FINTEPLA 2.2 MG/ML Oral solution

Зміст інструкції

1. Fintepla 2.2 mg/mL oral solution
   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. How to store Fintepla
   6. Contents of the pack and other information

Fintepla 2.2 mg/mL oral solution

fenfluramine

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced by you or your child during the use of this medicine. See the end of
section 4 for information on how to report adverse effects.

Read this leaflet carefully before you or your 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, pharmacist or nurse.
• This medicine has been prescribed only for you or your child. Do not give it to other people, even if their symptoms are the same as yours or your child's, as it could be dangerous.
• If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Fintepla is and what it is used for
• 2. What you need to know before you or your child takes Fintepla
• 3. How to take Fintepla
• 4. Possible side effects
• 5. How to store 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 add-on therapy for the treatment of epileptic seizures (attacks) in patients of
2 years of age or older who have a type of epilepsy called Dravet syndrome or one
called Lennox-Gastaut syndrome. It may help to reduce the number and severity of seizures.
The mechanism of action of Fintepla is not fully understood. However, it is believed to work by increasing
activity in the brain of a natural substance called serotonin and of the sigma-1 receptor, which is able to
reduce epileptic seizures.

2. What you need to know before you or your child take 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);
• if you or your child have a heart problem such as “valvulopathy” or “pulmonary arterial hypertension” (high pressure in the pulmonary arteries);
• if you or your child have taken monoamine oxidase inhibitors (MAOIs) in the last 2 weeks.

Do not take Fintepla if any of the above conditions apply to you. If you are unsure, ask 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;
• you or your child have had thoughts about harming yourself or ending your life;
• you or your child are taking a medicine called cyproheptadine, used to treat allergies or to improve appetite.

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 monitoring
Before you or your child start taking Fintepla, your doctor must check your heart with an echocardiogram (ECO). The doctor will check that your heart valves are working properly and that the pressure in the artery between your heart and lungs is not too high. Once you have started taking Fintepla, you or your child will have an echocardiogram every 6 months for the first 2 years and then once a year. If you stop taking Fintepla, you or your child will need to have an echocardiogram 3-6 months after the last dose.
Your doctor must also check your weight before and during treatment, as Fintepla can cause weight loss.

“Serotonin syndrome”
Tell your doctor or pharmacist before taking Fintepla if you or your child are taking medicines that can increase serotonin levels in the brain, as taking these medicines with Fintepla can cause serotonin syndrome, 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.

Be aware of the signs of serotonin syndrome, which include:

• being agitated, seeing things that are not there (hallucinations) or fainting;
• heart and circulation problems such as a fast heartbeat, fluctuating blood pressure, high body temperature, sweating;
• muscles twitching and not being coordinated;
• feeling unwell or sick and having diarrhoea.

Tell your doctor immediately if you notice any of the serious side effects described 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 medicines work. Also, some medicines can affect the way Fintepla works.
Fintepla can cause drowsiness. You or your child may feel more sleepy if you take other medicines such as antidepressants or alcohol with 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 it may be necessary to reduce the dose of Fintepla;
• “triptans”, MAOIs, SNRIs or SSRIs (see above under “Serotonin syndrome”);
• carbamazepine, primidone, rifampicin, phenobarbital and other barbiturates, phenytoin and efavirenz, as it may be necessary to increase the dose of Fintepla.

Also, tell your doctor or pharmacist if you or your child smoke, as it may be necessary to increase the dose of Fintepla.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding, ask your doctor for advice before taking this medicine.

Driving and using machines
Ask your doctor about driving, using machines, or if you or your child are doing activities such as cycling or other sports, as you may feel sleepy after taking this medicine.

Fintepla contains ethyl p-hydroxybenzoate (E 215) and methyl p-hydroxybenzoate (E 219)
which can cause allergic reactions (sometimes delayed).

Fintepla contains sulfur dioxide (E 220)
which rarely can cause hypersensitivity reactions and bronchospasm.

Fintepla contains glucose
which can be harmful to teeth.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Fintepla contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 12 mL, that is to say it is essentially ‘sodium-free’.

3. How to take Fintepla

Take this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, ask your doctor, pharmacist or nurse.

