Fampridine Sandoz

Package Leaflet: Information for the Patient

Fampridine Sandoz, 10 mg, Prolonged-Release Tablets

Fampridine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

Table of Contents of the Leaflet:

• 1. What is Fampridine Sandoz and What is it Used For
• 2. Important Information Before Taking Fampridine Sandoz
• 3. How to Take Fampridine Sandoz
• 4. Possible Side Effects
• 5. How to Store Fampridine Sandoz
• 6. Contents of the Package and Other Information

1. What is Fampridine Sandoz and What is it Used For

The active substance of Fampridine Sandoz is fampridine, which belongs to a group of medications called potassium channel blockers. The action of these medications involves inhibiting the flow of potassium from damaged nerve cells. The medication improves the conduction of impulses in the central nervous system, which affects the improvement of walking.
Fampridine Sandoz is used to improve walking in adults (over 18 years of age) with walking disabilities associated with multiple sclerosis (MS). In multiple sclerosis, the inflammatory process destroys the protective sheaths around the nerves, leading to muscle weakness and stiffness, as well as difficulty walking.

2. Important Information Before Taking Fampridine Sandoz

When Not to Take Fampridine Sandoz:

• if you are allergic to fampridine or any of the other ingredients of this medication (listed in section 6)
• if you have had a seizure (epileptic fit)
• if you have moderate or severe kidney disease
• if you are taking a medication called cimetidine
• if you are taking other medications containing fampridine. This may increase the risk of serious side effects.

You should consult your doctor before taking Fampridine Sandoz if any of the above warnings apply to you.

Warnings and Precautions

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

• if you have heart palpitations
• if you are prone to infections
• if you have factors that increase the risk of seizures and if you are taking medications that increase this risk
• if your doctor has diagnosed you with mild kidney disease
• if you have a history of allergic reactions.

If necessary, you should use walking aids (e.g., a cane) because the medication may cause dizziness or balance disorders, which can increase the risk of falls.
Tell your doctor before starting treatment with Fampridine Sandoz if any of the above warnings apply to you.

Children and Adolescents

This medication should not be used in children and adolescents under 18 years of age.

Elderly

Before starting treatment and during treatment, your doctor may check your kidney function.

Fampridine Sandoz and Other Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.

Do Not Take Fampridine Sandoz if You are Taking Other Medications Containing Fampridine.

Other Medications Affecting Kidney Function

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

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Fampridine Sandoz is not recommended during pregnancy.
Your doctor will assess the benefits of taking Fampridine Sandoz against the risk to the unborn child.
Do not breastfeed during treatment.

Driving and Operating Machines

Fampridine Sandoz may affect your ability to drive or operate machines because it may cause dizziness. If you experience such symptoms, do not drive or operate machines.

3. How to Take Fampridine Sandoz

Always take this medication exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist. Fampridine Sandoz is available only on prescription and should be administered under the supervision of a doctor experienced in the treatment of multiple sclerosis.
Your doctor will initially prescribe a supply of medication for 2 to 4 weeks. After 2 to 4 weeks, the effects of the treatment will be reassessed.

Recommended Dose

Onetablet in the morning and onetablet in the evening (at 12-hour intervals). Do not take more than two tablets per day. A 12-hour interval must be maintainedbetween doses. Tablets should not be taken more frequently than every 12 hours. Fampridine Sandoz is intended for oral use.
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.
This medication should be taken without food, on an empty stomach.

Taking More than the Recommended Dose of Fampridine Sandoz

If you have taken more tablets than recommended, contact your doctor immediately.
Show your doctor the packaging of Fampridine Sandoz.
After an overdose, excessive sweating, slight trembling, dizziness, confusion (disorientation), memory loss (amnesia), and seizures (epileptic fits) may occur. Other symptoms not listed here may also occur.

Missing a Dose of Fampridine Sandoz

If you miss a dose, 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 questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Fampridine Sandoz can cause side effects, although not everybody gets them.
If you experience a seizure, stop taking Fampridine Sandozand inform your doctor immediately.
If you experience 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 compression in the chest, and difficulty breathing, stop taking Fampridine Sandozand consult your doctor immediately.
Side effects are listed by frequency:

Very Common Side Effects

May affect more than 1 in 10 people:

• urinary tract infections

Common Side Effects

May affect up to 1 in 10 people:

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

Uncommon Side Effects

May affect up to 1 in 100 people:

• seizures
• allergic reaction (hypersensitivity reaction)
• severe allergic reaction (anaphylactic reaction)
• swelling of the face, lips, mouth, or tongue (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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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 49 21 309/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 medication.

5. How to Store Fampridine Sandoz

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Fampridine Sandoz Contains

• Active substanceis fampridine.
• Each prolonged-release tablet contains 10 mg of fampridine.
• Other ingredientsare: Tablet core: hypromellose, microcrystalline cellulose, colloidal silicon dioxide, anhydrous, magnesium stearate. Coating: hypromellose, titanium dioxide (E 171), macrogol.

What Fampridine Sandoz Looks Like and Contents of the Package

Fampridine Sandoz is white or almost white oval prolonged-release tablets, approximately 13 mm x 8 mm in size, with "L10" embossed on one side and smooth on the other.
Blisters of PA/Aluminum/Coex coating (modified PE, PE + moisture-absorbing agent, PE)//Aluminum, in a cardboard box containing:
14 prolonged-release tablets
28 prolonged-release tablets
56 prolonged-release tablets
98 prolonged-release tablets
196 (2x98) 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)
196 (2x98x1) prolonged-release tablet (single-dose blister)
Not all pack sizes may be marketed.

Marketing Authorization Holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Laboratorios Liconsa, SA
PI Miralcampo, Av Miralcampo 7,
19200 Azuqueca de Henares- Guadalajara
Spain
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

This Medication is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland)

Under the Following Names:

Austria
Fampridin Sandoz 10 mg Retardtabletten
Denmark
Fampridine "Sandoz", depottabletter
Germany
Fampridin HEXAL 10 mg Retardtabletten
Finland
Fampridine Sandoz 10 mg depottabletti
France
FAMPRIDINE SANDOZ LP 10 mg, comprimé à libération prolongée
Netherlands
Fampridine Sandoz 10 mg, tabletten met verlengde afgifte
Norway
Fampridine Sandoz 10 mg depottablett
Poland
Fampridine Sandoz
Portugal
Fampridina Sandoz
Spain
Fampridina Sandoz 10 mg comprimidos de liberación prolongada EFG
Sweden
Fampridine Sandoz 10 mg depottablett
Cyprus
Fampridine Sandoz 10 mg επικαλυμμένα με λεπτό υμένιο δισκία
Czech Republic
Fampridin Sandoz
Greece
Fampridine/Sandoz
Croatia
Fampridin Sandoz 10 mg tablete s produljenim oslobađanjem
Slovakia
Fampridine Sandoz 10 mg

For More Information on This Medication, Contact the Marketing Authorization Holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of Last Revision of the Leaflet:03/2024
Logo of the marketing authorization holder