RASAGILINE 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. RASAGILINE VIPHARM, 1 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Rasagiline Vipharm and what is it used for
4. Important information before taking Rasagiline Vipharm
   1. When not to take Rasagiline Vipharm
   2. Warnings and precautions
   3. Children and adolescents
   4. Rasagiline Vipharm with other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
5. How to take Rasagiline Vipharm
   1. If you take more Rasagiline Vipharm than you should
   2. If you forget to take Rasagiline Vipharm
   3. If you stop taking Rasagiline Vipharm
6. Possible side effects
   1. Reporting of side effects
7. How to store Rasagiline Vipharm
8. Contents of the pack and other information
   1. What Rasagiline Vipharm contains
   2. What Rasagiline Vipharm looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: July 2020

Package Leaflet: Information for the User

RASAGILINE VIPHARM, 1 mg, tablets

Rasagiline

Read the package leaflet carefully before taking the medicine, 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, pharmacist, or nurse.
• This medicine has been prescribed for you. 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Rasagiline Vipharm and what is it used for

Rasagiline Vipharm contains the active substance rasagiline and is used in adults to treat Parkinson's disease. It can be taken with or without levodopa (another medicine used to treat Parkinson's disease).
In Parkinson's disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a neurotransmitter in the brain that has an effect on movement control. Rasagiline Vipharm increases and maintains dopamine levels in these areas.

2. Important information before taking Rasagiline Vipharm

When not to take Rasagiline Vipharm

• if you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6),
• if you have severe liver problems.

While taking Rasagiline Vipharm, you must not take the following medicines:

• monoamine oxidase inhibitors (MAOIs) (used for example to treat depression, Parkinson's disease, or other conditions), including medicines and herbal remedies available without prescription, such as St. John's Wort.
• pethidine (a strong painkiller).

There must be at least 14 days between stopping Rasagiline Vipharm and starting MAOIs or pethidine.

Warnings and precautions

Before starting Rasagiline Vipharm, discuss with your doctor or pharmacist:

• if you have any liver problems
• if you have any worrying changes in your skin.

Tell your doctor if you or your family/carer notice that you are developing unusual behaviors such as compulsions, obsessive thoughts, or urges, which are beyond your control, including:

gambling, excessive shopping or spending, impulsive behavior, or an abnormally high sex drive, as these can be signs of impulse control disorders. Your doctor may need to adjust or stop your treatment (see section 4).

Rasagiline Vipharm may cause you to feel drowsy or fall asleep suddenly during the day, especially if you are also taking other medicines for Parkinson's disease.

Children and adolescents

Rasagiline Vipharm should not be used in children and adolescents. Therefore, it is not recommended for patients under 18 years of age.

Rasagiline Vipharm with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any you plan to take.

Particularly, tell your doctor if you are taking any of the following:

• certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants),
• ciprofloxacin - an antibiotic used in infections,
• dextromethorphan - a cough medicine,
• sympathomimetics, such as those found in eye drops, nasal decongestants, and oral or nasal decongestants containing ephedrine or pseudoephedrine.

Avoid taking Rasagiline Vipharm with antidepressants containing fluoxetine or fluvoxamine.

Do not start Rasagiline Vipharm until at least 5 weeks after stopping fluoxetine.

Do not start fluoxetine or fluvoxamine until at least 14 days after stopping Rasagiline Vipharm.

Tell your doctor or pharmacist if you smoke or intend to stop smoking. Smoking may decrease the amount of rasagiline in your blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, you should not take Rasagiline Vipharm, as it is not known whether rasagiline is harmful to the unborn baby.

Driving and using machines

Before driving or using machines, consult your doctor, as Parkinson's disease and rasagiline may affect your ability to perform these activities. Rasagiline may cause dizziness or drowsiness. It may also cause sudden sleep episodes.

These effects may be more pronounced when taking other medicines for Parkinson's disease or other medicines that cause drowsiness, or if you drink alcohol while taking Rasagiline Vipharm. Patients who have experienced drowsiness or sudden sleep episodes before or while taking Rasagiline Vipharm should not drive or use machines (see section 2).

