Fintepla 2.2 mg/ml oral solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Fintepla 2.2 mg/ml oral solution
fenfluramine
This medicinal product is subject to additional monitoring, which will enable rapid identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
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 as 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 they have the same symptoms as you or your child, as it may harm them.
- If you or your child experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Fintepla is and what it is used for
- What you need to know before you or your child take Fintepla
- How to take Fintepla
- Possible side effects
- How to store Fintepla
- Contents of the pack and other information
1. What Fintepla is and what it is used for
Fintepla contains the active substance fenfluramine.
Fintepla is used as an add-on treatment for seizures in patients aged 2 years and older who have either Dravet syndrome or Lennox-Gastaut syndrome, two types of epilepsy. It may help reduce the frequency and severity of seizures.
The exact way Fintepla works is not fully understood. However, it is believed 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 start taking 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 condition such as "cardiac valvular disease" or "pulmonary arterial hypertension" (high blood pressure in the arteries of the lungs);
- if you or your child have taken medicines used to treat depression called monoamine oxidase inhibitors (MAOIs) within the last 2 weeks.
Do not take Fintepla if any of the above conditions apply to you or your child. If you are unsure, consult your doctor, pharmacist, or nurse before taking Fintepla.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting Fintepla if:
- you or your child have glaucoma;
- you or your child have had thoughts about harming yourself or committing suicide;
- you or your child are taking a medicine called cyproheptadine, used to treat allergies or to improve appetite;
- you or your child have experienced an increase in seizure frequency;
- you or your child have experienced increased drowsiness.
If any of the above situations apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Fintepla.
Tests and monitoring
Before starting treatment with Fintepla, your doctor must check the patient's heart condition with an echocardiogram (ECHO). The doctor will verify that the heart valves show no abnormalities and that the blood pressure between the heart and the lungs is not too high. Once the patient has started taking Fintepla, echocardiograms will be required every 6 months during the first 2 years of treatment, and then once a year thereafter. If treatment with Fintepla is stopped, the patient will need an echocardiogram 3–6 months after the last dose.
Your doctor should also monitor the patient's weight before and during treatment, as Fintepla may cause weight loss or decreased appetite.
Serotonin syndrome
Tell your doctor or pharmacist before taking Fintepla if you or your child are taking medicines that can increase brain serotonin levels. This is because taking these medicines together with Fintepla may cause serotonin syndrome, a potentially life-threatening condition. Medicines that may 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 alert for possible symptoms of serotonin syndrome, which include:
- agitation, seeing things that are not there (hallucinations), or fainting;
- circulatory and heart problems such as rapid heartbeat, fluctuating blood pressure, high body temperature, and sweating;
- muscle tremors and lack of coordination;
- feeling unwell or actual illness and diarrhea.
Inform your doctor immediately if you experience any of the adverse effects listed above.
Other medicines and Fintepla
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might need to take any other medicines. This is because Fintepla may affect how other medicines work. In addition, some medicines may affect how Fintepla works.
Fintepla may cause drowsiness. The patient may feel even more drowsy if taking medicines such as antidepressants or alcohol at the same time as Fintepla.
In particular, inform your doctor or pharmacist if you or your child are taking, have recently taken, or might need to take:
- stiripentol, a medicine for epilepsy, as your dose of Fintepla may need to be reduced;
- "triptans", MAOI, SNRI, or SSRI medicines—see the section "Serotonin syndrome" above;
- carbamazepine, primidone, rifampicin, phenobarbital and other barbiturates, phenytoin, or efavirenz, as the dose of Fintepla may need to be increased;
- clobazam, valproate, and cannabidiol, which are medicines used to treat epilepsy.
Pregnancy and breastfeeding
If you or your daughter are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Driving and use of machines
Talk to your doctor about driving and operating machinery, or whether you or your child should engage in activities such as cycling or other sports, as you may feel drowsy or tired after taking this medicine.
Fintepla contains sodium ethyl p-hydroxybenzoate (E 215) and sodium methyl p-hydroxybenzoate (E 219)
These may cause allergic reactions (possibly delayed).
Fintepla contains sulfur dioxide (E 220)
Rarely, this may cause hypersensitivity reactions and bronchospasm.
Fintepla contains glucose
This may be harmful to teeth.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
Fintepla contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 12 ml; hence, it is essentially "sodium-free".
