Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - firdapse

Document Subject

Generated Narrative: MedicinalProductDefinition mp8e3f73294a020fb836dccebb0eb47004

identifier: http://ema.europa.eu/identifier/EU/1/09/601/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: FIRDAPSE 10 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8e3f73294a020fb836dccebb0eb47004

identifier: http://ema.europa.eu/identifier/EU/1/09/601/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - firdapse

Attesters

What is in this leaflet

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

FIRDAPSE is used to treat symptoms of a disease of the nerves and the muscles called Lambert-Eaton myasthenic syndrome or LEMS in adults. This disease is a disorder affecting the transmission of nerve impulses to muscles, resulting in muscle weakness. It can be associated with certain tumour types (paraneoplastic form of LEMS) or in the absence of these tumours (non-paraneoplastic form of LEMS).

In patients suffering from this disease, a chemical substance called acetylcholine, which communicates nerve impulses to muscles is not released normally and the muscle doesn't receive some or all of the nerve's signals.

FIRDAPSE works by increasing the release of acetylcholine and helps the muscle to receive the nerve signals.

Do not take FIRDAPSE If you are allergic to amifampridine, or any of the other ingredients of this medicine (listed in section 6) If you have uncontrolled asthma If you are epileptic Together with medicines that may change the electrical activity of your heart (QT-interval prolongation - detectable in the electrocardiogram), such as: Sultropride (a medicine prescribed to treat certain behavioural disorders in adults),
Antiarrhythmic medicine (e.g., disopyramide)
Medicines to treat digestive problems (e.g., cisapride, domperidone) Medicines to treat infections - antibiotics (e.g., rifampicin) and antifungals (e.g., ketoconazole) Together with medicines with a therapeutic dose close to the maximum safe dose If you were born with heart problems (congenital QT syndromes)

If you have any doubts, ask your doctor or pharmacist for advice.

Warnings and precautions Talk to your doctor or pharmacist before taking FIRDAPSE.

Tell your doctor if you have
Asthma A history of fits (convulsions) Kidney problems Liver problems

Your doctor will monitor carefully how FIRDAPSE works for you and may need to change the dose of the medicines you take. Your doctor will also monitor your heart at the start of your treatment and also every year thereafter.

If you have LEMS but do not have cancer, your doctor will make a thorough assessment of the potential risk of cancer with FIRDAPSE before commencing treatment.

Tell any physician you consult that you are using FIRDAPSE.

Stop the treatment and immediately consult your doctor in the event of: Fits (convulsions) Asthma

Other medicines and FIRDAPSE Tell your doctor if you are taking, have recently taken or might take any other medicines.

Some medicines may interact with FIRDAPSE when taken together. The following medicines must not be combined with FIRDAPSE:
Medicines that may change the electrical activity of your heart (QT-interval prolongation - detectable in the electrocardiogram) e.g., sultopride, disopyramide, cisapride, domperidone, rifampicin, and ketoconazole (see Do not take FIRDAPSE )

It is especially important to talk to your doctor if you are taking one of the following medicines or plan to start taking the following medicines: Medicines for malaria (e.g. halofantrine and mefloquine) Tramadol (a painkiller) Antidepressants - tricyclic antidepressants (e.g. clomipramine, amoxapine), selective serotonin reuptake inhibitors (e.g. citalopram, dapoxetine) and atypical antidepressants (e.g. buproprion) Medicines for mental problems (e.g. haloperidol, carbamazapine, chlorpromazine, clozapine) Medicines to treat Parkinson's disease - anticholinergics (e.g. trihexylphenidyl, mesylate), MAO-B inhibitors (e.g. selegiline, deprenyl), COMT inhibitors (e.g. entacapone) Medicines to treat allergies - antihistamines (e.g. terfenadine, astemizole, cimetidine) Medicines to relax your muscles - (e.g. mivacurium, pipercurium, suxamethonium) Sedatives (e.g. barbiturates)

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

FIRDAPSE should not be used if you are pregnant. You must use effective contraception throughout the treatment. If you discover that you are pregnant during the treatment, inform your doctor immediately.

It is not known whether FIRDAPSE is excreted in human breast milk. You and your doctor should discuss the risks and benefits of continuing to take FIRDAPSE while breastfeeding.

