Stiripentol Billev

Italy
Brand name Stiripentol Billev
Form capsules, hard gelatin
Active substance / Dosage
STIRIPENTOL
Prescription type Prescription only
ATC code
N03AX17
Registration number 051225
Manufacturer BILLEV PHARMA APS

Table of Contents

Package leaflet: Information for the user

Stiripentol Billev 250 mg hard capsules, 500 mg hard capsules

Stiripentol
Generic medicine
Please read all of this leaflet carefully before the child takes this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your paediatrician or pharmacist.
  • This medicine has been prescribed for your child only. Do not give it to other people, even if their symptoms are the same as your child's, as it may be harmful.
  • If the child experiences any side effects, including those not listed in this leaflet, contact your paediatrician or pharmacist. See section 4.

Contents of this leaflet

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

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

Stiripentol, the active substance of Stiripentolo Billev, belongs to a group of medicines called
antiepileptics.
It is used in combination with clobazam and valproate (other antiepileptic medicines) for the treatment of a
specific type of epilepsy known as severe myoclonic epilepsy in infancy (Dravet syndrome), which affects children. Your paediatrician has prescribed this medicine to help treat your child's epilepsy.

2. What you should know before your child takes Stiripentolo Billev

Do not give Stiripentolo Billev to your child:

  • If they are allergic to stiripentol or to any of the other ingredients of this medicine (listed in section 6).
  • If they have experienced delirious episodes (a mental state characterized by confusion, excitement, restlessness, and hallucinations).

Warnings and precautions
Talk to your paediatrician or pharmacist before administering Stiripentolo Billev:

  • If your child has kidney or liver problems.
  • Before starting treatment with Stiripentolo Billev, your child's liver function should be assessed, and monitoring should be repeated every 6 months.
  • Before starting treatment with Stiripentolo Billev, your child's blood cell count should be evaluated, and monitoring should be repeated every 6 months.

Due to frequent gastrointestinal side effects during treatment with Stiripentolo Billev, clobazam, and valproate—such as anorexia, loss of appetite, and vomiting—your child's growth rate must be closely monitored.
Other medicines and Stiripentolo Billev
Inform your paediatrician or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Talk to the doctor if your child is taking any of the following:

  • Medicines containing:
    • cisapride (used to treat symptoms of nighttime heartburn);
    • pimozide (used to treat symptoms of Tourette’s syndrome, such as meaningless sounds and uncontrollable, repetitive body movements);
    • ergotamine (used to treat migraine);
    • dihydroergotamine (used to relieve signs and symptoms of mental decline due to aging);
    • halofantrine (an antimalarial treatment);
    • quinidine (used to treat cardiac arrhythmias);
    • bepridil (used to relieve chest pain);
    • ciclosporin, tacrolimus, sirolimus (all three used to prevent rejection after liver, kidney, or heart transplantation);
    • statins (simvastatin and atorvastatin, both used to reduce cholesterol levels in the blood);
    • antiepileptic medicines containing: phenobarbital, primidone, phenytoin, carbamazepine, diazepam;
    • medicines containing: midazolam or triazolam (medicines that reduce anxiety and insomnia – when used together with Stiripentolo Billev, they significantly increase drowsiness in children);
    • chlorpromazine (used for mental illnesses such as psychosis).
    • If your child takes medicines containing: caffeine (a substance that helps keep the mind awake) or theophylline (a substance used in asthma), the combination with Stiripentolo Billev should be avoided, as it could increase blood levels of these substances, leading to gastrointestinal disturbances, increased heart rate, and insomnia.
  • If your child takes medicines metabolized by certain liver enzymes:
    • citalopram (used to treat depressive episodes);
    • omeprazole (used for gastric ulcer);
    • HIV protease inhibitors (used in the treatment of HIV);
    • astemizole, chlorpheniramine (antihistamines);
    • calcium antagonists (used to treat angina and cardiac rhythm disorders);
    • oral contraceptives;
    • propranolol, carvedilol, timolol (used to treat high blood pressure);
    • fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
    • haloperidol (an antipsychotic);
    • codeine, dextromethorphan, tramadol (used to treat pain).