3. How to take Fintepla
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in 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 following formula:
Weight (kg) × weight-based dose (mg/kg) ÷ 2.2 mg/ml = ml of dose twice daily
Always round the calculated dose up or down to the nearest graduation mark, following standard rounding conventions. For example, for a patient requiring a dose of 2.15 ml, the volume to be administered should be rounded up to 2.2 ml, as with the 3 ml syringe only 2.1 ml or 2.2 ml can be administered. Similarly, a volume of 1.13 ml should be rounded down to administer a volume of 1.1 ml. For a patient requiring a dose of 3.15 ml, the volume to be administered should be rounded up to 3.2 ml, as with the 6 ml syringe only 3.0 ml or 3.2 ml can be administered. Likewise, a volume of 4.25 ml should be rounded down to administer a volume of 4.2 ml.
The table below should only be used to verify the calculated dose volume. Table 1 does not replace the need to calculate the specific dose volume.
Table 1: Range of dose volumes in ml for checking the calculation
Dose without concomitant STP* | Dose with concomitant STP** | ||||
Weight category | Starting dose | Day 7–13 | Day 14 and onwards | Starting dose | Day 7 and onwards |
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 | |
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 | 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 of 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
- Your doctor will tell you how many millilitres to take for each dose.
- Take the medicine twice daily.
- Your doctor will start your treatment with a low dose. This dose will be gradually increased depending on how effective the medicine is and how it affects you.
- The maximum amount you may take is 6 ml twice daily.
- If you are taking stiripentol, the maximum amount you may take is 4 ml twice daily.
- Do not take more than the prescribed dose, as this may result in serious adverse 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 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 and 6 ml.
- Fintepla oral solution is compatible with most enteral feeding tubes.
- To flush the feeding tube, fill the syringe to be used for dose administration with water and flush the tube. Repeat this procedure 3 times.
3 ml syringe – green | 6 ml syringe – purple |
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| Write in the box the date on which you first opened the bottle. You must attach the bottle adapter the first time you open it. The following instructions explain how to attach the adapter. Inserting the bottle adapter: When the bottle is opened for the first time, you must press the adapter into it. Wash and dry your hands. Remove the bottle adapter from its packaging. Place the bottle on a flat, hard surface. Open the bottle. |
| Hold the bottle firmly. Align the adapter with the top of the bottle. Firmly press the adapter into place using the palm of your hand until it is level with the top of the bottle. Leave the adapter in place after using the medicine. Screw the cap back onto the bottle without removing the adapter. |
| Taking the medicine: Before measuring the dose, make sure the plunger is fully inserted into the oral syringe. Hold the medicine bottle securely on a flat, hard surface. Insert the tip of the oral syringe into the bottle adapter until it cannot be pushed any further. |
| Hold the syringe and bottle together and turn them upside down. Slowly pull back the plunger of the syringe to withdraw the correct dose. Hold the syringe and bottle together and turn them back upright. Holding the bottle firmly, gently remove the syringe from the adapter. |
| Place the tip of the syringe inside the patient's mouth. Gently push the plunger all the way down. A small amount will remain in the tip of the syringe. This is normal. Do not squirt the medicine toward the back of the throat, as this may cause choking. |
| Replace the cap on the bottle and screw it on tightly until it stops. Always leave the adapter attached to the bottle. |
| Cleaning the syringe: Wash the syringe with cold water and allow it to air dry after each use. Wash both the inside of the syringe and the plunger. Use the plunger to draw cold water into the syringe and expel it several times to clean thoroughly. It is acceptable to separate the plunger from the syringe and wash each part individually. Do not use detergent to clean the syringe or plunger. Do not wash the syringe or plunger in a dishwasher. The syringe and plunger must be completely dry before next use. |
If you or your child has taken more Fintepla than you should:
Consult your doctor or go directly to the hospital. Take the medicine container with you. The following effects may occur: agitation, drowsiness or confusion, flushing or feeling hot, 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 for the next dose, skip the missed dose.
- Do not take a double dose to make up for forgotten doses.
If you or your child stops taking Fintepla:
You must not stop treatment with Fintepla without first talking to your doctor. If your doctor decides to discontinue treatment with this medicine, they will instruct you to gradually reduce the daily dose. Gradually reducing the dose will reduce the risk of experiencing 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 further questions about 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 everyone experiences them.
Very common: may affect more than 1 in 10 people
- Decreased appetite
- Drowsiness
- Diarrhea
- Fatigue
Common: may affect up to 1 in 10 people
- Bronchitis
- Abnormal behavior
- Rapid mood changes
- Aggression
- Agitation
- Insomnia
- Tremor of hands, arms, or feet
- Difficulty coordinating movements, walking, and maintaining balance
- Decreased muscle tone
- Seizures
- Prolonged seizures (status epilepticus)
- Lethargy
- Weight loss
- Constipation
- Increased saliva production
- Vomiting
- Skin rash
- Low blood sugar level
- Elevated blood prolactin levels
Frequency not known (frequency cannot be estimated from available data):
- Heart valve disease
- Irritability
- Serotonin syndrome
- High blood pressure in the lung arteries (pulmonary arterial hypertension)
Inform your doctor or nurse if you notice any of the adverse effects listed above.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fintepla
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month indicated.
