Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Fampridine Mylan 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. Fampridine Mylan 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.
− 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). − if you have been told by a doctor that you have mild problems with your kidneys − If you have a 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 Mylan 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 Mylan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take Fampridine Mylan 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 for advice before taking this medicine. Fampridine Mylan is not recommended during pregnancy. Your doctor will consider the benefit of you being treated with Fampridine Mylan against the risk to your baby. You should not breast-feed whilst taking this medicine. Driving and using machines Fampridine Mylan 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.
• Urinary tract infection Common (may affect up to 1 in 10 people): • Feeling unsteady • Dizziness
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Fampridine Mylan 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. Fampridine Mylan 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 your Fampridine Mylan is supplied in bottles, the bottle will also contain a desiccant. Leave the desiccant in the bottle, do not swallow it. If you take more Fampridine Mylan than you should Contact your doctor immediately if you take too many tablets. Take the Fampridine Mylan 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 Mylan 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have a seizure, stop taking Fampridine Mylan 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 Mylan and see your doctor immediately. Side effects are listed below by frequency: Very common (may affect more than 1 in 10 people):
• 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) • 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 (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 www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store under "yellowcard". By reporting side effects you can help provide more information on the safety of this medicine.
− The active substance is fampridine. − Each prolonged-release tablet contains 10 mg fampridine. − The other ingredients are:
Pack sizes: Blisters: 10, 14, 20, 28, 30, 42, 50, 56, 60, 70, 84, 98, 100, 120 and 196 tablets. Bottles: 14 tablets, 28 tablets (2 bottles of 14) and 56 tablets (4 bottles of 14). Not all pack sizes may be marketed. Marketing Authorisation Holder Mylan, Potters Bar, EN6 1TL, United Kingdom. Manufacturer Micro Labs GmBH Lyoner Straße 20 60528 Frankfurt Germany Mylan Hungary Kft Mylan Utca, Komárom 2900 Hungary Pharmadox Healthcare Ltd KW20A Kordin Industrial Park, Paola, PLA3000, Malta Viatris UK Healthcare Ltd Building 20 Station Close, Potters Bar, EN6 1TL United Kingdom
This leaflet was last revised in 09/2025.
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 to protect the environment. 6. Content of the pack and other information What Fampridine Mylan contain
Tablet core: Hypromellose, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. Tablet coat: Hypromellose, titanium dioxide (E171) and macrogol. What Fampridine Mylan looks like and contents of the pack White to off-white coloured oval shaped biconvex, film-coated tablet debossed with "C51" on one side and plain on other side. Tablet dimensions approximately 13.00 mm (length) and 8.00 mm (width). Fampridine Mylan are available in blisters and bottles with child resistant closure and a silica gel desiccant canister.
Fampridine Mylan 10 mg Prolonged Release Tablets 10 mg comes as tablet containing 10 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Fampridine Mylan 10 mg Prolonged Release Tablets 10 mg is fampridine.
Medicines with the same active substance include: Fampyra 10 mg prolonged-release tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Fampridine Mylan 10 mg Prolonged Release Tablets 10 mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Fampridine Mylan is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7).
Treatment with fampridine is restricted to prescription and supervision by physicians experienced in the management of MS.
Posology
The recommended dose is one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening). Fampridine should not be administered more frequently or at higher doses than recommended (see section 4.4). The tablets should be taken without food (see section 5.2).
Missed dose
The usual dosing regimen should always be followed. A double dose should not be taken if a dose is missed.
Starting and evaluating Fampridine Mylan treatment
• Initial prescription should be limited to two to four weeks of therapy as clinical benefits should generally be identified within two to four weeks after starting Fampridine Mylan.
• An assessment of walking ability, e.g. the Timed 25 Foot Walk (T25FW) or Twelve Item Multiple Sclerosis Walking Scale (MSWS-12), is recommended to evaluate improvement within two to four weeks. If no improvement is observed, the treatment should be discontinued.
• This medicinal product should be discontinued if benefit is not reported by patients.
Re-evaluating Fampridine Mylan treatment
If decline in walking ability is observed, physicians should consider an interruption to treatment in order to reassess the benefits of fampridine (see above). The re-evaluation should include withdrawal of this medicinal product and performing an assessment of walking ability. Fampridine should be discontinued if patients no longer receive walking benefit.
Special populations
Elderly
Renal function should be checked in the elderly before starting treatment with this medicinal product. Monitoring renal function to detect any renal impairment is recommended in the elderly (see section 4.4).
Patients with renal impairment
Fampridine is contraindicated in patients with moderate and severe renal impairment (creatinine clearance <50 mL/min) (see sections 4.3 and 4.4).
Patients with hepatic impairment
No dose adjustment is required for patients with hepatic impairment.
Paediatric population
The safety and efficacy of fampridine in children aged 0 to 18 years have not been established. No data are available.
Method of administration
Fampridine Mylan is for oral use.
The tablet must be swallowed whole. It must not be divided, crushed, dissolved, sucked or chewed.
Hypersensitivity to fampridine or to any of the excipients listed in section 6.1.
Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine.
Patients with prior history or current presentation of seizure.
Patients with moderate or severe renal impairment (creatinine clearance <50 mL/min).
Concomitant use of fampridine with medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example, cimetidine.
Interaction studies have only been performed in adults.
Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine) is contraindicated (see section 4.3).
Fampridine is eliminated mainly via the kidneys with active renal secretion accounting for about 60% (see section 5.2). OCT2 is the transporter responsible for the active secretion of fampridine. Thus, the concomitant use of fampridine with medicinal products that are inhibitors of OCT2 for example, cimetidine are contraindicated (see section 4.3) and concomitant use of fampridine with medicinal products that are substrates of OCT2 for example, carvedilol, propranolol and metformin is cautioned (see section 4.4.)
Interferon: Fampridine has been administered concomitantly with interferon-beta and no pharmacokinetic medicinal product interactions were observed.
Baclofen: Fampridine has been administered concomitantly with baclofen and no pharmacokinetic medicinal product interactions were observed.
Pregnancy
There are limited amount of data from the use of fampridine in pregnant women.
Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure it is preferable to avoid the use of fampridine in pregnancy.
Breast-feeding
It is unknown whether fampridine is excreted in human or animal milk. Fampridine is not recommended during breast-feeding.
Fertility
In animal studies no effects on fertility were seen.
Fampridine has a moderate influence on the ability to drive and use machines (see section 4.8).
Symptoms
Acute symptoms of overdose with fampridine were consistent with central nervous system excitation and included confusion, tremulousness, diaphoresis, seizure, and amnesia.
Central nervous system adverse reactions at high doses of 4-aminopyridine include dizziness, confusion, seizures, status epilepticus, involuntary and choreoathetoid movements. Other side effects at high doses include cases of cardiac arrhythmias (for example, supraventricular tachycardia and bradycardia) and ventricular tachycardia as a consequence of potential QT prolongation. Reports of hypertension have also been received.
Management
Patients who overdose should be provided supportive care. Repeated seizure activity should be treated with benzodiazepine, phenytoin, or other appropriate acute anti-seizure therapy.
Ask anything about Fampridine Mylan 10 mg Prolonged Release Tablets 10 mg. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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