Driving and using machines This medicine may cause drowsiness, dizziness, fits (convulsions) and blurred vision, which may affect your ability to drive or use machines. Do not drive or operate machines if you experience these side effects.

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose you should take is established by your doctor based on the intensity of your symptoms and certain genetic factors. This dose suits you only.

The starting dose is 5 mg amifampridine (half a tablet) three times daily (i.e. 15 mg per day). Your doctor may increase this dose slowly first to 5 mg (half a tablet) four times daily (i.e. 20 mg per day). Then your doctor may continue to increase your total daily dose adding 5 mg (half a tablet) per day, every 4 or 5 days.

The maximum recommended dose is 60 mg per day (i.e. a total of six tablets to be taken at intervals during the day). Total daily doses above 20 mg should be divided into two to four separate doses. No single dose should exceed 20 mg (two tablets).

The tablets have a score-line to allow them to be broken in half. The tablets should be swallowed with some water and are to be taken with food.

Patients with liver/kidney problems: FIRDAPSE should be used with caution in patients with liver or kidney problems. A starting dose of 5 mg (half tablet) FIRDAPSE daily is recommended in patients with moderate or severe liver or kidney problems. For patients with mild liver or kidney problems a starting dose of 10 mg (5 mg twice a day) FIRDAPSE daily is recommended. For these patients the dose of FIRDAPSE should be increased more slowly than in those without liver or kidney problems with doses increased in 5 mg increments every 7 days. If any side effects occur, please consult your doctor as you may need to stop increasing the dose.

If you take more FIRDAPSE than you should If you take more FIRDAPSE than you should have, you may suffer from vomiting or a stomach ache. If you experience any of these symptoms, you should contact your doctor or pharmacist immediately.

If you forget to take FIRDAPSE If you forget to take FIRDAPSE, do not take a double dose to make up for the dose you have forgotten but continue to take your treatment as prescribed by your doctor.

If you stop taking FIRDAPSE If the treatment is stopped, you may experience symptoms such as tiredness, slow reflexes and constipation. Do not stop treatment without consulting your doctor.

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

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

Stop the treatment and immediately consult your doctor in the event of: Fits (convulsions) Asthma

Very common side effects which may affect more than 1 in 10 people are: Tingling and numbness around the mouth and extremities (such as feet and hands) Reduced sense of touch or sensation Nausea Dizziness Increase sweating, cold sweat

Common side effects which may affect up to 1 in 10 people are: Stomach ache
Cold hands and feet

Other side effects are: The intensity and incidence of most side effects depends on the dose you are taking. The following side effects have also been reported (frequencies cannot be estimated from the available data): Raynaud's syndrome (circulation disorder affecting the fingers and toes) Diarrhoea Fits (convulsions) Cough, excessive or viscous mucus in the breathing passage, asthma attack in asthmatic patients or patients with a history of asthma Blurred vision Heart rhythm disorders, fast or irregular heartbeats (palpitations) Weakness, tiredness, headache
Anxiety, sleep disorders, drowsiness Chorea (movement disorder), myoclonia (muscle spasm or twitching) Increase in certain liver enzymes (transaminases) seen on blood tests

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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.

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 packaging after EXP. The expiry date refers to the last day of that month.

Do not store above 30 C. Store in the original package, in order to protect from light and moisture.

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.

What FIRDAPSE contains The active substance is amifampridine. Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine. The other ingredients are microcrystalline cellulose, anhydrous colloidal silica and calcium stearate.

What FIRDAPSE looks like and contents of the pack White, round tablet, flat-faced on one side and scored on the other side. The tablets can be divided into equal halves. Perforated unit dose thermoformed blisters (Thermoformed aluminium-PVC/PVDC laminate sheets) containing 10 tablets. One box contains 100 tablets comprising 10 strips with 10 tablets each.

Marketing Authorisation Holder SERB S.A.
Avenue Louise 1050 Bruxelles Belgium

Manufacturers EXCELLA GmbH & Co KG N rnberger Strasse 90537 Feucht
Germany

SERB S.A.
Avenue Louise 1050 Bruxelles Belgium

This leaflet was last revised in

This medicine has been authorised under Exceptional Circumstances . This means that because of the rarity of this disease it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.

Detailed information on this medicine is available on the European Medicines Agency web site: