Fampridine Accord – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Fampridine Accord, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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.
ℹ️ 1. What Fampridine Accord is and what it is used for
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 pas s down the nerve more normally, which allows you to walk better.
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.
⚠️ 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 − if you have any factors or are taking any medicine which affects your risk of fits (seizure ).
26 − if you have been told by a doctor that you have mild problems with your kidneys. − if you have history of allergic reactions 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.
Tell your doctor before you take Fampridine Accord if any of these apply to you.
Children and adolescents
Do not give this medicine 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.
Pregnancy and breast -feeding If you are pregnant or breast -feeding , think you may be pregnant or are planning to have a baby , ask your doctor or pharmacist before for advice before taking this medicine.
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 are 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 in itial prescription for 2 to 4 weeks. After 2 to 4 weeks the treatment will be reassessed.
The recommended dose is 27 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.
Fampridine Accord is for oral use.
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.
This medicine should be taken without food, on an empty stomach.
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) 28 • Headache
- Feeling weak and tired
- Difficulty sleeping
- Anxiety
- Minor shaking (tremor )
- Numbness or tingling of skin
- Sore throat
- Common c old (nasopharyngitis )
- Flu (influenza )
- Viral infection
- 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 )
- Severe allergy (anaphylactic reaction )
- Swelling of the face, lips, mouth or tongue (angioedema )
- New onset or worsening of nerve pain in the face ( trigeminal neuralgia )
- Fast heart rate ( tachycardia )
- Dizziness or loss of consciousness (hypotension )
- Rash/itchy rash ( urticaria )
- Chest discomfort
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 in Appendix V . By 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 packag e 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.
- Each prolonged -release tablet contains 10 mg of fampridine
- The other ingredients are:
- Tablet core: Hypromellose (E464) , silica, colloidal anhydrous (E551 ), cellulose microcrystalline (E460), m agnesium stearate (E572);
- Film coating: h ypromellose (E464), titanium dioxide (E171), macrogol (E1521)
What Fampridine Accord looks like and contents of the pack
White to off whit e, oval shaped, biconvex, bevel -edged, film coated tablets, approximately 13.1 x 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, 49 x 1, 56 x 1 tablets, or in multipacks of 196 x 1 tablets (comprising 4 cartons, each containing 49 × 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 Accord Healthcare single member S.A.
64th Km National Road Athens, Lamia, Schimatari, 32009, Greece For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BE / BG / CZ / D K / DE / EE / IE / ES / FR / HR / IT / CY / LV / LT / LU / HU / MT / NL / AT / PL / PT / RO / SI / SK / FI / SE Accord Healthcare S.L.U.
Tel: +34 93 301 00 64 EL Win Medica A.E.
Tel: +30 210 7488 821
This leaflet was last revised in
30 Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu /.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Fampridine Accord (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/20/1477).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.