ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
FIRDAPSE 10 mg tablets
2.
Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
For a full list of excipients, see section 6.1.
3.
Tablet.
White, round, flat-faced and scored tablet on one face.
The tablets can be divided into equal halves.
4.
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
FIRDAPSE should be given in divided doses, three or four times a day. The recommended starting dose is
15 mg a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day.
No single dose should exceed 20 mg.
Tablets are to be taken with food.
For oral use only.
Paediatric and adolescent patients
FIRDAPSE is not recommended for use in this patient group aged below 18 years due to a lack of data on
safety and efficacy (see section 5.2).
Patients with renal or hepatic impairment
FIRDAPSE should be used with caution in patients with renal or hepatic impairment. A starting dose of 5 mg
FIRDAPSE is recommended in patients with moderate or severe impairment of renal or hepatic function. For
patients with mild impairment of renal or hepatic function a starting dose of 10 mg FIRDAPSE is
recommended. Patients should be titrated more slowly than those without renal or hepatic impairment with
doses increased in 5 mg increments every 7 days. If any adverse reaction occurs, upward dose titration
should be discontinued (see sections 4.4 and 5.2).
2
•
Hypersensitivity to the active substance, or to any of the excipients
•
Epilepsy
•
Uncontrolled asthma
•
Concomitant use with sultopride (see sections 4.5 and 5.1)
•
Concomitant use with medicinal products with a narrow therapeutic window (see section 4.5)
•
Concomitant use with medicinal products with a known potential to cause QTc prolongation
•
In patients with congenital QT syndromes (see section 4.4)
No studies have been conducted in patients with renal or hepatic impairment. In view of the risk of markedly
increased exposure to medicinal product, patients with renal or hepatic impairment must be carefully
monitored. The dose of amifampridine should be titrated more slowly in patients with renal and hepatic
impairment than those with normal renal and hepatic function. Upward dose titration should be discontinued
if any adverse reaction occurs (see section 4.2).
Exposure to amifampridine is associated with an increased risk for epileptic seizures. The risk of seizures is
dose-dependent and is increased in patients with risk factors which lower the epileptic threshold; including
use in combination with other medicinal products known to lower the epileptic threshold (see section 4.5). In
the event of a seizure, treatment should be discontinued.
Amifampridine has not been fully tested in carcinogenicity models, and the carcinogenicity risk associated
with treatment has not been determined. The use of amifampridine in patients with the non-paraneoplastic
form of LEMS should only be commenced following a thorough assessment of the risk-benefit to the patient.
Clinical and electrocardiogram (ECG) monitoring are indicated at the initiation of the treatment and yearly
thereafter. In case of signs and symptoms indicative of cardiac arrhythmias, ECG should be performed
immediately.
Patients must be told to inform any physician they consult that they are taking this medicinal product, since
close monitoring of a concomitant disease, particularly asthma, may be necessary.
No
in vitro
or
in vivo
interaction studies have been performed. Furthermore, it is not known how
amifampridine is eliminated.
Pharmacokinetic interactions
Medicinal products eliminated through metabolism or active secretion
There are no data on which enzymes are involved in the metabolism of amifampridine or the effects of
amifampridine on the metabolism or active secretion of other medicinal products. Thus, special care should
be taken in patients undergoing concomitant treatment with medicinal products eliminated through
metabolism or active secretion. Monitoring is advised when possible. The dose of the concomitantly given
medicinal product should be adjusted if necessary. Concomitant use of medicinal products with a narrow
therapeutic window is contraindicated (see section 4.3).
Substances which are potent inhibitors of enzymes that metabolise medicinal products (see section 5.2)
The mode of elimination of amifampridine is unknown. Potent enzyme inhibitors e.g. cimetidine,
ketoconazole may inhibit the metabolism of amifampridine giving rise to increased amifampridine exposure.
Patients should be closely monitored for adverse reactions when initiating treatment with a potent enzyme
inhibitor. If treatment with a potent inhibitor is discontinued, patients should be monitored for efficacy as an
increase of amifampridine dose may be necessary.
