FAMPRIDINE SANDOZ 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Fampridine Sandoz 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 more normally, which helps you walk better.

Fampridine 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.

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

Do not take Fampridine Sandoz

• 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 takeFampridine Sandoz 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 need to 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,
• if you have any risk factors or are taking any medicine that affects the risk of having seizures (fits)
• if your doctor has told you that you have mild kidney problems.

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 and Fampridine Sandoz

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

Do not take Fampridine Sandoz 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 your baby.

Breast-feeding must be stoppedduring 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 Sandoz

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine is only available on 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 one day. There must be 12 hoursbetween each tablet. Do not take the tablets more often than every 12 hours.

Fampridine Sandoz 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 without food, on an empty stomach.

If you take more Fampridine Sandoz than you should

Contact your doctor immediatelyif you take too many tablets.

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

If you have a overdose you may notice sweating, small tremors (shaking), dizziness, confusion, memory loss (amnesia) and seizures (fits). 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, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Fampridine Sandoz

If you forget to take a tablet, do not take a double dose to make up for the forgotten dose. 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, fampridine can cause side effects, although not everybody gets them.

If you have a seizure, stop taking Fampridine Sandozand 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 Sandozand 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 (shaking),
• numbness or tingling of 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 (fits),
• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylaxis),
• swelling of the face, lips, mouth or tongue (angioedema),
• onset 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fampridine Sandoz

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 that month.

Store below 25°C. Store the tablets in the original package to protect them from 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

Composition of Fampridine Sandoz

• The active substanceis fampridine.
• Each prolonged-release tablet contains 10 mg of fampridine.
• The other ingredientsare:
• Core of the tablet:hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate; coating: Opadry White (hypromellose, titanium dioxide (E-171), macrogol).

Appearance and packaging

Fampridine Sandoz is a white to off-white, oval, 13 x 8 mm, prolonged-release tablet, with “L10” on one face and the other face is smooth.

Fampridine Sandoz is available in PA/Alu blister packs, containing:

14 prolonged-release tablets

28 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

196 (2 x 98) prolonged-release tablets

14 x 1 (single-dose blister) prolonged-release tablets

28 x 1 (single-dose blister) prolonged-release tablets

56 x 1 (single-dose blister) prolonged-release tablets

98 x 1 (single-dose blister) prolonged-release tablets

196 (2 x 98 x 1) (single-dose blister) prolonged-release tablets

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios Liconsa S.A.

Avenida Miralcampo 7

Poligono Industrial Miralcampo

Azuqueca de Henares

19200 Guadalajara

Spain

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Date of last revision of this leaflet:June 2023.

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/.