Package Leaflet: Information for the User

Diacomit250mgOral Suspension Powder in a Blister

Diacomit 500 mg Oral Suspension Powder in a Blister

estiripentol

Read this leaflet carefully before your child starts taking the medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your child's doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to other people, even if they have the same symptoms, as it may harm them.
• If your child experiences any adverse effects, consult your child's doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Estiripentol, the active ingredient in Diacomit, belongs to a group of medications calledantiepileptics.

It is used in combination with clobazam and valproate (other antiepileptic medications) to treat a specific form of epilepsy called severe myoclonic epilepsy of infancy (Dravet syndrome), which affects children. Your child's doctor has prescribed this medication to help treat your child's epilepsy.

Your child MUST NOT take Diacomit

• if your child isallergicto estiripentol or to any of the other components of thismedication (listed in section 6).
• if your child has ever hadseizures with delirium(a mental state with confusion, emotion, restlessness, and hallucinations).

Warnings and precautions

Consult with your child's doctor or pharmacist before your child starts taking Diacomit

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

If your child has problems with any of the components of Diacomit (e.g. aspartame, glucose, sorbitol). In that case, see later: “Diacomit contains aspartame, glucose, sorbitol and sodium”.

Other medications and Diacomit

Inform your child's doctor or pharmacist if your child is taking, has taken recently, or may need to take any other medication.

Notify your doctor if your child is taking any of the following medications:

• medications thatcontain:

• cisapride (used to treat heartburn symptoms);
• pimozide (used to treat symptoms of Tourette's syndrome: vocal tics and involuntary, repetitive movements of the body);
• ergotamine (used to treat migraines);
• dihydroergotamine (used to alleviate symptoms of reduced mental capacity due to aging);
• halofantrine (a medication for antimalarial treatment);
• quinidine (used to treat cardiac arrhythmias);
• bepridil (used to control chest pain);
• ciclosporin, 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 medications that contain:

• phenobarbital, primidone, phenytoin, carbamazepine, diazepam.

• medications thatcontain:

• midazolam or triazolam (medications used to reduce anxiety and insomnia — combined with Diacomit cause excessive drowsiness in your child);
• chlorpromazine (used to treat mental illnesses such as psychosis).

• If your child is taking medications thatcontain:

• caffeine (this substance helps to recover mental alertness) or theophylline (this substance is used in case of asthma). Avoid combining it with Diacomit, as it may increase blood levels, leading to gastrointestinal disturbances, increased heart rate, and insomnia.

• If your child takes medications metabolized by certain liver enzymes:

• citalopram (used in the treatment of depression episodes);
• omeprazole (used to treat stomach ulcers);
• HIV protease inhibitors (used in HIV treatment);
• astemizole, chlorpheniramine (antihistamines);
• calcium channel blockers (used to treat angina or cardiac arrhythmias);
• oral contraceptives;
• propranolol, carvedilol, timolol (used to treat high blood pressure);
• fluoxetine, paroxetine, sertraline, imipramine, clomipramine (antidepressants);
• haloperidol (antipsychotics);
• codeine, dextromethorphan, tramadol (pain relievers).

Taking Diacomit with food and drinks

DO NOT take Diacomit with milk or dairy products (yogurt, creamy cheeses, etc.), fruit juices, carbonated beverages, or foods and drinks containing caffeine or theophylline (e.g. cola, chocolate, coffee, tea, or energy drinks).

Pregnancy and breastfeeding

If your daughter is pregnant or breastfeeding or thinks she may be pregnant or intends to become pregnant, consult your doctor before takingthis medication. During pregnancy, DO NOT interrupt an effective antiepileptic treatment.

It is not recommended to breastfeed during treatment with this medication.

Driving and operating machinery

This medication may cause drowsiness in your child.

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

Diacomit containsaspartame, glucose, sorbitol andsodium

This medication contains 2.5 mg of aspartame per 250 mg tablet and 5 mg per 500 mg tablet. Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains 2.4 mg of sorbitol per 250 mg tablet and 4.8 mg per 500 mg tablet.

Glucose may harm teeth.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Your child must takethese capsulesexactly as instructed by your child's doctor. In case of doubt, consult again with your child's doctor or pharmacist

Dose

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

When to take Diacomit

Your child must take this medication two or three times a day at regular intervalsas instructed by your child's doctor:for example, in the mornings, at noon, and at bedtime to coverthe night and daytime periods.

