FAMPYRA 10 mg Extended-Release Tablet

Зміст інструкції

1. Fampyra 10 mg prolonged-release tablets
   1. What is Fampyra and what is it 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. Package contents and other information

Fampyra 10 mg prolonged-release tablets

fampridine

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Fampyra and what is it used for

Fampyra contains the active substance fampridine, which belongs to the class of drugs defined as potassium
channel blockers. These medicines work by blocking the loss of potassium that occurs in
nerve cells damaged by multiple sclerosis (MS). This drug is believed to work
by facilitating the normal passage of signals along the nerve and consequently improving
the patient's walking ability.
Fampyra is a medicine used to improve walking in adults (aged 18 years and over) with
walking disability related to Multiple Sclerosis (MS). In
multiple sclerosis, inflammation destroys the protective sheath around 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 allergicto fampridine or any of the other ingredients of this medicine (listed in section 6)
• if you have or have ever had a seizure(also called a 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 doctorand do not takeFampyra.

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 predisposing you to seizures or are taking any medicine that affects your risk of seizures (seizure)
• if a doctor has told you that you have mild kidney problems
• if you have a history of allergic reactions.

You should use a support for walking (e.g., a cane) as needed because
this medicine may cause dizziness or instability, and therefore may lead to an increased
risk of falls.
If any of the above apply to you, tell your doctorbefore 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 the course of therapy, your doctor may check your kidney function.

Other medicines and Fampyra
Tell your doctor or pharmacistif 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 proceed with particular caution if fampridine is taken at the same time as
medicines that could affect how your kidneys eliminate medicines, such as
carvedilol, propranolol and metformin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
Fampyra is not recommended during pregnancy.
The doctor will assess the benefit-risk ratio of treatment with Fampyra for you and the
risks to the baby.
Do not breastfeed while taking this medicine.

Driving and using machines
Fampyra can affect your ability to drive or operate machines. The medicine can in fact
cause dizziness. Before driving or operating machines, make sure you do not
experience these effects.

3. How to take Fampyra

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. Fampyra is only available with a prescription and under the supervision
of doctors experienced in the treatment of multiple sclerosis.
Your doctor will give you an initial prescription for a period of 2 to 4 weeks. Treatment will be
re-evaluated after 2-4 weeks.

The recommended dose is
Onetablet in the morning and onetablet in the evening (12 hours apart). Do not take more than two
tablets a day. Allow 12 hoursbetween each tablet. Do not take the next tablet before 12 hours have passed since the previous one.
Fampyra is a medicine for oral use.

Swallow the tablet wholewith a glass of water. The tablet must not be broken,
powdered, 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 are supplied with Fampyra in a bottle, the bottle contains a desiccant. The desiccant should be left
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 you go to the doctor, take the Fampyra packaging with you.
In case of overdose, symptoms such as sweating, minor tremor ( tremor), dizziness, confusion, memory loss ( amnesia) and seizures ( epileptic seizure) may occur. It is
also possible that side effects not listed in the package leaflet may 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 allow 12 hoursbetween each tablet.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you should experience seizures, stop taking Fampyraand 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, redness or itching of the skin, tightness in the chest and breathing problems stop taking Fampyraand seek immediate medical attention.
Adverse effects are listed below in order of 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
• Feeling faint (vertigo)
• Headache
• Feeling tired or weak
• Difficulty sleeping
• Anxiety
• Minor tremor (tremor)
• Feeling of numbness or tingling
• Sore throat
• Common cold (nasopharyngitis)
• Flu
• Viral infection
• Difficulty breathing (shortness of breath)
• Feeling unwell (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 fit)
• Allergic reaction (hypersensitivity)
• Severe allergy (anaphylactic reaction)
• Swelling of the face, lips, mouth or tongue (angioedema)
• Onset or worsening of neuropathic facial pain (trigeminal neuralgia)
• Fast heartbeat (tachycardia)
• Fainting or loss of consciousness (hypotension)
• Skin 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 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 which is stated on the pack after Scad. or EXP. The
expiry date refers to the last day of that month.
Store at a temperature below 25°C. Keep the tablets in the original package to
protect them from light and moisture.
If you are supplied with Fampyra in a bottle, open one bottle at a time. Use within 7 days of first
opening.
Do not dispose of any medicine in 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 ingredient is fampridine. Each prolonged-release tablet contains 10 mg of fampridine
• The other ingredients 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 package contents
Fampyra is a white, oval, biconvex, 13 x 8 mm prolonged-release tablet, film-coated
and marked with the inscription A10 engraved on one side.
Fampyra is available in bottles and blisters.
Bottles
Fampyra is available in HDPE (high-density polyethylene) bottles. Each bottle contains
14 prolonged-release tablets and silica gel desiccant. Each pack contains
28 prolonged-release tablets (2 bottles) or 56 prolonged-release tablets (4 bottles).
Blisters
Fampyra is available in blisters of 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 on this medicinal product, 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

Altre fonti d’informazioni
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.