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FAMPRIDINE ACCORD 10 mg PROLONGED-RELEASE TABLETS

Ask a doctor about a prescription for FAMPRIDINE ACCORD 10 mg PROLONGED-RELEASE TABLETS

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use FAMPRIDINE ACCORD 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Fampridine Accord 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, as 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 experience 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 package leaflet:

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

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

Fampridine Accord 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 Accord 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, enabling you to walk better.

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

Do not take Fampridine Accord

  • 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 you have 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 doctorand do not takeFampridine Accord if any of these situations apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fampridine Accord:

  • 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
  • as this medicine may make you feel dizzy or unbalanced, it 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).

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

Children and adolescents

Do not give Fampridine Accord to children or adolescents under 18 years.

Elderly

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

Taking Fampridine Accord with other medicines

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

Do not take Fampridine Accord if you are taking other medicines that contain 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.

Taking Fampridine Accord with food and drinks

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

Pregnancy and breastfeeding

If you are pregnantor planning to become pregnant, consult your doctorbefore using this medicine.

It is not recommended to use Fampridine Accord during pregnancy.

Your doctor will weigh the benefits of treatment with Fampridine Accord for you against the risks for the baby.

Breastfeeding should be stoppedduring treatment with this medicine.

Driving and using machines

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

3. How to take Fampridine Accord

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

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

If you take more Fampridine Accord than you should

Contact your doctor immediately if you take too many tablets. If you go to the doctor, take the Fampridine Accord package with you.

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

If you forget to take Fampridine Accord

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 hoursbetween each tablet.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fampridine Accord can cause side effects, although not everybody gets them.

If you have a seizure, stop taking Fampridine Accordand inform 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, tightness in the chest, and breathing problems, stop taking Fampridine Accordand goto 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 tiredness
  • Difficulty sleeping
  • Anxiety
  • Small tremors (tremors)
  • Numbness or tingling of the skin
  • Sore throat
  • Common cold (nasopharyngitis)
  • Flu
  • 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)
  • Appearance or worsening of facial nerve pain (trigeminal neuralgia)
  • Fast heart rate (tachycardia)

Reporting of side effects

If you experience 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 through the national reporting system listed in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fampridine Accord

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 packaging after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Contents of Fampridine Accord

  • The active substanceis fampridine.
  • Each prolonged-release tablet contains 10 mg of fampridine
  • The other ingredients are:
  • Core of the tablet: hypromellose (E464), silica, colloidal anhydrous (E551), microcrystalline cellulose (E460), magnesium stearate (E572);
  • Coating of the tablet: hypromellose (E464), titanium dioxide (E171), macrogol (E1521)

Appearance of Fampridine Accord and contents of the pack

Oval, biconvex, beveled, white to off-white film-coated tablet, approximately 13 x 8 mm in size, and engraved with “FH6” on one side and smooth on the other.

Fampridine Accord 10 mg prolonged-release tablets are packaged in unit dose blister packs containing 28 x 1 or 56 x 1 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder:

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6a Planta,

Barcelona, 08039

Spain

Manufacturer:

Accord Healthcare Polska Sp.z.o.o.

Ul. Lutomierska 50,

95-200, Pabianice, Poland

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola PLA3000, Malta

Laboratori Fundació DAU

C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain

Date of last revision of this leaflet: {MM/AAAA}.

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu/.

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