InfoCons Consumer Protection informs you – Fintepla – Package Leaflet

Before anything else

Read all of this leaflet carefully before you or your child starts 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 experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Fintepla is and what it is used for

Fintepla contains the active substance fenfluramine.

Fintepla is used as adjunctive therapy to treat seizures (fits) in patients aged 2 years and over who have either a type of epilepsy called Dravet syndrome or one called Lennox -Gastaut syndrome. It can help to reduce the number and severity of seizures .

It is not completely known how Fintepla works. However, it is thought to work by increasing the activity in the brain of a natural substance called serotonin and the sigma 1 receptor, and this may reduce seizures.

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

Do not take Fintepla if

• you or your child are allergic to fenfluramine or any of the other ingredients of this medicine (listed in section 6)
• you or your child have a heart problem such as ‘valve disease’ or ‘pulmonary arterial hypertension’ (high pressure in the arteries of the lungs)
• you or your child have taken medicines used for the treatment of depression called monoamine oxidase inhibitors in the last 2 weeks.

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

Warnings and precautions

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

• you or your child have glaucoma 37 • you or your child have had thoughts about harming or killing yourself
• you or your child are taking a medicine called cyproheptadine, which is used to treat allergies or to improve appetite.
• you or your child have experienced an increase in frequency of seizures.
• you or your child have experienced more sleepiness.

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

Tests and checks Before you or your child start taking Fintepla your doctor must check the heart with an echocardiogram (ECHO). The doctor will check that the valves in the heart work properly and the pressure in the artery between the heart and lungs is not too high. Once you or your child has started taking Fintepla , you will have an echocardiogram check every 6 months for the first 2 years and then once a year. If Fintepla treatment is stopped, you or your child will need to have an echocardiogram 3-6 months after the la st dose.

Your doctor should also check your weight before and during your treatment as Fintepla can cause you to lose weight or decrease you r appetite . ‘Serotonin syndrome’ Tell your doctor or pharmacist before taking Fintepla if you or your child are taking medicines which can increase the levels of serotonin in your brain. This is because taking these medicines and Fintepla can cause serotonin syndrome, which is a life- threatening condition. Medicines that can increase serotonin levels include:

• ‘triptans’ (such as sumatriptan) – used for migraine
• MAOI medicines – used for depression
• SSRI or SNRI medicines – used for depression and anxiety.

Look out for the signs of serotonin syndrome which include:

• being agitated, seeing things which are not there (hallucinations) or passing out
• heart and circulation problems such as fast heartbeat, blood pressure going up and down, high body temperature, sweating
• twitching muscles and being uncoordinated
• feeling or being sick and diarrhoea.

Tell your doctor straight away if you notice any of the serious side effects above.

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 can affect the way some other medicines work. Also, some other medicines can affect the way Fintepla works.

Fintepla can make you or your child feel sleepy. You or your child may be even more sleepy if you take other medicines such as anti -depressants 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 dose of Fintepla may need to be reduced
• ‘triptans’, MAOI, SNRI or SSRI medicines – see above under ‘Serotonin syndrome’
• carbamazepine, primidone, rifampicin, phenobarbital and other barbiturates, phenytoin, and efavirenz, as your dose of Fintepla may need to be increased.
• clobazam, valproate and cannabidiol , which are medicines used to treat epilepsy .

38 Pregnancy and breast -feeding If you or your child are pregnant, think you or your child might be pregnant, or are planning to have a baby or are breast -feeding, ask your doctor for advice before taking this medicine.

Driving and using machines

Talk to your doctor about driving, using machines, or if you or your child undertake activities such as cycling or other sports, because you or your child may feel sleepy or tired after taking this medicine.

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

hydroxybenzoate (E 219) This may cause allergic reactions (possibly delayed).

Fintepla contains sulfur dioxide (E 220)

This may rarely cause hypersensitivity reactions and bronchospasm.

Fintepla contains glucose

This may be harmful to the teeth.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Fintepla contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 12 ml, that is to say essentially ‘sodium – free’.

💊 3. How to take Fintepla

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with them if you are not sure.