Stiripentolo Billev with food and drinks
Stiripentolo Billev must not be taken with milk or dairy products (yoghurt, creamy fresh cheeses, etc.), fruit juices, carbonated drinks, or foods and beverages containing caffeine or theophylline (e.g. cola, chocolate, coffee, tea, and energy drinks).
Pregnancy and breastfeeding
If your daughter is pregnant, breastfeeding, thinks she may be pregnant, or is planning a pregnancy, consult your doctor before she takes this medicine.
Effective antiepileptic therapy must NOT be stopped during pregnancy.
Breastfeeding is not recommended during treatment with this medicine.
Driving and using machines
This medicine causes significant drowsiness.
Your child should not use tools, machinery, or drive vehicles (e.g. bicycles) if they experience this symptom. Consult your paediatrician.
Stiripentolo Billev contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially “sodium-free”.

3. How to take Stiripentolo Billev

The child must take these capsules exactly as directed by the doctor. If you have
any doubts, consult the paediatrician or pharmacist.
Dosage
The dose will be adjusted by the doctor according to the child's age, body weight and medical condition. Generally,
the recommended dose is 50 mg per kg of body weight per day.
When to take Stiripentolo Billev
The child should take this medicine two or three times a day, at regular intervals, as instructed by the doctor, e.g. in the morning – at midday – in the evening before going to sleep, in order to cover the day-night period.
Dosage adjustment
Dose increases should be gradual and carried out over several weeks, while the doses of other antiepileptic drugs are simultaneously reduced. The doctor will inform you about the appropriate doses of other antiepileptic medicines.
If you feel that the effect of this medicine is too strong or too weak, inform the paediatrician or pharmacist. The doctor will adjust the dose according to the child's condition.
Inform the paediatrician if any adverse reactions occur, as the doctor may need to adjust the dose of this medicine and of other antiepileptic drugs.
There is a slight difference between Stiripentolo Billev capsules and Stiripentolo Billev oral suspension powder. Inform the doctor if the child has difficulties switching from capsules to oral suspension powder or vice versa. Any switch between capsule and powder formulations must be carried out under close supervision of the paediatrician.
If vomiting occurs a few minutes after administration, the medicine is presumed not to have been absorbed; therefore, another dose should be administered.
However, the situation is different if vomiting occurs more than one hour after administration, since stiripentol is rapidly absorbed.
In this case, a significant portion of the administered dose is presumed to have been systemically absorbed through the gastrointestinal tract. Therefore, re-administration is not required, nor is supplementation of the next dose.
How to take Stiripentolo Billev capsules
To ensure that the full amount of powder is taken by the patient, it is preferable not to open the capsule and to swallow it whole as a single unit of oral administration. The child must take Stiripentolo Billev with food and must not take it on an empty stomach.
For foods and drinks to avoid, see section 2 above: “Stiripentolo Billev with food and drink”.
If the child takes more Stiripentolo Billev than prescribed
If you know or suspect that the child has taken more medicine than prescribed, contact the paediatrician immediately.
If the child forgets to take Stiripentolo Billev
It is important that the child takes this medicine regularly every day at the same time. If the child forgets to take a dose, give it as soon as you remember, unless it is almost time for the next dose. In that case, the child should take the next dose at the usual time. The child must not take a double dose to make up for a missed dose.
If the child stops taking Stiripentolo Billev
The child must not stop treatment unless instructed by the doctor. Stopping treatment suddenly may lead to a sudden return of seizures.
If you have any doubts about how to use this medicine, consult the paediatrician 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 (particularly if Stiripentol Billev is taken together with sodium valproate, an antiepileptic medicine);
  • insomnia, drowsiness;
  • ataxia (inability to coordinate muscle movements), hypotonia (reduced muscle strength), dystonia (involuntary muscle contractions).

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

  • increased levels of liver enzymes, especially if Stiripentol Billev is taken together with the antiepileptic medicines carbamazepine and sodium valproate;
  • aggression, irritability, agitation, hyperexcitability (state of unusual excitement);
  • sleep disturbances;
  • hyperkinesia (exaggerated movements);
  • nausea, vomiting;
  • reduced number of a type of white blood cells.

