage
The dose is adjusted by the doctor according to your child’s condition, generally 50 mg per kg bodyweight and per day.
How to take the Diacomit capsules
These capsules should be swallowed whole with water. The capsules should not be chewed. For food and drinks to be avoided, see the section “Taking Diacomit with food and drink” above.
When to take Diacomit
Your child should take this medicine two or three times a day at regular intervals as directed by your child’s doctor.
Dose adjustment
Any increase in dose should be gradual over 3 days while the dose of the other antiepileptic medicine(s) is reduced at the same time. Your child’s doctor will tell you the new dose of the other antiepileptic medicine(s).
If you have the impression that the effect of this medicine is too strong or too weak, talk to your child’s doctor or pharmacist. The dose will be adjusted by the doctor according to your child’s condition.
Please consult your child’s doctor in the event of any side effects as the doctor may have to adjust the dose of this medicine and the other antiepileptic medicine(s).
There are slight differences between the Diacomit capsules and powder for oral suspension. If your child experiences any problems when switching from taking the capsules to the powder for oral suspension or vice versa please inform your doctor.
If your child takes more Diacomit than he or she should
Contact your child’s doctor if you know or think your child has taken more medicine than he or she should have.
If your child forgets to take Diacomit
It is important that your child takes this medicine regularly at the same time each day. If your child forgets to take a dose, he or she should take it as soon as you remember unless it is time for the next dose. In that case carry on with the next dose as normal. Your child should not take a double dose to make up for a forgotten individual dose.
If your child stops taking Diacomit
Your child must not stop taking this medicine unless the doctor tells you to. Stopping treatment suddenly can lead to an outbreak of seizures.
If you have any further questions on the use of this product, ask your child’s doctor or pharmacist.
What are possible side effects?
Like all medicines, Diacomit can cause side effects, although not everybody gets them.
Very common side effects (more than one in 10 patients):
• loss of appetite, weight loss (especially when combined with the antiepileptic medicine sodium valproate);
• insomnia (sleeplessness), drowsiness;
• ataxia (inability to coordinate muscle movements), hypotonia (low muscle strength), dystonia (muscle disorders).
fatigue tiredness.
To eliminate these side effects, your child’s doctor may have to change the dose of concomitant medicines, or the dosage of Diacomit.
If any of these side effects persists or gets serious, or if you notice any side effects not listed in this leaflet, please tell your child’s doctor or pharmacist.
How should it be stored?
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