Dose to be taken

• You will be told how many mL to take for each dose.
• Take the medicine twice a day.
• The doctor will start giving you or your child a low dose, which may then be gradually increased depending on the effectiveness of the medicine and its impact on 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 the 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 provided oral administration syringes to measure the dose, as illustrated 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 mL and 6.0 mL.
• Fintepla oral solution is compatible with most enteral feeding tubes.
• To flush the feeding tube, fill the syringe used for administration with water and flush the tube. Repeat the operation 3 times.

3 mL syringe: green 6 mL syringe: purple

Write the date of the first
opening of the bottle on the packaging.
The first time you open the bottle, it is
necessary to attach the specific adapter. The
instructions below indicate how to
apply the adapter.

Inserting the bottle adapter:
when you open the bottle for the first time,
the adapter must be inserted.
Wash and dry your hands.
Remove the bottle adapter from its
packaging.
Place the bottle on a flat
and stable surface.
Open the bottle.
Hold the bottle firmly.
Align the adapter with the top
open part of the bottle.
Push the bottle adapter inside with the palm of your hand until
the adapter is level with the
top of the bottle.
Leave the adapter inserted in the bottle
after using the medicine.
Screw the bottle cap onto the bottle with the adapter
left inserted.

Taking the medicine:
before measuring the dose, make sure the
plunger is pushed all the way down into the oral administration syringe.
Hold the medicine bottle with
firmness on a hard, flat surface.
Push the end of the oral administration syringe into the bottle adapter until you can no longer
push it further.

Hold the oral administration syringe and bottle together and
turn them upside down.
Slowly pull the plunger to draw
the correct dose.
Hold the oral administration syringe and bottle together and then
turn them over.
Holding the bottle firmly, gently remove
the oral administration syringe from the adapter.

Position the end of the oral administration syringe against the inside of the
patient's cheek.
Gently push the plunger until it is completely pressed down.
A small amount will remain at the end
of the syringe. This is normal.
Do not inject the medicine into the
back of the throat, as it may
cause choking.

Put the cap back on the bottle and turn until
it stops.
Always leave the adapter inserted in the
bottle.

Cleaning the syringe:
rinse the oral administration syringe with clean water and let it air dry after each use.
Rinse the inside of the syringe and the
plunger.
You can draw clean water into the syringe
with the plunger and push it out several times
to clean the syringe.
You can separate the plunger from the syringe
to rinse each part.
You can wash the syringe and plunger in
the dishwasher.
Before the next use, the syringe and
plunger must be completely
dry.

If you or your child takes too much Fintepla
Contact a doctor or go to the hospital immediately. Bring the medicine bottle with you.
The following effects may occur: agitation, drowsiness or confusion, redness or
feeling of warmth, chills and 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 make up for a missed dose.

If you or your child stop taking Fintepla
Treatment with Fintepla should not be stopped without consulting your doctor. If the doctor
decides to stop taking this medicine, he/she will ask you or your child to gradually reduce
the amount taken each day. Gradually reducing the dose reduces the risk of having
a seizure and status epilepticus.
Three to six months after the last dose of Fintepla, you or your child will need to have an
echocardiogram.
If you have any doubts about using 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.

Dravet Syndrome

Very common: may affect more than 1 in 10 people

• decreased appetite
• drowsiness
• diarrhoea
• high temperature
• feeling tired, sleepy or weak
• low blood sugar
• abnormal echocardiogram

Common: may affect up to 1 in 10 people

• bronchitis
• abnormal behaviour
• rapid changes in mood
• aggression
• agitation
• insomnia
• tremor of the hands, arms or legs
• problems with coordination of movements, walking and balance
• decreased muscle tone
• seizures
• prolonged seizures (status epilepticus)
• deep and prolonged sleep (lethargy)
• weight loss
• constipation
• excessive salivation
• increased prolactin in the blood
• skin rash

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

• high blood pressure in the arteries of the lungs (pulmonary arterial hypertension)
• heart valve disease
• irritability
• serotonin syndrome

Lennox-Gastaut Syndrome

Very common: may affect more than 1 in 10 people

• diarrhoea
• vomiting
• feeling tired, sleepy or weak
• drowsiness
• loss of appetite

Common: may affect up to 1 in 10 people

• aggression
• constipation
• excessive salivation
• bronchitis
• influenza
• pneumonia
• weight loss
• seizures
• prolonged seizures (status epilepticus)
• deep and prolonged sleep (lethargy)
• tremor of the hands, arms or legs
• Increased prolactin in the blood
• skin rash

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

• heart valve disease
• serotonin syndrome

Tell your doctor, pharmacist or nurse if you get any of these side effects.

