Fampridine Zentiva

Leaflet attached to the packaging: information for the user

Fampridine Zentiva 10 mg prolonged-release tablets

Fampridine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Fampridine Zentiva and what is it used for
• 2. Important information before taking Fampridine Zentiva
• 3. How to take Fampridine Zentiva
• 4. Possible side effects
• 5. How to store Fampridine Zentiva
• 6. Contents of the packaging and other information

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

The active substance of Fampridine Zentiva is fampridine, which belongs to a group of medicines called potassium channel blockers. The action of these medicines involves inhibiting the outflow of potassium from damaged nerve cells. The medicine improves the conduction of impulses in the central nervous system, which affects the improvement of walking.
Fampridine Zentiva is used to improve walking in adult patients (over 18 years of age) with multiple sclerosis (MS) with walking disorders. In multiple sclerosis, the inflammatory process destroys the nerve sheaths, leading to muscle weakness and stiffness, as well as difficulty walking.

2. Important information before taking Fampridine Zentiva

When not to take Fampridine Zentiva:

allergicto fampridine or any of the other ingredients of this medicine (listed in section 6)seizures(epileptic)kidney diseaseother medicines containing fampridine. This may increase the risk of serious side effects.

Consult a doctor before takingFampridine Zentiva if any of the above warnings apply to the patient.

Warnings and precautions

Before starting treatment with Fampridine Zentiva, discuss it with your doctor or pharmacist:

If necessary, the patient should use walking aids, such as a cane, as this medicine may cause dizziness or balance disorders, which can increase the risk of falls.
Tell your doctorbefore starting treatment with Fampridine Zentiva if any of the above warnings apply to the patient.

Children and adolescents

Fampridine Zentiva should not be given to children or adolescents under 18 years of age.

Elderly

Before starting treatment and during treatment, the doctor may check the patient's kidney function.

Fampridine Zentiva and other medicines

Tell your doctor or pharmacistabout 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 you are taking another medicine containing fampridine.

Other medicines that affect kidney function

The doctor will exercise particular caution when administering fampridine with other medicines that may affect the elimination of medicines by the kidneys, such as carvedilol, propranolol, or metformin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Fampridine Zentiva is not recommended for pregnant women.
The doctor will assess the benefits of taking the medicine against the risk to the unborn child.
Do not breastfeedduring treatment.

Driving and using machines

Fampridine Zentiva may affect the ability to drive and use machines, as it may cause dizziness. If such symptoms occur, do not drive or operate machines.

3. How to take Fampridine Zentiva

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Fampridine Zentiva is available only on prescription and should be taken under the supervision of a doctor experienced in the treatment of multiple sclerosis.
The doctor will initially prescribe a supply of the medicine for 2 to 4 weeks. After 2 to 4 weeks, the doctor will reassess the effects of the treatment.

Recommended dose

Onetablet in the morning and onetablet in the evening (at 12-hour intervals). Do not take more than two tablets per day. It is necessary to maintain a 12-hour intervalbetween tablets. Do not take tablets more frequently than every 12 hours.
Swallow the tablets whole, with a glass of water. Do not divide, crush, dissolve, suck, or chew the tablets, as this may increase the risk of side effects.
Swallow each tablet whole, with a glass of water. Do not divide, crush, dissolve, suck, or chew the tablets. This may increase the risk of side effects.
Fampridine Zentiva should be taken on an empty stomach.

Taking a higher dose of Fampridine Zentiva than recommended

In case of taking a higher dose than recommended, contact your doctor immediately.
Show your doctor the packaging of Fampridine Zentiva.
After an overdose, excessive sweating, slight trembling (seizures), dizziness, confusion, memory loss (amnesia), and seizures (epileptic) 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 once to make up for the missed dose. Always leave a 12-hour intervalbetween doses.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fampridine Zentiva can cause side effects, although not everybody gets them.
If a seizure occurs, stop taking Fampridine Zentiva and inform your doctor immediately.

Zentiva

If the patient experiences one or more symptoms of an allergic reaction (hypersensitivity), such as swelling of the face, lips, tongue, or throat, redness or itching of the skin, feeling of pressure in the chest, and difficulty breathing, stop taking Fampridine Zentiva and contact your doctor immediately.
Side effects are listed according to their frequency:

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
• vertigo (systemic vertigo)
• headache
• weakness and fatigue
• sleep disorders
• anxiety
• slight trembling (seizures)
• tingling or numbness of the skin
• sore throat
• common cold (pharyngitis)
• flu
• viral infection
• breathing difficulties (dyspnea)
• nausea (nausea)
• vomiting
• constipation
• stomach disorders
• back pain
• palpitations (palpitations)

Uncommon

May affect up to 1 in 100 people

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

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 4921 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help 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 month.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fampridine Zentiva contains

• The active substance isfampridine.
• Each prolonged-release tablet contains 10 mg of fampridine.
• 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, oval, prolonged-release tablet, approximately 13 x 8 mm in size, with the inscription L10 on one side and smooth on the other.
Fampridine Zentiva is available in a blister pack with a desiccant, made of aluminum/aluminum foil
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 (single-dose blister)
28 x 1 prolonged-release tablet (single-dose blister)
56 x 1 prolonged-release tablet (single-dose blister)
98 x 1 prolonged-release tablet (single-dose blister)
Not all pack sizes or types may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Zentiva, k.s.,
U kabelovny 130,
Dolní Mĕcholupy,
102 37 Prague 10,
Czech Republic
Manufacturer:
Laboratorios Liconsa, SA
PI Miralcampo, Av Miralcampo 7,
Azuqueca de Henares- Guadalajara
Spain
Prestige Promotion Verkaufsförderung & Werbeservice GmbH
Borsigstrasse 2
63755 Alzenau
Germany
This medicine is authorized 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

To obtain more detailed information on this medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00
Date of last revision of the leaflet:December 2023