Rasagiline vipharm

Package leaflet: Information for the user

RASAGILINE VIPHARM, 1 mg, tablets
Rasagilinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• 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.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

Rasagiline Vipharm contains the active substance rasagiline and is used in adults to treat
Parkinson's disease. It may be given in combination with levodopa (another medicine used in the treatment of
Parkinson's disease) or without levodopa.
In Parkinson's disease, there is a loss of cells that produce dopamine in the brain. Dopamine
acts in the brain as a neurotransmitter influencing motor control. Rasagiline Vipharm
increases and maintains dopamine concentration in these areas.

2. Important information before using Rasagiline Vipharm

When not to use Rasagiline Vipharm

• if the patient is allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver function impairment.

The following medicines must not be taken during treatment with Rasagiline Vipharm:

• monoamine oxidase inhibitors (MAOIs) (used, for example, in the treatment of depression, Parkinson's disease, or for any other indication), including medicines and herbal products available without a prescription, such as St. John's wort.
• pethidine (a strong painkiller).

At least 14 days must pass between stopping Rasagiline Vipharm and starting treatment with MAO inhibitors or pethidine.
Warnings and precautions
Before starting treatment with Rasagiline Vipharm, discuss the following with your doctor or pharmacist:

• if the patient has any liver function disorders,
• if the patient has suspicious skin changes.

Inform your doctor if the patient or their family members notice unusual behaviours resulting from an irresistible urge, compulsion, or desire to perform certain actions that may be harmful to the patient or others. These behaviours are known as impulse control disorders. Such behaviours have been observed in patients treated with Rasagiline Vipharm and (or) other medicines used in the treatment of Parkinson's disease, including compulsions, obsessive thoughts, pathological gambling, uncontrolled spending, impulsive actions, excessive sexual drive, or increased sexual thoughts and feelings. Your doctor may decide to adjust the dose or discontinue the medicine (see section 4).
Rasagiline Vipharm may cause drowsiness and sudden sleep onset during daily activities, especially when other dopaminergic medicines (used in the treatment of Parkinson's disease) are taken concomitantly. Further information is provided in the section: Driving and operating machinery.
Children and adolescents
The use of Rasagiline Vipharm in children and adolescents is not recommended. Therefore, Rasagiline Vipharm should not be used in patients under 18 years of age.
Rasagiline Vipharm and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking any of the following medicines:

• certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants),
• ciprofloxacin – an antibiotic used to treat infections,
• dextromethorphan – a cough suppressant,
• sympathomimetics, such as those contained in eye drops, nasal decongestants (administered nasally or orally), and cold remedies containing ephedrine or pseudoephedrine.

Concomitant use of Rasagiline Vipharm with antidepressants containing fluoxetine or fluvoxamine should be avoided.
Rasagiline Vipharm may be started at least 5 weeks after discontinuation of fluoxetine.
Fluoxetine or fluvoxamine may be started at least 14 days after stopping Rasagiline Vipharm.
Inform your doctor or pharmacist if the patient smokes or intends to stop smoking. Smoking may reduce the amount of rasagiline in the blood.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
If the patient is pregnant, she should avoid taking Rasagiline Vipharm, as the effects of rasagiline on pregnancy and the unborn child are unknown.
Driving and operating machinery
Consult your doctor before driving or operating machinery, as Parkinson's disease and the use of rasagiline may affect the ability to perform these activities. Rasagiline may cause dizziness or drowsiness. It may also cause episodes of sudden sleep.
These effects may be more pronounced when other medicines used to treat symptoms of Parkinson's disease or other medicines causing drowsiness are taken, or if the patient consumes alcohol while taking Rasagiline Vipharm. Patients who experience drowsiness and (or) episodes of sudden sleep before or during treatment with Rasagiline Vipharm should not drive or operate machinery (see section 2).

3. How to use Rasagiline Vipharm

This medicine should always be taken as directed by the physician or pharmacist. In case of
doubt, consult a doctor or pharmacist.
The recommended dose of Rasagiline Vipharm is 1 tablet of 1 mg taken orally once daily. Rasagiline Vipharm may be taken with food or independently of meals.
Taking more than the recommended dose of Rasagiline Vipharm
If a patient thinks they have taken more tablets of Rasagiline Vipharm than recommended,
they should immediately contact a doctor or pharmacist. The patient should bring the
carton/blister pack or bottle of Rasagiline Vipharm to show to the doctor or pharmacist.
Symptoms reported following overdose of Rasagiline Vipharm include slightly
euphoric mood (mild form of mania), extremely high blood pressure, and serotonin syndrome (see
section 4).
Missing a dose of Rasagiline Vipharm
Do not take a double dose to make up for a missed dose. Take the next dose of Rasagiline Vipharm at the usual time.
Stopping treatment with Rasagiline Vipharm
Do not stop taking Rasagiline Vipharm without first discussing it with the doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, contact a doctor immediately.
The patient may require urgent medical advice or treatment:

• if they experience unusual behaviour such as compulsions, obsessive thoughts, gambling addiction, uncontrollable shopping or spending, impulsive behaviour, increased sexual drive or intensified thoughts about sex (impulse control disorders, see section 2),
• if they see or hear things that are not there (hallucinations),
• if any of the following symptoms occur together: hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome),
• if they notice suspicious skin changes, as patients with Parkinson's disease have an increased risk of skin cancer (not only melanoma) (see section 2).

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

• involuntary body movements (dyskinesias),
• headache.

Common (may affect up to 1 in 10 people)

• abdominal pain,
• fall,
• allergy,
• fever,
• flu,
• malaise (weakness),
• neck pain,
• chest pain (angina pectoris),
• low blood pressure upon standing with symptoms resembling dizziness/feeling faint (orthostatic hypotension),
• decreased appetite,
• constipation,
• dry mouth,
• nausea and vomiting,
• bloating with gas release,
• abnormal blood test results (leukopenia),
• joint pain,
• musculoskeletal pain (muscle and bone pain),
• arthritis,
• numbness and weakness in the hand (carpal tunnel syndrome),
• weight loss,
• unusual dreams,
• impaired coordination of muscle groups (balance disorders),
• depression,
• dizziness,
• prolonged muscle tension (dystonia),
• runny nose (rhinitis),
• skin irritation (dermatitis),
• rash,
• eye congestion (conjunctivitis),
• sudden urge to urinate.

Uncommon (may affect up to 1 in 100 people)

• stroke,
• myocardial infarction,
• blister-like rash (vesiculobullous rash).

Unknown frequency: cannot be estimated from available data

• elevated blood pressure,
• excessive sleepiness,
• sudden sleep attacks.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions 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
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions allows the collection of additional information on the safety of the 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 stated on the outer carton, bottle, or blister pack following "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Blister packs: No special temperature storage instructions. Store in the original blister pack to protect from light.
Bottles: Do not store above 30°C. Store in the original bottle to protect from light.
Medicines must not be disposed of via the sewage system 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 hemitartrate).
The other ingredients are: microcrystalline cellulose, pregelatinized starch (maize), colloidal anhydrous silica, magnesium stearate.

What Rasagiline Vipharm looks like and contents of the pack
White or almost white, round, flat tablets with bevelled edges and an embossed mark "1" on one side, 8 mm in diameter.

Blister packs: OPA/Aluminium/PVC/Aluminium 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 Authorisation Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: +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 authorised in the European Economic Area countries under the following names:
Poland RASAGILINE VIPHARM
Hungary RASAGILINE VIPHARM 1 mg tablet
Slovakia RASAGILINE VIPHARM 1 mg tablets