Fampyra 10 mg prolonged-release tablets

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. 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 is a medicine used to improve walking in adults (18 years of age or older) with multiple sclerosis (MS) who have walking disability. In multiple sclerosis, inflammation destroys the protective covering of 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. These work by slowing the release of potassium from nerve cells damaged by MS. This medicine is believed to act by allowing nerve signals to travel more normally along the nerve, thereby enabling improved walking.

2. What you need to know before starting to take 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 seizures or have ever had an epileptic 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 take any other medicine containing fampridine. This could increase the risk of serious adverse effects.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Fampyra:

• if you are aware of your heartbeat (palpitations)
• if you are prone to infections
• you should use walking support, such as a cane, as needed, since this medicine may make you feel dizzy or unbalanced, which could increase the risk of falls
• if you have any risk factors or are taking any medicines that affect the risk of seizures (epileptic seizures)
• if your doctor has told you that you have mild kidney problems.

You should use walking support, such as a cane, as needed, since this medicine may make you feel dizzy or unbalanced, which could increase the risk of falls.

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

Children and adolescents

Do not give Fampyra to children or adolescents under 18 years of age.

Elderly people

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

Taking Fampyra with other medicines

Tell your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicine.

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

Other medicines that affect the kidneys

Your doctor will exercise special caution if you receive fampridine at the same time as another medicine that may affect the kidney elimination of other medicines, for example carvedilol, propranolol, and metformin.

Taking Fampyra with food and drink

Fampyra should be taken without food, on an empty stomach.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, consult your doctor before using this medicine.

Use of Fampyra during pregnancy is not recommended.

Your doctor will assess the benefit of Fampyra treatment for you against the risk to the baby.

Breastfeeding must be discontinued during treatment with this medicine.

Driving and using machines

Fampyra may affect a person's ability to drive and use machines, as it may cause dizziness. Make sure it does not affect you before driving or using machines.

3. How to take Fampyra

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. Fampyra can only be obtained with a prescription and under the supervision of doctors experienced in MS.

Your doctor will initially prescribe treatment for 2 to 4 weeks. After this 2- to 4-week period, your doctor will reassess the treatment.

The recommended dose is

One tablet in the morning and one tablet at night (12 hours apart). Do not take more than two tablets in one day. You must wait 12 hours between each tablet. Do not take the tablets more frequently than every 12 hours.

Swallow the tablet whole with water. Do not split, crush, dissolve, suck, or chew the tablet. Doing so may increase the risk of experiencing adverse 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 immediately if you take too many tablets.

If you go to the doctor, bring the Fampyra pack with you.

If you experience an overdose, you may notice sweating, slight shaking (tremors), dizziness, confusion, memory loss (amnesia), and seizures (epileptic fits). You may also experience 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 the missed dose.

There must always be 12 hours between each tablet.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Fampyra may cause adverse effects, although not everyone gets them.

If you have a seizure, 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 seek medical help immediately.

The adverse effects listed below are categorized by frequency:

Very common adverse effects

May affect more than 1 in 10 people:

• Urinary tract infection

Common adverse effects

May affect up to 1 in 10 people:

• Loss of balance

• Dizziness

• Sensation of spinning (vertigo)

• Headache

• Feeling of weakness and fatigue

• Difficulty sleeping

• Anxiety

• Small involuntary movements (tremors)

• Numbness or tingling of the skin

• Sore throat

• Common cold (nasopharyngitis)

• Influenza

• Breathing difficulty (shortness of breath)

• Nausea

• Vomiting

• Constipation

• Stomach discomfort

• Back pain

• Awareness of heartbeat (palpitations)

Uncommon adverse effects

May affect up to 1 in 100 people:

• Seizures (epileptic seizures)

• Allergic reaction (hypersensitivity)

• Onset or worsening of facial nerve pain (trigeminal neuralgia)

• Fast heartbeat (tachycardia)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V*. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 25°C. Keep the tablets in the original container to protect them from light and moisture.

If Fampyra is supplied in bottles, only open one bottle at a time. After first opening, use within 7 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and additional information / Additional information

Composition of Fampyra

• The active substance is fampridine.

Each prolonged-release tablet contains 10 mg of fampridine.

• The other components are:

Tablet core: Hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate;
Film-coating: Hypromellose, titanium dioxide (E-171), Macrogol 400.

Appearance of the product and contents of the pack

Fampyra is a prolonged-release, film-coated tablet, 13 x 8 mm, oval, biconvex, white to off-white in colour, with "A10" engraved on one side.

Fampyra is available in blister packs or bottles.

Bottles

Fampyra is supplied in HDPE (high-density polyethylene) bottles. Each bottle contains
14 tablets and a silica gel desiccant. Each package contains 28 tablets (2 bottles) or
56 tablets (4 bottles).

Blister packs

Fampyra is supplied in blister packs containing 14 tablets each. Each package contains 28 tablets (2 blisters) or 56 tablets (4 blisters).

Only certain pack sizes or presentations may be marketed.

Marketing Authorisation Holder and Manufacturer

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 more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: {monthYYYY}.

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