10 mg tablets
amifampridine

1. What FIRDAPSE is and what it is used for

FIRDAPSE is used to treat the symptoms of a nerve and muscle disease called Lambert-Eaton’s myasthenic syndrome or LEMS in adults. This disease is a disorder that affects the transmission of nerve impulses to muscles and causes muscle weakness. It can be associated with certain tumor types and is then called the paraneoplastic form of LEMS. If these tumors are not present, they are referred to as a non-paraneoplastic form of LEMS.

In patients suffering from this disease, release decreases one of a chemical substance called acetylcholine which normally transmits the nerve signals to the muscle, and the muscle cannot receive any or all of the nerve signals.

FIRDAPSE works by increasing the release of acetylcholine and helping the muscle to receive the nerve impulse.

2. What you need to know before taking FIRDAPSE

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 have epilepsy,
  • together with drugs that may affect the electrical activity of the heart (prolonged QT interval – can be detected by electrocardiogram ), such as:
    • subtorrid (a medicine that is prescribed for the treatment of certain behavioral disorders in adults)
    • medicines for heart rhythm disorders (eg disopyramide )
    • medicines to treat digestive problems (eg cisapride, domperidone)
    • medicines to treat infections – antibiotics (eg rifampicin) and antifungal medicines (eg ketoconazole )
  • together with medicinal products that have a therapeutic dose close to the maximum safe dose,
  • if you have a congenital heart problem (congenital QT syndrome).

Ask your doctor or pharmacist if you have any questions.

Warnings and cautions

Talk to your doctor or pharmacist before taking FIRDAPSE.

Tell your doctor if you have any

  • asthma
  • previous episodes of convulsions (seizures)
  • kidney problems
  • liver problem

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

If you have LEMS but not cancer, your doctor will make an in-depth assessment of the potential risk of cancer with FIRDAPSE before starting treatment.

Tell them you are taking FIRDAPSE for each doctor you consult.

Discontinue treatment and consult your doctor immediately if you experience any of the following:

  • Convulsions (seizures)
  • Asthma

Other medicines and FIRDAPSE

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

Some medicines may affect or be affected by FIRDAPSE when used at the same time. The following medicines must not be taken with FIRDAPSE:

  • Drugs that can alter the electrical activity of the heart (prolonged QT interval – detected by ECG ) 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 any of the following medicines or are planning to start taking any of the following medicines:

  • Medicines for malaria (for example halofantrine and mefloquine).
  • Tramadol (a painkiller).
  • Antidepressants – tricyclic antidepressants (eg clomipramine, amoxapine), selective serotonin reuptake inhibitors (eg citalopram, dapoxetine), and atypical antidepressants (eg bupropion).
  • Medicines for mental health problems (eg haloperidol, carbamazepine, chlorpromazine, clozapine).
  • Drugs for treating Parkinson’s disease – anticholinergics (eg trihexyphenidyl, mesylate), MAO-B inhibitors (eg selegiline, deprenyl), COMT inhibitors (eg entacapone).
  • Drugs used to treat allergies – antihistamines (eg terfenadine, astemizole, cimetidine).
  • Muscle relaxants – (eg mivacurium, peppercurium, suxamethonium).
  • Sedatives (for example barbiturates ).

Pregnancy and breastfeeding

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.

Do not use FIRDAPSE if you are pregnant. You must use effective contraception throughout the treatment. Tell your doctor immediately if you notice that you are pregnant during treatment.

It is unknown whether FIRDAPSE is excreted in human breast milk. You and your doctor should discuss the risks and benefits of continuing to take FIRDAPSE while breast-feeding.

Driving and using machines

This medicine may cause drowsiness, dizziness, convulsions (seizures), and blurred vision, which may affect your ability to drive or use machines. Do not drive or use machines if you notice any of these side effects.

3. How to take FIRDAPSE

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

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

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

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

The tablets have a break notch that allows them to be broken into two halves. The tablets should be swallowed with water and should be taken with food.

Patients with kidney or liver problems:

FIRDAPSE should be used with caution in patients with kidney or liver problems. A daily starting dose of 5 mg (half a tablet) FIRDAPSE is recommended for patients with moderate or severe kidney or liver problems. For patients with mild kidney or liver problems, a daily starting dose of 10 mg (5 mg twice daily) FIRDAPSE is recommended. For these patients, dose one of FIRDAPSE should be increased more slowly than for patients without renal or hepatic problems with dose increases in increments of 5 mg every seven days. Consult your doctor if any side effects occur as it may be necessary to stop increasing the dose.

If you take more FIRDAPSE then you should

If you take more F IRDAPSE than you should you may experience vomiting and stomach pain. If you notice any of these symptoms, contact your doctor or pharmacist immediately.

If you forget to take FIRDAPSE

Do not take a double dose to make up for a missed dose if you have forgotten to take the F IRDAPSE, but continue to take your treatment according to your doctor’s prescription.

If you stop taking FIRDAPSE

If treatment is stopped, you may notice symptoms such as fatigue, 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.

4. Possible side effects

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

Discontinue treatment and consult your doctor immediately if you experience any of the following:

  • Convulsions (seizures).
  • Asthma.

Very common side effects that may affect more than 1 in 10 people are:

  • Tingling and numbness around the mouth and extremities (such as feet and hands),
  • Impaired sense of touch
  • Nausea
  • Dizziness
  • Increased sweating, cold sweats

Common side effects that may occur in up to 1 in 10 users are:

  • Magont
  • Cold hands and feet.

Other side effects:

Intensity one and the incidence of most side effects depend on the dose you take. The following side effects have also been reported (affects an unknown number of users):

  • Raynaud’s phenomenon (a circulatory disorder that affects fingers and toes).
  • Diarrhea.
  • Convulsions (seizures).
  • Cough, excess mucus or viscous mucus in the respiratory tract, asthma attack in asthmatic patients or patients with previous asthma.
  • Dimsyn.
  • Disturbed heart rhythm, fast or irregular heartbeat (palpitations).
  • Weakness, fatigue, headache.
  • Anxiety, sleep disorders, drowsiness.
  • Korea (movement disorders), myoclonus (muscle cramps or twitching).
  • An increase in certain liver enzymes ( transaminases ) seen on blood tests.

5. How to store FIRDAPSE

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 carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store in the original package. Sensitive to light. Moisture sensitive.

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.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and the contents of the pack

White, round tablets, flat on one side and with a scoreline on the other side.

The tablets can be divided into two equal parts.

Perforated heat-sealed single-dose blister (heat-sealed aluminum-PVC / PVDC laminate blister) with 10 tablets.

One box contains 100 tablets (10 strips of 10 tablets each).

Marketing Authorisation Holder

SERB SA

Avenue Louise 480

1050 Brussels

Belgium

Manufacturer:
EXCELLA GmbH & Co. KG

Nürnberger Strasse 12

90537 Moisture

Germany

BioMarin International Limited
Shanbally, Ringaskiddy, Co. Cork, P43 R298

Ireland

Muhammad Nadeem

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