Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - fampyra

Document Subject

Generated Narrative: MedicinalProductDefinition mp40c8dbb155810b203735f0693961138c

identifier: http://ema.europa.eu/identifier/EU/1/11/699/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Fampyra 10 mg prolonged-release tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-40c8dbb155810b203735f0693961138c

identifier: http://ema.europa.eu/identifier/EU/1/11/699/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - fampyra

Attesters

What is in this leaflet

1. What Fampyra is and what it is used for
2. What you need to know before you take Fampyra
3. How to take Fampyra
4. Possible side effects
5. How to store Fampyra
6. Contents of the pack and other information

Fampyra 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.

Fampyra 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.

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 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 Fampyra if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fampyra:

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 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 Fampyra 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 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 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 before for advice before taking this medicine.

Fampyra is not recommended during pregnancy.

Your doctor will consider the benefit of you being treated with Fampyra against the risk to your baby.

You should not breast-feed whilst taking this medicine.

Driving and using machines

Fampyra 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.

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

Fampyra 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 Fampyra 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 Fampyra than you should

Contact your doctor immediately if you take too many tablets. Take the Fampyra 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 Fampyra

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 Fampyra 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 Fampyra 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

Store below 25 C. Store the tablets in the original package in order to protect from light and moisture.

If your Fampyra is supplied in bottles, only one bottle should be opened at a time. After first opening use within 7 days.

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.

What Fampyra 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, titanium dioxide (E-171), polyethylene glycol What Fampyra looks like and contents of the pack

Fampyra is an off-white, film coated, oval biconvex 13 x 8 mm prolonged-release tablet with A10 on one side.

Fampyra is supplied in either blister packs or bottles.

Bottles

Fampyra comes in HDPE (high-density polyethylene) bottles. Each bottle contains 14 prolonged- released tablets and a silica gel desiccant. Each pack contains 28 prolonged-released tablets (2 bottles) or 56 prolonged-released tablets (4 bottles).

Blisters

Fampyra comes in foil blisters of 14 prolonged-released tablets each. Each pack contains 28 prolonged-released tablets (2 blisters) or 56 prolonged-released tablets (4 blisters).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Biogen Netherlands B.V. Prins Mauritslaan 1171 LP Badhoevedorp The Netherlands

Manufacturer

Alkermes Pharma Ireland Ltd, Monksland, Athlone, Co. Westmeath, Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Biogen Belgium N.V./S.A. T l/Tel: +32 2 219 12 Lietuva Biogen Lithuania UAB Tel: +37 0 5 259 6

Te .: +359 2 962 12 Luxembourg/Luxemburg Biogen Belgium N.V./S.A. T l/Tel: +32 2 219 12 esk republika Biogen (Czech Republic) s.r.o. Tel: +420 255 706 Magyarorsz g Biogen Hungary Kft. Tel.: +36 (1) 899 9Danmark Biogen (Denmark) A/S Tlf: +45 77 41 57 Malta Pharma MT limited Tel: +356 213 37008/9

Deutschland Biogen GmbH Tel: +49 (0) 89 99 6Nederland Biogen Netherlands B.V. Tel: +31 20 542 2Eesti Biogen Estonia O
Tel: +372 618 9Norge Biogen Norway AS Tlf: +47 23 40 01
Genesis Pharma SA : +30 210 8771 sterreich Biogen Austria GmbH Tel: +43 1 484 46 Espa a Biogen Spain SL Tel: +34 91 310 7Polska Biogen Poland Sp. z o.o. Tel.: +48 22 351 51 France Biogen France SAS T l: +33 (0)1 41 37 95 Portugal Biogen Portugal Sociedade Farmac utica Unipessoal, Lda Tel: +351 21 318 8Hrvatska Biogen Pharma d.o.o. Tel: +385 (0) 1 775 73 Rom nia Johnson & Johnson Romania S.R.L. Tel: +40 21 207 18 Ireland Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 463 7Slovenija Biogen Pharma d.o.o. Tel: +386 1 511 02 sland Icepharma hf S mi: +354 540 8Slovensk republika Biogen Slovakia s.r.o. Tel: +421 2 323 340 Italia Biogen Italia s.r.l. Tel: +39 02 584 9Suomi/Finland Biogen Finland Oy Puh/Tel: +358 207 401
Genesis Pharma (Cyprus) Ltd : +357 22765Sverige Biogen Sweden AB Tel: +46 8 594 113 Latvija Biogen Latvia SIA Tel: +371 68 688 United Kingdom (Northern Ireland) Biogen Idec (Ireland) Limited Tel: +44 (0) 1628 50 1This leaflet was last revised in

Other sources of information

You can get a larger print version of this leaflet by calling the local representatives (see list above).

Detailed information on this medicine is available on the European Medicines Agency web site: