Package leaflet: Information for the patient

Fampridine Sandoz, 10 mg, prolonged-release tablets
Fampridinum
Read the entire leaflet carefully before starting to take this medicine, because it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Fampridine Sandoz is and what it is used for
Important information before taking Fampridine Sandoz
How to take Fampridine Sandoz
Possible side effects
How to store Fampridine Sandoz
Contents of the pack and other information

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

The active substance in Fampridine Sandoz 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. The drug improves nerve impulse conduction in the central nervous system, thereby enhancing walking ability.
Fampridine Sandoz is used to improve walking ability in adults (over 18 years of age) with walking impairment due to multiple sclerosis (MS). In multiple sclerosis, the inflammatory process damages the protective sheaths around nerves, leading to muscle weakness, stiffness, and difficulty walking.

2. Important information before using Fampridine Sandoz

When not to use Fampridine Sandoz:

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 seizures (epileptic fits)
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 effects.

The patient should consult a doctor and not take Fampridine Sandoz if any
of the above warnings apply.
Warnings and precautions
Before starting treatment with Fampridine Sandoz, discuss the following with your doctor or
pharmacist:

if the patient experiences palpitations (rapid or irregular heartbeat)
if the patient is prone to infections
if the patient has risk factors for seizures (epileptic fits), or if the patient is taking medicines that may increase this risk
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 (e.g. a cane), as the medicine may
cause dizziness or balance disturbances, which could increase the risk of falls.
Inform your doctor before starting treatment with Fampridine Sandoz if any
of the above warnings apply to the patient.
Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Elderly patients
Before starting treatment and during therapy, the doctor may assess kidney function.
Fampridine Sandoz and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken,
or plans to take.
Do not take Fampridine Sandoz if you are 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 kidney elimination of drugs, such as carvedilol, propranolol, or
metformin.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult her doctor or pharmacist before using this medicine.
Fampridine Sandoz is not recommended during pregnancy.
The doctor will assess the benefits of taking Fampridine Sandoz against the potential risks to
the unborn child.
Breastfeeding must not be undertaken during treatment.
Driving and operating machinery
Fampridine Sandoz may affect the ability to drive and operate machinery,
as it may cause dizziness. If such symptoms occur, the patient should not
drive or operate machinery.
3. How to take Fampridine Sandoz
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist. Fampridine Sandoz is available only by prescription and
should be administered under the supervision of a doctor experienced in the treatment of multiple sclerosis.
The doctor will initially prescribe a supply of medicine for 2 to 4 weeks. After 2 to 4 weeks, the doctor will reassess
the treatment effects.
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. A 12-hour interval between doses must be maintained. Tablets must not be taken more frequently than every 12 hours. Fampridine Sandoz is intended for oral use.
Fampridine Sandoz is intended for oral use.
Tablets must be swallowed whole with water. Tablets must not be divided, crushed,
dissolved, sucked, or chewed, as this may increase the risk of adverse effects.
This medicine should be taken on an empty stomach, without food.
Taking more than the recommended dose of Fampridine Sandoz
If more tablets than recommended have been taken, contact a doctor immediately.
Show the doctor the Fampridine Sandoz packaging.
After overdose, excessive sweating, mild tremor, 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 a dose is missed, do not take two tablets at once to make up for the missed dose. There must always be a 12-hour interval between doses.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If a seizure occurs, stop taking the medicine
Fampridine Sandoz and inform your doctor immediately.
If the patient experiences one or more symptoms of allergy (hypersensitivity), such as: swelling of the face,
lips, mouth, throat or tongue, redness or itching of the skin, feeling of tightness in the chest,
or difficulty breathing, stop taking Fampridine Sandoz and
seek medical advice immediately.

Adverse reactions are listed below by frequency:
Very common adverse reactions
May occur in more than 1 in 10 people:

urinary tract infections

Common adverse reactions
May occur in less than 1 in 10 people:

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

Uncommon adverse reactions
May occur in less than 1 in 100 people:

seizures
allergic reaction (hypersensitivity reaction)
severe allergic reaction (anaphylactic reaction)
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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 49 21 309 / website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Fampridine Sandoz

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

6. Contents of the pack and other information

What Fampridine Sandoz contains

The active substance is fampridine.
Each prolonged-release tablet contains 10 mg of fampridine.
Other ingredients are:
Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Coating: hypromellose, titanium dioxide (E 171), macrogol.

What Fampridine Sandoz looks like and contents of the pack
Fampridine Sandoz is a white or almost white, oval film-coated tablet, approximately 13 mm x 8 mm in size,
with "L10" embossed on one side and smooth on the reverse.
The tablets are packaged in PA/Aluminium/Coex (modified PE, PE + moisture-absorbing agent, PE)//Aluminium foil blisters,
contained in a cardboard box with the following quantities:
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 (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)
196 (2x98x1) prolonged-release tablets (unit dose blister)
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
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 medicinal product is authorised 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 further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Tel. 22 209 70 00

Logo of the Marketing Authorisation Holder