Fampridine zentiva

Patient Information Leaflet

Fampridine Zentiva 10 mg prolonged-release tablets
Fampridinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

The active substance in Fampridine Zentiva is fampridine, which belongs to a group of medicines known as potassium channel blockers. These medicines work by inhibiting the outflow of potassium from damaged nerve cells. This improves the conduction of nerve impulses in the central nervous system, thereby improving walking ability.
Fampridine Zentiva is used to improve walking in adults (aged over 18 years) with multiple sclerosis (MS) who have walking difficulties. In multiple sclerosis, inflammatory processes damage the nerve sheaths, leading to muscle weakness, stiffness, and difficulty walking.

2. Important information before taking Fampridine Zentiva

When not to take Fampridine Zentiva:

• if the patient is allergic to fampridine or to any of the other ingredients of this medicine (listed in section 6)
• if the patient currently has or has ever had a seizure (epileptic fit)
• if the patient has been diagnosed by a doctor or nurse with moderate or severe kidney disease
• if the patient is taking a medicine called cimetidine
• if the patient is taking other medicines containing fampridine. This may increase the risk of serious adverse reactions.

Consult a doctor and do not take Fampridine Zentiva if any of the above warnings apply to the patient.
Warnings and precautions
Before starting treatment with Fampridine Zentiva, discuss the following with a doctor or pharmacist:

• if the patient experiences palpitations (rapid or irregular heartbeat)
• if the patient is prone to infections
• if the patient has factors or is taking medicines that may increase the risk of seizures (epileptic fits)
• if the patient has been diagnosed with mild kidney disease
• if the patient has a history of allergic reactions

If necessary, the patient should use walking aids such as a cane, as this medicine may cause dizziness or balance disorders, which may increase the risk of falls.
Inform the doctor before starting treatment with Fampridine Zentiva if any of the above warnings apply.
Children and adolescents
Fampridine Zentiva must not be given to children or adolescents under 18 years of age.
Elderly patients
Before starting and during treatment, the doctor may assess kidney function.
Fampridine Zentiva and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Fampridine Zentiva if the patient is taking another medicine containing fampridine.
Other medicines affecting kidney function
The doctor will exercise particular caution when administering fampridine together with other medicines that may affect renal excretion of drugs, such as carvedilol, propranolol, or metformin.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Fampridine Zentiva is not recommended for pregnant women.
The doctor will assess the benefits of treatment against the potential risks to the unborn child.
Breastfeeding must be discontinued during treatment.
Driving and using machines
Fampridine Zentiva may affect the ability to drive and operate machinery because it may cause dizziness. If such symptoms occur, the patient must not drive or operate machinery.

3. How to take Fampridine Zentiva

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist. Fampridine Zentiva is available only by prescription
and should be administered under the supervision of a physician experienced in the treatment of
multiple sclerosis.
The physician will initially prescribe a supply of medicine for 2 to 4 weeks. After 2 to 4 weeks, the
therapeutic effects will be re-evaluated.
Recommended dose
One tablet in the morning and one tablet in the evening (12 hours apart). Do not take
more than two tablets per day. It is essential to maintain a 12-hour interval between
consecutive tablets. Tablets should not be taken more frequently than every 12 hours.
Tablets must be swallowed whole with water. Do not divide, crush, dissolve, suck or chew the tablets,
as this may increase the risk of adverse effects.
Each tablet should be swallowed whole with water. Do not divide, crush, dissolve, suck or chew the tablets.
Doing so may increase the risk of adverse effects.
Fampridine Zentiva should be taken on an empty stomach.
Taking more Fampridine Zentiva than recommended
If more medicine has been taken than recommended, seek immediate medical advice
from a doctor.
Show the doctor the Fampridine Zentiva packaging.
After an overdose, excessive sweating, mild tremors (seizures), dizziness, confusion,
memory loss (amnesia), and epileptic seizures may occur. Other symptoms not listed here may also occur.
Missing a dose of Fampridine Zentiva
If a dose is missed , do not take two tablets at the same time to make up for the missed dose.
Always maintain a 12-hour interval between doses.
If you have any further questions regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If a seizure occurs, stop taking Fampridine Zentiva immediately and inform your doctor without delay.
If the patient experiences one or more symptoms of allergy (hypersensitivity), such as: swelling of the face,
lips, mouth, throat or tongue, skin redness or itching, feeling of pressure in the chest, or breathing difficulties,
stop taking Fampridine Zentiva and contact your doctor immediately.

The adverse effects are listed below by frequency of occurrence:

Very common
May affect more than 1 in 10 people:

• urinary tract infections

Common
May affect up to 1 in 10 people:

• balance disorders
• dizziness
• sensation of spinning (vertigo)
• headache
• weakness and fatigue
• sleep disorders
• anxiety
• slight tremor (tremors)
• tingling or numbness of the skin
• sore throat
• common cold (nasopharyngitis)
• influenza (flu)
• viral infection
• breathing difficulties (dyspnoea)
• nausea
• vomiting
• constipation
• gastrointestinal disturbances
• back pain
• palpitations (awareness of heartbeat)

Uncommon
May affect up to 1 in 100 people:

• seizures (epileptic fits)
• allergic reaction (hypersensitivity reaction)
• severe allergic reaction (anaphylactic shock)
• swelling of the face, lips, mouth or tongue (angioedema)
• new episode or worsening of facial nerve pain (trigeminal neuralgia)
• rapid heartbeat (tachycardia)
• dizziness or loss of consciousness (hypotension)
• rash/itchy rash (urticaria)
• chest discomfort

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 4921 301, Fax: +48 22 4921 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Fampridine Zentiva
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from moisture.
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 protect the environment.

6. Contents of the pack and other information

What Fampridine Zentiva contains

• The active substance is fampridine.
• Each prolonged-release tablet contains 10 mg of fampridine.
• The other ingredients are:
• tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate;
• tablet coating: Opadry White (hypromellose, titanium dioxide (E171), macrogol).

What Fampridine Zentiva looks like and contents of the pack
Fampridine Zentiva is a white to off-white, prolonged-release, oval-shaped coated tablet, approximately 13 x 8 mm in size, with the imprint "L10" on one side and plain on the other.
Fampridine Zentiva is supplied in aluminum/aluminum blisters with a desiccant, containing:
14 prolonged-release tablets
28 prolonged-release tablets
56 prolonged-release tablets
98 prolonged-release tablets
196 prolonged-release tablets
14 x 1 prolonged-release tablet (unit dose blister)
28 x 1 prolonged-release tablet (unit dose blister)
56 x 1 prolonged-release tablet (unit dose blister)
98 x 1 prolonged-release tablet (unit dose blister)
Not all pack sizes or types may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Zentiva, k.s.,
U kabelovny 130,
Dolní Měcholupy,
102 37 Prague 10,
Czech Republic

Manufacturers:
Laboratorios Liconsa, S.A.
P.I. Miralcampo, Av. Miralcampo 7,
Azuqueca de Henares, Guadalajara,
Spain

Prestige Promotion Verkaufsförderung & Werbeservice GmbH
Borsigstrasse 2
63755 Alzenau
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Finland: Fampridine Zentiva 10 mg Depottabletti
Germany: Fampridin Zentiva 10 mg Retardtabletten
France: FAMPRIDINE ZENTIVA LP 10 mg, comprimé à libération prolongée
Poland: Fampridine Zentiva
Sweden, Denmark, Norway: Fampridin Zentiva

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00