ESTIRIPENTOL BILLEV 250 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Estiripentol Billev 250 mg hard capsules EFG

Estiripentol Billev 500 mg hard capsules EFG

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as your child's.
• 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. See section 4.

Contents of the pack

1. What is Estiripentol Billev and what is it used for
2. What you need to know before your child takes Estiripentol Billev
3. How to take Estiripentol Billev
4. Possible side effects
5. Storage of Estiripentol Billev
6. Contents of the pack and other information

1. What is Estiripentol Billev and what is it used for

Estiripentol, the active substance of Estiripentol Billev, belongs to a group of medicines called antiepileptics.

It is used together with clobazam and valproate (other antiepileptic medicines) to treat a certain form of epilepsy called severe myoclonic epilepsy in infancy (Dravet syndrome) that affects children. Your child's doctor has prescribed this medicine to help treat epilepsy.

2. What you need to know before your child takes Estiripentol Billev

Do not give Estiripentol Billev to your child if:

• your child is allergic to estiripentol or any of the other ingredients of this medicine (listed in section 6);
• your child has ever suffered from delirium (a mental state with confusion, emotion, restlessness, and hallucinations).

Warnings and precautions

Consult your child's doctor or pharmacist before giving Estiripentol Billev to your child:

• Your child's liver function should be evaluated before starting treatment with estiripentol and checked every 6 months.
• Your child's blood count should be evaluated before starting treatment with estiripentol and checked every 6 months.
• Your child's growth rate should be carefully monitored due to gastrointestinal side effects with estiripentol, clobazam, and valproate, such as anorexia, loss of appetite, and vomiting.

Other medicines and Estiripentol Billev

Tell your child's doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.

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

• medicines containing:
  • cisapride (used to treat symptoms of nocturnal heartburn);
  • pimozide (used to treat symptoms of Tourette's syndrome: vocal tics and repetitive, uncontrollable body movements);
  • ergotamine (used to treat migraine);
  • dihydroergotamine (used to relieve signs and symptoms of reduced mental capacity due to the aging process);
  • halofantrine (an antimalarial drug);
  • quinidine (used to treat heart rhythm disorders);
  • bepridil (used to control chest pain);
  • cyclosporin, tacrolimus, sirolimus (all used to prevent rejection in liver, kidney, and heart transplants);
  • statins (simvastatin and atorvastatin, both used to reduce blood cholesterol levels).
  • antiepileptic medicines containing:

phenobarbital, primidone, phenytoin, carbamazepine, diazepam.

• medicines containing:

midazolam or triazolam (medicines used to reduce anxiety and insomnia – combined with estiripentol, they can cause significant drowsiness in your child);

chlorpromazine (used for mental illnesses such as psychosis).

• If your child is taking medicines that contain:
  • caffeine (these substances help to restore mental alertness) or theophylline (this substance is used in case of asthma). Their combination with estiripentol should be avoided, as it can increase their blood levels, leading to digestive disorders, increased heart rate, and insomnia.

• If your child is taking medicines that are metabolized by certain liver enzymes:
  • citalopram (used in the treatment of depressive episodes);
  • omeprazole (used for stomach ulcers);
  • HIV protease inhibitors (used in the treatment of HIV);
  • astemizole, chlorphenamine (antihistamines);
  • calcium channel blockers (used in the treatment of angina or heart rhythm problems);
  • oral contraceptives;
  • propranolol, carvedilol, timolol (used in the treatment of high blood pressure);
  • fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
  • haloperidol (antipsychotic);
  • codeine, dextromethorphan, tramadol (used to treat pain).

Taking Estiripentol Billev with food and drinks

Do not take estiripentol with milk or dairy products (yogurt, creamy cheeses, etc.), fruit juices, fizzy drinks, or foods and drinks that contain caffeine or theophylline (e.g., cola, chocolate, coffee, tea, or energy drinks).

Pregnancy and breastfeeding

If your daughter is pregnant or breastfeeding, thinks she may be pregnant, or plans to become pregnant, consult her doctor before taking this medicine.

During pregnancy, antiepileptic treatment should not be interrupted.

Breastfeeding is not recommended during treatment with this medicine.

Driving and using machines

This medicine can cause drowsiness in your child.

Your child should not operate tools or machines or drive if they are affected in this way. Consult your child's doctor.

Estiripentol Billev contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., it is essentially "sodium-free".

3. How to take Estiripentol Billev

Your child should take these capsules exactly as their doctor has told them. If they are unsure, they should consult their doctor or pharmacist again.

Dose

The doctor will adjust the dose according to your child's age, weight, and condition, usually 50 mg per day per kilogram of body weight.

When to take Estiripentol Billev

Your child should take this medicine two or three times a day at regular intervals as indicated by their doctor: for example, in the mornings, at noon, and at bedtime to cover the night and daytime periods.

