FINTEPLA 2.2 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Fintepla 2.2 mg/ml Oral Solution

fenfluramine

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you or your child start 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 doctor, pharmacist, or nurse.
• This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or your child's.
• If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Fintepla and what is it used for

Fintepla contains the active substance fenfluramine.

Fintepla is used as an adjunctive treatment for seizures in patients aged 2 years and older with a type of epilepsy called Dravet syndrome or Lennox-Gastaut syndrome. It may help reduce the number and severity of seizures.

The exact way Fintepla works is not known. However, it is thought to work by increasing brain activity of a substance called serotonin and the sigma 1 receptor, which may reduce seizures.

2. What you need to know before you or your child take Fintepla

Do not take Fintepla

• if you are allergic to fenfluramine or any of the other ingredients of this medicine (listed in section 6);
• if you have a heart problem such as 'valvular heart disease' or 'pulmonary arterial hypertension' (high blood pressure in the arteries of the lungs);
• if you have taken medicines called monoamine oxidase inhibitors (MAOIs) in the last 2 weeks.

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

Warnings and precautions

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

• you or your child have glaucoma;
• you or your child have had thoughts of harming yourself or suicide;
• you or your child are taking a medicine called cyproheptadine, which is used to treat allergies or to improve appetite.

If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before taking Fintepla.

Tests and checks

Before starting treatment with Fintepla, your doctor will check your heart with an echocardiogram (ECG). The doctor will check that the heart valves are not abnormal and that the blood pressure between the heart and lungs is not too high. Once you have started taking Fintepla, you will need to have 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 the last dose.

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

'Serotonin syndrome'

Tell your doctor or pharmacist before taking Fintepla if you or your child are taking medicines that may increase the level of serotonin in the brain. This is because taking these medicines with Fintepla may cause serotonin syndrome, a condition that can be life-threatening. Medicines that may increase serotonin levels are:

• 'triptans' (such as sumatriptan) used for migraine;
• MAOI medicines used for depression;
• SSRI or SNRI medicines 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 heart problems such as a fast heartbeat, changes in blood pressure, high body temperature, sweating;
• muscle tremors and lack of coordination;
• feeling sick or being sick and diarrhea.

Tell your doctor immediately if you experience any of these side effects.

Other medicines and Fintepla

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines. This is because Fintepla may affect how other medicines work. Also, some medicines may affect how Fintepla works.

Fintepla may cause drowsiness. You or your child may feel even more drowsy if you take medicines such as antidepressants or alcohol at the same time as Fintepla.

In particular, tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take:

• stiripentol, a medicine for epilepsy, as your Fintepla dose may need to be reduced;
• 'triptans', MAOIs, SSRIs, or SNRIs (see 'Serotonin syndrome' above);
• carbamazepine, primidone, rifampicin, phenobarbital, and other barbiturates, phenytoin, or efavirenz, as your Fintepla dose may need to be increased.

You should also talk to a doctor or pharmacist if you or your child smoke, as you may need to have your Fintepla dose increased.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Talk to your doctor about driving and using machines, or if you or your child plan to take part in activities such as cycling or other sports, as you may feel drowsy after taking this medicine.

Fintepla contains sodium ethyl p-hydroxybenzoate (E 215) and sodium methyl p-hydroxybenzoate (E 219)

May cause allergic reactions (possibly delayed).

Fintepla contains sulfur dioxide (E 220)

May rarely cause hypersensitivity reactions and bronchospasm.

Fintepla contains glucose

May be harmful to teeth.

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Fintepla contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 12 ml, i.e., essentially 'sodium-free'.

3. How to take Fintepla

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

Weight (kg) x dose based on weight (mg/kg) ÷ 2.2 mg/ml = dose volume twice 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. Table 1 does not replacethe need to calculate the specific dose volume.

How much to take

• Your doctor will tell you how many milliliters to take for each dose.
• Take the medicine twice a day.
• The doctor will start treatment with a low dose. This dose will be gradually increased according to how well the medicine works and how it affects you or your child.
• The maximum amount that can be taken is 6 ml twice a day.
• If you are taking stiripentol, the maximum amount that can be taken is 4 ml twice a day.
• Do not take more than the prescribed dose, as this may cause serious side effects.

How to take this medicine

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

If you or your child take more Fintepla than you should

Consult a doctor or go to the hospital immediately. Take the medicine bottle with you. The following effects may happen: agitation, drowsiness, or confusion, flushing or feeling hot, tremors or sweating.

If you or your child forget to take Fintepla

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

If you or your child stop taking Fintepla

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

Between 3 and 6 months after the last dose of Fintepla, you or your child will need to have an echocardiogram.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very Common: may affect more than 1 in 10 people

• Decreased appetite
• Somnolence
• Diarrhea

• Feeling tired, somnolent, or weak

Common: may affect up to 1 in 10 people

• bronchitis
• abnormal behavior
• rapid mood changes
• aggressiveness
• agitation
• insomnia
• tremor of hands, arms, or feet
• problems coordinating movements, walking, and maintaining balance
• decreased muscle tone
• seizures
• prolonged seizures (status epilepticus)
• lethargy
• weight loss
• constipation
• excessive salivation
• vomiting
• skin rash

low blood sugar level

• elevated prolactin levels in blood

Frequency Not Known(frequency cannot be estimated from available data):

• valvular heart disease
• irritability
• serotonin syndrome
• high blood pressure in the pulmonary arteries (pulmonary arterial 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 the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fintepla

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiration date shown on the box and vial after CAD. The expiration date is the last day of the month indicated.
• Do not refrigerate or freeze.
• It must be used before 3 months have passed since the first opening of the vial.
• Wash the syringe after each use.
• If a syringe is damaged or lost, or if you cannot read the dose marks it presents, use another syringe for oral administration from those included in the package or consult your pharmacist.
• Medicines should not be thrown away through drains or into the trash. Ask your pharmacist how to dispose of containers and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Fintepla Composition

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

The other components are:

• Sodium ethyl p-hydroxybenzoate (E 215)
• Sodium methyl p-hydroxybenzoate (E 219)
• Sucralose (E 955)
• Hydroxyethylcellulose (E 1525)
• Monosodium phosphate (E 339)
• Disodium phosphate (E 339)
• Cherry flavor powder:
• Acacia (E 414)
• Glucose (from corn)
• Ethyl benzoate
• Natural flavor preparations
• Natural flavoring substances
• Flavoring substances
• Maltodextrin (corn)
• Sulfur dioxide (E 220)

• Potassium citrate (E 332)
• Citric acid monohydrate (E 330)
• Water for injectable preparations

Product Appearance and Package Contents

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

• It is possible that in your country, only some package sizes are marketed.

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

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Date of Last Revision of this Prospectus:

Other Sources of Information

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