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

  • double vision, if Stiripentol Billev is taken together with the antiepileptic medicine carbamazepine;
  • light sensitivity;
  • skin rash, skin allergy, urticaria (itchy, pink swellings on the skin);
  • fatigue (tiredness).

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

  • decreased platelet count in the blood;
  • abnormal liver function test.

To manage these side effects, the paediatrician may need to adjust the dose of Stiripentol Billev or of one of the other prescribed medicines.

Reporting of side effects

If the child experiences any side effect, including those not listed in this leaflet, talk to the paediatrician or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stiripentol Billev

Keep this medicine out of the sight and reach of children.
The child must not take this medicine after the expiry date stated on the label and on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Stiripentolo Billev contains

  • The active substance is stiripentol. Stiripentolo Billev 250 mg: each capsule contains 250 mg of stiripentol. Stiripentolo Billev 500 mg: each capsule contains 500 mg of stiripentol.
  • The other components are: Capsule contents: sodium starch glycolate type A, povidone K 30, sodium lauryl sulfate, and magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127) (only in Stiripentolo Billev 250 mg), indigo carmine (E132) (only in Stiripentolo Billev 250 mg). Printing ink: shellac, propylene glycol (E1520), iron oxide black (E172), potassium hydroxide.

Description of the appearance of Stiripentolo Billev and pack sizes
Stiripentolo Billev 250 mg is an opaque hard capsule, pink in colour, marked “SP 250” on the body.
Stiripentolo Billev 500 mg is an opaque hard capsule, white in colour, marked “SP 500” on the body.
Stiripentolo Billev is supplied in bottles with child-resistant closures containing 30, 60 or 90 capsules.
Not all pack sizes may be marketed.
Stiripentolo Billev is also available as an oral suspension powder in sachets containing 250 mg and 500 mg.

Marketing Authorisation Holder
Billev Pharma ApS,
Slotsmarken 10
2970 Hoersholm,
Denmark

Manufacturer
Misom Labs Malta Life Sciences Park
LS2.01.06, Industrial Estate
San Gwann
SGN 3000
Malta

This leaflet was last updated on

Package leaflet: Information for the user

Stiripentolo Billev 250 mg Powder for oral suspension in sachets, 500 mg Powder for oral suspension in sachets

Stiripentol
Generic Medicine
Please read this leaflet carefully before your child takes this medicine as it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your paediatrician or pharmacist.
  • This medicine has been prescribed for your child only. Do not give it to others, even if their symptoms are the same as your child's, as it may be harmful.
  • If your child experiences any adverse reaction, including those not listed in this leaflet, contact your paediatrician or pharmacist. See section 4.

Contents of this leaflet

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

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

Stiripentol, the active substance in Stiripentolo Billev, belongs to a group of medicines called antiepileptics.
It is used in combination with clobazam and valproate (other antiepileptic medicines) for the treatment of a specific type of epilepsy known as severe myoclonic epilepsy in infancy (Dravet syndrome), which affects children. Your paediatrician has prescribed this medicine to help treat your child's epilepsy.

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

Do not give Stiripentolo Billev to your child:

  • If they are allergic to stiripentol or to any of the other ingredients of this medicine (listed in section 6).
  • If they have experienced delirious episodes (a mental state characterized by confusion, excitement, restlessness, and hallucinations).

Warnings and precautions
Talk to your paediatrician or pharmacist before administering Stiripentolo Billev:

  • If your child has kidney or liver problems.
  • Before starting treatment with Stiripentolo Billev, your child’s liver function should be assessed, and checks should be repeated every 6 months.
  • Before starting treatment with Stiripentolo Billev, a blood cell count should be performed, and checks should be repeated every 6 months.

