FAMPRIDINE QUALIGEN 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Fampridine Qualigen 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 Qualigen contains the active ingredient fampridine, which belongs to a group of medications called potassium channel blockers. They work by slowing down 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 Qualigen

Do not take Fampridine Qualigen

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fampridine Qualigen:

• 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 may increase the risk of falls
• if you have any risk factors or are taking any medication that affects the risk of having seizures (epileptic fits)
• 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 if any of these situations apply to you.

Children and adolescents

Do not give this medication 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 Qualigen

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

Do not take this medication 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 that may affect the elimination of other medications by the kidneys, such as carvedilol, propranolol, and metformin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The use of Fampridine Qualigen is not recommended during pregnancy.

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

Breastfeeding should be interrupted during treatment with this medication.

Driving and using machines

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

3. How to take Fampridine Qualigen

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again. This medication 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 a day. You must wait 12 hoursbetween each tablet. Do not take the tablets more frequently than every 12 hours.

Fampridine Qualigen is administered orally.

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

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

If you take more Fampridine Qualigen than you should

Contact your doctor immediatelyif you take too many tablets.

If you go to the doctor, take the Fampridine Qualigen package with you.

If you experience an overdose, you may notice sweating, small tremors, dizziness, confusion, memory loss (amnesia), and seizures (epileptic fits). You may also notice other effects not mentioned here.

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

If you forget to take Fampridine Qualigen

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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

If you have a seizure, stop taking Fampridine Qualigenand 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 Fampridine Qualigen and go to the 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 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
• 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 (epileptic fits)
• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, 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: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fampridine Qualigen

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

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

Store below 30°C.

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 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 Qualigen

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

Core of the tablets: hypromellose, microcrystalline cellulose (E460), anhydrous colloidal silica, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), macrogol 400.

Appearance of the product and package contents

Fampridine Qualigen is a white to off-white, oblong, biconvex, film-coated tablet, with a major diameter of 12.9-13.4 mm and a minor diameter of 7.9-8.4 mm.

Fampridine Qualigen is available in blister packs, in packages of 28, 56, and 196 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

or

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23,

40764 Langenfeld

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany Fampridin neuraxpharm 10 mg Retardtabletten

Austria Fampridin neuraxpharm 10 mg Retardtabletten

Spain Fampridina Qualigen 10 mg prolonged-release tablets EFG

Date of the last revision of this package leaflet:April 2023.

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