3
Substances which are potent inducers of enzymes that metabolise medicinal products (see section 5.2)
Potent inducers of enzymes that metabolise medicinal products e.g barbiturates, carbamazepine, rifamycins
may increase amifampridine elimination and give rise to subtherapeutic exposure of amifampridine. A dose
adjustment might be needed during the first weeks after such treatment is initialised or ended.
Currently, there is no information on the interaction of amifampridine with cytochrome P450.
Pharmacodynamic interactions
Based on the pharmacodynamic properties of FIRDAPSE, the following should be considered:
Concomitant use with sultopride is contraindicated as this combination may lead to an enhanced risk of
ventricular tachycardia, notably torsade de pointes (see sections 4.3 and 5.1).
Combinations requiring precautions for use
Medicinal products known to lower the epileptic threshold
The concomitant use of FIRDAPSE and substances known to lower the epileptic threshold leads to an
increased risk of seizures. The decision to administer proconvulsant or epileptic-threshold lowering
substances concomitantly should be carefully considered in the light of the severity of the associated risks.
These substances include most anti-depressants (tricyclic antidepressants, selective serotonin uptake
inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, bupropion and tramadol (see
sections 4.4 and 5.1).
Combinations to be taken into consideration
Medicinal products with atropinic effects
The concomitant use of FIRDAPSE and medicinal products with atropinic effects may reduce the effect of
both active substances and should be taken into consideration. Medicinal products with atropinic effects
include tricyclic anti-depressants, most H1 atropinic anti-histamines, anticholinergic, anti-Parkinson
medicinal products, atropinic antispasmodics, disopyramide, phenothiazine neuroleptics and clozapine.
Medicinal products with cholinergic effects
The concomitant use of FIRDAPSE and medicinal products with cholinergic effects (e.g. direct or indirect
cholinesterase inhibitors) may lead to an increased effect of both products and should be taken into
consideration.
Non depolarising muscle relaxant acting medicinal products
The concomitant use of FIRDAPSE and medicinal products with non-depolarising muscle relaxant effects
(e.g. mivacurium, pipercurium) may lead to a decreased effect of both products and should be taken into
consideration.
Depolarising muscle relaxant acting medicinal products
The concomitant use of FIRDAPSE and medicinal products with depolarising muscle relaxant effects (e.g.
suxamethonium) may lead to a decreased effect of both products and should be taken into consideration.
4
No adequate clinical data on exposed pregnancies are available for amifampridine. No pre-clinical safety
data are available regarding the effects of amifampridine on reproductive function (see section 5.3).
FIRDAPSE should not be used during pregnancy.
Both men and women of childbearing potential must use effective contraception during FIRDAPSE
treatment.
It is unknown whether amifampridine is excreted in human breast milk. The excretion of amifampridine in
milk has not been studied in animals. FIRDAPSE should not be used during breast-feeding.
No studies on the effects on the ability to drive and use machines have been performed. However, due to
adverse reactions such as drowsiness, dizziness, seizures and blurred vision,
FIRDAPSE may have minor or
moderate influence on the ability to drive or use machines (see section 4.8).
Lambert-Eaton myasthenic syndrome is a very rare genetic disorder. Consequently, there is very little
information on the adverse reactions of amifampridine treatment due to the small number of patients
involved.
The most commonly reported adverse reactions in the published literature are paraesthesias (such as
peripheral and peribucal paraesthesias) and gastro-intestinal disorders (such as epigastralgia, diarrhoea,
nausea and abdominal pain). The intensity and incidence of most adverse reactions is dose-dependent.
The following adverse reactions have also been reported:
•
Psychiatric disorders: Sleep disorders.
•
Nervous system disorders: Convulsions, anxiety, drowsiness, dizziness, weakness, fatigue, headache,
chorea, myoclonia.
•
Eye disorders: Blurred vision.
•
Cardiac disorders: Cardiac rhythm disorders, palpitations.
•
Vascular disorders: Raynaud's syndrome, cold extremities.
•
Respiratory, thoracic and mediastinal disorders: Cough, bronchial hypersecretion, asthma attack in
asthmatic patients or patients with a history of asthma.