Due to frequent gastrointestinal side effects during treatment with Stiripentolo Billev,
clobazam and valproate—such as anorexia, loss of appetite, and vomiting—the child’s growth rate
should be monitored very closely.
Other medicines and Stiripentolo Billev
Inform your paediatrician or pharmacist if your child is taking, has recently taken, or might
take any other medicines.
Talk to the 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 symptoms of Tourette syndrome, for example, production of meaningless sounds and uncontrollable, repetitive movements of the body);
    • ergotamine (used to treat migraine);
    • dihydroergotamine (used to relieve signs and symptoms of reduced mental capacity due to aging);
    • halofantrine (an antimalarial drug);
    • quinidine (used to treat cardiac arrhythmias);
    • bepridil (used to relieve chest pain);
    • ciclosporin, tacrolimus, sirolimus (all three used to prevent rejection following liver, kidney, or heart transplantation);
    • statins (simvastatin and atorvastatin, both used to reduce cholesterol levels in the blood).
    • antiepileptic medicines containing: phenobarbital, primidone, phenytoin, carbamazepine, diazepam.
    • medicines containing: midazolam or triazolam (medicines that reduce anxiety and insomnia; when used in combination with Stiripentolo Billev, they significantly increase drowsiness in the child);
    • chlorpromazine (used for mental illnesses such as psychosis).

If your child is taking medicines containing:
caffeine (a substance that helps keep the mind awake) or theophylline (a substance used in asthma).
The combination with Stiripentolo Billev should be avoided, as it could increase the blood concentrations of these substances, leading to gastrointestinal disturbances, increased heart rate, and insomnia.
If your child takes medicines metabolized by certain liver enzymes:

  • citalopram (used to treat depressive episodes);
  • omeprazole (used for gastric ulcer);
  • HIV protease inhibitors (used in the treatment of HIV);
  • astemizole, chlorpheniramine (antihistamines);
  • calcium antagonists (used to treat angina and cardiac rhythm disorders);
  • oral contraceptives;
  • propranolol, carvedilol, timolol (used to treat high blood pressure);
  • fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
  • haloperidol (antipsychotic);
  • codeine, dextromethorphan, tramadol (used to treat pain).

Stiripentolo Billev with food and drinks
Stiripentolo Billev must not be taken with milk or dairy products (yoghurt, creamy fresh cheeses, etc.), fruit juices, carbonated beverages, or foods and drinks containing caffeine or theophylline (e.g., cola, chocolate, coffee, tea, and energy drinks).
Pregnancy and breastfeeding
If your daughter is pregnant, breastfeeding, suspects she may be pregnant, or is planning a
pregnancy, consult your doctor before taking this medicine.
Effective antiepileptic therapy must NOT be discontinued during pregnancy.
Breastfeeding is not recommended during treatment with this medicine.
Driving and using machines
This medicine causes significant drowsiness.
Your child should not use tools, machinery, or drive vehicles (e.g., bicycle) if they experience this
symptom. Consult your paediatrician.
Stiripentolo Billev contains sucrose, aspartame (E951), benzyl alcohol, and sodium

  • Sucrose: if your doctor has told you that your child has an intolerance to certain sugars, contact them before taking this medicine.
  • Aspartame (E 951): this medicine contains 2.5 mg of aspartame per 250 mg sachet and 5 mg of aspartame per 500 mg sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
  • This medicine contains a flavouring with benzyl alcohol. Benzyl alcohol may cause allergic reactions.
  • Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., it is essentially “sodium-free”.

