Diacomit 500 mg powder for oral suspension in sachets

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.

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.

Take special care with Diacomit if your child has kidney or liver problems. if your child is using medicines containing --------- cisapride used to treat symptoms of night time heartburn pimozide used to treat the symptoms of Tourettes syndrome e.g. vocal outbursts and uncontrolled, repeated movements of the body ergotamine used to treat migraine dihydroergotamine used to relieve the signs and symptoms of decreased mental capacity due to the aging process halofantrine an antimalarial drug quinidine used to treat abnormal heart rhythms bepridil used to control chest pain cyclosporine, tacrolimus, sirolimus all three used to prevent rejections of liver, kidney and heart transplants statins simvastatin and atorvastatin, both used to reduce the amount of cholesterol in blood.

---if your child uses one of the following products antiepileptic medicines containing phenobarbital, primidone, phenytoin, carbamazepine, diazepam. medicines containing midazolam or triazolam drugs used to reduce anxiety and sleeplessness in combination with Diacomit they may make your child very sleepy chlorpromazine used for mental illness such as psychosis. medicines, beverages and foods containing caffeine or theophylline these substances help restore mental alertness. The combination with Diacomit should be avoided as it may increase their blood levels, leading to digestive disorders, racing heart and insomnia.

If your child has problems with certain ingredients of Diacomit (e.g. aspartame, glucose, sorbitol). In this case, please see below: ?Important information about some of the ingredients of Diacomit?.

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.

Important information about some of the ingredients of Diacomit

Contains a source of phenylalanine. May be harmful for people with phenylketonuria. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Your child should always take the contents of each sachet 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 powder for oral suspension

The powder should be mixed in a glass of water and should be taken immediately after mixing during the meal. 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.

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).

Common side effects (between one in 100 patients and one in 10 patients):
? raised levels of liver enzymes, especially when given with either of the antiepileptic medicines carbamazepine and sodium valproate;
? aggressiveness, irritability, agitation, hyperexcitability (state of being unusually excitable);

sleep disorders abnormal sleeping hyperkinesis exaggerated movements nausea, vomiting a low number of a type of white blood cells.

Uncommon side effects between one in 1,000 patients and one in 100 patients double vision when used in combination with the antiepileptic medicine carbamazepine sensitivity to light rash, skin allergy, urticaria pinkish, itchy swellings on the skin 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.

Keep out of the reach and sight of children. Your child should not take Diacomit after the expiry date, which is stated on the label. The expiry date refers to the last day of that month. Store in the original package in order to protect from light.

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.

What Diacomit 250 mg contains

? The active substance is stiripentol. Each sachet contains 250 mg of stiripentol. ? The other ingredients in this medicine are povidone K29/32, sodium starch glycolate type A, glucose liquid (spray dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.

What Diacomit 500 mg contains

? The active substance is stiripentol. Each sachet contains 500 mg of stiripentol. ? The other ingredients in this medicine are povidone K29/32, sodium starch glycolate type A, glucose liquid (spray dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.

What Diacomit 250 mg looks like and contents of the pack

This medicine is a pale pink powder supplied in sachets.
Cartons contain either 30, 60, or 90 sachets. Not all pack sizes may be marketed. Diacomit is also available as 250 mg and 500 mg capsules for oral use and 500 mg powder for oral suspension in sachets.

What Diacomit 500 mg looks like and contents of the pack

This medicine is a pale pink powder supplied in sachets.
Cartons contain either 30, 60, or 90 sachets. Not all pack sizes may be marketed. Diacomit is also available as 250 mg and 500 mg capsules for oral use and 250 mg powder for oral suspension in sachets.

Marketing Authorisation Holder

Biocodex
7 avenue Gallieni - 94250 Gentilly - France
Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr

Manufacturer

Biocodex
1 avenue Blaise Pascal - F-60000 Beauvais - France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
AT/BE/BG/CZ/CY/EE/EL/ES/FR/HU/IE/IS/IT/LT/LU/LV/MT/NL/PL/PT/RO/SI/SK/UK Biocodex
7 avenue Gallieni - F-94250 Gentilly
Tél/Tel.: + 33 (0)1 41 24 30 00
e-mail: webar@biocodex.fr

DE

Desitin Arzneimittel GmbH
Weg beim Jäger 214
D-22335 Hamburg
Tel: +49 (0)40 59101 525
e-mail: epi.info@desitin.de

DK

Desitin Pharma AS
Havnegade 55, st. tv.
1058 Kopenhagen K
Denmark
Tel: 0045-33-73 00 73
e-mail: desitin@desitin.dk

NO

Desitin Pharma AS
Niels Leuchs vei 99
1359 Eiksmarka
Norway
Tel: 0047 67 15 92 30
e-mail: firmapost@desitin.no

FI/SE

Desitin Pharma AB
Krokslätts Torg 5
43137 Mölndal
Sweden
Tel: 0046-31-20 23 10
e-mail: info@desitin.se

This leaflet was last approved in

This medicine has been given ?conditional approval?. This means that there is more definitive evidence to come about this medicine for the treatment of this form of epilepsy when stiripentol is used in conjunction with clobazam and valproate. The European Medicines Agency (EMA) will review new information on the medicine every year and this leaflet will be updated as necessary.

Detailed information on this medicine is available on the European Medicine Agency (EMA) website: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

12 Areas Quality, Non-clinical, Clinical, Pharmacovigilance Due date for the follow-up measure or for the first interim report if a precise date cannot be committed t