STIRIPENTOLO 250 mg Капсулы Твердые

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1. Stiripentolo Billev 250 mg hard capsules, 500 mg hard capsules
   1. What is Stiripentolo Billev and what is it 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
2. Stiripentolo Billev 250 mg Powder for oral suspension in sachets, 500 mg Powder for oral suspension in sachets
   1. What is Stiripentolo Billev and what is it 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

Stiripentolo Billev 250 mg hard capsules, 500 mg hard capsules

Stiripentolo

Generic medicine

Read this leaflet carefully before the 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 pediatrician or pharmacist.
• This medicine has been prescribed only for your child. Do not give it to other people, even if they have the same symptoms as your child, as it could be dangerous.
• If the child experiences any side effects, including those not listed in this leaflet, ask your pediatrician 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 is Stiripentolo Billev and what is it used for

Stiripentol, the active substance of Stiripentolo Billev, belongs to a group of medicines called
antiepileptics.
It is used together with clobazam and valproate (other antiepileptic medicines) for the treatment of a
particular form of epilepsy called severe myoclonic epilepsy of infancy (Dravet syndrome) which
affects children. Your pediatrician 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 your child is allergic to stiripentol or any of the other ingredients of this medicine (listed in section 6).
• If your child has had delirious attacks (a mental state characterized by confusion, excitement, restlessness and hallucinations).

Warnings and precautions
Talk to your pediatrician or pharmacist before giving Stiripentolo Billev:

• If your child has kidney or liver problems
• Before starting therapy with Stiripentolo Billev, your child's liver function must be assessed and checks must be repeated every 6 months
• Before starting therapy with Stiripentolo Billev, the blood cell count must be assessed and checks must 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
must be monitored very carefully.

Other medicines and Stiripentolo Billev
Tell your pediatrician or pharmacist if your child is taking, has recently taken or might
take any other medicines.
Talk to your doctor if your child is taking any of the following:

• medicines containing:
• cisapride (used to treat symptoms of heartburn);
• pimozide (used to treat symptoms of Tourette's syndrome, for example making meaningless sounds and involuntary, repetitive movements of the body);
• ergotamine (used to treat migraine);
• dihydroergotamine (used to relieve signs and symptoms of reduced mental capacity due to the aging process);
• halofantrine (antimalarial treatment);
• quinidine (used to treat heart arrhythmias);
• bepridil (used to relieve chest pain);
• cyclosporine, tacrolimus, sirolimus (all three are used to prevent rejection following liver, kidney and 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 combined with Stiripentolo Billev they significantly increase the child's drowsiness);
• 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 for asthma) the combination with Stiripentolo Billev should be avoided as it may increase the concentrations of these substances in the blood with resulting digestive disorders, accelerated heartbeat and insomnia.
• If your child is taking medicines 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, chlorpheniramine (antihistamines)
• calcium channel blockers (used in the treatment of angina and heart rhythm disorders);
• 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 in the treatment of pain)

Stiripentolo Billev with food and drink
Stiripentolo Billev should not be taken with milk or its derivatives (yogurt, creamy fresh cheeses,
etc.), fruit juices, carbonated drinks 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 or breastfeeding, thinks she may be pregnant or is planning a
pregnancy, ask your doctor for advice before taking this medicine.
Effective antiepileptic therapy should NOT be stopped during pregnancy.
Breastfeeding with breast milk is not recommended during treatment with this medicine.

Driving and using machines
This medicine causes significant drowsiness.
The child should not use tools, machinery, drive vehicles (e.g. bicycle) if they experience this
symptom. Ask your pediatrician for advice.

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 following the doctor's instructions exactly. If you have any doubts, consult your pediatrician or pharmacist.

Dose
The dose is adjusted by the doctor based on the child's age, weight and condition, generally administering 50 mg per kg of body weight per day.

When to take Stiripentolo Billev
The child must take this medicine two or three times a day, at regular intervals, as instructed by the doctor, for example in the morning – at noon – in the evening before going to bed, in order to cover the day-night period

Dose adjustment
Increases in dosage must be gradual and occur over several weeks, while the dose of other antiepileptic drugs is reduced simultaneously. The doctor will inform you of the dose of other antiepileptic drugs.
If you feel that the effect of this medicine is too strong or too weak, inform your pediatrician or pharmacist. The doctor will adjust the dose based on the child's condition.
Inform your pediatrician if any of the undesirable effects occur, as the doctor may need to adjust the dose of this medicine and other antiepileptic medicines.
There is a slight difference between Stiripentolo Billev capsules and Stiripentolo Billev powder for oral suspension. Inform the doctor if the child has difficulty switching from taking the capsules to taking the powder for oral suspension or vice versa. Any switch from the capsule formulation to the powder and vice versa must be carried out under strict control of the pediatrician.
In case of vomiting a few minutes after taking the medicine, it is assumed that the medicine has not been absorbed, therefore another dose must be administered.
However, the situation is different if the episode of vomiting occurs more than an hour after taking the medicine, as stiripentol is rapidly absorbed.
In this case, it is assumed that a significant portion of the administered dose has been absorbed systemically by the digestive system. Therefore, it is not necessary to proceed with a new administration or an integration of the next dose.

