Fampyra

Patient Information Leaflet

Fampyra 10 mg prolonged-release tablets

fampridine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Fampyra is and what it is used for
2. What you need to know before taking Fampyra
3. How to take Fampyra
4. Possible side effects
5. How to store Fampyra
6. Contents of the pack and other information

1. What Fampyra is and what it is used for

Fampyra contains the active substance fampridine, which belongs to a class of medicines known as potassium channel blockers. These medicines work by blocking the loss of potassium that occurs in nerve cells damaged by multiple sclerosis (MS). This medicine is thought to act by facilitating the normal transmission of nerve signals, thereby improving the patient's walking ability.
Fampyra is a medicine used to improve walking in adult patients (aged 18 years and older) with MS-related walking disability. In multiple sclerosis, inflammation destroys the protective sheath surrounding the nerves, resulting in muscle weakness, muscle stiffness, and difficulty walking.

2. What you need to know before taking Fampyra

Do not take Fampyra

• if you are allergic to fampridine or to any of the other ingredients of this medicine (listed in section 6)
• if you have or have ever had an epileptic seizure (also called a convulsive seizure 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 other medicines containing fampridine. In this case, the risk of serious side effects may increase

If any of the above apply to you, tell your doctor and do not take Fampyra.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fampyra:

• if you feel your heartbeat ( palpitations )
• if you are particularly prone to infections
• if you have any factors that increase your risk of seizures or are taking any medicine that affects your risk of seizures ( epileptic seizure )
• if a doctor has told you that you have mild kidney problems
• if you have a history of allergic reactions

You should use walking support (e.g., a walking stick) as needed, because this medicine may cause dizziness or instability, thereby increasing the risk of falls.
If any of the above apply to you, tell your doctor before taking Fampyra.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age.
Elderly
Before starting treatment and during therapy, your doctor may check your kidney function.
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.
Medicines that affect the kidneys
Your doctor will exercise particular caution if fampridine is taken together with medicines that may affect how your kidneys eliminate medicines, for example carvedilol, propranolol, and metformin.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Fampyra is not recommended during pregnancy.
Your doctor will assess the benefits that treatment with Fampyra may provide you against the risks it may pose to the unborn child.
Do not breastfeed while being treated with this medicine.
Driving and using machines
Fampyra may affect your ability to drive or operate machinery. The medicine may cause dizziness. Before driving or operating machinery, make sure you are not affected in this way.

3. How to take Fampyra

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. Fampyra is available only by prescription and must be used under the supervision of doctors experienced in the treatment of multiple sclerosis.
Your doctor will initially prescribe the medicine for a period of 2 to 4 weeks. Treatment will be re-evaluated after 2–4 weeks.
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 per day. Leave 12 hours between each tablet. Do not take the next tablet before 12 hours have passed since the previous one.
Fampyra is an oral medicine.
Swallow the tablet whole with a glass of water. The tablet must not be broken, crushed, dissolved, sucked, or chewed, as this could increase the risk of side effects.
This medicine must be taken without food, on an empty stomach.
If you receive Fampyra in a bottle, the bottle contains a desiccant. Leave the desiccant inside the bottle. Do not swallow it.
If you take more Fampyra than you should
If you take too many tablets, contact your doctor immediately.
When visiting the doctor, bring the Fampyra packaging with you.
Symptoms of overdose may include sweating, mild shaking (tremor), dizziness, confusion, memory loss (amnesia), and seizures (epileptic seizure). Other side effects not listed may also occur.
If you forget to take Fampyra
If you forget to take a tablet, do not take a double dose to make up for the missed tablet. You must always leave 12 hours between each tablet.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you have seizures , stop taking Fampyra and inform your doctor immediately.
If you experience one or more of the following allergic symptoms ( hypersensitivity ): swelling of the face, mouth, lips, throat or tongue, skin redness or itching, chest tightness and breathing difficulties, stop taking Fampyra and contact your doctor immediately.

The 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 of unsteadiness
• Dizziness
• Sensation of dizziness ( vertigo )
• Headache
• Feeling of tiredness or weakness
• Difficulty sleeping
• Anxiety
• Mild trembling ( tremor )
• Sensation of numbness or tingling of the skin
• Sore throat
• Common cold ( nasopharyngitis )
• Influenza
• Viral infection
• Breathing difficulties (shortness of breath)
• Feeling of discomfort (nausea)
• Vomiting
• Constipation
• Stomach discomfort
• Back pain
• Awareness of your heartbeat ( palpitations )

Uncommon side effects
May affect up to 1 in 100 people:

