250 mg and 500 mg hard capsules 
stiripentol

Read all of this leaflet carefully before your child starts taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your child’s doctor or pharmacist.
  • This medicine has been prescribed for your child only. Do not give it to others. It can harm them, even if they show signs of illness similar to your child’s.
  • If your child has any side effects, talk to your child’s doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Diacomit is and what it is used for 
2. What you need to know before your child takes Diacomit 
3. How your child should take Diacomit 
4. Possible side effects 
5. How to store Diacomit 
6. Packaging content and other information 

1. What Diacomit is and what it is used for

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

It is used together with clobazam and valproate (other medicines for epilepsy ) to treat a certain form of epilepsy, called severe myoclonic epilepsy in childhood (Dravet’s syndrome), which affects children. Your child’s doctor has prescribed this medicine to treat your child’s epilepsy. It should always be taken in combination with clobazam and valproate as prescribed by a doctor.

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

Your child should NOT take Diacomit

  • if your child is allergic to stiripentol or any of the other ingredients of this medicine (listed in section 6).
  • if your child has ever had delirium attacks (a mental condition with confusion, agitation, restlessness, and hallucinations).

Warnings and cautions

Talk to your child’s doctor or pharmacist before administering Diacomit if:

  • Your child has kidney or liver problems.
  • Your child’s liver function should be assessed before starting treatment with Diacomit and checked every 6 months during treatment.
  • Your child’s blood count should be assessed before starting Diacomit treatment and checked every 6 months during treatment.
  • Your child’s growth rate should be closely monitored during treatment with stiripentol, clobazam, and valproate, as gastrointestinal side effects such as anorexia, loss of appetite and vomiting are common.

Other medicines and Diacomit

Tell your child’s doctor or pharmacist if your child is taking, has recently taken, or might take any other medicine. Tell your doctor if your child is taking any of the following medicines:

  • medicines containing:
    • cisapride (used to treat symptoms of heartburn at night);
    • pimozide (used to treat symptoms of Tourette’s syndrome such as vocal outbursts and uncontrolled, repetitive body movements);
    • ergotamine (used to treat migraines );
    • dihydroergotamine (used to relieve signs and symptoms of reduced mental capacity due to aging);
    • halofantrine (anti-malaria );
    • quinidine (used to treat abnormal heart rhythms);
    • bepridil (used to control chest pain);
    • ciclosporin, tacrolimus, sirolimus (all three are used to prevent rejection of new liver, kidney, or heart after organ transplantation);
    • statins ( simvastatin and atorvastatin, both used to reduce the amount of cholesterol in the blood).
    • antiepileptic drugs containing: 
      phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
    • drugs that contain:
      midazolam or triazolam (drugs used to reduce anxiety and insomnia – in combination with Diacomit, they can make your child very sleepy); chlorpromazine (used in mental illness such as psychosis ).
       
    • If your child is taking medicines that contain: 
      Caffeine (this substance helps to restore mental alertness) or Theophylline (this substance is used in asthma ). Combination with Diacomit should be avoided, as it may increase the levels of caffeine/theophylline in the blood, leading to indigestion, heart failure,e, and insomnia.
  • If your child is taking medicines that are metabolized by certain liver enzymes :
    • citalopram (used to treat depression);
    • omeprazole (used for stomach ulcers );
    • HIV protease inhibitors (used to treat HIV );
    • astemizole, chlorpheniramine ( antihistamine is);
    • calcium channel blockers (used to treat cardiovascular problems);
    • oral contraceptives ( birth control pills );
    • propranolol, carvedilol, timolol (used to treat high blood pressure );
    • fluoxetine, paroxetine  sertraline, imipramine, clomipramine (antidepressants);
    • haloperidol (antipsychotic);
    • codeine, dextromethorphan, tramadol (used to treat pain).

Diacomit with food and drink

DO NOT take Diacomit with milk or dairy products (yogurt, soft cheese, etc.), fruit juices, carbonated drinks, or foods and drinks that contain caffeine or theophylline (such as cola, chocolate, coffee, tea, and energy drinks).

 Pregnancy and breastfeeding

If your baby is pregnant or breastfeeding, thinks she may be pregnant, or is planning to have a baby, consult your baby’s doctor before taking this medicine. During pregnancy, effective treatment of epilepsy must NOT be interrupted.


Breastfeeding 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, bicycles, or drive a vehicle if it is affected in this way. Consult your child’s doctor.

Diacomit contains sodium

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

How your child should take Diacomit

Your child should always take these capsules according to the doctor’s instructions. If you are not sure, talk to your child’s doctor or pharmacist.

Dosage

The dose is adjusted by your doctor according to your child’s age, weight, and condition, usually 50 mg per kg body weight and day.

When to take Diacomit 
Your child should take this medicine two or three times a day at regular intervals according to the doctor’s instructions, such as morning-noon-evening to cover the whole day.

Dose adjustment

Dose escalation should be progressive and take place over a few weeks, while the dose of a ( dose s) of the other (s) drug (s) against epilepsy is reduced. Your child’s doctor will inform you about the new dose of the other medicine (s) for epilepsy.

