Diacomit - patient leaflet, side effects, dosage

1. What Diacomit is and what it is used for

Stiripentol, the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics.

It is used in conjunction with clobazam and valproate (other antiepileptic medicines) 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.

2. What you need to know before your child takes Diacomit

Your child must NOT take Diacomit

• if your child is allergic to stiripentol or to any of the other ingredients of this medicine (listed in

section 6).

• if your child has ever experienced attacks of delirium (a mental state with confusion,

excitement, restlessness and hallucinations).

Warnings and precautions

Talk to your child’s doctor or pharmacist before taking Diacomit

• if your child has kidney or liver problems.
• Your child’s liver function should be assessed prior to starting Diacomit and checked every 6

months.

• Your child’s blood count should be assessed prior to starting Diacomit and checked every 6

months.

• Because the frequency of gastrointestinal side effect with Diacomit, clobazam and valproate,

such as anorexia, loss of appetite, vomiting, your child’s growth rate should be carefully monitored.

Other medicines and Diacomit

Tell your child’s doctor or pharmacist if your child is using, has recently used or might use any other medicines.

Tell your doctor if your child is taking any of the following medicines:

• medicines containing:

• – cisapride (used to treat symptoms of night-time heartburn);

• – pimozide (used to treat the symptoms of Tourette's 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 treatment);

• – 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).

• - antiepileptic medicines containing:

phenobarbital, primidone, phenytoin, carbamazepine, diazepam.

• - medicines containing:

midazolam or triazolam (medicines used to reduceand- in combination with Diacomit they may make your child very sleepy);

chlorpromazine (used for mental illness such as psychosis).

• - If your child takes medicines containing:

caffeine (this substance helps restore mental alertness) or theophylline (this substance is used in case of asthma). 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 takes medicines metabolized by certain liver enzymes:

• – citalopram (used in the treatment of depressive episodes);

• – omeprazole (used in case of gastric ulcer);

• – HIV protease inhibitors (used in the treatment of HIV);

• – astemizole, chlorpheniramine (antihistamines);

• – calcium channel blockers (used in the treatment of angor or troubles of heart rhythm);

• – oral contraceptives;

• – propranolol, carvedilol, timolol (used in the treatment of high blood pressure);

• – fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants) ;

• – haloperidol (antipsychotics);

• – codeine, dextromethorphan, tramadol (used in the treatment of pain).

Diacomit with food and drink

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 and breast-feeding

If your child is pregnant or breast-feeding, think she may be pregnant or is planning to have a baby, ask your doctor for advice before taking this medicine.

During pregnancy, effective antiepileptic treatment must NOT be stopped.

Breast-feeding is not recommended during treatment with this 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.

Diacomit contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. How to take Diacomit

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 age, weight and condition, generally 50 mg per kg bodyweight and per day.

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, for example morning – noon – bedtime to cover the night-and-day period.

Dose adjustment

Dose increases should be gradual, taking place over a few weeks while the dose(s) of the other antiepileptic medicine(s) is (are) 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.

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. In case of switch between capsule and powder formulations it should be done under the close supervision of your child’s doctor.

In case of vomiting within the first few minutes of intake it is assumed that no medicine has been absorbed and a new dose should be given.

However, the situation is different if the vomiting occurs more than one hour after medicine intake because stiripentol is quickly absorbed.

In such a case, it is assumed that a significant fraction of the administered dose has been absorbed systemically from the digestive tract. Thus, there would be no need for a new intake or for an adjustment of the next dose.

How to take the Diacomit capsules

To ensure that the whole amount of powder is taken by the patient, it is preferable not to open the capsule and to swallow it as a single oral administration unit form. Your child should take Diacomit with food, it should NOT be taken on an empty stomach. For food and drinks to be avoided, see the section “Diacomit with food and drink” above.

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 medicine, ask your child’s doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than one in 10 people):

• 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

(involuntary muscle contractions).

Common side effects (may affect up to 1 in 10 people):

• 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 (may affect up to 1 in 100 people):

• 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).

Rare side effects (may affect up to 1 in 1,000 people)

• decrease of platelet level in the blood;
• abnormal liver function test.

To eliminate these side effects, your child’s doctor may have to change the dose of Diacomit or one of the other medicines prescribed for your child.

Reporting of side effects

If your child gets any side effects, talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diacomit

• Keep this medicine out of the sight and reach of children.
• Your child should not take Diacomit after the expiry date, which is stated on the label after “EXP”. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Diacomit 100 mg contains

• The active substance is stiripentol. Each hard capsule contains 100 mg of stiripentol.
• The other ingredients of the capsule are povidone, sodium starch glycolate and magnesium stearate (E470b).
• The capsule shell is made of gelatin, titanium dioxide (E171), erythrosine (E127), indigotin (E132).

What Diacomit 100 mg looks like and contents of the pack

Diacomit 100 mg hard capsule is white/pink and imprinted with “Diacomit 100 mg”.

The hard capsules are supplied in plastic bottles containing 100 capsules in cardboard cartons.

Marketing Authorisation Holder

Biocodex, 7 avenue Gallieni – F-94250 Gentilly – France

Tel: + 33 1 41 24 30 00 – e-mail:

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/CY/E­L/ES/FR/HR/HU/I­E/IS/IT/LU/MT/NL/PL/PT/SI

Biocodex

7 avenue Gallieni – F-94250 Gentilly

OpaH^ua/ raXXia/ France/ Francia/ Franciaorszag/ Frakkland/ Francija/ Franza/ Frankrijk/ Francja

Tel/Tel/Ten/T­qX/Simi: + 33 (0)1 41 24 30 00

e-mail:

CZ

Desitin Pharma spol. s r.o

Opletalova 25

11121 Prague 1

Czech Republic

Tel: 00420–2–222 45 375

e-mail:

DE

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Germany

Tel: +49 (0)40 59101 525

e-mail:

DK

Biocodex Oy

Metsänneidonkuja 8

02130 Espoo

Finland

Tel: +358 9 329 59100

e-mail:

EE

Biocodex OÜ

Väike-Paala 1

11415 Tallinn

Estonia

Tel: +372 605 6014

e-mail:

FI

Biocodex Oy

Metsänneidonkuja 8

02130 Espoo

Finland

Tel: +358 9 329 59100

e-mail:

LT

Biocodex UAB

Savanor@ av. 349

LT-51480 Kaunas

Lithuania

Tel: +370 37 408681

e-mail:

LV

Biocodex SIA

Kalnini A, Märupes nov.,

Märupe, LV-2167

Latvia

Tel: +371 67 619365

e-mail:

NO

Biocodex AS

C/O regus Lysaker

Lysaker Torg 5, 3 etg

NO-1366 Lysaker

Norway

Tel: +47 66 90 55 66

e-mail:

RO

Desitin Pharma s.r.l

Sevastopol street, no 13–17

Diplomat Business Centre, office 102

Sector 1, 010991 Bucharest

Romania

Tel: 004021–252–3481

e-mail:

SE

Biocodex AB

Knarrnäsgatan 7

164 40 Kista

Sweden

Tel: +46 8 615 2760

e-mail:

SK

Desitin Pharma s.r.o.

Trojicne namestie 13 82106 Bratislava

Slovakia

Tel: 00421–2–5556 38 10

e-mail:

UK (NI)

Alan Pharmaceuticals,

Acre House, 11–15 William Road,

London NW1 3ER,

England

Tel +44 (0) 20 7284 2887

Email:

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicine Agency website:. There are also links to other websites about rare diseases and treatments.