•
Hepatobiliary disorders: Elevated liver enzyme levels (transaminases).
Given the very limited data available it is not possible to estimate the frequencies of individual adverse
reactions.
There is little experience with overdose. Since the effects are dose dependent, the manifestations of acute
overdose are expected to include general weakness combined with diffuse paraesthesias, nausea, vomiting,
convulsions and cardiac rhythm disorders. Patient should discontinue the treatment in the event of overdose.
No specific antidote is known. Supportive care should be given as clinically indicated, including close
monitoring of vital signs and cardiac status of the patient.
5
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: other nervous system medicinal products ATC code: N07XX05.
Amifampridine blocks voltage-dependent potassium channels, thereby prolonging pre-synaptic cell
membrane depolarisation. Prolonging the action potential enhances the transport of calcium into the nerve
ending. The resulting increase in intra-cellular calcium concentrations facilitates exocytosis of acetylcholine-
containing vesicles, which in turn enhances neuromuscular transmission.
It improves muscle strength and resting compound muscle action potential (CMAP) amplitudes with an
overall weighted mean difference of 1.69 mV (95% CI 0.60 to 2.77).
The pharmacodynamic profile of amifampridine has been studied for a range of doses. A prospective,
placebo-controlled, randomised study in 26 patients with Lambert-Eaton myasthenic syndrome (LEMS)
reported clinical efficacy for amifamipridine at the standard recommended maximum dose of 60 mg/day
(Sanders
et al
2000). Two further studies in a total of 57 patients with LEMS have reported data from higher
doses of amifamipridine. McEvoy
et al
1989, reported data from a short-term study in 12 patients with
LEMS which demonstrated that administration of amifamipridine at doses up to 100 mg/day for a period of 3
days was effective in treating the autonomic and motor symptoms of LEMS. Sanders
et al
1998 presented
data on efficacy and safety of amifamipridine treatment at doses up to 100 mg/day in 45 patients with LEMS
who were treated for an average of 31 months. Therefore, in exceptional circumstances higher doses up to a
maximum of 80 mg/day may be of benefit when given with the appropriate safety monitoring. It is
recommended that dose titration from 60 mg/day to 80 mg/day is performed in 5 mg increments every 7
days. Upward dose titration should be discontinued if any adverse event or ECG abnormality is observed.
This medicinal product has been authorised under ‘exceptional circumstances’.
This means that due to the rarity of the disease it has not been possible to obtain complete information on
this medicinal product.
The European Medicines Agency (EMA) will review any new information which may become available
every year and this SmPC will be updated as necessary.
5.2 Pharmacokinetic properties
Absorption:
Amifampridine is rapidly absorbed, and peak plasma (T
max
) concentrations are reached 20 minutes to 1 hour
after ingestion. The effect of concomitant food intake on the absorption of amifampridine has not yet been
studied.
Distribution:
No studies have been performed.
Biotransformation:
There are no data on metabolites of amifampridine, and the metabolising enzymes have not been identified.
Elimination:
The mode of elimination of amifampridine is not known. Amifampridine may be mainly eliminated via the
kidneys.
The elimination half-life is approximately 2 hours. Amifampridine can no longer be detected in the serum 24
hours after administration.
Special populations:
There are no data on the pharmacokinetics of amifampridine in paediatric patients and patients with renal or
hepatic impairment (see sections 4.2 and 4.4).
6
The effect of age on the pharmacokinetics of amifampridine has not been studied.
5.3 Preclinical safety data
Only limited preclinical data for amifampridine are available.
In safety pharmacology studies in rats, no central nervous system related effects were seen up to 40 mg/kg.
In a repeat-dose toxicity studies in rats and dogs, effects on the central nervous system, increased liver and
kidney weight and cardiac effects (second degree atrio-ventricular block) were seen. No safety margins to
human exposure were achieved in the animal studies due to the sensitivity of the animal models used.
No long-term toxicity studies of more than 4 weeks' duration have been conducted.
Amifamipridine was not genotoxic in a standard battery of
in vitro
and
in vivo
tests, but the results of full
carcinogenicity studies are not available.
