Patient leaflet - Stiripentol 250 mg hard capsules

1. WHAT STIRIPENTOL IS AND WHAT IT IS USED FOR

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

It is used in conjunction with clobazam and valproate (other antiepileptic drugs) to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravets 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 STIRIPENTOL

Do NOT give Stiripentol to your child if he or she:

is allergic to Stiripentol or to any of the other ingredients of this medicine (listed in section 6)
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 giving Stiripentol:

if your child has kidney or liver problems
if your child’s liver function should be assessed prior to starting Stiripentol and checked every 6 months
your child’s blood count should be assessed prior to starting Stiripentol and checked every 6 months

Because of the frequency of gastrointestinal side effects with stiripentol, clobazam and valproate, such as anorexia, loss of appetite, and vomiting, your child’s growth rate should be monitored carefully.

Other medicines and Stiripentol

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 nighttime heartburn)
pimozide (used to treat the symptoms of Tourette’s syndrome e.g. vocal outburst 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
- midazolam or triazolam (medicines used to reduce anxiety and sleeplessness – in combination with Stiripentol they may make your child very sleepy)
- chlorpromazine (used for mental illnesses 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 striripentol should be avoided as it may increase their blood levels, leading to digestive disorders, racing heart and insomnia
- If your child takes medicine metabolised 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 for the treatment of angor or troubles of heart rhythm)
- oral contraceptives (used to prevent pregnancy)
- 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).

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, dietary supplements and herbal medicines.

Stiripentol with food and drink

Do NOT take Stiripentol with milk or dairy products (yoghurt, soft cream cheeses etc), fruit juice, fizzy drinks, food and drinks that contain caffeine or theophylline (for example cola, chocolate, coffee, tea and energy drinks).

Pregnancy and breast-feeding

Pregnancy

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

Breast-feeding is not recommended during treatment with this medicine.

Driving and using machines

This medicine could make your child feel sleepy. Your child should not use any tools, machines, ride or drive in a vehicle if affected in this way. Check with your child’s doctor.

Stiripentol 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 STIRIPENTOL

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 of bodyweight, and per day.

When to take Stiripentol

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. PACKAGE LEAFLET: INFORMATION FOR THE USER STIRIPENTOL 250 MG & 500 MG HARD CAPSULES

Client: Kinedexe UK PL Number: 44710/0027 44710/0028 Size: 150mm x 260mm

Product: Stiripentol Capsules 60s PIL Page 1 Date: 21.01.25 Colours: ■ Black

260 x 150 mm FRONT

150.00 mm

14mm

8mm

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 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 other antiepileptic medicine(s).

There are slight differences between the Stiripentol capsules and powder for oral suspension. If your child experiences any problems when switching from taking capsules to 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 childs 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 the 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 Stiripentol capsules

These capsules should be swallowed whole with water. The capsules should not be chewed. Your child should take Stiripentol with food; it should NOT be taken on an empty stomach.

For food and drinks to be avoided, see section 2, “Stiripentol with food and drink” above.

If your child takes more Stiripentol 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 Stiripentol

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 they 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 Stiripentol

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.

4. POSSIBLE SIDE EFFECTS

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

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

loss of appetite, and weight loss (especially when combined with the antiepileptic medicine sodium valproate)
sleeplessness (insomnia), drowsiness
inability to coordinate muscle movements (ataxia), low muscle strength (hypotonia), involuntary muscle contractions (dystonia).

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)
exaggerate movements (hyperkinesis)
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, pinkish, itchy swellings on the skin (urticaria)
- tiredness (fatigue).

Rare side effects (may affect up to 1 in 1000 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 stiripentol or one of the other medicines prescribed for your child.

Reporting of side effects

If your child gets any side effects, talk to their doctor, pharmacist or nurse. 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.

5. HOW TO STORE STIRIPENTOL Keep this medicine out of the sight and reach of children.

Your child should not take Stiripentol after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Stiripentol 250 mg contains

The active substance is stiripentol. Each hard capsule contains 250 mg of stiripentol.
The other ingredients are sodium starch glycolate, povidone K 30, sodium lauryl sulphate and magnesium stearate.
The capsule shell is made of gelatin. Erythrosine (E127), indigo carmine (E132) and titanium dioxide (E171).

What Stiripentol 500 mg contains

The active substance is stiripentol. Each hard capsule contains 500 mg of stiripentol.
The other ingredients are sodium starch glycolate, povidone K 30, sodium lauryl sulphate and magnesium stearate.
The capsule shell is made of gelatin and titanium dioxide (E171).

What Stiripentol 250 mg hard capsules look like and contents of the pack

Stiripentol 250 mg is an opaque pink capsule imprinted with SP250 on body.

The hard capsules are supplied in plastic bottles containing 30, 60 or 90 capsules. Not all pack sizes may be marketed.

What Stiripentol 500 mg hard capsules look like and contents of the pack

Stiripentol 250 mg is an opaque white capsule imprinted with SP500 on body.