Prospect: information for the patient

Fintepla 2,2 mg/ml oral solution

fenfluramine

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You may contribute by reporting any adverse effects you experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before you or your child starts taking this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you or your child, and it should not be given to other people even if they have the same symptoms as you or your child, as it may harm them.
• If you or your child experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Fintepla contains the active ingredient fenfluramina.

Fintepla is used as a complementary treatment to treat seizure crises in patients 2 years of age and older who have either a type of epilepsy called Dravet syndrome or one called Lennox-Gastaut syndrome. It may help reduce the number and severity of seizures.

The exact mechanism of action of Fintepla is not known. However, it is believed to act by increasing the brain activity of a substance called serotonin and the sigma 1 receptor, which may reduce seizures.

Do not take Fintepla

• if you are allergic to fenfluramine or any of the other components of this medication (listed in section 6);
• if you have a heart problem such as "heart valve disease" or "pulmonary hypertension" (elevated blood pressure in the pulmonary arteries);
• if you have taken certain medications called monoamine oxidase inhibitors in the last 2 weeks.

Do not take Fintepla if any of the above conditions apply to you. If you are unsure, consult your doctor, pharmacist, or nurse before taking Fintepla.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Fintepla if:

• you or your child has glaucoma;
• you or your child has had thoughts of self-harm or suicide;
• you or your child is taking a medication called ciproheptadine, used to treat allergies or improve appetite.

If any of the above situations apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Fintepla.

Analysis and controls

Before starting treatment with Fintepla, your doctor must review your heart condition with an echocardiogram (ECO). The doctor will check that your heart valves are not abnormal and that the blood pressure between your heart and lungs is not too high. Once you have started taking Fintepla, you will need to undergo an echocardiogram every 6 months for the first 2 years and then once a year. If you stop taking Fintepla, you will need to have an echocardiogram 3-6 months after your last dose.

Your doctor will also need to check your weight before treatment and during treatment, as Fintepla may cause weight loss.

“Serotonin syndrome”

Inform your doctor or pharmacist before taking Fintepla if you or your child is taking medications that may increase the level of serotonin in the brain. This is because taking these medications with Fintepla may cause serotonin syndrome, a condition that can be fatal. The medications that may increase serotonin levels are:

• “triptans” (such as sumatriptan) used for migraines;
• monoamine oxidase inhibitors (MAOIs) used for depression;
• selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) used for depression and anxiety.

Be aware of the possible symptoms of serotonin syndrome, which include:

• agitation, seeing things that are not there (hallucinations), or fainting;
• circulatory and cardiac problems such as a rapid pulse, blood pressure fluctuations, high body temperature, sweating;
• muscle tremors and lack of coordination;
• feeling unwell or actual illness and diarrhea.

Inform your doctor immediately if you experience any of these adverse effects.

Other medications and Fintepla

Inform your doctor or pharmacist if you or your child is taking, has taken recently, or may need to take any other medication. This is because Fintepla may affect the mechanism of action of other medications. Additionally, some medications may affect the mechanism of action of Fintepla.

Fintepla may cause drowsiness. You may feel even drowsier if you take medications such as antidepressants or alcohol at the same time as Fintepla.

Particularly, inform your doctor or pharmacist if you or your child is taking, has taken recently, or may need to take:

• estiripentol, a medication for epilepsy, as your Fintepla dose may need to be reduced;
• “triptans”, MAOIs, SSRIs, or SNRIs, see above the section “Serotonin syndrome”;
• carbamazepine, primidone, rifampicin, phenobarbital, and other barbiturates, phenytoin, or efavirenz, as you may need to increase your Fintepla dose.

You should also speak with a doctor or pharmacist if you or your child smokes, as you may need to increase your Fintepla dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Driving and operating machinery

Speak with your doctor about driving and operating machinery, or if you or your child is going to engage in activities such as cycling or other sports, as you may feel drowsy after taking this medication.

Fintepla contains p-hydroxybenzoic acid ethyl ester (E 215) and p-hydroxybenzoic acid methyl ester (E 219)

It may cause allergic reactions (possibly delayed).

Fintepla contains sulfur dioxide (E 220)

Rarely, it may cause hypersensitivity reactions and bronchospasm.

Fintepla contains glucose

It may harm teeth.

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

Fintepla contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 12 ml; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor, pharmacist, or nurse will calculate the dose volume up to the recommended maximum dose using the formula:

Weight (kg) x dose based on weight (mg/kg) ÷ 2.2mg/ml = ml of dosetwice a day

The calculated dose should be rounded to the nearest graduated increment..

The following table should only be used as a check of the calculated dose volume. Table1does not replacethe need to calculate the specific dose volume.

How much to take

• Your doctor will tell you how many milliliters to take in each dose.
• Take the medication twice a day.
• Your doctor will start the treatment with a low dose. This dose will be gradually increased according to the level of effectiveness of the medication and how it affects the patient.
• The maximum amount that can be taken by the patient is 6 ml twice a day.
• If you are taking estiripentol, the maximum amount that can be taken is 4 ml twice a day.
• Do not take more than the prescribed dose as it may cause severe side effects.

