Fampyra
fampridine
fampridine
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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Fampyra is and what it is used for
What you need to know before you take Fampyra
How to take Fampyra
Possible side effects
How to store Fampyra
Contents of the pack and other information
Fampyra contains the active substance fampridine which belongs to a group of medicines called potassium channel blockers. They work by stopping potassium leaving the nerve cells which have been damaged by MS. This medicine is thought to work by letting signals pass down the nerve more normally, which allows you to walk better.
Fampyra is a medicine used to improve walking in adults (18 years and over) with Multiple Sclerosis (MS) related walking disability. In multiple sclerosis, inflammation destroys the protective sheath around the nerves leading to muscle weakness, muscle stiffness and difficulty walking.
if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6)
if you have a seizure or have ever had a seizure (also referred to as a fit or convulsion)
if your doctor or nurse has told you that you have moderate or severe kidney problems
if you are taking a medicine called cimetidine
if you are taking any other medicine containing fampridine. This may increase your risk of serious side effects
Talk to your doctor or pharmacist before taking Fampyra:
if you feel aware of your heartbeat (palpitations)
if you are prone to infections
if you have any factors or are taking any medicine which affects your risk of fits (seizure).
if you have been told by a doctor that you have mild problems with your kidneys
if you have history of allergic reactions
You should use a walking aid, such as a cane, as needed because this medicine may make you feel dizzy or unsteady this may result in an increased risk of falls.
Do not give this medicine to children or adolescents under the age of 18 years.
Before starting treatment and during treatment your doctor may check that your kidneys are working properly.
Your doctor will be especially careful if fampridine is given at the same time as any medicine which may affect how your kidneys eliminate medicines for example carvedilol, propranolol and metformin.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before for advice before taking this medicine.
Fampyra is not recommended during pregnancy.
Your doctor will consider the benefit of you being treated with Fampyra against the risk to your baby. You should not breast-feed whilst taking this medicine.
Fampyra may have an effect on people’s ability to drive or use machines, it can cause dizziness. Make sure you are not affected before you start driving or use machinery.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Fampyra is only available by prescription and under the supervision of doctors experienced in MS.
Your doctor will give you an initial prescription for 2 to 4 weeks. After 2 to 4 weeks the treatment will be reassessed.
Fampyra is for oral use.
This medicine should be taken without food, on an empty stomach.
If your Fampyra is supplied in bottles, the bottle will also contain a desiccant. Leave the desiccant in the bottle, do not swallow it.
Contact your doctor immediately if you take too many tablets. Take the Fampyra box with you if you go to see the doctor.
In overdose you may notice sweating, minor shaking (tremor), dizziness, confusion, memory loss (amnesia) and fits (seizure). You may also notice other effects not listed here.
If you forget to take a tablet, do not take two tablets at once to make up for a missed dose. You must
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.
If you experience one or more of the following allergic (hypersensitivity) symptoms: swollen face, mouth, lips, throat or tongue, reddening or itching of the skin, chest tightness and breathing problems stop taking Fampyra and see your doctor immediately.
Side effects are listed below by frequency:
May affect more than 1 in 10 people:
Urinary tract infection
May affect up to 1 in 10 people:
Feeling unsteady
Dizziness
Spinning sensation (vertigo)
Headache
Feeling weak and tired
Difficulty sleeping
Anxiety
Minor shaking (tremor)
Numbness or tingling of skin
Sore throat
Common cold (nasopharyngitis)
Flu (influenza)
Viral infection
Difficulty breathing (shortness of breath)
Feeling sick (nausea)
Being sick (vomiting)
Constipation
Upset stomach
Back pain
Heartbeat that you can feel (palpitations)
May affect up to 1 in 100 people
Fits (seizure)
Allergic reaction (hypersensitivity)
Severe allergy (anaphylactic reaction)
Swelling of the face, lips, mouth or tongue (angioedema)
New onset or worsening of nerve pain in the face (trigeminal neuralgia)
Fast heart rate (tachycardia)
Dizziness or loss of consciousness (hypotension)
Rash/itchy rash (urticaria)
Chest discomfort
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 package after EXP. The expiry date refers to the last day of that month.
Store below 25 °C. Store the tablets in the original package in order to protect from light and moisture. If your Fampyra is supplied in bottles, only one bottle should be opened at a time. After first opening
use within 7 days.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is fampridine.
Each prolonged-release tablet contains 10 mg of fampridine
The other ingredients are:
Tablet core: hypromellose, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate; film coat: hypromellose, titanium dioxide (E-171), polyethylene glycol 400
Fampyra is an off-white, film coated, oval biconvex 13 x 8 mm prolonged-release tablet with A10 on one side.
Fampyra is supplied in either blister packs or bottles. Bottles
Fampyra comes in HDPE (high-density polyethylene) bottles. Each bottle contains 14 prolonged- released tablets and a silica gel desiccant. Each pack contains 28 prolonged-released tablets (2 bottles) or 56 prolonged-released tablets (4 bottles).
Blisters
Fampyra comes in foil blisters of 14 prolonged-released tablets each. Each pack contains 28 prolonged-released tablets (2 blisters) or 56 prolonged-released tablets (4 blisters).
Not all pack sizes may be marketed.
Biogen Netherlands B.V. Prins Mauritslaan 13
1171 LP Badhoevedorp The Netherlands
Alkermes Pharma Ireland Ltd, Monksland, Athlone, Co. Westmeath, Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Biogen Lithuania UAB Tel: +37 0 5 259 6176
ТП ЕВОФАРМА
Teл.: +359 2 962 12 00
Biogen (Czech Republic) s.r.o. Tel: +420 255 706 200
Biogen Hungary Kft. Tel.: +36 (1) 899 9883
Biogen (Denmark) A/S Tlf: +45 77 41 57 57
Pharma MT limited Tel: +356 213 37008/9
Biogen GmbH
Tel: +49 (0) 89 99 6170
Biogen Netherlands B.V. Tel: +31 20 542 2000
Biogen Estonia OÜ Tel: +372 618 9551
Biogen Norway AS Tlf: +47 23 40 01 00
Genesis Pharma SA
Τηλ: +30 210 8771500
Biogen Austria GmbH Tel: +43 1 484 46 13
Biogen Spain SL Tel: +34 91 310 7110
Biogen Poland Sp. z o.o. Tel.: +48 22 351 51 00
Biogen France SAS
Tél: +33 (0)1 41 37 95 95
Biogen Portugal Sociedade Farmacêutica Unipessoal, Lda
Tel: +351 21 318 8450
Biogen Pharma d.o.o. Tel: +385 (0) 1 775 73 22
Johnson & Johnson Romania S.R.L. Tel: +40 21 207 18 00
Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 463 7799
Biogen Pharma d.o.o. Tel: +386 1 511 02 90
Icepharma hf
Sími: +354 540 8000
Biogen Italia s.r.l. Tel: +39 02 584 9901
Biogen Finland Oy Puh/Tel: +358 207 401 200
Genesis Pharma (Cyprus) Ltd
Τηλ: +357 22765715
Biogen Sweden AB Tel: +46 8 594 113 60
Biogen Latvia SIA Tel: +371 68 688 158
Biogen Idec (Ireland) Limited Tel: +44 (0) 1628 50 1000
You can get a larger print version of this leaflet by calling the local representatives (see list above).