• Seizures ( epileptic seizure )
• Allergic reaction ( hypersensitivity )
• Severe allergic reaction ( anaphylactic reaction )
• Swelling of the face, lips, mouth or tongue ( angioedema )
• Onset or worsening of facial neuropathic pain ( trigeminal neuralgia )
• Increased heart rate ( tachycardia )
• Dizziness or loss of consciousness ( hypotension )
• Skin rash/rash with itching ( urticaria )
• Chest discomfort

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fampyra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp" or "EXP".
The expiry date refers to the last day of that month.
Store below 25°C. Keep the tablets in the original packaging to protect them from light and moisture.
If Fampyra is supplied to you in a bottle, open one bottle at a time. Use within 7 days of first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fampyra contains

• The active substance is fampridine. Each prolonged-release tablet contains 10 mg of fampridine.
• The other components are: Tablet core: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate; film coating: hypromellose, titanium dioxide (E-171), polyethylene glycol 400.

Description of the appearance of Fampyra and contents of the pack

Fampyra is a whitish, oval, biconvex prolonged-release tablet, 13 x 8 mm, film-coated and marked with the inscription A10 on one side.

Fampyra is available in bottles and in blisters.

Bottles
Fampyra is available in HDPE (high-density polyethylene) bottles. Each bottle contains 14 prolonged-release tablets and a silica gel desiccant. Each pack contains 28 prolonged-release tablets (2 bottles) or 56 prolonged-release tablets (4 bottles).

Blister packs
Fampyra is available in blister packs containing 14 prolonged-release tablets each. Each pack contains 28 prolonged-release tablets (2 blisters) or 56 prolonged-release 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Merz Therapeutics Benelux B.V. Merz Therapeutics GmbH
Bredaseweg 63 Eckenheimer Landstraße 100
4844 CK Terheijden 60318 Frankfurt am Main
Nederland/Pays-Bas/Niederlande Vokietija
Tél/Tel: +31 (0) 762057088 Tel: +49 (0) 69 15 03 0

България Luxembourg/Luxemburg
Merz Therapeutics GmbH Merz Therapeutics Benelux B.V.
Eckenheimer Landstraße 100 Bredaseweg 63
60318 Frankfurt am Main 4844 CK Terheijden
Germany Pays-Bas/Niederlande
Tel.: +49 (0) 69 15 03 0 Tél/Tel: +31 (0) 762057088

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

Danmark Malta
Merz Therapeutics Nordics AB Merz Therapeutics GmbH
Gustav III:s Boulevard 32 Eckenheimer Landstraße 100
169 73 Solna 60318 Frankfurt am Main
Sweden Ġermanja
Tlf.: +46 8 368000 Tel: +49 (0) 69 15 03 0

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

Eesti Norge
Merz Therapeutics GmbH Merz Therapeutics Nordics AB
Eckenheimer Landstraße 100 Gustav III:s Boulevard 32
60318 Frankfurt am Main 169 73 Solna
Germany Sweden
Tel: +49 (0) 69 15 03 0 Tlf: +46 8 368000

Ελλάδα Österreich
Merz Therapeutics GmbH Merz Pharma Austria GmbH
Eckenheimer Landstraße 100 Guglgasse 17
60318 Frankfurt am Main 1110 Vienna
Germany Tel: +43 (0) 1 865 88 95
Tel: +49 (0) 69 15 03 0

España Polska
Merz Therapeutics Iberia S.L. Merz Therapeutics GmbH
Avenida de Bruselas 6 Eckenheimer Landstraße 100
28108 Alcobendas Madrid 60318 Frankfurt am Main
Spain Germany
Tel: +34 91 117 8917 Tel.: +49 (0) 69 15 03 0

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

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

Ireland Slovenija
Merz Pharma UK Ltd. Merz Therapeutics GmbH
Suite B, Breakspear Park, Breakspear Way Eckenheimer Landstraße 100
Hemel Hempstead 60318 Frankfurt am Main
Hertfordshire Germany
HP2 4TZ Tel: +49 (0) 69 15 03 0
United Kingdom
Tel: +44 (0)208 236 0000

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

Italia Suomi/Finland
Merz Pharma Italia Srl Merz Therapeutics Nordics AB
Via Fabio Filzi 25 A Gustav III:s Boulevard 32
20124 Milan 169 73 Solna
Italy Sweden
Tel: +39 02 66 989 111 Tlf: +46 8 368000

Κύπρος Sverige
Merz Therapeutics GmbH Merz Therapeutics Nordics AB
Eckenheimer Landstraße 100 Gustav III:s Boulevard 32
60318 Frankfurt am Main 169 73 Solna
Germany Sweden
Tel: +49 (0) 69 15 03 0 Tel: +46 8 368000

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

Other sources of information
You can request a printed version of this package leaflet in larger characters by contacting the local representative (see list above).
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.