10 mg prolonged-release tablet is
fampridine
1. What Fampyra is and what it is used for
Fampyra is a medicine used to improve the ability to walk in adults (18 years and older) with impaired ability to walk in connection with multiple sclerosis (MS). In multiple sclerosis, inflammation destroys the protective sheath around the nerves, leading to muscle weakness, muscle stiffness, and difficulty walking.
Fampyra 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 damaged by MS. This drug is believed to work by allowing signals to pass along the nerve in a more normal way that allows you to walk better.
What you need to know before you take Fampyra
Do not take Fampyra
- if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6).
- if you have seizures or have ever had seizures (also called seizures or convulsions).
- if your doctor or nurse has told you that you have moderate or severe kidney problems.
- if you are taking a medicine containing cimetidine.
- if you are taking any other medicine containing fampridine. This may increase the risk of serious side effects.
Tell your doctor and do not take Fampyra if any of these apply to you.
Warnings and cautions
Talk to your doctor or pharmacist before taking Fampyra.
- if you have is aware of your heartbeat (palpitations).
- if you are prone to infection you.
- continue to use walking aids, such as a cane, if necessary.
- there may be an increased risk of falling as this medicine may make you feel dizzy or unsteady.
- if you have any factors or are taking any medicine that affects your risk of seizures (seizures).
- if your doctor has told you that you have mild kidney problems.
Tell your doctor before taking Fampyra if this applies to you.
Children and young people
Do not give Fampyra to children or adolescents under 18 years of age.
Older
Before starting treatment, and during treatment, your doctor may check that your kidneys are working properly.
Children and young people
Do not give Fampyra to children or adolescents under 18 years of age.
Other medicines and Fampyra
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Fampyra if you are taking any other medicine containing fampridine.
Other drugs that affect the kidneys
Your doctor will be especially careful if fampridine is given at the same time as any medicine that may affect the way your kidneys excrete medicines, such as carvedilol, propranolol,l, and metformin.
A vampire with food and drink
Fampyra should be taken without food, on an empty stomach.
Pregnancy and breastfeeding
If you are pregnant or planning to have a baby, ask your doctor for advice before using this medicine.
Fampyra is not recommended during pregnancy.
Your doctor will consider the benefits of Fampyra treatment against the risk to your child.
You should not breast-feed while taking this medicine.
Driving and using machines
Vampires can affect the ability to drive or use machines, as they can cause dizziness. Feel that you are not affected before you start driving or using machines.
How to take Fampyra
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Fampyra is only available by prescription, and under the supervision of a physician experienced in MS.
The doctor prescribes the first prescription for 2 to 4 weeks of treatment. After 2 to 4 weeks, a new evaluation of the treatment is made.
The recommended dose is
One tablet in the morning and one tablet in the evening (every 12 hours). Do not take more than two tablets a day. You must allow 12 hours between each tablet. Do not take the tablets more often than every 12 hours.
Swallow each tablet whole with a little water. Do not divide, crush, dissolve, suck or chew the tablet. This may increase the risk of you getting side effects.
If your Fampyra tablets are supplied in a jar, the jar also contains s desiccant. Leave the desiccant in the jar, do not swallow it.
If you take more Fampyra then you should
Contact your doctor immediately if you have taken too many tablets.
Take the Fampyra carton with you if you visit a doctor.
In case of overdose, you may experience sweating, minor tremors, dizziness, confusion, memory loss, and seizures. You may also notice other symptoms not listed here.
If you forget to take Fampyra
Do not take a double dose to make up for a forgotten dose. You must always allow 12 hours between each tablet.
If you have any further questions on the use of this product, 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 get seizures, stop taking Fampyra and tell your doctor immediately.
If you get one or more of the following symptoms of allergy ( hypersensitivity ): swelling of the face, mouth, lips, throat, or tongue, redness or itching of the skin, constriction in the chest, and breathing problems, you should stop taking Fampyraand to consult your doctor immediately.