3. How to take Rasagiline Vipharm

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of Rasagiline Vipharm is 1 tablet of 1 mg taken by mouth once a day. Rasagiline Vipharm can be taken with or without food.

If you take more Rasagiline Vipharm than you should

If you think you have taken more tablets than you should, contact your doctor or pharmacist immediately. Take the carton or blister pack with you to show the doctor or pharmacist.

Symptoms reported after an overdose of Rasagiline Vipharm include: mildly euphoric mood (mild mania), severely high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagiline Vipharm

Do not take a double dose to make up for a forgotten dose. Take the next dose of Rasagiline Vipharm at the usual time.

If you stop taking Rasagiline Vipharm

Do not stop taking Rasagiline Vipharm without first discussing it with your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rasagiline Vipharm can cause side effects, although not everybody gets them.

If you experience any of the following side effects, contact your doctor immediately. You may need urgent medical attention or treatment:

• if you experience unusual behaviors such as compulsions, obsessive thoughts, or urges, which are beyond your control, including gambling, excessive shopping or spending, impulsive behavior, or an abnormally high sex drive (impulse control disorders, see section 2).
• if you see or hear things that are not there (hallucinations).
• if you experience any of the following symptoms: hallucinations, fever, involuntary movements, and sweating (serotonin syndrome).
• if you notice any suspicious changes in your skin, as patients with Parkinson's disease have an increased risk of skin cancer (not only melanoma) (see section 2).

Other side effects

Very common (may affect more than 1 in 10 people)

• involuntary movements (dyskinesia),
• headache.

Common (may affect up to 1 in 10 people)

• abdominal pain,
• falls,
• allergic reactions,
• fever,
• flu,
• malaise (weakness),
• neck pain,
• chest pain (angina pectoris),
• low blood pressure when standing up with symptoms like dizziness/lightheadedness (orthostatic hypotension),
• decreased appetite (loss of appetite),
• constipation,
• dry mouth,
• nausea and vomiting,
• flatulence,
• abnormal blood test results (leukopenia),
• joint pain,
• musculoskeletal pain (musculoskeletal pain),
• arthritis,
• numbness and weakness of the hand (carpal tunnel syndrome),
• weight loss,
• abnormal dreams,
• difficulty with coordination (balance disorders),
• depression,
• dizziness,
• prolonged muscle contractions (dystonia),
• runny nose (rhinitis),
• skin irritation (dermatitis),
• rash,
• eye irritation (conjunctivitis),
• sudden urge to urinate.

Uncommon (may affect up to 1 in 100 people)

• stroke,
• heart attack,
• blistering rash (bullous rash).

Frequency not known: cannot be estimated from the available data

• high blood pressure,
• excessive drowsiness,
• sudden sleep episodes.

Reporting of 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 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, Poland

Phone: +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 Rasagiline Vipharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, bottle, or blister after "EXP". The expiry date refers to the last day of that month.

Blisters:No special storage precautions.

Store in the original blister to protect from light.

Bottles:Do not store above 30°C. Store in the original bottle to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rasagiline Vipharm contains

The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).

The other ingredients are: microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate.

What Rasagiline Vipharm looks like and contents of the pack

White or almost white, round, flat tablets with beveled edges and engraved with "1" on one side, 8 mm in diameter.

Blisters:OPA/Aluminum/PVC/Aluminum blisters in cardboard boxes, containing 7, 10, 28, 30, 100, or 112 tablets.

Bottles:HDPE bottle with LDPE cap and a desiccant, in a cardboard box, containing 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Vipharm S.A., ul. A. i F. Radziwiłłów 9, 05-850 Ożarów Mazowiecki, Poland

Phone: +48 22 679 51 35, Fax: +48 22 678 92 87, e-mail: [email protected]

Manufacturer

Genepharm S.A., 18 km Marathon Avenue, 15351 Pallini Attiki, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: RASAGILINE VIPHARM

Hungary: RASAGILINE VIPHARM 1 mg tabletta

Slovakia: RASAGILINE VIPHARM 1 mg tablets

Date of last revision of the leaflet: July 2020