FAMPRIDINE AUROVITAS 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fampridine Aurovitas 10 mg prolonged-release tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Fampridine Aurovitas and what is it used for

Fampridine Aurovitas contains the active substance fampridine, which belongs to a group of medicines called potassium channel blockers. They work by slowing down the release of potassium from damaged nerve cells in Multiple Sclerosis (MS). It is thought that this medicine works by allowing signals to pass through the nerve in a more normal way, which helps you to walk better.

Fampridine is a medicine used to improve walking in adults (18 years or older) with MS who have walking disability. In multiple sclerosis, inflammation damages the protective covering of the nerves, leading to muscle weakness, muscle stiffness, and difficulty walking.

2. What you need to know before you take Fampridine Aurovitas

Do not takeFampridineAurovitas

• if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6).
• if you have had seizures (fits or convulsions) or if your doctor or nurse has told you that you have a history of seizures.
• 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 another medicine that contains fampridine. This could increase the risk of you having serious side effects.

Tell your doctor and do not takethis medicine if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking this medicine.

• if you are aware of your heartbeat (palpitations).
• if you are prone to infections.
• if you have any risk factors or are taking any medicines that affect the risk of having seizures (fits or convulsions).
• if your doctor has told you that you have mild kidney problems.
• if you have a history of allergic reactions.

You should use a walking aid, such as a walking stick, as needed, because this medicine may make you feel dizzy or unsteady and may increase the risk of falls.

Tell your doctor beforeyou take this medicine if any of these apply to you.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years.

Elderly

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

Other medicines andFampridineAurovitas

Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines.

Do not take this medicine 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.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Fampridine should not be used during pregnancy.

Your doctor will weigh up the benefit of treatment with fampridine for you against the risk for the baby.

Breast-feeding should be stopped during treatment with this medicine.

Driving and using machines

Fampridine 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 Fampridine Aurovitas

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine can only be obtained with a prescription and under the supervision of doctors with experience in MS.

Your doctor will initially prescribe treatment for 2 to 4 weeks. After this period of 2 to 4 weeks, 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 one day. There must be 12 hoursbetween each tablet. Do not take the tablets more often than every 12 hours.

Fampridine is taken by mouth.

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.

This medicine should be taken on an empty stomach, without food.

If you take moreFampridineAurovitas than you should

Contact your doctor immediatelyif you take too many tablets.

If you go to a doctor, take the pack of this medicine with you.

If you have a overdose you may notice sweating, small tremors (tremors), dizziness, confusion, memory loss (amnesia), and seizures (fits or convulsions). You may also notice other effects not mentioned here.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeFampridineAurovitas

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 further questions on the use of this product, 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 have a seizure, stop taking fampridineand 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 fampridine and see a 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 that everything is spinning (vertigo).
• Headache.
• Feeling weak and tired.
• Difficulty sleeping.
• Anxiety.
• Small tremors (tremors).
• Numbness or tingling in the skin.
• Sore throat.
• Common cold (nasopharyngitis).
• Flu.
• Viral infection.
• Breathing difficulties (shortness of breath).
• Feeling sick (nausea).
• Being sick (vomiting).
• Constipation.
• Stomach upset.
• Back pain.
• Feeling your heartbeat (palpitations).

Uncommon side effects(may affect up to 1 in 100 people):

• Seizures (fits or convulsions).
• Allergic reaction (hypersensitivity).
• Severe allergic reaction (anaphylactic reaction).
• Swelling of the face, lips, mouth, or tongue (angioedema).
• Appearance or worsening of facial nerve pain (trigeminal neuralgia).
• Fast heart rate (tachycardia).
• Dizziness or fainting (hypotension).
• Redness of the skin with itching (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 via the Spanish Medicines Agency's website for reporting adverse reactions (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fampridine Aurovitas

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 and blister after EXP. The expiry date is the last day of the month shown.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fampridine Aurovitas contains

• The active substance is fampridine. Each prolonged-release tablet contains 10 mg of fampridine.
• The other ingredients are:

Core of the tablet:microcrystalline cellulose (grade 102), hypromellose type 2208 (100 mPa.s, grade for controlled release),colloidal anhydrous silica, and magnesium stearate.

Coating of the tablet:hypromellose 2910 (5 mPa.s),macrogol 400, talc, titanium dioxide (E171).

Appearance and packaging

Prolonged-release tablet.

White or almost white, oval (13.1 x 8.1 mm approximately), biconvex, film-coated tablets with "FN" on one side and "10" on the other.

Fampridine Aurovitas prolonged-release tablets are available in blister packs.

Blister pack sizes:

14, 16, 24, 28, 30, 56, 60, 98, 100, 196, and 200 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Fampridin PUREN 10 mg Retardtabletten

Spain: Fampridina Aurovitas 10 mg comprimidos de liberación prolongada EFG

France: Fampridine Arrow LP 10 mg, comprimé à libération prolongée

Netherlands: Fampridine Aurobindo 10 mg, tabletten met verlengde afgifte

Portugal: Fampridina Generis

Date of last revision of this leaflet: May 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).