FAMPRIDINE TEVA 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

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

1. What is Fampridina Teva and what is it used for

Fampridina Teva is a medicine used to improve walking in adults (18 years or older) with walking disability related to multiple sclerosis (MS). In multiple sclerosis, inflammation destroys the protective covering of the nerves, causing muscle weakness, muscle stiffness, and difficulty walking.

This medicine contains the active substance fampridine, which belongs to a group of medicines called potassium channel blockers. They work by preventing potassium from leaving damaged nerve cells in multiple sclerosis. It is thought that this medicine works by allowing signals to pass through the nerve more normally, which helps you walk better.

2. What you need to know before you take Fampridina Teva

DO NOT takeFampridina Teva

• if you are allergicto fampridine or any of the other ingredients of this medicine (listed in section 6)
• if you have had a seizureor have ever had a seizure(also known as 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 may increase the risk of serious side effects.

Tell your doctor and DO NOT takethis medicine if any of the above applies to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you feel your heart beating (palpitations)
• if you are prone to infections
• you should use walking aids, such as a stick, as needed
• as this medicine may make you feel dizzy or unsteady, which may increase the risk of falls
• if you have any factor or are taking any medicine that affects the risk of seizures (fits)
• if your doctor has told you that you have mild kidney problems.

Tell your doctor before takingthis medicine if any of the above applies to you.

Children and adolescents

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

Elderly patients

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

Other medicines and Fampridina Teva

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

DO NOT takethis medicineif you are taking any other medicine that contains fampridine.

Other medicines that affect the kidneys

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

Pregnancy and breast-feeding

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

This medicine is not recommended during pregnancy.

Your doctor will weigh the benefit of treatment with this medicine for you against the risk for the baby.

Do not breast-feedwhile you are taking this medicine.

Driving and using machines

This medicine 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 Fampridina Teva

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 with a doctor's prescription and under the supervision of a doctor with experience in the treatment of multiple sclerosis.

Your doctor will initially prescribe treatment for 2 to 4 weeks. After 2 to 4 weeks, the treatment will be reassessed.

The recommended dose is

Onetablet in the morning and onetablet in the evening (with a 12-hour interval). Do not take more than two tablets a day. You must wait 12 hoursbetween each tablet. Do not take the tablets more often than every 12 hours.

This medicine is for oral use.

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

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

If you take more Fampridina Teva than you should

Contact your doctor immediatelyif you have taken too many tablets.

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

In an overdose, you may notice sweating, small shakes (tremors), dizziness, confusion, memory loss (amnesia), and seizures (fits). You may also notice other side 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, indicating the medicine and the amount taken.

If you forget to take Fampridina Teva

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 takingthis medicineand 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 takingthis medicineand go to your doctor immediately.

The following side effects are listed by frequency:

Very common side effects(may affect up to 1 in 10 people)

• Urinary tract infection

Common side effects(may affect up to 1 in 10 people)

• Feeling unsteady
• Dizziness
• Feeling like everything is spinning (vertigo)
• Headache
• Feeling weak and tired
• Difficulty sleeping
• Anxiety
• Small shakes (tremors)
• Numbness or tingling in the skin
• Sore throat
• Common cold (nasopharyngitis)
• Flu
• Difficulty breathing (shortness of breath)
• Feeling sick (nausea)
• Vomiting
• Constipation
• Stomach upset
• Back pain
• Heart beating that can be felt (palpitations).

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

• Seizures (fits)
• Allergic reaction (hypersensitivity)
• Worsening of facial nerve pain (trigeminal neuralgia)
• Fast heart rate (tachycardia).

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 Fampridina Teva

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 blister and the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Store in the original package to protect 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 Fampridina Teva contains

• The active substanceis fampridine. Each prolonged-release tablet contains 10 mg of fampridine.
• The other ingredientsare:
• • Core of the tablet: calcium hydrogen phosphate dihydrate, hypromellose, colloidal anhydrous silica, magnesium stearate.
  • Coating: hypromellose, titanium dioxide (E171), and macrogol 400.

Appearance and packaging

The tablets are white to off-white, biconvex, oval-shaped, film-coated, with the inscription R10 on one side and no inscription on the other. The dimensions of the tablets are approximately 8 mm x 13 mm.

Fampridina Teva is available in blister packs of 28 and 56 tablets and unit-dose blister packs of 28x1 and 56x1 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas 28108

Madrid (Spain)

Manufacturer

Balkanpharma Dupnitsa AD

3, Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

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

Germany: Fampridin-ratiopharm 10 mg Retardtabletten

Croatia: Fampridin Teva 10 mg tablete s produljenim oslobadanjem

Denmark: Fampridin Teva

Spain: Fampridina Teva 10 mg comprimidos de liberación prolongada EFG

Slovakia: Fampridín Teva 10 mg tablety s predlženým uvolnovaním

Slovenia: Fampridin Teva 10 mg tablete s podaljšanim sprošcanjem

France: FAMPRIDINE TEVA LP 10 mg, comprimé à libération prolongée

Lithuania: Fampridine Teva 10 mg pailginto atpalaidavimo tabletes

Netherlands: Fampridine Teva 10 mg, tabletten met verlengde afgifte

Norway: Fampridin Teva

Poland: Fampridine Teva

Portugal: Fampridina Teva

Czech Republic: Fampridine Teva

Date of last revision of this leaflet:July 2021

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