- Do not refrigerate or freeze.
- Must be used within 3 months after first opening of the bottle.
- If a syringe becomes damaged or lost, or if you cannot read the dose markings, use another oral syringe from those included in the package or consult your pharmacist.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Fintepla
The active substance is fenfluramine. Each millilitre 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 flavouring powder:
- Acacia (E 414)
- Glucose (from corn)
- Ethyl benzoate
- Natural flavouring preparations
- Natural flavouring substances
- Flavouring substances
- Maltodextrin (corn)
- Sulphur dioxide (E 220)
- Potassium citrate (E 332)
- Citric acid monohydrate (E 330)
- Water for injections
Nature of the product and contents of the container
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Fintepla oral solution is supplied as a clear, colourless, slightly viscous liquid with a cherry aroma.
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The solution is contained in a white bottle with a child-resistant and tamper-proof cap.
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Each carton contains:
- Bottle with 60 ml of oral solution, one bottle adapter, two 3 ml oral dosing syringes with 0.1 ml graduations, and two 6 ml oral dosing syringes with 0.2 ml graduations.
- Bottle with 120 ml of oral solution, one bottle adapter, two 3 ml oral dosing syringes with 0.1 ml graduations, and two 6 ml oral dosing syringes with 0.2 ml graduations.
- Bottle with 250 ml of oral solution, one bottle adapter, two 3 ml oral dosing syringes with 0.1 ml graduations, and two 6 ml oral dosing syringes with 0.2 ml graduations.
- Bottle with 360 ml of oral solution, one bottle adapter, two 3 ml oral dosing syringes with 0.1 ml graduations, and two 6 ml oral dosing syringes with 0.2 ml graduations.
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Please note that in your country only certain pack sizes may be available.
Marketing Authorisation 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
or
UCB Pharma SA
Chemin du Foriest
1420 Braine-l’Alleud
Belgium
For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium UCB Pharma S.A./NV Tel/Tel: + 32 / (0)2 559 92 00 | Lithuania UAB Medfiles Tel: +370 5 246 16 40 |
| Luxembourg/Luxembourg UCB Pharma SA/NV Tél/Tel: + 32 / (0)2 559 92 00 (Belgium/Belgium) |
Czech Republic UCB s.r.o. Tel: + 420 221 773 411 | Hungary UCB Magyarország Kft. Tel.: + 36-(1) 391 0060 |
Denmark UCB Nordic A/S Tlf: + 45 / 32 46 24 00 | Malta Pharmasud Ltd. Tel: + 356 / 21 37 64 36 |
Germany UCB Pharma GmbH Tel: + 49 /(0) 2173 48 4848 | Netherlands UCB Pharma B.V. Tel.: + 31 / (0)76-573 11 40 |
Estonia OÜ Medfiles Tel: +372 730 5415 | Norway UCB Nordic A/S Tlf: + 47 / 67 16 5880 |
Greece UCB Α.Ε. Tel: + 30 / 2109974000 | Austria UCB Pharma GmbH Tel: + 43-(0)1 291 80 00 |
Spain UCB Pharma, S.A. Tel: + 34 / 91 570 34 44 | Poland 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 (Pharmaceutical Products), Lda Tel: + 351 21 302 5300 |
Croatia Medis Adria d.o.o. Tel: +385 (0) 1 230 34 46 | Ireland UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395 |
Romania UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 04 | Slovenia Medis, d.o.o. Tel: + 386 1 589 69 00 |
Iceland Vistor hf. Tel: + 354 535 7000 | Slovakia UCB s.r.o., organizational unit Tel: + 421 (0) 2 5920 2020 |
Italy UCB Pharma S.p.A. Tel: + 39 / 02 300 791 | Finland/Sweden UCB Pharma Oy Finland Puh/Tel: + 358 9 2514 4221 |
Cyprus Lifepharma (Z.A.M.) Ltd Tel: + 357 22 056300 | Sweden UCB Nordic A/S Tel: + 46 / (0) 40 294 900 |
Latvia Medfiles SIA Tel: +371 67 370 250 |
Date of the most recent review of this leaflet:
Other sources of information
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 medicinal products.