Patient leaflet - Fampridine Abdi 10 mg prolonged-release tablets

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

Fampridine Abdi contains the active substance fampridine which belongs to a group of medicines called potassium channel blockers. They work by stopping potassium from 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 Abdi 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 Abdi

Do not take Fampridine Abdi

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.
if you have renal impairment or are using medicinal products that are substrates of OCT2 for example, carvedilol, propranolol and metformin.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Fampridine Abdi:

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 and this may result in an increased risk of falls.

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 Abdi

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

Do not take Fampridine Abdi 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. 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 and concomitant use of fampridine with medicinal products that are substrates of OCT2 for example, carvedilol, propranolol and metformin is cautioned.

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 Abdi is not recommended during pregnancy.

Your doctor will consider the benefit of you being treated with Fampridine Abdi against the risk to your baby. You should not breast-feed whilst taking this medicine.

Driving and using machines

Fampridine Abdi may affect people’s ability to drive or use machines, it can cause dizziness. Make sure you are not affected before you start driving or using machinery.

3. How to take Fampridine Abdi

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Fampridine Abdi 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 Abdi 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 Abdi than you should

Contact your doctor immediately if you take too many tablets.

Take the Fampridine Abdi 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 Abdi

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 Abdi

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 Abdi 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)
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, 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 at: 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 Abdi

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 package 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 Abdi contains

The active substance is fampridine.

Each prolonged-release tablet contains 10 mg of fampridine

The other ingredients are:

Tablet core: hypromellose, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate; film coat: hypromellose (E464), titanium dioxide (E171), Macrogol (MW 400) (E1521)

What Fampridine Abdi looks like and contents of the pack

Prolonged-release tablet

Fampridine Abdi is an off-white, film coated oval biconvex tablet with flat edge, debossed “F 10” on one side and plain on other side.

Fampridine Abdi comes in blisters. Each pack contains 28 or 56 prolonged-released tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Abdi Farma GmbH

Donnersbergstraße 4

64646 Heppenheim

Germany

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

PLA 3000 PAOLA

Malta