Reporting of side effects
If you get 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 through the national reporting
system listed in Annex 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 package and on the 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.
• Wash the syringe after each use.
• If a syringe is lost or damaged, or if you cannot read the dosage indicators on a syringe, use another one provided in the package, or contact your pharmacist.
• 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 Fintepla contains
The active ingredient is called fenfluramine. Each mL contains 2.2 mg of fenfluramine (as 2.5 mg of
fenfluramine hydrochloride).
The other ingredients are:

• sodium ethyl-p-hydroxybenzoate (E 215)
• sodium methyl-p-hydroxybenzoate (E 219)
• sucralose (E 955)
• hydroxyethylcellulose (E 1525)
• sodium phosphate monobasic (E 339)
• sodium phosphate dibasic (E 339)
• cherry flavouring powder: or acacia (E 414) or glucose (corn) or ethyl benzoate or natural flavouring preparations or natural flavourings or flavourings or maltodextrin (corn) or sulphur dioxide (E 220)
• potassium citrate (E 332)
• citric acid monohydrate (E 330)
• water for injections

Description of Fintepla and contents of the pack

• Fintepla oral solution is supplied as a clear, colourless and slightly viscous liquid with a cherry taste.
• The solution is available in a white bottle fitted with a child-resistant and tamper-evident closure.
• Each pack contains one of the following types: or a bottle containing 60 mL of oral solution, a bottle adapter, two 3 mL oral dispensing syringes with 0.1 mL graduations and two 6 mL syringes with 0.2 mL graduations or a bottle containing 120 mL of oral solution, a bottle adapter, two 3 mL oral dispensing syringes with 0.1 mL graduations and two 6 mL syringes with 0.2 mL graduations or a bottle containing 250 mL of oral solution, a bottle adapter, two 3 mL oral dispensing syringes with 0.1 mL graduations and two 6 mL syringes with 0.2 mL graduations or a bottle containing 360 mL of oral solution, a bottle adapter, two 3 mL oral dispensing 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 and Manufacturer
Marketing Authorisation Holder:
UCB Pharma S.A.,
Allée de la Recherche 60,
B-1070 Brussels,
Belgium
Manufacturer:
Millmount Healthcare Ltd,
Millmount Site, Block 7,
City North Business Campus,
Stamullen,
Co. Meath,
K32 YD60,
Ireland
For further information on this medicinal product, contact the local representative of the 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

Ireland
UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 395

Slovenija
Medis, d.o.o.
Tel: + 386 1 589 69 00

Ísland
Vistor hf.
Simi: + 354 535 7000

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

United Kingdom (Northern Ireland)
UCB (Pharma) Ireland Ltd.
Tel : + 353 / (0)1-46 37 395

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu. Also, links to other websites on rare diseases and
related therapeutic treatments are provided.

Latvija
Medfiles SIA
Tel: . +371 67 370 250

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR VARIATIONS TO THE
MARKETING AUTHORISATION
Scientific conclusions
Considering the evaluation by the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for fenfluramine, the PRAC’s scientific
conclusions are as follows:
Considering the known risk of valvular heart disease (VHD)/pulmonary arterial hypertension (PAH) at
higher doses of fenfluramine, previously used to treat obesity in adult patients, the first defined case
of valvular heart disease in a child treated with lower doses of fenfluramine (6.6 mg/day) for Dravet
Syndrome (DS) is of particular importance. VHD and PAH represent very important risks of
fenfluramine for the treatment of DS and Lennox-Gastaut Syndrome (LGS). Considering the
serotonergic stimulation of the heart valve tissue as a plausible mechanism of action and the known
association between VHD/PAH and higher doses of fenfluramine used as an appetite suppressant, the
PRAC considers that this single case justifies an update to the product information to provide physicians
with the most up-to-date evidence on this important risk. The medicinal product information
containing fenfluramine must be amended accordingly.
After reviewing the PRAC recommendation, the Committee for Human Medicinal Products (CHMP)
agrees with the PRAC’s overall conclusions and the justification for the recommendation.

Justification for variations to the marketing authorisation
Based on the scientific conclusions on fenfluramine, the CHMP considers that the benefit/risk ratio of
the medicinal products containing fenfluramine remains unchanged, subject to the proposed changes
to the product information.
The CHMP recommends the variation to the marketing authorisation.