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. Dose one is adjusted by the doctor based on your child’s condition.

Consult your child’s doctor if any side effects occur, as your doctor may need to adjust the dose of one of these medicines and the other medicines for epilepsy.

There is some difference between the Diacomit capsules and the powder for oral suspension. If your child has problems changing from capsules to powder to oral suspension or vice versa, tell your child’s doctor. If your child switches between capsules and powders, it should be done under the close supervision of your child’s doctor.

If vomiting within a few minutes of taking Diacomit, it is assumed that the drug has not been absorbed and then a new dose should be given. 
However, the situation is different if vomiting occurs more than one hour after ingestion, as stiripentol is rapidly absorbed. In such cases, it is assumed that a large part of one dose has been absorbed in the gastrointestinal tract, and no new dose (or adjustment of the next dose ) is necessary.

How to take Diacomit capsules 
These capsules should be swallowed whole with water. The capsules should not be chewed. Your child should take Diacomit with food, NOT on an empty stomach. For food and beverages to be avoided, see the section “Diacomit with food and drink” above.

If your child has taken too much Diacomit

Contact your child’s doctor if you know or think that your child has taken more medicines than he or she should.

If your child forgets to take Diacomit

Your child must take their medication 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 to take the next dose. In that case, continue with the next dose as usual. Your child should not take a double dose to make up for a forgotten dose.

If your child stops taking Diacomit

Your child must not stop taking this medicine unless instructed to do so by a doctor. Sudden cessation of treatment can lead to epileptic seizures.

If you have any further questions on the use of this product, 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.

A very common side effect is (can occur in more than 1 in 10):

  • loss of appetite, weight loss (especially when combined with the antiepileptic drug sodium valproate);
  • insomnia, drowsiness;
  • ataxia (inability to coordinate muscle movements), hypotension (low muscle strength), dystonia (involuntary muscle contractions).

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

  • elevated levels of liver enzymes, especially when co-administered with the antiepileptic drugs carbamazepine and sodium valproate;
  • aggression, irritability, arousal, hyperexcitability (conditions of unusual irritability);
  • sleep disorders (abnormal sleep);
  • hyperkinesia (excessive movements);
  • nausea, vomiting;
  • a low number of a kind of white blood cells.

Less common side effects are (may affect up to 1 in 100):

  • double vision when used in combination with the antiepileptic drug carbamazepine;
  • photosensitivity;
  • skin rash, skin allergy, urticaria (pink, itchy bumps on the skin);
  • fatigue.

Rare side effects are (may affect up to 1 in 1000)):

  • reduction of platelets in the blood;
  • abnormal values ​​in liver function tests.

For your child to avoid these side effects, your doctor may need to change the dose of one of Diacomit or any of the other medicines prescribed to your child.

5. How to store Diacomit

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.
  • Store in the original package. Sensitive to 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.

6. Contents of the packaging and other information

Content declaration

What Diacomit 250 mg contains

  • The active substance is stiripentol. Each hard capsule contains 250 mg stiripentol.
  • The other ingredients in the capsule are povidone K29 / 32, sodium starch glycolate type A and magnesium stearate.
  • The capsule cover is made of gelatin, titanium dioxide (E171), erythrosine (E127), indigotin (E132).
  • The ink contains shellac (E904), black iron oxide (E172).

What Diacomit 500 mg contains

  • The active substance is stiripentol. Each hard capsule contains 500 mg of stiripentol.
  • The other ingredients are povidone K29 / 32, sodium starch glycolate type A and magnesium stearate.
  • The capsule cover is made of gelatin, titanium dioxide (E171).
  • The ink contains shellac (E904), black iron oxide (E172).

What the medicine looks like and the contents of the pack

What Diacomit 250 mg looks like and what the package contains 
Diacomit 250 mg hard capsule is pink and marked with “Diacomit 250 mg”. 
The hard capsules are delivered in plastic jars containing 30, 60, or 90 capsules in cardboard boxes. Not all pack sizes may be marketed.

What Diacomit 500 mg looks like and what the package contains 
Diacomit 500 mg hard capsule is white and marked with “Diacomit 500 mg”. 
The hard capsules are delivered in plastic jars containing 30, 60, or 90 capsules in cardboard boxes. Not all pack sizes may be marketed. 
Diacomit is also available as 250 mg and 500 mg powder for oral suspension in sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder 
Biocodex 
7 avenue Gallieni – 94250 Gentilly – France 
Tel: + 33 1 41 24 30 00 – Email: medinfo@biocodex.com

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

Contact the representative of the marketing authorization holder to find out more about this medicine:

AT / BE / BG / CY / EL / ES / FR / HR / HU / IE / IS / IT / LU / MT / NL / PL / PT / SI / UK 
Biocodex 
7 avenue Gallieni – F-94250 Gentilly 
/ранция / Γαλλία / France / France / Franciaország / France / France / France / France / France 
Tel / Tel / Tel / Tel / Phone: + 33 (0) 1 41 24 30 00 
e-mail: medinfo@biocodex.com

Muhammad Nadeem

Leave a Reply