FAMPRIDINE SUN 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fampridine Sun 10 mg prolonged-release tablets EFG

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

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

Fampridine Sun is a medicine used to improve walking in adults (18 years or older) with multiple sclerosis (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.

Fampridine Sun 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 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.

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

Do not take Fampridine Sun

• if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6)
• if you have had a seizure (also called a fit or convulsion) or have a history of seizures
• if your doctor 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 serious side effects.

Tell your doctor and do not take Fampridine Sun if any of these apply to you.

If you are not sure, consult your doctor before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting Fampridine Sun:

• 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, because this medicine can make you feel dizzy or unsteady and may increase the risk of falls
• if you have any risk factors or are taking any medicines that affect the risk of having seizures
• if your doctor has told you that you have mild kidney problems
• if you have a history of allergic reactions.

Tell your doctor before taking Fampridine Sun if any of these apply to you.

Children and adolescents

Do not give Fampridine Sun 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 and Fampridine Sun

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Do not take Fampridine Sun 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 Fampridine Sun with food and drinks

Fampridine Sun should be taken on an empty stomach, without food.

Pregnancy and breastfeeding

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

Fampridine Sun is not recommended during pregnancy.

Your doctor will assess the benefits of treatment with this medicine for you against the risks for your baby.

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

Driving and using machines

Fampridine can 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 Sun

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. You can only get Fampridine Sun 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 2 to 4 week period, the treatment will be re-evaluated.

The recommended dose is:

One tablet in the morning and one tablet in the evening (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 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 side effects.

If you take more Fampridine Sun than you should

Contact your doctor immediately if you take too many tablets.

If you go to a doctor, take the Fampridine Sun pack with you.

If you have taken too much, you may notice sweating, small tremors, dizziness, confusion, memory loss (amnesia), and seizures. You may also notice other effects not mentioned here.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Fampridine Sun

If you forget to take a tablet, do not take a double dose to make up for the missed doses.

There must always be 12 hours between each tablet.

If you have any further questions on 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.

More serious side effects

If you have a seizure, stop taking Fampridine Sun and tell 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 Fampridine Sun and go to the doctor immediately.

Other side effects

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 of weakness and tiredness
• Difficulty sleeping
• Anxiety
• Small tremors
• Numbness or tingling in the skin
• Sore throat
• Common cold (nasopharyngitis)
• Flu
  • Viral infection

• Difficulty breathing (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
• Allergic reaction (hypersensitivity)
  • Severe allergy (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 loss of consciousness (hypotension)
  • Skin rash/itchy skin 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 via the Spanish Medicines Agency's website (http://www.aemps.gob.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Fampridine Sun

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.

Aluminium/aluminium blister: This medicine does not require any special storage conditions.

PVC/PVDC/Aluminium blister: Store the tablets in the original packaging to protect them from light and moisture.

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 Sun contains

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

Core of the tablets: hypromellose, povidone, microcrystalline cellulose (E460), magnesium stearate

Coating of the tablets: hypromellose, talc (E553b), ethyl cellulose (E462), triacetin (E1518), titanium dioxide (E171)

Printing ink: shellac (E904), iron oxide black (E172), propylene glycol (E1520), ammonium hydroxide (E527)

Appearance and packaging

Fampridine Sun is a film-coated tablet, 7.65 ± 0.20 mm in diameter, round, biconvex, with beveled edges, and white to off-white in color, with one face smooth and the other face engraved with 429 in black ink.

Fampridine Sun is available in aluminium/aluminium blister packs and PVC/PVDC/aluminium blister packs.

.

Blister packs

Fampridine Sun is available in blister packs of 14 tablets each. Each pack contains 28 tablets (2 blisters), 56 tablets (4 blisters), or 196 tablets (14 blisters).

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Or

Terapia S.A.

124 Fabricii Street

400632, Cluj-Napoca

Cluj County

Romania

For further information about this medicine, contact the local representative of the marketing authorisation holder

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

France Fampridine SUN

Germany Fampridin BASICS

Netherlands Fampridine SUN

Spain Fampridina SUN 10 mg prolonged-release tablets EFG

United Kingdom (Northern Ireland) Fampridine SUN

Date of last revision of this leaflet: January 2024.

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)