fenfluramine
Fintepla · ATC code N03
Also known as: Fenfluramin
- Key facts
- Active substance
- fenfluramine
- ATC code
- N03
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Fintepla 2.2 mg/ml oral solution
- Marketing authorisation holder
- UCB Pharma S.A.
- Information as of
- 2026-10-27
Key facts
Fenfluramine is a serotonergic antiepileptic (Fintepla oral solution). It is used as add-on therapy for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome from 2 years of age.
What it is used for
- Seizures in Dravet syndrome, add-on to other antiepileptics, from 2 years of age
- Seizures in Lennox-Gastaut syndrome, add-on to other antiepileptics, from 2 years of age
Dosing
- Initiated by physicians experienced in epilepsy; dispensed under a controlled access programme
- Without stiripentol: start 0.1 mg/kg twice daily, day 7 0.2 mg/kg, day 14 0.35 mg/kg twice daily; maximum 26 mg daily
- With stiripentol (Dravet syndrome only): start 0.1 mg/kg, maintenance 0.2 mg/kg twice daily; maximum 17 mg daily
- Volume calculated from body weight; details and check table in the full text
Contraindications
- Hypersensitivity to the active substance or any of the excipients
- Aortic or mitral valvular heart disease
- Pulmonary arterial hypertension
- Within 14 days of MAO inhibitors (serotonin syndrome)
Important warnings
- Can cause valvular heart disease and pulmonary arterial hypertension
- Echocardiogram before starting, every 6 months for the first 2 years, then annually, and 3-6 months after the last dose
- If pathological findings occur, benefit and risk are evaluated with a cardiologist
- Decreased appetite and weight loss
- Risk of serotonin syndrome
Side effects
- Most common: decreased appetite (31.9%), fatigue (17.6%), diarrhoea (16.7%), somnolence (15%)
- Common: bronchitis, abnormal behaviour, aggression, insomnia, ataxia, seizure, weight decreased
- Also reported: valvular heart disease, pulmonary arterial hypertension, serotonin syndrome
Interactions
- Other CNS depressants and serotonergic medicines (SSRIs, SNRIs, tricyclic antidepressants, triptans, MAOIs, certain antipsychotics) increase the risk
- Pharmacokinetic interactions (including stiripentol) are in the full text
Pregnancy and breastfeeding
- Limited data; as a precaution, use during pregnancy is preferably avoided
- Breast-feeding: a risk to the suckling child cannot be excluded
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- FinteplaUCB Pharma S.A. · EMEA/H/C/003933
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Fintepla
- Liechtenstein
- Fintepla
- Norway
- Fintepla
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Another question about this substance?
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Sources
- European Medicines Agency. Fintepla – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.