FAMPYRA 10 mg PROLONGED-RELEASE TABLETS
How to use FAMPYRA 10 mg PROLONGED-RELEASE TABLETS
Translated with AI
This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
Show originalContents of the leaflet
Introduction
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.
- 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.
Contents of the pack and other information:
- What is Fampyra and what is it used for
- What you need to know before you take Fampyra
- How to take Fampyra
- Possible side effects
- Storage of Fampyra
- Contents of the pack and further information
1. What is Fampyra and what is it used for
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.
2. What you need to know before you take Fampyra
Do not take Fampyra
- if you are allergicto fampridine or any of the other ingredients of this medicine (listed in section 6)
- if you have had seizuresor have ever had a seizure(also called 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 that contains fampridine. This could increase the risk of you having serious side effects.
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:
- if you are aware of your heartbeat (palpitations)
- if you are prone to infections
- you may need to use a walking aid, such as a walking stick, as needed, since this medicine may make you feel dizzy or unbalanced, which can increase the risk of falls
- if you have any risk factors or are taking any medicine that affects the risk of having seizures
- if your doctor has told you that you have mild kidney problems.
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.
3. How to take Fampyra
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.
4. Possible side effects
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:
- Urinary tract infection
Common side effects
May affect up to 1 in 10 people:
- Lack of balance
- Dizziness
- Feeling of spinning (vertigo)
- Headache
- Feeling of weakness and tiredness
- Difficulty sleeping
- Anxiety
- Small tremors (tremors)
- Numbness or tingling of the skin
- Sore throat
- Common cold (nasopharyngitis)
- Flu
- Breathing difficulties (shortness of breath)
- Nausea
- Vomiting
- Constipation
- Stomach upset
- Back pain
- Heartbeat that can be felt (palpitations)
Uncommon side effects
May affect up to 1 in 100 people
- Seizures (fits)
- Allergic reaction (hypersensitivity)
- Appearance or worsening of facial nerve pain (trigeminal neuralgia)
- Fast heart rate (tachycardia)
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.
5. Storage of Fampyra
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.
6. Contents of the pack and further information / Further information
Composition of Fampyra
You can obtain a larger print version of this leaflet by calling the local representatives (see list below).
Composition of Fampyra
- The active substanceis fampridine.
- Each prolonged-release tablet contains 10 mg of fampridine
- The other ingredientsare:
- Core of the tablets: Hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate; film coating: Hypromellose, titanium dioxide (E-171), Macrogol 400
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/.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to FAMPYRA 10 mg PROLONGED-RELEASE TABLETSDosage form: MODIFIED-RELEASE TABLET, 10 mgActive substance: fampridineManufacturer: Accord Healthcare S.L.U.Prescription requiredDosage form: MODIFIED-RELEASE TABLET, 10 mgActive substance: fampridineManufacturer: Aurovitas Spain, S.A.U.Prescription requiredDosage form: MODIFIED-RELEASE TABLET, 10 mgActive substance: fampridineManufacturer: Neuraxpharm Spain S.L.Prescription required
Online doctors for FAMPYRA 10 mg PROLONGED-RELEASE TABLETS
Discuss questions about FAMPYRA 10 mg PROLONGED-RELEASE TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.
Frequently Asked Questions
