Fampridine Accord - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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.

What is in this leaflet :

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

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

• 3. How to take Fampridine Accord

• 4. Possible side effects

• 5. How to store Fampridine Accord

• 6. Contents of the pack and other information

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

Fampridine Accord is a medicine used to improve walking in adults (18 years and over) with Multiple Sclerosis (MS) related walking disability. In multiple sclerosis, inflammation destroys the protective sheath around 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 stopping potassium leaving the nerve cells which have been damaged by MS. This medicine is thought to work by letting signals pass down the nerve more normally, which allows you to walk better.

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

Do not take Fampridine Accord

• – if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6)

• – if you have a seizure or have ever had a seizure (also referred to 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 containing fampridine. This may increase your risk of serious side effects

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Fampridine Accord:

• – if you feel aware of your heartbeat (palpitations )

• – if you are prone to infections

• – you should use a walking aid, such as a cane, as needed

• – because this medicine may make you feel dizzy or unsteady this may result in an increased risk

of falls

• – if you have any factors or are taking any medicine which affects your risk of fits (seizure ).

• – if you have been told by a doctor that you have mild problems with your kidneys.

Tell your doctor before you take Fampridine Accord if any of these apply to you.

Children and in adolescents

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

Elderly

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

Other medicines and Fampridine Accord

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

Do not take Fampridine Accord if you are taking any other medicine containing fampridine.

Other medicines that affect the kidneys

Your doctor will be especially careful if fampridine is given at the same time as any medicine which may affect how your kidneys eliminate medicines for example carvedilol, propranolol and metformin.

Fampridine Accord with food and drink

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

Pregnancy and breast-feeding

If you are pregnant , or are planning to become pregnant, tell your doctor before you take

Fampridine Accord.

Fampridine Accord is not recommended during pregnancy.

Your doctor will consider the benefit of you being treated with Fampridine Accord

against the risk to your baby.

You should not breast-feed whilst taking this medicine.

Driving and using machines

Fampridine Accord may have an effect on people’s ability to drive or use machines, it can cause

dizziness. Make sure you’re not affected before you start driving or use machinery.

3. How to take Fampridine Accord

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Fampridine Accord is only available by prescription and under the supervision of doctors experienced in MS.

Your doctor will give you an initial prescription for 2 to 4 weeks. After 2 to 4 weeks the treatment will be reassessed.

The recommended dose is

One tablet in the morning and one tablet in the evening (12 hours apart). Do not take more than two tablets in a day. You must leave 12 hours between each tablet. Do not take the tablets more often than every 12 hours.

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

If you take more Fampridine Accord than you should

Contact your doctor immediately if you take too many tablets.

Take the Fampridine Accord box with you if you go to see the doctor.

In overdose you may notice sweating, minor shaking (tremor ), dizziness, confusion, memory loss (amnesia ) and fits (seizure ). You may also notice other effects not listed here.

If you forget to take Fampridine Accord

If you forget to take a tablet , do not take two tablets at once to make up for a missed dose. You must always leave 12 hours between each tablet.

If you have any further questions on the use of this medicine, 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 taking Fampridine Accord and tell your doctor immediately.

If you experience one or more of the following allergic (hypersensitivity ) symptoms: swollen face, mouth, lips, throat or tongue, reddening or itching of the skin, chest tightness and breathing problems stop taking Fampridine Accord and see your doctor immediately.

Side effects are listed below 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:

• Feeling unsteady
• Dizziness
• Spinning sensation (vertigo)
• Headache
• Feeling weak and tired
• Difficulty sleeping
• Anxiety
• Minor shaking (tremor)
• Numbness or tingling of skin
• Sore throat
• Common cold (nasopharyngitis)
• Flu (influenza)
• Difficulty breathing (shortness of breath)
• Feeling sick (nausea)
• Being sick (vomiting)
• Constipation
• Upset stomach
• Back pain
• Heartbeat that you can feel (palpitations)

Uncommon side effects

May affect up to 1 in 100 people

• Fits (seizure)
• Allergic reaction (hypersensitivity)
• Worsening of nerve pain in the face (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 national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Fampridine Accord contains

• – The active substance is fampridine.

What Fampridine Accord looks like and contents of the pack

White to off white, oval shaped, biconvex, bevel-edged, film coated tablets, approximately

13.1 × 8.1 mm in dimensions, debossed with ‘FH6’ on one side and plain on other side.

Fampridine Accord 10 mg prolonged-release tablets are packed in perforated unit-dose blister packs containing 28 x1 or 56 × 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

Laboratoři Fundació DAU

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

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:.

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