FIRDAPSE 10 mg tablets

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 (hypersensitive) to amifampridine, or any of the other ingredients of FIRDAPSE,
• If you have uncontrolled asthma,
• If you are epileptic,
• In combination with sultopride (a medicine prescribed to treat certain behavioural disorders in adults),
• In combination with medicines that may change the electrical activity of your heart (QT-interval prolongation - detectable in the electrocardiogram),
• In combination 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.

Take special care with 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

Taking other medicines
You may need to take special precautions or change your dose of FIRDAPSE if you are taking FIRDAPSE with some other medicines. It is especially important to mention to your doctor if you are taking one of the following medicines:

• Medicines for malaria (e.g. halofantrine and mefloquine)
• Disopyrimide (an antiarrhythmic medication)
• 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 treat digestive problems (e.g. cisapride, domperidone)
• Medicines to treat infections - antibiotics (e.g. rifampicin) and antifungals (e.g. ketoconazole)
• Medicines to relax your muscles - (e.g. mivacurium, pipercurium, suxamethonium)
• Sedatives (e.g. barbiturates)

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

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.

You should not breastfeed whilst taking this medicinal product.

Ask your pharmacist or doctor for advice before taking any medicine.

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 FIRDAPSE 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. This dose suits you only.

The starting dose is 5 mg (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 FIRDAPSE is recommended in patients with moderate or severe impairment of liver or kidney function. For patients with mild impairment of liver or kidney function a starting dose of 10 mg FIRDAPSE 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 adverse events 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 feel weak, nauseous, and experience mild tingling or numbness in part of your body. Depending on how much FIRDAPSE you have taken, you may also suffer from convulsions, vomiting or problems with your heart (cardiac rhythm disorders). 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 product, ask your doctor or pharmacist.

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

Stop the treatment and immediately consult your doctor in the event of:

• Fits (convulsions)
• Asthma

The most commonly reported side effects are:

• Tingling and numbness around the mouth and extremities (such as feet and hands),
• Stomach ache, diarrhoea, feeling sick and abdominal pain.

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):

• Fits (convulsions),
• Cough, excessive or viscous mucus in the breathing passage, asthma attack in asthmatic patients or patients with a history of asthma,
• Raynaud's syndrome (circulation disorder affecting the fingers and toes), cold hands and feet,
• Blurred vision,
• Heart rhythm disorders, fast or irregular heartbeats, also called palpitations,
• Weakness, tiredness, headache,
• Anxiety, dizziness, sleep disorders, drowsiness,
• Chorea (movement disorder), myoclonia (muscle spasm or twitching),
• Increase in certain liver enzymes (transaminases) seen on blood tests.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, flat-faced and scored tablet on one face.
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 and Manufacturer

Marketing Authorisation Holder:

BioMarin Europe Limited
164 Shaftesbury Avenue
London, WC2H 8HL
United Kingdom

Manufacturers:

AGEPS-EPHP (Agence Générale des Equipements et Produits de Santé ?
Etablissement pharmaceutique des hôpitaux de Paris)
7, rue du Fer à Moulin ? BP 09
F-75221 Paris Cedex 05
FRANCE

Catalent UK Packaging Ltd.
Wingates Industrial Park,
Westhoughton, Bolton,
Lancs, BL5 3XX
United Kingdom

This leaflet was last approved in {MM/YYYY}

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 (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.