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

Weight (kg) x Weight -based dosage (mg/kg) ÷ 2.2 mg/ml = ml dose to be taken twice daily Always round t he calculated dose up or down to the nearest graduation mark , following standard rounding conventions. For example, for a patient that needs a dose of 2.15 ml, the applied volume needs to be rounded up to 2.2 ml as the 3 ml syringe can only deliver 2.1 ml or 2.2 ml. Likewise a volume of 1.13 ml would need to be rounded down to a delivered volume of 1.1 ml. For a patient that needs a dose of 3.15 ml, the applied volume needs to be rounded up to 3.2 ml as the 6 ml syringe can only deliver 3.0 ml or 3.2 ml. Likewise a volume of 4.25 ml would need to be rounded down to a delivered volume of 4.2 ml.

The table below must only be used as a check on the calculated dose volume. Table 1 does not replace the requirement to calculate the specific dose volume.

Table 1: Range of dose volumes in ml for calculation check Dosing without concomitant STP* Dosing with concomitant STP** Weight category Starting dose Day 7 -13 Day 14 and further Starting dose Day 7 and further 0.1 mg/kg twice daily 0.2 mg/kg twice daily 0.35 mg/kg twice daily 0.1 mg/kg twice daily 0.2 mg/kg twice daily 39 3-5 kg 0.1-0.2 ml 0.3-0.5 ml 0.5-0.8 ml 0.1-0.2 ml 0.3-0.5 ml 5-7 kg 0.2-0.3 ml 0.5-0.6 ml 0.8-1.1 ml 0.2-0.3 ml 0.5-0.6 ml 7-10 kg 0.3-0.5 ml 0.6-0.9 ml 1.1-1.6 ml 0.3-0.5 ml 0.6-0.9 ml 10-15 kg 0.5-0.7 ml 0.9-1.4 ml 1.6-2.4 ml 0.5-0.7 ml 0.9-1.4 ml 15-20 kg 0.7-0.9 ml 1.4-1.8 ml 2.4-3.2 ml 0.7-0.9 ml 1.4-1.8 ml 20-30 kg 0.9-1.4 ml 1.8-2.7 ml 3.2-4.8 ml 0.9-1.4 ml 1.8-2.7 ml 30-38 kg 1.4-1.7 ml 2.7-3.4 ml 4.8-6 ml (maximum dose) 1.4-1.7 ml 2.7-3.4 ml 38-43 kg 1.7-2 ml 3.4-4 ml 6 ml (maximum dose) 1.7-2 ml 3.4-4 ml (maximum dose) 43-55 kg 2-2.5 ml 4-5 ml 6 ml (maximum dose) 2-2.5 ml 4 ml (maximum dose) 55-65 kg 2.5-3 ml 5-6 ml (maximum dose) 6 ml (maximum dose) 2.5-3 ml 4 ml (maximum dose) 65-86 kg 3-4 ml 6 ml (maximum dose) 6 ml (maximum dose) 3-4 ml (maximum dose) 4 ml (maximum dose) 86-130 kg 4-6 ml (maximum dose) 6 ml (maximum dose) 6 ml (maximum dose) 4 ml (maximum dose) 4 ml (maximum dose) *Without concomitant STP: The maximum dose 13 mg twice daily corresponds to 6 ml twice daily. **With concomitant STP: The maximum dose of 8.6 mg twice daily corresponds to 4 ml twice daily.

How much to take

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

Taking 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 your dose, as explained below.
• Use the green 3 ml syringe for doses up to 3 ml.
• Use the purple 6 ml syringe for doses between 3.2 ml and 6 ml.
• Fintepla oral solution is compatible with most enteral feeding tubes.
• To flush the feeding tube, fill the syringe used for dosing with water and flush the tube. Do this 3 times.

40 3 ml syringe – green 6 ml syringe – purple Write on the carton the date you first opened the bottle.

You must attach the bottle adaptor the first time you open the bottle. The following instructions tell you how to attach the adaptor.

Inserting the bottle adaptor :

When the bottle is first opened the bottle adaptor must be pushed into the bottle.

Wash and dry your hands.

Remove the bottle adaptor from its packaging.

Place the bottle on a flat, firm surface.

Open the bottle.

Hold the bottle firmly.

Line up the bottle adapter with the open top of the bottle.

Push the bottle adaptor into the bottle with your palm until the adaptor is flush with the top of the bottle.

Leave in the bottle adaptor after using the medicine.

Screw the bottle cap onto the bottle with the bottle adaptor left in.

Taking the medicine:

Before you measure out the dose, make sure the plunger is pushed all the way into the oral syringe.

Hold the bottle of medicine firmly on a hard, flat surface.

Push the tip of the oral syringe into the bottle adaptor until it cannot be pushed further.

Hold the oral syringe and bottle together and turn upside down.

Slowly pull the plunger to draw up the right dose.

Hold the oral syringe and bottle together and then turn over.

Holding the bottle firmly, gently pull the oral syringe out of the bottle adaptor.

Place the tip of the oral syringe against the inside of the patient’s cheek.

Gently push the plunger until it is fully pressed. There will be a small volume left in the tip of the syringe. This is normal.

Do not squirt the medicine into the back of the throat as this may cause choking.

Place the cap back on the bottle and turn until it stops.

Always leave the adaptor in place in the bottle.

Cleaning the syringe:

Rinse the oral syringe with cold water and allow it to air dry after each use.

Rinse the inside of the syringe and the plunger.

Cold water can be pulled into the syringe with the plunger and pushed out several times to clean the syringe.

It is okay to separate the plunger from the syringe to rinse each part. Do not use detergent to clean the syringe and plunger.

Do not clean the syringe and plunger in a dishwasher.

The syringe and plunger must be completely dry before the next use.

If you or your child take more Fintepla than you or your child should Talk to a doctor or go to a hospital straight away. Take the medicine bottle with you. The following effects may happen: being agitated, sleepy or confused, being flushed or hot, shivering and sweating.

If you or your child forget to take Fintepla

• Take it as soon as you remember it. However, if it is nearly time to take 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. If your doctor decides to stop this medicine, the doctor will ask you or your child to slowly lower the amount taken each day. Slowly lowering the dose will reduce the risk of having a seizure and status epilepticus.

Three to s ix 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common : may affect more than 1 in 10 people

• decreased appetite
• sleepiness
• diarrhoea
• tiredness

Common : may affect up to 1 in 10 people

• bronchitis
• abnormal behaviour
• rapid mood changes
• aggression
• agitation
• insomnia
• trembling of the hands, arms or legs
• having problem with coordination of movements, walking and balance
• decreased muscle tone
• seizures
• long- lasting seizures (status epilepticus)
• lethargy
• weight loss
• constipation
• increased production of saliva
• vomiting
• rash
• lower blood sugar
• increased blood prolactin

Not known (frequency cannot be estimated from the available data)

• irritability
• serotonin syndrome
• high blood pressure in the arteries of the lungs (pulmonary arterial hypertension)
• heart valve disease Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Fintepla

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.
• Do not refrigerate or freeze.
• Use within 3 months of first opening the bottle.

44 • If you lose or damage a syringe, or cannot read the dose markings on a syringe, use another oral syringe provided in your pack, or speak to your pharmacist.

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

📦 6. Contents of the pack and other information

What Fintepla contains

The active substance is called fenfluramine. Each ml contains 2.2 mg of fenfluramine (as 2.5 mg fenfluramine hydrochloride).

The other ingredients are:

• Sodium ethyl para -hydroxybenzoate (E 215)
• Sodium methyl para -hydroxybenzoate (E 219)
• Sucralose (E 955)
• Hydroxyethylcellulose (E 1525)
• Monosodium phosphate (E 339)
• Disodium phosphate (E 339)
• Cherry flavouring powder: o Acacia (E 414) o Glucose (maize) o Ethyl benzoate o Natural flavouring preparations o Natural flavouring substances o Flavouring substances o Maltodextrin (maize) o Sulphur dioxide (E 220)
• Potassium citrate (E 332)
• Citric acid monohydrate (E 330)
• Water for injections

What Fintepla looks like and contents of the pack

• Fintepla oral solution is supplied as a clear, colourless, cherry -flavoured slightly viscous liquid.
• The solution is available in a white bottle with a childresistant, tamperevident cap.
• Each carton contains either: o Bottle containing 60 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations. o Bottle containing 120 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations. o Bottle containing 250 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations. o Bottle containing 360 ml oral solution, a bottle adaptor, two 3 ml oral syringes with 0.1 ml graduations, and two 6 ml syringes with 0.2 ml graduations.
• Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium

Manufacturer

Millmount Healthcare Ltd, Millmount Site, Block 7, 45 City North Business Campus, Stamullen, Co. Meath, K32 YD60 Ireland Or UCB Pharma SA Chemin du Foriest 1420 Braine -l’Alleud Belgium For any information about this medicine, please contact the local representative of Marketing Authorisation Holder:

België/Belgique/Belgien UCB Pharma S.A./NV Tél/Tel: + 32 / (0)2 559 92 00 Lietuva UAB Medfiles Tel: +370 5 246 16 40 България Ю СИ БИ България ЕООД Teл.: + 359 (0) 2 962 30 49 Luxembourg/Luxemburg UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00 ( Belgique/Belgien) Česká republika UCB s.r.o.

Tel: + 420 221 773 411 Magyarország UCB Magyarország Kft.

Tel.: + 36- (1) 391 0060 Danmark UCB Nordic A/S Tlf: + 45 / 32 46 24 00 Malta Pharmasud Ltd.

Tel: + 356 / 21 37 64 36 Deutschland UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4848 Nederland UCB Pharma B.V.

Tel.: + 31 / (0)76- 573 11 40 Eesti OÜ Medfiles Tel: +372 730 5415 Norge UCB Nordic A/S Tlf: + 47 / 67 16 5880 Ελλάδα UCB Α.Ε.

Τηλ: + 30 / 2109974000 Österreich UCB Pharma GmbH Tel: + 43 -(0)1 291 80 00 España UCB Pharma, S.A.

Tel: + 34 / 91 570 34 44 Polska UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o.

Tel: + 48 22 696 99 20 France UCB Pharma S.A.

Tél: + 33 / (0)1 47 29 44 35 Portugal UCB Pharma (Produtos Farmacêuticos), Lda Tel: + 351 21 302 5300 Hrvatska Medis Adria d.o.o.

Tel: +385 (0) 1 230 34 46 România UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 04 46 Ireland UCB (Pharma) Ireland Ltd.

Tel: + 353 / (0)1- 46 37 395 Slovenija Medis, d.o.o.

Tel: + 386 1 589 69 00 Ísland UCB Nordic A/S Sími : + 45 / 32 46 24 00 Slovenská republika UCB s.r.o., organizačná zložka Tel: + 421 (0) 2 5920 2020 Italia UCB Pharma S.p.A.

Tel: + 39 / 02 300 791 Suomi/Finland UCB Pharma Oy Finland Puh/Tel: + 358 9 2514 4221 Κύπρος Lifepharma (Z.A.M.) Ltd Τηλ: + 357 22 056300 Sverige UCB Nordic A/S Tel: + 46 / (0) 40 294 900 Latvija Medfiles SIA Tel: . +371 67 370 250

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . There are also links to other websites about rare diseases and treatments.

ANNEX I V SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION (S) 48 Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR (s) for fenfluramine , the scientific conclusions of PRAC are as follows:

New definite cases of valvular heart disease (VHD) and pulmonary arterial hypertension (PAH) were identified in the post -marketing setting, which are possibly related to fenfluramine used to treat DS and LGS. VHD and PAH represent important risks of fenfluramine for the treatment of DS and LGS.

Taking into account the serotonergic stimulation of c ardiac valve tissue as a plausible mechanism of action, the known association between VHD/PAH and higher doses of fenfluramine used as an appetite suppressant and a first definite case of valvular heart disease in a child treated with lower doses of fenfluramine (6.6 mg/day) for DS identified in the last PSUR, the PRAC considers that the identification of further definite cases of VHD as well as PAH, which are possibly related to fenfluramine, warrants an update of the product information to provide clinicians with the most up- to- date evidence on this important risk.

Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.

Grounds for the variation to the terms of the Marketing Authorisation (s) On the basis o f the scientific conclusions for fenfluramine the CHMP is of the opinion that the benefit- risk balance of the medicinal product(s) containing fenfluramine is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Fintepla (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/20/1491).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.