Side effects are listed below by frequency:
Very common side effects are
May affect more than 1 in 10 patients:
- Urinary tract infection
Common side effects are
May affect up to 1 in 10 patients:
- Feeling unsteady
- Dizziness
- Scams ( vertigo )
- Headache
- The feeling of weakness and tiredness
- Difficulty sleeping
- Anxiety
- Minor tremors
- Numbness and tingling in the skin
- Sore throat
- Cold ( nasopharyngitis )
- Influenza
- Breathing difficulties (shortness of breath)
- Nausea
- Vomiting
- Constipation
- Upset stomach
- Back pain
- Palpitations ( palpitation )
Uncommon side effects are
May affect up to 1 in 100 patients:
- Seizures
- Allergic reaction ( hypersensitivity )
- Exacerbation of nerve pain in the face ( trigeminal neuralgia )
- Rapid heartbeat ( tachycardia )
5. How to store Fampyra
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 carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the original package. Sensitive to light. Moisture sensitive.
If your Fampyra tablets are supplied in a jar, only one jar should be opened at a time. Used within 7 days after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is fampridine.
- One prolonged-release tablet contains 10 mg fampridine
- Other ingredients are:
- Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silicon, magnesium stearate. film coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 400.
What the medicine looks like and the contents of the pack
Fampyra is a yellowish-white, film-coated, oval, biconvex 13 x 8 mm prolonged-release tablet with A10 on one side.
Fampyra is supplied in either cans or blister packs.
Cans
Fampyra is delivered in cans of HDPE (high-density polyethylene). Each jar contains 14 tablets and a desiccant of silica gel. Each pack contains 28 tablets (2 cans) or 56 tablets (4 cans).
Blister packs
Fampyra comes in a blistering film of 14 tablets. Each blister pack contains 28 tablets (2 blister cards) or 56 tablets (4 blister cards).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Biogen Netherlands BV
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
Manufacturer
Alkermes Pharma Ireland Ltd,
Monksland, Athlone, Co. Westmeath, Ireland
You can get a version of this information, with larger text, by contacting the agent (see below).
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienBiogen Belgium NV / SATel: +32 2 219 12 18 | LithuaniaUAB “JOHNSON & JOHNSON”Tel: +370 5 278 68 88 |
| BulgariaTP WATERMARMATel: +359 2 962 12 00 | Luxembourg / LuxemburgBiogen Belgium NV / SATel: +32 2 219 12 18 |
| Czech RepublicBiogen (Czech Republic) sroTel: +420 255 706 200 | HungaryBiogen Hungary Kft.Tel .: +36 1 8 999 883 |
| DenmarkBiogen Denmark A / STel: +45 77 41 57 57 | MaltaPharma MT LimitedTel: +356 21337008 |
| GermanyBiogen GmbHTel: +49 (0) 89 99 6170 | The NetherlandsBiogen International BVTel: +31 20 542 2000 |
| EestiUAB “JOHNSON & JOHNSON”Eesti subsidiaryTel: +372 617 7410 | NorwayBiogen Norway ASTel: +47 23 00 52 50 |
| GreeceGenesis Pharma SA:Ηλ: +30 210 8771500 | AustriaBiogen Austria GmbHTel: +43 1 484 46 13 |
| SpainBiogen Iberia SLTel: +34 91 310 7110 | PolandBiogen Poland sp. z ooTel .: +48 22 351 51 00 |
| FranceBiogen FranceTel: +33 (0) 1 41 37 95 95 | PortugalBiogen Idec Portugal Sociedade Pharmacêutica Unipessoal, LdaTel: +351 21 318 8450 |
| CroatiaMedis Adria dooTel: +385 (0) 1 230 34 46 | RomaniaMedison Pharma SRLTel: +40 31 7104035 |
| IrelandBiogen (Ireland) Ltd.Tel: +353 (0) 1 463 7799 | SloveniaBiogen dooTel: +386 1 511 02 90 |
| IcelandIcepharma hfPhone: +354 540 8000 | Slovak RepublicBiogen (Slovak Republic) sroTel: +421 2 323 340 08 |
| ItalyBiogen Italia srlTel: +39 02 584 9901 | Finland / FinlandBiogen Finland OyPuh / Tel: +358 207 401 200 |
| LatviaUAB “JOHNSON & JOHNSON”branch LatvijāTel: +371 678 93561 | United KingdomBiogen Idec LimitedTel: +44 (0) 1628 50 1000 |
Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.