Package leaflet: Information for the user

Fampridine Teva, 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 as yours.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

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

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

2. Important information before using Fampridine Teva

When NOT to take Fampridine Teva:

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

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

if the patient experiences palpitations (heart palpitations)
if the patient is prone to infections
if necessary, the patient should use walking aids (e.g. a cane), as the medicine may cause dizziness or balance disturbances, which may increase the risk of falls
if the patient has risk factors for seizures (epileptic fits) or is taking medicines that may increase this risk
if the patient has been diagnosed with mild kidney disease by a doctor.

Inform your doctor before starting treatment with Fampridine Teva if any of the
above warnings apply to the patient.
Children and adolescents
Fampridine Teva must not be given to children or adolescents under 18 years of age.
Elderly patients
Before starting treatment and during therapy, the doctor may assess kidney function.
Fampridine Teva 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 Teva 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, suspects she may be pregnant, or is planning to have a child, she should
consult a doctor before using this medicine.
Fampridine Teva is not recommended for use in pregnant women.
The doctor will evaluate the benefits of taking Fampridine Teva against the potential risks to
the unborn child.
Breastfeeding must be avoided during treatment with this medicine.
Driving and operating machinery
Fampridine Teva 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 Teva

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist. Fampridine Teva is available only by prescription and should be administered
under the supervision of a physician experienced in the treatment of multiple sclerosis.
Your doctor will initially prescribe the medicine for a period of 2 to 4 weeks. After 2 to 4 weeks, the
treatment effects 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 per day. A 12-hour interval must be maintained between consecutive doses. Do not take
tablets more frequently than every 12 hours.
Fampridine Teva should be taken orally.
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.
Fampridine Teva should be taken without food, on an empty stomach.
Taking more Fampridine Teva than recommended
If you take more than the recommended dose, contact your doctor immediately.
Show your doctor the Fampridine Teva packaging.
Overdose may cause excessive sweating, mild tremor, dizziness, confusion (disorientation), memory loss
(amnesia), and seizures (epileptic). Other symptoms not listed here may also occur.
Missing a dose of Fampridine Teva
If you miss a dose, do not take a double dose to make up for the missed dose. Always maintain 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If a seizure occurs, you must stop taking the medicine
Fampridine Teva and immediately inform your doctor.
If a 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
and difficulty breathing, you must stop taking Fampridine Teva and immediately
contact a doctor.

The side effects are listed below according to their 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 disturbances
anxiety
slight tremor
tingling or numbness of the skin
sore throat
cold (nasopharyngitis)
flu
breathing difficulties
nausea
vomiting
constipation
stomach discomfort
back pain
palpitations (pounding heartbeat).

Uncommon
May affect up to 1 in 100 people:

seizures (epileptic seizures)
allergic reaction (hypersensitivity reaction)
worsening of facial nerve pain (trigeminal neuralgia)
rapid heartbeat (tachycardia).

Reporting of side effects
If any side effects occur, including any side effects not listed in
this leaflet, inform your doctor or pharmacist. Side effects can be reported
directly to the Department of 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 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 help provide more information on the
safety of this medicine.

5. How to store Fampridine Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton
after “EXP:” or “Expiry date (EXP):”. The expiry date refers to the last day of the stated month.
There are no special temperature storage instructions for this medicine. Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fampridine Teva contains

The active substance is fampridine. Each prolonged-release tablet contains 10 mg of fampridine.
The other ingredients are:
Tablet core: calcium hydrogen phosphate dihydrate, hypromellose 2208, colloidal anhydrous silica, magnesium stearate.
Tablet coating: hypromellose 2910, titanium dioxide (E 171), macrogol 400.

What Fampridine Teva looks like and contents of the pack
White to off-white, biconvex, oval, prolonged-release coated tablets,
with the imprint "R10" on one side and no imprint on the other side.
The tablet measures approximately 8 mm x 13 mm.
Fampridine Teva is available in blisters containing 28 and 56 tablets, in multipacks
containing 196 tablets (two packs of 98 tablets), and in unit dose blisters of 28x1 and 56x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel.: (22) 345 93 00

Manufacturer/Importer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Croatia: Fampridin Teva
Czech Republic: Fampridine Teva
Denmark: Fampridin Teva
France: Fampridine Teva
Spain: Fampridina Teva
Netherlands: Fampridine Teva
Lithuania: Fampridine Teva
Germany: Fampridin-ratiopharm
Norway: Fampridin Teva
Poland: Fampridine Teva
Portugal: Fampridina Teva
Slovakia: Fampridín Teva
Slovenia: Fampridin Teva