How to take this medication

• Take this medication orally.
• Take the medication with food or between meals.
• Fintepla oral solution is compatible with a ketogenic diet.
• The medication is a liquid. Use the oral syringes provided to measure the dose, as explained below.
• Use the 3 ml green syringe for doses up to 3.0 ml.
• Use the 6 ml purple syringe for doses between 3.2 and 6.0 ml.
• Fintepla oral solution is compatible with most enteral feeding tubes.
• To clean the feeding tube, fill the syringe to be used with water and clean the tube. Repeat the process three times.

If you or your child takes more Fintepla than you should, the correct action is:

Consult with your doctor or go to the hospital directly. Bring the medication bottle with you. You may experience the following effects: agitation, drowsiness or confusion, hot flashes or heat, tremors or sweating.

If you or your child forgets to take Fintepla

• Take it as soon as you remember. However, if it is almost time to take the next dose, skip the missed dose.
• Do not take a double dose to compensate for the missed doses.

If you or your child interrupts treatment with Fintepla

Do not interrupt treatment with Fintepla without talking to your doctor first. If your doctor decides to stop treatment with this medication, they will ask you to gradually reduce the amount you take each day. Gradually reducing the dose will reduce the risk of seizures and status epilepticus.

Between three and six months after the last dose of Fintepla, the patient should undergo an echocardiogram.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Very Frequent: may affect more than 1out of every 10people

• Decreased appetite
• Drowsiness
• Diarrhea

• Feeling tired, drowsy, or weak

Frequent: may affect up to 1out of every 10people

• Bronchitis
• Abnormal behavior
• Rapid mood changes
• Aggression
• Restlessness
• Insomnia
• Tremors in hands, arms, or feet
• Difficulty coordinating movements, walking, and maintaining balance
• Decreased muscle tone
• Seizures
• Long-term seizures (status epilepticus)
• Lethargy
• Weight loss
• Constipation
• Excessive salivation
• Vomiting
• Skin rash

Low blood sugar level

• Elevated prolactin levels in blood

Unknown Frequency(frequency cannot be estimated from available data):

• Cardiac valvular disease
• Irritability
• Serotonin syndrome
• Elevated blood pressure in pulmonary arteries (pulmonary hypertension)

Inform your doctor or nurse if you notice any of the adverse effects listed above.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box and the bottle after CAD. The expiration date is the last day of the month indicated.
• Do not refrigerate or freeze.
• Use before 3 months have passed since the first opening of the bottle.
• Wash the syringe after each use.
• If a syringe deteriorates or is lost, or you cannot read the dosage markings on it, use another oral syringe included in the package or consult with your pharmacist.
• Medications should not be thrown away 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 Fintepla

The active ingredient is fenfluramine. Each milliliter contains 2.2 mg of fenfluramine(as fenfluramine hydrochloride).

The other components are:

• P-hydroxybenzoic acid sodium ethyl ester(E 215)
• P-hydroxybenzoic acid sodium methyl ester(E 219)
• Sucralose (E 955)
• Hydroxyethylcellulose (E 1525)
• Monosodium phosphate (E 339)
• Dipotassium phosphate (E 339)
• Cherry flavor powder:
• Acacia (E 414)
• Maize glucose
• Ethylbenzoate
• Natural flavor preparations
• Natural flavor substances
• Flavor substances
• Maize maltodextrin
• Sulfur dioxide (E 220)

• Potassium citrate (E 332)
• Monohydrated citric acid (E 330)
• Water for injectable preparations

Appearance of the product and contents of the package

• Fintepla oral solution is supplied as a clear, colorless, slightly viscous liquid with a cherry flavor.
• The solution is presented in a white bottle with a child-resistant and tamper-evident cap.
• Each pack contains:
• Bottle with 60 ml of oral solution, a bottle adapter, two oral syringes of 3 ml with graduations of 0.1 ml, and two syringes of 6 ml with graduations of 0.2 ml.
• Bottle with 120 ml of oral solution, a bottle adapter, two oral syringes of 3 ml with graduations of 0.1 ml, and two syringes of 6 ml with graduations of 0.2 ml.
• Bottle with 250 ml of oral solution, a bottle adapter, two oral syringes of 3 ml with graduations of 0.1 ml, and two syringes of 6 ml with graduations of 0.2 ml.
• Bottle with 360 ml of oral solution, a bottle adapter, two oral syringes of 3 ml with graduations of 0.1 ml, and two syringes of 6 ml with graduations of 0.2 ml.

• Only some package sizes may be marketed in your country.

Marketing authorization holder and manufacturer

Marketing authorization holder:

UCB Pharma S.A.,

Allée de la Recherche 60,

B-1070 Bruxelles,

Belgium

Manufacturer:

Millmount Healthcare Ltd,

Millmount Site, Block 7,

City North Business Campus,

Stamullen,

Co. Meath,

K32 YD60,

Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.There are also links to other websites on rare diseases and orphan medicines.