Fampyra 10 mg comprimidos de liberacion prolongada

Leaflet: information for the user

Fampyra 10 mg prolonged-release tablets

fampridina

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. How to take Fampyra
2. Possible side effects
3. Storage of Fampyra

1. Contents of the pack and additional information

Fampyra is a medication 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 ingredient fampridine, which belongs to a group of medications called potassium channel blockers. They work by slowing the release of potassium from damaged nerve cells caused by MS. It is believed that this medication acts by allowing signals to pass through the nerve in a more normal way, enabling better walking.

Do not take Fampyra

• if you areallergicto fampridina or any of the other components of this medication (listed in section 6)
• if you have seizures or have ever had aseizure(also known as an attack or convulsion)
• if your doctor or nurse has told you that you havemoderate or severe kidney problems
• if you are taking a medication called cimetidina
• if you are taking any other medication that contains fampridina. It may increase the risk of severe side effects.

Inform your doctoranddo not takeFampyra if any of these situations apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fampyra:

• if you are aware of your heart rate (palpitations)
• if you are prone to infections

• you will need to use some support for walking, such as a cane, as neededsince this medication may make you feel dizzy or unbalanced, which may increase the risk of falls

• if you have any risk factors or are taking any medication that affects the risk of seizures (seizures)

• if your doctor has told you that you have mild kidney problems.

Inform your doctor beforetaking Fampyra if any of these situations apply to you.

Children and adolescents

Do not administer Fampyra to children or adolescents under 18 years old.

Older adults

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

Taking Fampyra with other medications

Inform your doctor or pharmacistif you are using or have used recently or may need to useany other medication.

Do not take Fampyra if you are taking other medications that contain fampridina.

Other medications that affect the kidneys

Your doctor will take special care if you receive fampridina at the same time as another medication that may affect the elimination of other medications by the kidneys, for example carvedilol, propranolol, and metformin.

Taking Fampyra with food and drinks

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

Pregnancy and breastfeeding

If you are pregnantor intend to become pregnant,consult your doctor beforeusingthis medication.

This medication is not recommended during pregnancy.

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

You must interrupt breastfeedingduring treatment with this medication.

Driving and operating machinery

Fampyra may affect people's ability to drive and operate machinery, causing dizziness. Make sure it does not affect you before starting to drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Fampyra can only be obtained with a prescription and under the supervision of experienced EM doctors.

Your doctor will initially prescribe treatment for 2 to 4 weeks. After this 2 to 4 week period, your treatment will be re-evaluated.

The recommended dose is

Onetablet in the morning andonetablet at night (12 hours apart). Do not take morethan two tablets in a day.You must allow 12 hoursto pass between each tablet. Do not take the tablets more frequently than every 12 hours.

Swallow the tablet whole,with water. Do not divide, crush, dissolve, suck, or chew thetablet. This could increase the risk of adverse effects.

If your Fampyra is presented in bottles, the bottle will also contain a desiccant. Leave the desiccant in the bottle, do not ingest it.

If you take more Fampyra than you should

Immediately contact your doctorif you take too many tablets.

If you visit your doctor, bring the Fampyra box with you.

If you experience an overdose

You may notice sweating, small tremors (shaking, dizziness, confusion, memory loss (amnesia), and seizures (epileptic crises). 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 compensate for the missed doses.

Always allow 12 hoursto pass between each tablet.

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

Like all medicines, Fampyra can cause side effects, although not everyone will experience them.

If you have a seizure, 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, chest tightness, and breathing problems,stop taking Fampyraandseekmedical attention 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:

• Loss of balance

• Dizziness

• Sensation of spinning (vertigo)

• Headache

• Sensation of weakness and fatigue

• Difficulty sleeping

• Anxiety

• Tremors

• Numbness or tingling in the skin

• Sore throat

• Common cold (nasopharyngitis)

• Influenza

• Dyspnea (shortness of breath)

• Nausea

• Vomiting

• Constipation

• Abdominal discomfort

• Back pain

• Palpitations

Uncommon side effects

May affect up to 1 in 100 people:

• Seizures (epileptic crises)

• Allergic reaction (hypersensitivity)

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

• Tachycardia (rapid heart rate)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through thenational notification system included in theAppendixV*. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

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 ingredientis fampridine.
• Each prolonged-release tablet contains 10 mg of fampridine
• The other componentsare:
• Core of the tablets: Hypromellose, microcrystalline cellulose, anhydrous colloidal silica,

stearate of magnesium; film coating: Hypromellose, titanium dioxide (E-171), Macrogol 400

Appearance of the product and contents of the pack

Fampyra is a prolonged-release tablet, 13 x 8 mm, oval, biconvex, white, with A10 engraved on one side.

Fampyra is presented in blister packs or bottles

Bottles

Fampyra is presented 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 presented in blister packs of 14 tablets each. Each pack contains 28 tablets (2 blister packs) or 56 tablets (4 blister packs).

Only some sizes or presentations of packs 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 request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet: {monthYYYY}.

More detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.