How to take Stiripentolo Billev capsules
To ensure that the entire amount of powder is taken by the patient, it is preferable not to open the capsule and swallow it as a single oral unit of administration. The child must take Stiripentolo Billev with food, and must not take it on an empty stomach.
For foods and beverages to avoid, see section 2 above: “Stiripentolo Billev with food and beverages”.

If the child takes more Stiripentolo Billev than they should
If you know or think that the child has ingested more medicine than they should, contact your pediatrician.

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, they should take it as soon as they remember, unless it is time for the next dose. In this case, the child should take the next dose as usual. The child should not take a double dose to make up for a missed single dose.

If the child stops taking Stiripentolo Billev
The child must notstop treatment unless instructed by the doctor. Suddenly stopping treatment may lead to a sudden onset of seizures.
If you have any doubts about the use of this medicine, consult your pediatrician 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 Stiripentolo Billev is associated 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 enzymes in the liver, especially if Stiripentolo Billev is associated with carbamazepine and sodium valproate antiepileptic medicines;
• aggression, irritability, agitation, hyperexcitability (unusual state of excitement);
• sleep disorders;
• hyperkinesia (exaggeration of 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 Stiripentolo Billev is associated with the antiepileptic medicine carbamazepine;
• sensitivity to light;
• skin rash, skin allergy, urticaria (pink, itchy swellings on the skin);
• fatigue (tiredness).

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

• decreased level of platelets in the blood;
• abnormal liver function test.

To eliminate these side effects, the pediatrician may need to change the dosage of Stiripentolo
Billev or one of the other prescribed medicines.

Reporting of side effects
If your child gets any side effect, talk to your doctor or pharmacist. You can also report side effects directly through 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 Stiripentolo Billev

Keep this medicine out of the sight and reach of children.
The child must not take this medicine after the expiry date which is 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 particular storage temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Stiripentolo Billev contains

• The active ingredient 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 ingredients are: Capsule content: sodium starch glycolate type A, povidone K 30, sodium lauryl sulfate and magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171) erythrosine (E127) (only Stiripentolo Billev 250 mg), indigotin (E132) (only Stiripentolo Billev 250 mg). Printing ink: shellac, propylene glycol (E1520), black iron oxide (E172), potassium hydroxide.

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

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

Stiripentolo

Equivalent Medicinal Product

Read this leaflet carefully before the 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 doctor or pharmacist.
• This medicine has been prescribed only for your child. Do not give it to other people, even if they have the same symptoms as the child because it could be dangerous.
• If the child experiences any side effects, including those not listed in this leaflet, ask your doctor 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 the 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 is Stiripentolo Billev and what is it used for

Stiripentol, the active substance of Stiripentolo Billev, belongs to a group of medicines called
antiepileptics.
It is used together with clobazam and valproate (other antiepileptic medicines) for the treatment of a
particular form of epilepsy called severe myoclonic epilepsy of infancy (Dravet syndrome) which
affects children. Your pediatrician 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 any of the other ingredients of this medicine (listed in section 6).
• If they have had delirious attacks (a mental state characterized by confusion, excitement, restlessness and hallucinations).

Warnings and precautions
Talk to your pediatrician or pharmacist before giving Stiripentolo Billev:

• If your child has kidney or liver problems.
• Before starting therapy with Stiripentolo Billev, your child's liver function must be assessed and checks must be repeated every 6 months.
• Before starting therapy with Stiripentolo Billev, a blood cell count must be performed and checks must 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
must be monitored very carefully.

Other medicines and Stiripentolo Billev
Tell your pediatrician or pharmacist if your child is taking, has recently taken or might
take any other medicines.
Talk to your doctor if your child is taking any of the following medicines:

• medicines containing:
• cisapride (used to treat symptoms of heartburn);
• pimozide (used to treat symptoms of Tourette's syndrome, for example making meaningless sounds and involuntary, repetitive body movements);
• ergotamine (used for the treatment of migraine);
• dihydroergotamine (used to relieve the signs and symptoms of reduced mental capacity due to the aging process);
• halofantrine (an antimalarial drug);
• quinidine (used for the treatment of heart arrhythmias);
• bepridil (used to relieve chest pain);
• cyclosporine, tacrolimus, sirolimus (all three are used to prevent rejection following liver, kidney and 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 in association with Stiripentolo Billev significantly increase the child's drowsiness);
• 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
case of asthma).
The combination with Stiripentolo Billev should be avoided as it may increase the
concentrations of these substances in the blood with resulting digestive disorders,
accelerated heartbeat and insomnia.
If your child is taking medicines 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, chlorpheniramine (antihistamines)
• calcium antagonists (used treatment of angina and heart rhythm disturbances);
• 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 in the treatment of pain).

