Diacomit 500mg hard capsules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

1. What Diacomit is and what it is used for
2. What you need to know before you take Diacomit
3. How to take Diacomit
4. Possible side effects
5 How to store Diacomit
6. Contents of the pack and other information

• if you are allergic to stiripentol or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever experienced attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations).

Talk to your doctor or pharmacist before taking Diacomit

• If you have kidney or liver problems.
• Your liver function should be assessed prior to starting Diacomit and checked every 6 months.
• Your 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 growth rate should be carefully monitored.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Tell your doctor if you are 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 reduce anxiety and sleeplessness – in combination with Diacomit they may make you very sleepy);
    chlorpromazine (used for mental illness such as psychosis).
  • If you are taking 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 your blood levels, leading to digestive disorders, racing heart and insomnia.
• If you are taking 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.

Do NOT take Diacomit with fruit juice, fizzy drinks or food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks).

If you are pregnant or breast-feeding, think you may be pregnant or are 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.

This medicine may make you feel sleepy.

You should not use any tools, machines, ride or drive if affected in this way. Check with your doctor.

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

The dose is adjusted by the doctor according to your age, weight and condition, generally 50 mg per kg bodyweight and per day.

You should take this medicine two or three times a day at regular intervals as directed by your doctor, for example morning - noon - bed-time 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 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 doctor or pharmacist. The dose will be adjusted by the doctor according to your condition.

Please consult your 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 you experience 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 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.

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.

For food and drinks to be avoided, see the section “Diacomit with food and drink” above.

Contact your doctor if you know or think you have taken more medicine than you should have.

It is important that you take this medicine regularly at the same time each day. If you forget to take a dose, you 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. You should not take a double dose to make up for a forgotten individual dose.

You must not stop taking this medicine unless the doctor tells you to. Stopping treatment suddenly can lead to an outbreak of seizures.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is stiripentol. Each hard capsule contains 250 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).
• The printing ink contains shellac (E904), black iron oxide (E172).

• The active substance is stiripentol. Each hard capsule contains 500 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).
• The printing ink contains shellac (E904), black iron oxide (E172).

Diacomit 250 mg hard capsule is pink and printed with “Diacomit 250 mg”.

The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard cartons.

Not all pack sizes may be marketed.

Diacomit 500 mg hard capsule is white and printed with “Diacomit 500 mg”.

The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules in cardboard cartons.

Not all pack sizes may be marketed.

Diacomit is also available as 250 mg and 500 mg powder for oral suspension in sachets.

For any information about this medicine, please contact the Marketing Authorisation Holder.