3. How to take Stiripentolo Billev

The child must take the contents of this sachet exactly as directed by the
physician. If you have any doubts, consult your paediatrician or pharmacist.
Dosage
The dose is adjusted by the doctor according to the child's age, body weight and medical condition. Generally,
a dose of 50 mg per kg of body weight per day is administered.
When to take Stiripentolo Billev
The child must take this medicine two or three times a day, at regular intervals, as directed by the doctor, e.g.
in the morning – at midday – in the evening before going to sleep, in order to cover the day-night period.
Dosage adjustment
Dosage increases should be gradual and occur over several weeks, while the doses of other antiepileptic drugs are
simultaneously reduced. Your doctor will inform you about the dosage of other antiepileptic medicines.
If you feel that the effect of this medicine is too strong or too weak, inform your paediatrician or pharmacist.
The doctor will adjust the dose according to the child's condition.
If the child experiences any adverse effects, contact the doctor, who may need to adjust the dose of this medicine
and of other antiepileptic drugs.
There is a slight difference between Stiripentolo Billev capsules and Stiripentolo Billev oral suspension powder
in sachets. Inform the doctor if the child has difficulty switching from capsules to oral suspension powder or vice versa.
Any switch between the capsule formulation and the powder formulation must be carried out under close supervision
of the paediatrician.
In case of vomiting occurring a few minutes after administration, it is assumed that the medicine has not been absorbed,
and therefore another dose should be administered.
However, the situation is different if vomiting occurs more than one hour after administration, since stiripentol is rapidly absorbed.
In this case, it is assumed that a significant portion of the administered dose has already been systemically absorbed
through the gastrointestinal tract. Therefore, re-administration or supplementation of the next dose is not necessary.
How to take Stiripentolo Billev
The powder must be dissolved in a glass of water and taken immediately during meals, after stirring. The child must take
Stiripentolo Billev with food; it must not be taken on an empty stomach.
For foods and drinks to avoid, see section 2 above: “Stiripentolo Billev with food and drink”.
If the child takes more Stiripentolo Billev than prescribed
If you know or suspect that the child has taken more medicine than prescribed, contact your paediatrician immediately.
If the child forgets to take Stiripentolo Billev
It is important that the child takes this medicine regularly every day at the same time. If the child forgets to take a dose,
it should be taken as soon as remembered, unless it is almost time for the next dose. In that case, the child should take
the next dose as usual. The child must not take a double dose to make up for a missed single dose.
If the child stops taking Stiripentolo Billev
The child must not stop treatment unless instructed by the doctor. Stopping treatment suddenly may lead to a sudden
onset of seizures.
If you have any doubts about how to use this medicine, consult your paediatrician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Very common side effects (may occur in more than 1 in 10 people):

  • loss of appetite, weight loss (particularly when Stiripentol Billev is used in combination with sodium valproate, an antiepileptic medicine);
  • insomnia, drowsiness;
  • ataxia (inability to coordinate muscle movements), hypotonia (reduced muscle strength), dystonia (involuntary muscle contractions).

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

  • increased liver enzyme levels, especially when Stiripentol Billev is used in combination with the antiepileptic drugs carbamazepine and sodium valproate;
  • aggression, irritability, agitation, hyperexcitability (state of unusual excitement);
  • sleep disturbances;
  • hyperkinesia (excessive movements);
  • nausea, vomiting;
  • reduced number of a type of white blood cells.

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

  • double vision when Stiripentol Billev is used in combination with the antiepileptic drug carbamazepine;
  • light sensitivity;
  • skin rash, skin allergy, urticaria (itchy, pink swellings on the skin);
  • asthenia (weakness, fatigue).

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

  • decreased platelet count in the blood;
  • abnormal liver function test.

To manage these side effects, the paediatrician may need to adjust the dose of Stiripentol Billev or of one of the other prescribed medicines.

Reporting of side effects

If the child experiences any side effects, including those not listed in this leaflet, consult the paediatrician or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Stiripentol Billev

Keep this medicine out of the sight and reach of children.
The child should not take this medicine after the expiry date stated on the sachet and on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light. This medicine does not require any special storage temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Stiripentolo Billev contains

  • The active substance is stiripentol. Stiripentolo Billev 250 mg: each sachet contains 250 mg of stiripentol. Stiripentolo Billev 500 mg: each sachet contains 500 mg of stiripentol.
  • The other ingredients are: sodium starch glycolate type A, povidone K 30, sodium lauryl sulfate, magnesium stearate, sodium carmellose, hydroxyethylcellulose, sucrose, aspartame (E951), titanium dioxide (E171), mixed fruit flavouring (containing propylene glycol [E1520] and benzyl alcohol), erythrosine (E127).

Description of the appearance of Stiripentolo Billev and package contents
Stiripentolo Billev is a crystalline, light pink powder for oral suspension, contained in sachets.
Stiripentolo Billev is supplied in cartons containing 30, 60 or 90 sachets.
Not all pack sizes may be marketed.
Stiripentolo Billev is also available as hard capsules containing 250 mg and 500 mg.
Marketing Authorization Holder
Billev Pharma ApS,
Slotsmarken 10
2970 Hoersholm,
Denmark
Manufacturer
Misom Labs Malta Life Sciences Park
LS2.01.06, Industrial Estate
San Gwann
SGN 3000
Malta
This leaflet was last updated on