Rasagiline synthon

Patient Information Leaflet

Rasagilina Synthon, 1 mg, tablets
rasagiline
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

Rasagilina Synthon contains the active substance rasagiline and is used in adults for the treatment of Parkinson's disease. It may be administered either 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 nerve cells that produce dopamine in the brain. Dopamine acts as a neurotransmitter involved in controlling movement. Rasagilina Synthon increases and maintains dopamine levels in these brain areas.

2. Important information before using Rasagilina Synthon

When not to use Rasagilina Synthon
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 impairment of liver function.

The following medicines must not be taken during treatment with Rasagilina Synthon:

• Monoamine oxidase inhibitors (MAO inhibitors), used, for example, in the treatment of depression associated with Parkinson's disease or for any other indication, including over-the-counter medicines and herbal remedies such as St. John's wort.
• Pethidine (a strong painkiller). At least 14 days must elapse between stopping Rasagilina Synthon and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions
Before starting treatment with Rasagilina Synthon, discuss this with your doctor.

• if the patient has mild or moderate impairment of liver function
• the patient should inform their doctor about any concerning skin changes. Treatment with Rasagilina Synthon may increase the risk of skin cancer.

Patients or their caregivers should inform the doctor if they notice unusual behaviours in the patient, resulting from an irresistible impulse, compulsion or urge to perform certain actions that may be harmful to the patient or others. These behaviours are known as impulse control disorders. In patients treated with Rasagilina Synthon and (or) other medicines used in the treatment of Parkinson's disease, such behaviours have been observed, including obsessions, obsessive thoughts, pathological gambling, uncontrolled spending, impulsive actions, increased sexual drive, or intensified sexual thoughts and feelings. The doctor may decide to adjust the dose or discontinue the medicine (see section 4).
Rasagilina Synthon 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 using machines.

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

Rasagilina Synthon and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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 Rasagilina Synthon with antidepressants containing fluoxetine or fluvoxamine should be avoided. Rasagilina Synthon may be started at least 5 weeks after discontinuation of fluoxetine. Fluoxetine or fluvoxamine may be started at least 14 days after stopping Rasagilina Synthon.

Inform your doctor or pharmacist if the patient smokes or plans to stop smoking. Smoking may reduce the amount of Rasagilina Synthon in the blood.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnant patients should avoid taking Rasagilina Synthon, as the effects of Rasagilina Synthon on pregnancy and the unborn child are unknown.

Driving and using machines
Patients should consult their doctor before driving or operating machinery, as Parkinson's disease and treatment with Rasagilina Synthon may affect the ability to perform these activities. Rasagilina Synthon 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 sedative medicines are taken concomitantly, or if the patient consumes alcohol while taking Rasagilina Synthon. Patients who experience drowsiness and (or) sudden sleep episodes before or during treatment with Rasagilina Synthon should not drive or operate machinery (see section 2).

3. How to use Rasagilina Synthon

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of doubt,
consult the doctor or pharmacist.
The recommended dose of Rasagilina Synthon is 1 tablet of 1 mg taken orally once daily. Rasagilina Synthon
may be taken with food or independently of meals.
Use of a higher than recommended dose of Rasagilina Synthon
If the patient feels that they have taken more tablets of Rasagilina Synthon than recommended, they should
immediately contact a doctor or pharmacist. The cardboard box/bottle of Rasagilina Synthon should be brought
along to show to the doctor or pharmacist.
Symptoms reported after overdose of Rasagilina Synthon include: slightly euphoric mood (a mild form of 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 missed dose. Take the next dose at the usual time.
Stopping treatment with Rasagilina Synthon
Do not stop taking Rasagilina Synthon without first consulting the doctor.
If there are any further doubts regarding the use of this medicine, consult the 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 behaviours such as compulsions, obsessive thoughts, gambling addiction, uncontrollable shopping or spending, impulsive behaviour, increased sexual drive or excessive 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).

Contact a doctor if the patient notices suspicious skin changes, as there may be an increased risk of skin cancer (melanoma) during treatment with this medicine (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 (orthostatic hypotension) • decreased appetite • constipation • dry mouth • nausea and vomiting • bloating with gas release • abnormal blood test results (leukopenia) • joint pain • musculoskeletal pain (musculoskeletal pain) • arthritis • numbness and muscle weakness in the hand (carpal tunnel syndrome) • weight loss • nightmares • impaired coordination of muscle groups (balance disorders) • depression • dizziness • prolonged muscle tension (dystonia) • nasal discharge (rhinitis) • skin irritation (dermatitis) • rash • eye congestion (conjunctivitis) • sudden urge to urinate
Uncommon (may affect up to 1 in 100 people)
Stroke • myocardial infarction • blistering rash (vesiculobullous rash)
Unknown frequency: cannot be estimated from available data
Increased blood pressure • excessive sleepiness • sudden sleep onset
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rasagilina Synthon

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton or blister pack after “Expiry date”. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must 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 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, maize starch, pregelatinized maize starch, talc, stearic acid.

What Rasagilina Synthon looks like and contents of the pack
White or almost white, elongated tablets (approximately 11.5 mm x 6 mm), biconvex on both sides,
with the imprint "R9SE" on one side and "1" on the other.
Tablets are available in blisters containing 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
The 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
The Netherlands

This medicinal product is authorised in the European Economic Area under the following names:
Finland Rasabon 1 mg tabletti
Hungary Razagilin-Q Pharma 1 mg tabletta
Iceland Rasagiline WH
Italy Rasabon 1 mg compresse
Croatia Razagilina Makpharm 1 mg tablete
The Netherlands Rasagiline Synthon 1 mg, tabletten
Poland Rasagilina Synthon
23/04/2021