Dose adjustment

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

If you feel that the effect of this medication isstrong or too weak, consult with your child's doctor or pharmacist. The doctor will adjust the dose according to your child's condition.

There are slightdifferences between the capsules and theoral suspension powder of Diacomit. Please consult your doctor if your child experiences any problems when switching from capsules to oral suspension powder, orvice versa.If you switch from one formulation toanother between capsules andoral suspension powder,it must be done under thestrict supervision of your child's doctor.

In the event of vomiting in the first minutes after administrationit is considered that the medication has not been absorbed and a new dose should be administered.

However, the situation changes if vomiting occurs more than an hour after medication intake since stiripentol is rapidly absorbed.

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

How to takeDiacomit oral suspension powder

The powder must be dissolved in a glass of water and must be taken immediately after dissolution during a meal. Your child must take Diacomit with food and MUST NOT take it on an empty stomach. To know the foods and beverages to be avoided, consult the previous section “Taking Diacomit with foods and beverages”.

If your child takes more Diacomit than they should

Consult your child's doctor if you know or believe that your child has taken more medication than they should.

If your child forgets to take Diacomit

It is essential that your child takes this medication regularly at the same time every day. If your child forgets to take adoses, 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 compensate for the missed doses.

If your child interrupts treatment with Diacomit

Your child should not stop taking this medication unless the doctor tells you to. Stopping treatment may cause a seizure.

If you have any other doubts about the use of this medication, ask your child's doctor or pharmacist.

Like all medications, this medication may have adverse effects, although not everyone will experience them.

Very Frequent Adverse Effects(may affect more than one in 10 people):

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

• ataxia (inability to coordinate muscle movements), hypotonia (poor muscle strength), dystonia (involuntary muscle contractions).

Frequent Adverse Effects(may affect up to one in 10 people):

• elevation of liver enzyme levels, especially when administered with the antiepileptic medications carbamazepine or valproate sodium;
• aggressiveness, irritability, agitation, hyperexcitability (unusual excitability);
• sleep disturbances (abnormalities of sleep);

• hyperkinesia (exaggerated movements);

• nausea, vomiting;
• low count of a type of white blood cell.

Infrequent Adverse Effects(may affect up to one in 100 people):

• double vision when used with the antiepileptic medication carbamazepine;
• light sensitivity;
• eruption, skin allergy, urticaria (inflammation of the skin with a pink tone and accompanied by itching);
• fatigue (tiredness).

Rare Adverse Effects(may affect up to one in 1,000 people):

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

To eliminate these adverse effects, the child's doctor may have to adjust the dose of Diacomit or one of the other medications prescribed to the child.

Reporting Adverse Effects

If your child experiences any type of adverse effect, consult the child's doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.* By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the reach and sight of children.

• Your child should not use this medication after the expiration date that appears on the label after “EXP”. The expiration date is the last day of the month indicated.
• Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Diacomit250mg

• The active ingredient is stiripentol. Each sachet contains 250 mg of stiripentol.
• The other components of the sachet are povidone, sodium starch glycolate, liquid glucose (dried by spray drying), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavor (contains sorbitol), sodium caramel, hydroxyethylcellulose.

Composition of Diacomit500mg

• The active ingredient is stiripentol. Each sachet contains 500 mg of stiripentol.
• The other components of the sachet are povidone, sodium starch glycolate, liquid glucose (dried by spray drying), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavor (contains sorbitol), sodium caramel, hydroxyethylcellulose.

Appearance of Diacomit 250 mg and packaging contents

This medicine is a light pink powder packaged in sachets.

The boxes contain 30, 60 or 90 sachets. Some packaging sizes may only be marketed.

Appearance of Diacomit 500 mg and packaging contents

This medicine is a light pink powder packaged in sachets.

The boxes contain 30, 60 or 90 sachets. Some packaging sizes may only be marketed.

Diacomit is also available in oral capsule form of 250 mg and 500 mg.

Marketing Authorization Holder

Biocodex

22 rue des Aqueducs – F-94250 Gentilly - France

Tel: + 33 1 41 24 30 00 - e-mail:[email protected]

Responsible Person

Biocodex

1 avenue Blaise Pascal - F-60000 Beauvais - France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

AT/BE/BG/CY/DK/EL/ES/FR/HR/HU/IE/IS/IT/LU/MT/NL/NO/PL/PT/SE/SI

Biocodex

22 rue des Aqueducs – F-94250 Gentilly

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