Patient leaflet - Fampridine Sun 10 mg prolonged-release tablets
1. What Fampridine is and what it is used for
Fampridine 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 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 use Fampridine
Do NOT take Fampridine
- 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 if any of these apply to you. If you are not sure, talk to your doctor before using this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fampridine:
- 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 if any of these apply to you.
Children and adolescents
Do not give Fampridine 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
Tell your doctor if you are taking, have recently taken or might take any other medicines. Do not take Fampridine 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 with food and drink
Fampridine 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 taking this medicine.
Fampridine is not recommended during pregnancy.
Your doctor will consider the benefit of you being treated with this medicine against the risk to your baby.
You should not breast-feed while you are taking this medicine.
Driving and using machines
Fampridine 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 use Fampridine
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Fampridine 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 use more Fampridine than you should
Contact your doctor immediately if you take too many tablets.
Take the Fampridine 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 use Fampridine
Do not take a double dose to make up for a forgotten tablet. 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.
Most serious side effects
If you have a seizure, stop taking Fampridine 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 tell your doctor straight away.
Other side effects
Side effects are listed below by frequency:
Very common (may affect more than 1 in 10 people)
- urinary tract infection.
Common (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 (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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Fampridine
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 and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Fampridine contains
- The active substance is fampridine. Each prolonged-release tablet contains 10 mg of fampridine
The other ingredients are:
Tablet core: hypromellose, povidone, microcrystalline cellulose (E460), magnesium stearate Film coating: hypromellose, talc (E553b), ethyl cellulose (E462), triacetin (E1518), titanium dioxide (E171)
Imprinting ink: shellac glaze (E904), iron oxide black (E172), propylene glycol (E1520), ammonium hydroxide (E527)
What Fampridine looks like and contents of the pack
Fampridine is a white to off-white, round, biconvex, bevelled edge, film-coated tablet with diameter of 7.65 ± 0.20 mm imprinted with “429” in black ink on one side and plain on the other side.
Fampridine is supplied in blister packs.
SUN EUROPE United Kingdom
Blank Space
Blank Space
89 mm
30 mm
151 mm
300 mm
30 mm
Back side of Barcode
Close Size : 30x73 mm
Self-adhesive BLANK (NO TEXT) side tear taping
Blister packs
Fampridine comes in foil blisters of 14 tablets each. Each carton contains 28 tablets (2 blisters), 56 tablets (4 blisters) or 196 tablets (14 blisters).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania
This medicinal product is authorised in the Member States of the EEA under the following names
France Fampridine SUN
Germany Fampridin BASICS
The Netherlands Fampridine SUN
Spain Fampridina SUN
United Kingdom Fampridine SUN
This leaflet was last revised in November 2020.
SUN EUROPE United Kingdom