Stiripentolo Billev with food and drink
Stiripentolo Billev should not be taken with milk or its derivatives (yogurt, creamy fresh cheeses,
etc.), fruit juices, carbonated drinks 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 or breastfeeding, suspects she is pregnant or is planning a
pregnancy, ask your doctor for advice before taking this medicine.
Effective antiepileptic therapy should NOT be stopped during pregnancy.
Breastfeeding with breast milk is not recommended during treatment with this medicine.

Driving and operating machinery
This medicine causes significant drowsiness.
The child should not use tools, machinery, drive vehicles (e.g. bicycle) if they experience this
symptom. Ask your pediatrician for advice.

Stiripentolo Billev contains sucrose, aspartame (E951), benzyl alcohol and sodium

• Sucrose: if your doctor has told you that your child has an intolerance to some 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 condition that causes phenylalanine to build up because the body cannot process it properly.
• This medicine contains a flavoring with benzyl alcohol. Benzyl alcohol can 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 always following exactly the doctor's instructions.
If you have any doubts, consult your pediatrician or pharmacist.

Dosage
The dose is adjusted by the doctor based on the child's age, weight and condition, generally
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, according to the
doctor's instructions, e.g. in the morning – at noon – in the evening before going to bed, in order to
cover the day-night period.

Dose adjustment
Increases in the dose must be gradual and occur over several weeks, while the dose
of other antiepileptic drugs is simultaneously reduced. The doctor will inform you of the dose
of other antiepileptic drugs.
If you feel that the effect of this medicine is too strong or too weak, inform your pediatrician
or pharmacist. The doctor will adjust the dose according to the child's condition.
If the child experiences any undesirable effect, consult your doctor, who may need to
adjust the dose of this medicine and other antiepileptic medicines.
There is a slight difference between Stiripentolo Billev capsules and Stiripentolo Billev powder for oral suspension
in sachets. Inform the doctor if the child has difficulty switching from taking capsules
to taking powder for oral suspension or vice versa. Any switch from
capsule formulation to powder and vice versa must be carried out under strict control of
the pediatrician.
In case of vomiting a few minutes after taking the medicine, it is assumed that the medicine has not been absorbed,
therefore another dose must be administered.
However, the situation is different if the episode of vomiting occurs more than an hour
after taking the medicine, as stiripentol is rapidly absorbed. In this case, it is assumed that a significant portion
of the administered dose has been absorbed systemically by the digestive system. It is therefore not necessary to proceed with a new administration or an integration of the subsequent dose.

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, and must not take it on an
empty stomach.
For foods and beverages to avoid, see section 2 above: “Stiripentolo Billev with food and beverages”.

If the child takes more Stiripentolo Billev than they should
If you know or think that the child has ingested more medicine than they should, contact your pediatrician.

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, they should take it as soon as they remember, unless it is
time for the next dose. In this case, they should take the next dose as usual. The child should not
take a double dose to make up for a missed single dose.

If the child stops taking Stiripentolo Billev
The child must notstop treatment unless instructed by the doctor. Suddenly stopping
treatment may lead to a sudden onset of seizures.
If you have any doubts about the use of this medicine, consult your pediatrician 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 Stiripentolo Billev is associated with sodium valproate, an antiepileptic medicine);
• insomnia, drowsiness;
• ataxia (inability to coordinate muscle movements), hypotonia (decreased muscle strength), dystonia (involuntary muscle contractions).

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

• increased levels of enzymes in the liver, especially if Stiripentolo Billev is associated with antiepileptic drugs carbamazepine and sodium valproate;
• aggression, irritability, agitation, hyperexcitability (unusual state of excitement);
• sleep disorders;
• hyperkinesia (exaggeration of 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 Stiripentolo Billev is associated with the antiepileptic drug carbamazepine;
• sensitivity to light;
• 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 level of platelets in the blood;
• abnormal liver function test.

To eliminate these side effects, the pediatrician may need to change the dosage of Stiripentolo
Billev or one of the other prescribed medicines.

Reporting of side effects
If your child gets any side effects, talk to your pediatrician or pharmacist. You can also report side effects directly through 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 Stiripentolo Billev

Keep this medicine out of the sight and reach of children.
The child must not take this medicine after the expiry date which is 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 particular storage temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Stiripentolo Billev contains

• The active ingredient 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: type A sodium starch glycolate, povidone K 30, sodium lauryl sulfate, magnesium stearate, sodium carboxymethylcellulose, hydroxyethylcellulose, sucrose, aspartame (E951), titanium dioxide (E171), mixed fruit flavouring (contains propylene glycol [E1520] and benzyl alcohol), erythrosine (E127).

Description of the appearance of Stiripentolo Billev and contents of the pack
Stiripentolo Billev is presented as a light pink crystalline oral suspension powder,
contained in sachets.
Stiripentolo Billev is supplied in packs containing 30, 60 or 90 sachets.
Not all pack sizes may be marketed.
Stiripentolo Billev is also available in hard capsules of 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 in