No reproductive toxicity or carcinogenicity studies have been performed.
6.
6.1 List of excipients
Microcrystalline cellulose
Anhydrous colloidal silica
Calcium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from light and moisture.
6.5
Nature and contents of container
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.
6.6 Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
7
7.
BioMarin Europe Limited
164 Shaftesbury Avenue
London, WC2H 8HL
United Kingdom
8.
EU/1/09/601/001
9.
23 December 2009
Detailed information on this medicine is available on the European Medicines Agency (EMA) website:
http://www.ema.europa.eu
8
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
C.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
AUTHORISATION HOLDER
9
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers responsible for batch release
AGEPS (Agence générale des équipements et produits de santé)
7, rue du Fer à Moulin
F-75005 Paris
France
Catalent UK Packaging Ltd.
Wingates Industrial Park,
Westhoughton, Bolton,
Lancs, BL5 3XX
United Kingdom
The printed package leaflet of the medicinal product must state the name and address of the manufacturer
responsible for the release of the concerned batch.
B. CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Characteristics, section 4.2).
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable
•
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, as described in version version 1.4 dated
15 October 2009 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and
functioning before and whilst the product is on the market.
Risk Management Plan
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the
Pharmacovigilance Plan, as agreed in version 0.2 dated 20 April 2009 of the Risk Management Plan (RMP)
presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the
RMP agreed by the CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the
updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
In addition, an updated RMP should be submitted
•
When new information is received that may impact on the current Safety Specification,
Pharmacovigilance Plan or risk minimisation activities
•
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
•
At the request of the EMA
10
C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION
HOLDER
The Marketing Authorisation Holder shall complete the following programme of studies within the specified
time frame, the results of which shall form the basis of the continuous reassessment of the benefit/risk
profile.
Area
Description
Due date
Clinical
To perform a thorough QT/QTC study in healthy
volunteers in line with ICH E14 guidelines.
Est. start: June 2010
Est. finish: December 2010
Report: March 2011
Clinical
To perform a food interaction study with
amifampridine phosphate in healthy volunteer subjects.
Est. start: June 2010
Est. finish: August 2010
Report: November 2010
Clinical
To establish a Lambert Eaton Patient Registry as
defined in the RMP and also incorporating measures of
efficacy.
Est. start: July 2010
Annual reports:
September 2011
September 2012
September 2013
September 2014
September 2015
September 2016
September 2017
Non-clinical To perform carcinogenicity testing in an appropriate
model.
Est. start: March 2010
Est. finish: March 2013
Report: September 2013
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A: LABELLING
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1.
FIRDAPSE 10 mg tablets
amifampridine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains amifampridine phosphate equivalent to 10 mg of amifampridine.
3.
LIST OF EXCIPIENTS
4.
100 tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP {MM/YYYY}
9.
SPECIAL STORAGE CONDITIONS
Do not store above 30ºC.
Store in the original blister in order to protect from light and moisture.
14
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
BioMarin Europe Limited
164 Shaftesbury Avenue
London, WC2H 8HL
United Kingdom
EU/1/09/601/001
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
FIRDAPSE
15
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Perforated unit dose thermoformed blisters
1.
FIRDAPSE 10 mg
amifampridine
2.
BioMarin Europe Limited
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
OTHER
16
B: PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
FIRDAPSE 10 mg tablets
amifampridine
Read all of this leaflet carefully before you start taking this medicine.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
•
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.
In this leaflet
:
1. What FIRDAPSE is and what it is used for
2. Before you take FIRDAPSE
3. How to take FIRDAPSE
4. Possible side effects
5.
How to store FIRDAPSE
6.
1.
WHAT FIRDAPSE IS AND WHAT IT IS USED FOR
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.
18
Further information
2.
BEFORE YOU TAKE FIRDAPSE
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.
19
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.
3.
HOW TO TAKE FIRDAPSE
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.
20
4.
POSSIBLE SIDE EFFECTS
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.
5.
HOW TO STORE FIRDAPSE
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.
21
6.
FURTHER INFORMATION
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.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site:
http://www.ema.europa.eu
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Source: European Medicines Agency
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