Dose adjustment

Dose increases should be gradual, replacing, over several weeks, the doses of other antiepileptic medicines, which will be reduced at the same time. Your child's doctor will inform you of the new dose of the other antiepileptic medicines.

If you think the effect of this medicine is too strong or too weak, consult your child's doctor or pharmacist. The doctor will adjust the dose according to your child's condition.

In case of side effects, consult your child's doctor, as it may be necessary to adjust the dose of estiripentol or other antiepileptic medicines.

There are slight differences between the capsules and the oral suspension of Estiripentol Billev. Please consult your doctor if your child experiences any problems when switching from capsules to oral suspension or vice versa. If switching between capsule and powder formulations, it should be done under the strict supervision of your child's doctor.

In case of vomiting in the first few minutes after taking the medicine, it is considered that the medicine has not been absorbed and a new dose should be given.

However, the situation changes if vomiting occurs more than an hour after taking the medicine, as estiripentol is rapidly absorbed.

If this is the case, it will be considered that a significant fraction of the administered dose has been systemically absorbed in the digestive tract. Therefore, there will be no need to take a new dose to adjust the next dose.

How to take the capsules of Estiripentol Billev

To ensure that the patient takes the complete amount of powder, it is preferable not to open the capsule and to swallow it as a single oral dose. Your child should take Estiripentol Billev with food and not on an empty stomach. To know which foods and drinks to avoid, see the previous section "Taking Estiripentol Billev with food and drinks".

If your child takes more Estiripentol Billev than they should

Consult your child's doctor if you know or think your child has taken more of the medicine than they should.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If your child forgets to take Estiripentol Billev

It is important that your child takes this medicine regularly at the same time every day. If your child forgets to take a dose, they should take it as soon as you remember, unless it is time for 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 forgotten doses.

If your child stops taking Estiripentol Billev

Your child should not stoptaking this medicine unless their doctor tells them to. Stopping treatment can cause a seizure crisis.

If you have any other questions about 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 1 in 10 people):

• loss of appetite, weight loss (especially in combination with the antiepileptic medicine valproate sodium);
• insomnia, 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):

• increased liver enzyme levels, especially when administered with the antiepileptic medicines carbamazepine or valproate sodium;
• aggression, irritability, agitation, hyperexcitability (state of unusual excitability);
• sleep disorders (sleep anomalies);
• hyperkinesia (exaggerated movements);
• nausea, vomiting;
• low white blood cell count.

Uncommon side effects(may affect up to 1 in 100 people):

• double vision when used with the antiepileptic medicine carbamazepine;
• photosensitivity;
• rash, skin allergy, urticaria (skin inflammation of a pink color and accompanied by itching);
• fatigue (tiredness).

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

• decrease in blood platelet count;
• abnormal liver function test.

To eliminate these side effects, your child's doctor may need to vary the dose of estiripentol or other antiepileptic medicines.

Reporting of side effects

If your child experiences any side effects, talk to your child's doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Estiripentol Billev

Keep this medicine out of the sight and reach of children.

Do not give this medicine to your child after the expiry date stated on the label and carton. The expiry date is the last day of the month stated.

Store in the original package to protect from light. This medicine does not require any special storage temperature.

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 protect the environment.

6. Contents of the pack and other information

Composition of Estiripentol Billev

• The active substance is estiripentol.

Estiripentol Billev 250 mg: each capsule contains 250 mg of estiripentol.

Estiripentol Billev 500 mg: each capsule contains 500 mg of estiripentol.

• The other ingredients are:

Capsule content: sodium carboxymethylcellulose type A, povidone K30, sodium lauryl sulfate, and magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127) (only Estiripentol Billev 250 mg), and indigo carmine (E132) (only Estiripentol Billev 250 mg).

Printing ink: shellac (E904), propylene glycol (E1520), iron oxide black (E172), and potassium hydroxide.

Appearance of the product and contents of the pack

Estiripentol Billev 250 mg is a hard, opaque, pink capsule with "SP250" printed on the body.

Estiripentol Billev 500 mg is a hard, opaque, white capsule with "SP500" printed on the body.

Estiripentol Billev is available in child-resistant closure bottles containing 30, 60, or 90 capsules.

Not all pack sizes may be marketed.

Estiripentol Billev is also available as an oral suspension in sachets of 250 mg and 500 mg.

Marketing authorisation holder

Billev Pharma ApS

Slotsmarken 10

2970 Hoersholm

Denmark

Manufacturer

Misom Labs Limited

Malta Life Sciences Park

LS2.01.06, Industrial Estate

San Gwann

SGN 3000

Malta

Date of last revision of this leaflet:05/2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/