


Ask a doctor about a prescription for FAMPYRA 10 mg PROLONGED-RELEASE TABLETS
Package Leaflet: Information for the User
Fampyra 10 mg prolonged-release tablets
fampridine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Contents of the pack and other information:
Fampyra is a medicine used to improve walking in adults (18 years or older) with multiple sclerosis (MS) who have walking disability. In multiple sclerosis, inflammation damages the protective covering of the nerves, leading to muscle weakness, muscle stiffness, and difficulty walking.
Fampyra contains the active substance fampridine, which belongs to a group of medicines called potassium channel blockers. They work by slowing down the release of potassium from damaged nerve cells. It is thought that this medicine works by allowing signals to pass through the nerve in a more normal way, which helps you walk better.
Do not take Fampyra
Tell your doctorand do not takeFampyra if any of these apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before starting Fampyra:
Tell your doctor beforetaking Fampyra if any of these apply to you.
Children and adolescents
Do not give Fampyra to children or adolescents under 18 years.
Elderly
Before starting treatment and during treatment, your doctor may check that your kidneys are working properly.
Taking Fampyra with other medicines
Tell your doctor or pharmacistif you are using or have recently used or might use any other medicines.
Do not take Fampyra if you are taking other medicines that contain fampridine.
Other medicines that affect the kidneys
Your doctor will be careful if you are given fampridine at the same time as another medicine that may affect how other medicines are removed from the body by the kidneys, such as carvedilol, propranolol, and metformin.
Taking Fampyra with food and drink
Fampyra should be taken on an empty stomach, without food.
Pregnancy and breastfeeding
If you are pregnantor planning to become pregnant, consult your doctor beforetaking this medicine.
Fampyra is not recommended during pregnancy.
Your doctor will weigh the benefits of treatment with Fampyra against the risks for the baby.
Breastfeeding must be stoppedduring treatment with this medicine.
Driving and using machines
Fampyra may affect your ability to drive or use machines. It can cause dizziness. Make sure it does not affect you before you start driving or using machines.
Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Fampyra can only be obtained with a doctor's prescription and under the supervision of doctors with experience in MS.
Your doctor will initially prescribe treatment for 2 to 4 weeks. After this 2 to 4 week period, the treatment will be re-evaluated.
The recommended dose is
Onetablet in the morning and onetablet in the evening (12 hours apart). Do not take more than two tablets in a day. There must be 12 hoursbetween each tablet. Do not take the tablets more often than every 12 hours.
Swallow the tablet whole, with water. Do not divide, crush, dissolve, suck, or chew the tablet. This could increase the risk of you having side effects.
If your Fampyra comes in bottles, the bottle will also contain a desiccant. Leave the desiccant in the bottle; do not swallow it.
If you take more Fampyra than you should
Contact your doctor immediatelyif you take too many tablets.
If you go to a doctor, take the Fampyra pack with you.
If you have taken too much Fampyra, you may notice sweating, small tremors (tremors), dizziness, confusion, memory loss (amnesia), and seizures (fits). You may also notice other effects not mentioned here.
If you forget to take Fampyra
If you forget to take a tablet, do not take a double dose to make up for forgotten doses.
There must always be 12 hoursbetween each tablet.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Fampyra can cause side effects, although not everybody gets them.
If you have a seizure, stop taking Fampyraand tell your doctor immediately.
If you experience one or more of the following allergic reactions (hypersensitivity): swelling of the face, mouth, lips, throat, or tongue, redness or itching of the skin, chest tightness, and breathing problems, stop taking Fampyraand goto the doctor immediately.
The following side effects are listed by frequency:
Very common side effects
May affect more than 1 in 10 people:
Common side effects
May affect up to 1 in 10 people:
Uncommon side effects
May affect up to 1 in 100 people
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 carton after EXP. The expiry date refers to the last day of the month shown.
Store below 25°C. Store the tablets in the original package to protect them from light and moisture.
If Fampyra comes in bottles, only open one bottle at a time. After the first opening of the bottle, use within 7 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Composition of Fampyra
You can obtain a larger print version of this leaflet by calling the local representatives (see list below).
Composition of Fampyra
Appearance and packaging of the product
Fampyra is a film-coated, prolonged-release tablet, 13 x 8 mm, oval, biconvex, and white, with A10 engraved on one side.
Fampyra is available in blister packs or bottles
Bottles
Fampyra is available in HDPE (high-density polyethylene) bottles. Each bottle contains 14 tablets and a silica gel desiccant. Each pack contains 28 tablets (2 bottles) or 56 tablets (4 bottles).
Blister packs
Fampyra is available in blister packs of 14 tablets each. Each pack contains 28 tablets (2 blisters) or 56 tablets (4 blisters).
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Acorda Therapeutics Ireland Limited
10 Earlsfort Terrace
Dublin 2, D02 T380
Ireland
Tel: +353 (0)1 231 4609
Manufacturer:
Novo Nordisk Production Ireland Limited, Monksland, Athlone, Co. Westmeath, Ireland
Patheon France SAS, 40 Boulevard de Champaret, 38300 Bourgoin Jallieu, France.
You can ask for more information about this medicine from the local representative of the marketing authorisation holder:
Belgium Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 | Lithuania Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
| Luxembourg Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
Czech Republic Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 | Hungary Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
Denmark Merz Therapeutics Nordics AB Gustav III S Boulevard 32 Regus Solna 169 73 Sweden Tel: +46 8 368000 | Malta Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
Germany Merz Therapeutics GmbH Eckenheimer Landstrasse 100 60318 Frankfurt Tel: +49 (0) 69 15 03 0 | Netherlands Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
Estonia Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 | Norway Merz Therapeutics Nordics AB Gustav III S Boulevard 32 Regus Solna 169 73 Sweden Tel: +46 8 368000 |
Greece Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 | Austria Merz Pharma Austria GmbH Guglgasse 17 1110 Vienna Tel: +43 (0) 1 865 88 95 |
Spain Merz Therapeutics Iberia S.L. Avenida de Bruselas 6 28108 Alcobendas Madrid Tel: +34 91 117 8917 | Poland Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
France Merz Pharma France Tour EQHO 2, Avenue Gambetta 92400 Courbevoie Tel: +33 1 47 29 16 77 | Portugal Merz Therapeutics Iberia S.L. Avenida de Bruselas 6 28108 Alcobendas Madrid Tel: +34 91 117 8917 |
Croatia Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 | Romania Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
Ireland Merz Pharma UK Ltd. Suite B, Breakspear Park, Breakspear Way Hemel Hempstead Hertfordshire HP2 4TZ United Kingdom Tel: +44 (0)208 236 0000 | Slovenia Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
Iceland Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 | Slovakia Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
Italy Merz Pharma Italia Srl Via Fabio Filzi 25 A 20124 Milan Tel: +39 02 66 989 111 | Finland Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
Cyprus Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 | Sweden Merz Therapeutics Nordics AB Gustav III S Boulevard 32 Regus Solna 169 73 Tel: +46 8 368000 |
Latvia Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace Dublin 2, D02 T380 Ireland Tel: +353 (0)1 231 4609 |
Date of last revision of this leaflet: {monthYear}.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for FAMPYRA 10 mg PROLONGED-RELEASE TABLETS – subject to medical assessment and local rules.