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FAMPYRA 10 mg PROLONGED-RELEASE TABLETS

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About the medicine

How to use FAMPYRA 10 mg PROLONGED-RELEASE TABLETS

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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.

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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:

  1. What is Fampyra and what is it used for
  2. What you need to know before you take Fampyra
  1. How to take Fampyra
  2. Possible side effects
  3. Storage of Fampyra
  1. 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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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

Text with information about Acorda Therapeutics Ireland Limited, address in Dublin, and Irish phone number

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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Frequently Asked Questions

Is a prescription required for FAMPYRA 10 mg PROLONGED-RELEASE TABLETS?
FAMPYRA 10 mg PROLONGED-RELEASE TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in FAMPYRA 10 mg PROLONGED-RELEASE TABLETS?
The active ingredient in FAMPYRA 10 mg PROLONGED-RELEASE TABLETS is fampridine. This information helps identify medicines with the same composition but different brand names.
Who manufactures FAMPYRA 10 mg PROLONGED-RELEASE TABLETS?
FAMPYRA 10 mg PROLONGED-RELEASE TABLETS is manufactured by Merz Therapeutics Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of FAMPYRA 10 mg PROLONGED-RELEASE TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether FAMPYRA 10 mg PROLONGED-RELEASE TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to FAMPYRA 10 mg PROLONGED-RELEASE TABLETS?
Other medicines with the same active substance (fampridine) include FAMPRIDINE ACCORD 10 mg PROLONGED-RELEASE TABLETS, FAMPRIDINE AUROVITAS 10 mg PROLONGED-RELEASE TABLETS, FAMPRIDINE QUALIGEN 10 mg PROLONGED-RELEASE TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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