Rasagilina Sinthon

Package Leaflet: Information for the User

Rasagilina Synthon, 1 mg, tablets

rasagiline

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

• 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 those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Rasagilina Synthon and what is it used for

Rasagilina Synthon 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 that has an effect on movement control. Rasagilina Synthon increases and maintains dopamine levels in these areas.

2. Important information before taking Rasagilina Synthon

When not to take Rasagilina Synthon

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.

Do not take the following medicines while taking Rasagilina Synthon:

• monoamine oxidase inhibitors (MAOIs) used to treat depression or other conditions, including medicines and herbal products available without prescription, such as St. John's Wort.
• pethidine (a strong painkiller). There should be at least 14 days between stopping Rasagilina Synthon and starting MAOIs or pethidine.

Warnings and precautions

Before taking Rasagilina Synthon, discuss with your doctor:

• if you have mild or moderate liver problems
• if you have a history of skin cancer or if you are at risk of developing skin cancer

Tell your doctor if you or your family/caregivers notice that you are developing unusual behaviors such as compulsions, obsessive thoughts, or excessive gambling, spending, eating, or sexual activity. These behaviors are called impulse control disorders.
Rasagilina Synthon can cause drowsiness and sudden sleep attacks, especially when taken with other medicines for Parkinson's disease. See section 2.

Children and adolescents

Rasagilina Synthon should not be used in children and adolescents. Therefore, it is not recommended to use Rasagilina Synthon in patients under 18 years of age.

Rasagilina Synthon with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about any medicines you plan to take.
In particular, tell your doctor if you are taking any of the following medicines:

• certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants),
• ciprofloxacin - an antibiotic used to treat infections,
• dextromethorphan - a cough medicine,
• sympathomimetics, such as eye drops, nasal decongestants, and oral decongestants, and cold medicines containing ephedrine or pseudoephedrine. Do not take Rasagilina Synthon with fluoxetine or fluvoxamine. You can start taking Rasagilina Synthon at least 5 weeks after stopping fluoxetine. You can start taking fluoxetine or fluvoxamine at least 14 days after stopping Rasagilina Synthon.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, you should not take Rasagilina Synthon, as it is not known whether it can affect the unborn baby.

Driving and using machines

Ask your doctor for advice before driving or using machines, as Parkinson's disease and Rasagilina Synthon can affect your ability to perform these activities. Rasagilina Synthon can cause dizziness or drowsiness.
It can also cause sudden sleep attacks.
These effects can be more severe when taking other medicines for Parkinson's disease or other medicines that cause drowsiness, or if you drink alcohol while taking Rasagilina Synthon. Patients who have experienced drowsiness or sudden sleep attacks before or while taking Rasagilina Synthon should not drive or operate machinery (see section 2).

3. How to take Rasagilina Synthon

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 Rasagilina Synthon is 1 tablet of 1 mg taken orally once a day. Rasagilina Synthon can be taken with or without food.

Overdose of Rasagilina Synthon

If you think you have taken too many Rasagilina Synthon tablets, contact your doctor or pharmacist immediately. Take the package and any remaining tablets with you to show the doctor or pharmacist.
Symptoms reported after overdose of Rasagilina Synthon include: slightly euphoric mood (mild mania), extremely high blood pressure, and serotonin syndrome (see section 4).

Missed dose of Rasagilina Synthon

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

Stopping treatment with Rasagilina Synthon

Do not stop taking Rasagilina Synthon without first talking to 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, Rasagilina Synthon 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 excessive gambling, spending, eating, or sexual activity (impulse control disorders, see section 2).
• 2).
• if you see or hear things that are not there (hallucinations).
• if you experience any of the following symptoms: hallucinations, fever, agitation, tremor, 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).

Tell your doctor if you notice any suspicious changes in your skin, as Rasagilina Synthon may increase the risk of skin cancer (melanoma) (see section 2).
Other side effects:
Very common (may affect more than 1 in 10 people)
Involuntary movements of the body (dyskinesia) • headache
Common (may affect up to 1 in 10 people)
Abdominal pain • falls • allergy • fever • flu-like symptoms • general feeling of being unwell (weakness) • neck pain • chest pain (angina pectoris) • low blood pressure when standing up with symptoms similar to dizziness (orthostatic hypotension) • decreased appetite (decreased appetite) • constipation • dry mouth • nausea and vomiting • bloating with gas • abnormal blood test results (leukopenia) • joint pain • muscle pain (musculoskeletal pain) • arthritis • numbness and weakness of the hand (carpal tunnel syndrome) • weight loss • nightmares • difficulty coordinating muscle groups (balance disorders) • depression • dizziness • prolonged muscle tension (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 (vesiculobullous rash)
Frequency not known: cannot be estimated from the available data
High blood pressure • excessive drowsiness • sudden sleep attacks

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug 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
e-mail: ndl@urpl.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rasagilina Synthon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Rasagilina Synthon contains

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The other ingredients are: microcrystalline cellulose, tartaric acid, corn starch, corn starch paste, talc, stearic acid.

What Rasagilina Synthon looks like and contents of the pack

White or almost white, oblong (approximately 11.5 mm x 6 mm), biconvex tablets with "R9SE" engraved on one side and "1" on the other side.
Tablets are available in blisters of 7, 10, 28, 30, 100, and 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Synthon BV
Microweg 22
6545CM Nijmegen
Netherlands

Manufacturer

Synthon Hispania S.L.
C/Castelló n°1
Pol. Las Salinas
08830 Sant Boi de Llobregat
Spain
Synthon s.r.o. Blansko
Brnenska 32/c.p.597
678 01 Blansko
Czech Republic
Synthon BV
Microweg 22
6545CM Nijmegen
Netherlands

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

Finland
Rasabon 1 mg tablets
Hungary
Razagilin-Q Pharma 1 mg tablets
Iceland
Rasagiline WH
Italy
Rasabon 1 mg tablets
Croatia
Razagilina Makpharm 1 mg tablets
Netherlands
Rasagiline Synthon 1 mg, tablets
Poland
Rasagilina Synthon

Date of last revision of the package leaflet:

23/04/2021