fampridine: package leaflet

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.

Do not take Fampyra

− 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

Tell your doctor and do not take Fampyra if any of these apply to you.

Warnings and precautions

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.

Tell your doctor before you take Fampyra if any of these apply to you.

Children and adolescents

Do not give this medicine to children or adolescents under the age of 18 years.

Elderly

Before starting treatment and during treatment your doctor may check that your kidneys are working properly.

Other medicines and Fampyra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Fampyra if you are taking any other medicine containing fampridine.

Other medicines that affect the kidneys

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.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

The recommended dose is

One tablet in the morning and one tablet in the evening (12 hours apart). Do not take more than two tablets in a day. You must leave 12 hours between each tablet. Do not take the tablets more often than every 12 hours.

Fampyra is for oral use.

Swallow each tablet whole, with a drink of water. Do not divide, crush, dissolve, suck or chew the tablet. This may increase your risk of side effects.

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.

If you take more Fampyra than you should

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 Fampyra

If you forget to take a tablet, do not take two tablets at once to make up for a missed dose. You must always leave 12 hours between each tablet.

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 have a seizure, stop taking Fampyra and tell your doctor immediately.

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:

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:
- 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)

Uncommon side effects

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

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 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.

What Fampyra contains

−
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

What Fampyra looks like and contents of the pack

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.

Marketing Authorisation Holder

Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Germany

Manufacturer

Novo Nordisk Production Ireland Limited, Monksland, Athlone, Co. Westmeath, Ireland

Patheon France SAS, 40 Boulevard de Champaret, 38300 Bourgoin Jallieu, France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Merz Therapeutics Benelux B.V.
Bredaseweg 63
4844 CK Terheijden
Nederland/Pays-Bas/Niederlande
Tél/Tel: +31 (0) 762057088

Lietuva
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Vokietija
Tel: +49 (0) 69 15 03 0

България
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Германия
Teл.: +49 (0) 69 15 03 0

Luxembourg/Luxemburg
Merz Therapeutics Benelux B.V.
Bredaseweg 63
4844 CK Terheijden
Pays-Bas/Niederlande
Tél/Tel: +31 (0) 762057088

Česká republika
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Německo
Tel: +49 (0) 69 15 03 0

Magyarország
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Németország
Tel.: +49 (0) 69 15 03 0

Danmark
Merz Therapeutics Nordics AB
Gustav III:s Boulevard 32
169 73 Solna
Sverige
Tlf.: +46 8 368000

Malta
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Ġermanja
Tel: +49 (0) 69 15 03 0

Deutschland
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Tel: +49 (0) 69 15 03 0
Nederland
Merz Therapeutics Benelux B.V.
Bredaseweg 63
4844 CK Terheijden
Nederland
Tel: +31 (0) 762057088

Eesti
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Saksamaa
Tel: +49 (0) 69 15 03 0

Norge
Merz Therapeutics Nordics AB
Gustav III:s Boulevard 32
169 73 Solna
Sverige
Tlf: +46 8 368000

Ελλάδα
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Γερμανία
Τηλ: +49 (0) 69 15 03 0

Österreich
Merz Pharma Austria GmbH
Guglgasse 17
1110 Vienna
Tel: +43 (0) 1 865 88 95
España
Merz Therapeutics Iberia S.L.
Avenida de Bruselas 6
28108 Alcobendas Madrid
Tel: +34 91 117 8917
Polska
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Niemcy
Tel.: +49 (0) 69 15 03 0

France
Merz Pharma France
Tour EQHO
2, Avenue Gambetta
92400 Courbevoie
Tél: +33 1 47 29 16 77
Portugal
Merz Therapeutics Iberia S.L.
Avenida de Bruselas 6
28108 Alcobendas Madrid
Espanha
Tel: +34 91 117 8917

Hrvatska
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Njemačka
Tel: +49 (0) 69 15 03 0

România
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Germania
Tel: +49 (0) 69 15 03 0

Ireland
Merz Pharma UK Ltd.
Suite B, Breakspear Park, Breakspear Way
Hemel Hempstead
Hertfordshire
HP2 4TZ
United Kingdom
Tel: +44 (0)208 236 0000

Slovenija
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Nemčija
Tel: +49 (0) 69 15 03 0
Ísland
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Þýskaland
Sími: +49 (0) 69 15 03 0

Slovenská republika
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Nemecko
Tel: +49 (0) 69 15 03 0

Italia
Merz Pharma Italia Srl
Via Fabio Filzi 25 A
20124 Milan
Tel: +39 02 66 989 111

Suomi/Finland
Merz Therapeutics Nordics AB
Gustav III:s Boulevard 32
169 73 Solna
Sverige
Tlf: +46 8 368000

Κύπρος
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Γερμανία
Τηλ: +49 (0) 69 15 03 0

Sverige
Merz Therapeutics Nordics AB
Gustav III:s Boulevard 32
169 73 Solna
Tel: +46 8 368000

Latvija
Merz Therapeutics GmbH
Eckenheimer Landstraße 100
60318 Frankfurt am Main
Vācija
Tel: +49 (0) 69 15 03 0

This leaflet was last revised in

Other sources of information

You can get a larger print version of this leaflet by calling the local representatives (see list above).

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.