FAMPYRA 10 mg Prolonged-Release Tablets

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.

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:

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/.