Patient leaflet - Elupria 10 mg prolonged-release tablets
1. What Elupria is and what it is used for
Elupria 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.
Elupria 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 Elupria
Do not take Elupria
- 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 Elupria if any of these apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Elupria:
- 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 (seizures)
- if you have been told by a doctor that you have mild problems with your kidneys
- if you have history of allergic reactions
Tell your doctor before you take Elupria if any of these apply to you.
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 in adolescents
Do not give Elupria 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 Elupria
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Elupria 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.
Elupria with food and drink
Elupria should be taken without food, on an empty stomach.
Pregnancy and breast-feeding
If you are pregnant, or breast-feeding, think you may be pregnant or are planning tohave a baby,ask your doctor or pharmacist beforetaking this medicine. Elupria is not recommended during pregnancy.
Your doctor will consider the benefit of you being treated with Elupria against the risk to your baby.
You should not breast-feed whilst taking this medicine.
Driving and using machines
Elupria 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 Elupria
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Elupria 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.
Elupria 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 Elupria than you should
Contact your doctor immediately if you take too many tablets. Take the Elupria 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 (seizures). You may also notice other effects not listed here.
If you forget to take Elupria
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 Elupria 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 Elupria 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 (seizures)
- 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 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 Elupria
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.
Store below 30°C.
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. Contents of the pack and other information
What Elupria 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
Tablet film coating: Opadry Y-1-7000 White consisting of hypromellose, titanium dioxide (E 171) and macrogol.
What Elupria looks like and contents of the pack
Elupria is a white to off-white, oblong, biconvex, film-coated tablet, approximately 13 mm x 8 mm.
Elupria is supplied in blister strips.
Each pack contains 28 or 56 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Neuraxpharm UK Ltd
First Floor, Building 1410, Arlington Business Park,
Theale, Reading,
Berkshire RG7 4SA,
United Kingdom
Manufacturers:
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08790 Sant Joan Despí (Barcelona)
Spain
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23,
40764 Langenfeld
Germany