Package leaflet: Information for the user

Rasagilina Aurobindo 1 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rasagilina Aurobindo is and what it is used for
What you need to know before taking Rasagilina Aurobindo
How to take Rasagilina Aurobindo
Possible side effects
How to store Rasagilina Aurobindo
Contents of the pack and other information

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

Rasagilina Aurobindo contains the active substance rasagilina and is used in the treatment of
Parkinson's disease. It can be used with or without levodopa (another medicine used to treat Parkinson's
disease).
In Parkinson's disease, there is a loss of dopamine-producing cells in the brain. Dopamine is a chemical in
the brain involved in controlling movement. Rasagilina Aurobindo helps increase and maintain stable
levels of dopamine in the brain.

2. What you need to know before taking Rasagilina Aurobindo

Do not take Rasagilina Aurobindo:

If you are allergic to rasagiline or to 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 Aurobindo:

Monoamine oxidase inhibitors (MAOIs) (used, for example, for the treatment of depression or Parkinson's disease, or for any other indication), including prescription and non-prescription medicines and herbal products such as St. John's wort.
Pethidine (a strong analgesic). Wait at least 14 days after stopping treatment with Rasagilina Aurobindo before starting treatment with MAO inhibitors or pethidine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rasagilina Aurobindo

If you have any liver function problems.
Talk to your doctor if you notice any suspicious changes in your skin.

Inform your doctor if you, your family members, or caregivers notice that you are developing unusual behaviors that make you unable to resist the impulse, urge, or desire to carry out certain activities that may be dangerous or harmful to yourself or others. These behaviors are known as impulse control disorders. In patients taking Rasagilina Aurobindo and/or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviors, abnormally increased sexual desire, or an increase in sexual thoughts or urges have been observed. Your doctor may need to adjust your dose or discontinue treatment (see section 4).
Rasagilina Aurobindo may cause drowsiness and may cause you to fall asleep suddenly during daytime activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). For further information, refer to the section "Driving and use of machines".
Children and adolescents
There is no indication for the specific use of Rasagilina Aurobindo in children and adolescents.
Therefore, the use of Rasagilina Aurobindo is not recommended in children and adolescents under 18 years of age.
Other medicines and Rasagilina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
The antibiotic ciprofloxacin, used to treat infections
Dextromethorphan, a medicine used for cough
Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine. Avoid using Rasagilina Aurobindo with antidepressants containing fluoxetine or fluvoxamine. Before starting treatment with Rasagilina Aurobindo, you must wait at least five weeks after stopping treatment with fluoxetine. Before starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with Rasagilina Aurobindo. Inform your doctor or pharmacist if you are a smoker or plan to stop smoking. Smoking may reduce the amount of Rasagilina Aurobindo in your blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Avoid taking Rasagilina Aurobindo if you are pregnant, as the effects of Rasagilina Aurobindo on pregnancy and the fetus are unknown.
Driving and use of machinery
Ask your doctor for advice before driving or operating machinery, as Parkinson's disease itself, as well as treatment with Rasagilina Aurobindo, may affect your ability to do so.
Rasagilina Aurobindo may cause dizziness and drowsiness; it may also cause sudden episodes of falling asleep.
This effect may be increased if you are taking other medicines to treat symptoms of Parkinson's disease, or if you are taking medicines that cause drowsiness, or if you drink alcohol while taking Rasagilina Aurobindo. If you have experienced drowsiness and/or sudden episodes of falling asleep in the past or during treatment with Rasagilina Aurobindo, do not drive or operate machinery (see section 2).

3. How to take Rasagilina Aurobindo

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 Aurobindo is 1 tablet of 1 mg taken orally once daily. Rasagilina Aurobindo may be taken with or without food.
If you take more Rasagilina Aurobindo than you should
If you think you have taken more tablets of Rasagilina Aurobindo than you should, contact your doctor or pharmacist immediately. Take the pack or blister of Rasagilina Aurobindo with you to show to the doctor or pharmacist.
Symptoms reported after overdose of Rasagilina Aurobindo included slightly euphoric mood (a mild form of mania), extremely high blood pressure, and serotonin syndrome (see section 4).
If you forget to take Rasagilina Aurobindo
Do not take a double dose to make up for the forgotten tablet. Take the next dose as scheduled.
If you stop taking Rasagilina Aurobindo
Do not stop taking Rasagilina Aurobindo without first talking to your doctor.
If you have any questions about how to use 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.
Contact your doctor immediately if you notice any of the following symptoms. You may need immediate
medical advice or treatment:

If you develop unusual behaviour such as compulsions, obsessive thoughts, gambling addiction, excessive shopping or spending, impulsive behaviour, abnormally increased sex drive or increased sexual thoughts (impulse control disorders) (see section 2).
If you see or hear things that are not there (hallucinations).
Any combination of hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome).
If you notice suspicious skin changes, 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 reaction
Fever
Flu-like illness (influenza)
General feeling of being unwell (malaise)
Neck pain
Chest pain (angina pectoris)
Low blood pressure upon standing, with symptoms such as dizziness or lightheadedness (orthostatic hypotension)
Decreased appetite
Constipation
Dry mouth
Nausea and vomiting
Flatulence
Abnormal blood test results (leucopenia)
Joint pain (arthralgia)
Musculoskeletal pain
Inflammation of joints (arthritis)
Numbness and weakness of the hand muscle (carpal tunnel syndrome)
Loss of body weight
Abnormal dreams
Difficulty in muscle coordination (balance disorders)
Depression
Dizziness (vertigo)
Prolonged muscle contractions (dystonia)
Runny nose (rhinitis)
Skin irritation (dermatitis)
Rash
Red eyes (conjunctivitis)
Urinary urgency

Uncommon (may affect up to 1 in 100 people)

Stroke (cerebrovascular accident)
Heart attack (myocardial infarction)
Rash with blisters (bullous erythema)

Not known: frequency cannot be estimated from the available data

High blood pressure
Excessive sleepiness
Sudden onset of sleep

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rasagilina Aurobindo

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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rasagilina Aurobindo contains

The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
The other components are microcrystalline cellulose, tartaric acid, maize starch, pregelatinized maize starch, talc, stearic acid.

Description of the appearance of Rasagilina Aurobindo and package contents
Rasagilina Aurobindo tablets are white to off-white, oblong (approximately 11.5 mm x 6 mm), biconvex, with "R9SE" engraved on one side and "1" on the other side.
Tablets are available in packs containing 28 tablets.
Tablets are also available in blisters of 7, 10, 28, 30, 50, 90, 100 and 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturers
Synthon Hispania SL - C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat, Barcelona (Spain)
Synthon s.r.o. Brněnská 32/čp. 597, Blansko 678 01 – Czech Republic
Synthon BV - Microweg 22 - 6545 CM Nijmegen - Netherlands
APL Swift Services (Malta) Limited - HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia - BBG 3000, Malta
Milpharm Limited - Ares Block, Odyssey Business Park, West End Road, Ruislip - HA4 6QD, United Kingdom

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Rasagiline AB 1 mg, tabletten
Germany Rasagilin PUREN 1 mg Tabletten
Spain Rasagilina Aurovitas Spain 1 mg comprimidos EFG
Italy Rasagilina Aurobindo
Romania Rasagilina Aurobindo 1 mg comprimate
Portugal Rasagilina Aurovitas
Netherlands Rasagiline Aurobindo 1 mg, tabletten
United Kingdom Rasagiline Milpharm 1 mg tablets