FAMPRIDINE STADA 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fampridine Stada 10 mg prolonged-release tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Fampridine Stada and what is it used for
2. What you need to know before taking Fampridine Stada
3. How to take Fampridine Stada
4. Possible side effects
5. Storage of Fampridine Stada
6. Package contents and additional information

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

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

Fampridine Stada 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 in MS. It is believed that this medication works by allowing signals to pass through the nerve in a more normal way, enabling you to walk better.

2. What you need to know before taking Fampridine Stada

Do not take Fampridine Stada if:

• you are allergicto fampridine or any of the other ingredients of this medication (listed in section 6)
• you have 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
• you are taking a medication called cimetidine
• you are taking another medication that contains fampridine. This may increase the risk of serious side effects.

Talk to your doctorand do not takefampridine if any of these situations apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take fampridine:

• 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 cane, as needed, since this medication may make you feel dizzy or unbalanced, and this may increase the risk of falls
• if there are risk factors or you are taking any medication that increases the risk of seizures.
• if your doctor has told you that you have mild kidney problems.

Tell your doctor beforetaking fampridine if any of these situations apply to you.

Children and adolescents

Do not give fampridine to children or adolescents under 18 years of age.

Elderly people

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

Other medications and Fampridine Stada

Tell your doctor or pharmacistif you are using or have recently used or may need to use any other medication.

Do not take Fampridine Stada if you are taking other medications that contain fampridine.

Other medications that affect the kidneys

Your doctor will be particularly careful if you receive fampridine at the same time as another medication (such as carvedilol, propranolol, and metformin) that may affect the elimination of other medications by the kidneys.

Taking Fampridine Stada with food

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

Pregnancy and breastfeeding

If you are pregnantor plan to become pregnant, consult your doctor beforeusing this medication.

Using fampridine during pregnancy is not recommended.

Your doctor will weigh the benefits of treatment with fampridine for you against the risk to the baby.

Breastfeeding should be discontinuedduring treatment with this medication.

Driving and using machines

Fampridine may affect your ability to drive and use machines, as it may cause dizziness. Make sure it does not affect you before driving or using machines.

3. How to take Fampridine Stada

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again. Fampridine can only be obtained with a prescription and under the supervision of doctors experienced in MS.

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

The recommended dose is

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 a 12-hour intervalbetween each tablet. Do not take the tablets more frequently than every 12 hours.

Swallow the tablet wholewith water. Do not divide, crush, dissolve, suck, or chew the tablet, as this may increase the risk of side effects.

If you take more Fampridine Stada than you should

Immediately contact your doctorif you take too many tablets. If you go to the doctor, take the fampridine box with you.

If you experience an overdose, you may notice sweating, small tremors (tremors), dizziness, confusion, memory loss (amnesia), and seizures. 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 medication and the amount ingested.

If you forget to take Fampridine Stada

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

There must always be a 12-hour intervalbetween each tablet.

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

4. Possible side effects

Like all medications, fampridine can cause side effects, although not everyone will experience them.

If you have a seizure, stop taking fampridine and 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 difficulties, stop taking fampridineand 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
• sensation of spinning (vertigo)
• headache
• feeling of weakness and fatigue
• difficulty sleeping
• anxiety
• small tremors (tremors)
• numbness or tingling in the skin
• sore throat
• common cold (nasopharyngitis)
• flu
• difficulty breathing (shortness of breath)
• nausea
• vomiting
• constipation
• stomach upset
• back pain
• heart palpitations

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

• seizures (seizures)
• allergic reaction (hypersensitivity)
• onset or worsening of facial nerve pain (trigeminal neuralgia)
• rapid heart rate (tachycardia)

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fampridine Stada

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

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

Store below 25°C. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fampridine Stada

• The active ingredient is fampridine.

Each prolonged-release tablet contains 10 mg of fampridine

• The other ingredients are:

Core of the tablets:

Hydroxypropyl methylcellulose

Microcrystalline cellulose

Anhydrous colloidal silica

Magnesium stearate

Coating:

Hydroxypropyl methylcellulose

Titanium dioxide (E-171)

Macrogol

Appearance of the product and package contents

Coated tablet, approximately 13 x 8 mm, oval, and white to off-white, marked with L10 on one side and smooth on the other side.

It is presented in blister packs (aluminum with desiccant/aluminum) packaged in cardboard boxes containing:

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

C/Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

Date of the last revision of this package leaflet:March 2022

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