Fampridine Teva

Package Leaflet: Information for the User

Fampridine Teva, 10 mg, prolonged-release tablets

Fampridine

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

• Keep this package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

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

Fampridine Teva is used to improve walking in adult patients (over 18 years of age) with multiple sclerosis (MS) with walking disability. In multiple sclerosis, the inflammatory process damages the nerve sheaths, leading to muscle weakness and stiffness and difficulty walking.
The active substance of Fampridine Teva is fampridine, which belongs to a group of drugs that block potassium channels. The action of these drugs is to inhibit the outflow of potassium from nerve cells damaged in MS. It is believed that the drug improves impulse conduction in the central nervous system, which affects the improvement of walking.

2. Important information before taking Fampridine Teva

When NOT to take Fampridine Teva:

• if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6)
• if you have had a seizure (convulsion)
• if you have moderate or severe kidney disease, as determined by your doctor or nurse
• if you are taking a medicine containing cimetidine
• if you are taking another medicine containing fampridine. This may increase the risk of serious side effects.

Consult your doctor BEFORE takingFampridine Teva if any of the above warnings apply to you.

Warnings and precautions

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

• if you have palpitations (heart palpitations)
• if you are prone to infections
• you 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 you have factors that increase the risk of seizures (convulsions) or if you are taking medicines that increase this risk
• if your doctor has determined that you have mild kidney disease.

Tell your doctorbefore starting treatment with Fampridine Teva if any of the above warnings apply to you.

Children and adolescents

Fampridine Teva should not be given to children and adolescents under 18 years of age.

Elderly

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

Fampridine Teva and other medicines

Tell your doctor or pharmacist about all medicinesyou are taking or have recently taken, as well as medicinesyou plan to take.
Do not take Fampridine Teva if you are taking another medicine containing fampridine.

Other medicines that affect kidney function

Your doctor will exercise special 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 you are pregnant, think you may be pregnant, or plan to become pregnant, you should

consult your doctorbefore taking this medicine.

Fampridine Teva is not recommended for women who are pregnant.
Your doctor will assess the benefits of taking Fampridine Teva against the risk to the unborn child.
Do not breastfeedwhile taking this medicine.

Driving and using machines

Fampridine Teva may affect your ability to drive or operate machinery, as it may cause dizziness. If you experience this type of symptom, do not drive or operate machinery.

3. How to take Fampridine Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Fampridine Teva 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 the medicine for a period of 2 to 4 weeks. After 2 to 4 weeks, the doctor will reassess the effects of the treatment.

Recommended dose is

Onetablet in the morning and onetablet in the evening (at 12-hour intervals). Do not take more than two tablets a day. A 12-hour interval must be maintainedbetween doses. Tablets should not be taken more frequently than every 12 hours.
Fampridine Teva should be taken orally.
Swallow the tablets wholewith water. Do not divide, crush, dissolve, suck, or chew the tablets, as this may increase the risk of side effects.
Fampridine Teva should be taken on an empty stomach, without food.

Taking a higher dose of Fampridine Teva than recommended

If you take more than the recommended dose, contact your doctor immediately.
Show your doctor the package of Fampridine Teva.
After overdose, excessive sweating, slight tremor, dizziness, confusion (disorientation), memory loss (amnesia), and seizures (convulsions) may occur. 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 leave a 12-hour intervalbetween doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience a seizure (convulsion), stop taking Fampridine Teva immediatelyand inform your doctor.
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 Teva immediatelyand contact your doctor.
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 disturbances
• dizziness
• vertigo (vestibular dizziness)
• headache
• weakness and fatigue
• sleep disturbances
• anxiety
• slight tremor
• tingling or numbness of the skin
• sore throat
• common cold (nasopharyngitis)
• flu
• breathing difficulties
• nausea
• vomiting
• constipation
• gastrointestinal disturbances
• back pain
• palpitations (heart palpitations).

Uncommon

May affect up to 1 in 100 people

• seizures (convulsions)
• allergic reaction (hypersensitivity reaction)
• worsening of trigeminal neuralgia
• rapid heartbeat (tachycardia).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. 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 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 and carton after EXP.: or Expiry Date (EXP.). The expiry date refers to the last day of the month.
There are no special storage precautions for this medicine. Store in the original package to protect from light and moisture.
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 Teva contains

• The active substance isfampridine. 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, film-coated prolonged-release tablets with the imprint R10 on one side and without imprint on the other side.
The tablet dimensions are approximately 8 mm x 13 mm.
Fampridine Teva is available in blisters of 28 and 56 tablets, multipacks containing 196 (2 packs of 98) tablets, and single-dose blisters of 28x1 and 56x1 tablets.
Not all pack sizes may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area 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

Date of last revision of the package leaflet: March 2023