RASAGILINA 1 mg Coated Tablet

Зміст інструкції

1. Rasagilina Aurobindo 1 mg tablets
   1. What is Rasagilina Aurobindo and what is it used for
   2. What you need to know before taking Rasagilina Aurobindo
   3. How to take Rasagilina Aurobindo
   4. Possible side effects
   5. How to store Rasagilina Aurobindo
   6. Package contents and other information

Rasagilina Aurobindo 1 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Rasagilina Aurobindo contains the active substance rasagiline 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 cells that produce dopamine in the brain. Dopamine is a chemical substance in the brain involved in controlling movements. Rasagilina Aurobindo
helps to increase and maintain constant 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 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 medicines and herbal products without a prescription, such as St. John's Wort.
• Pethidine (a strong painkiller). Wait at least 14 days after stopping treatment with Rasagilina Aurobindo before starting treatment with MAOIs 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 skin changes.

Tell your doctor if you, your family members or your caregivers notice that you are developing
unusual behaviours that make you unable to resist the impulse, urge or desire to
perform certain activities that are dangerous or harmful to you or others. These behaviours are called impulse control disorders. In patients taking Rasagilina Aurobindo and/or other medicines used for
treating Parkinson's disease, behaviours such as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviours and an abnormally high sexual drive or increased sexual thoughts or desires have been observed. Your doctor may need to adjust the
dose or stop treatment (see section 4).
Rasagilina Aurobindo can cause drowsiness and may cause you to fall asleep suddenly during daytime activities, especially if you are taking other dopaminergic medicines (used for the treatment of Parkinson’s
disease). For further information, refer to the section “Driving and using machines”.

Children and adolescents
There is no indication for a specific use of Rasagilina Aurobindo in children and adolescents.
Therefore, the use of Rasagilina Aurobindo is not recommended in children and adolescents under the age of
18 years.

Other medicines and Rasagilina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Especially tell your doctor if you are taking any of the following medicines:

• Some antidepressants (selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
• Ciprofloxacin, an antibiotic used to treat infections
• Dextromethorphan, a medicine used for cough
• Sympathomimetics such as those found in eye drops, nasal and oral decongestants and cold medicines 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. Tell your doctor or pharmacist if you are a smoker or intend to quit smoking. Smoking may reduce the amount of Rasagilina Aurobindo in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking Rasagilina Aurobindo if you are pregnant, because the effects of Rasagilina
Aurobindo on pregnancy and the fetus are unknown.

Driving and using machines
Ask your doctor before driving and using machines, as Parkinson's disease itself as well as treatment with Rasagilina Aurobindo can affect your ability to do so.
Rasagilina Aurobindo can make you feel dizzy and drowsy; it can also cause sudden episodes
of sleepiness.
This may be increased if you are taking other medicines to treat the symptoms of Parkinson’s
disease or if you are taking medicines that can make you feel sleepy, or if you drink alcohol while
taking Rasagilina Aurobindo. If you have experienced drowsiness and/or sudden episodes of sleepiness in
the past or while taking Rasagilina Aurobindo, do not drive or use machines (see section
2).

3. How to take Rasagilina Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose of Rasagilina Aurobindo is 1 tablet of 1 mg taken by mouth, once a
day. Rasagilina Aurobindo can be taken with or without food.

If you take more Rasagilina Aurobindo than you should
If you think you have taken more Rasagilina Aurobindo tablets than you should, seek immediate
medical advice or contact your pharmacist. Bring the package/blister of Rasagilina Aurobindo with you to show to the doctor or
pharmacist.
Symptoms reported after an overdose of Rasagilina Aurobindo included a slightly
euphoric mood (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 a missed tablet. Take the next dose
as normal, when it is time to take it.

If you stop taking Rasagilina Aurobindo
Do not stop taking Rasagilina Aurobindo without first talking to your doctor.
If you have any further questions on the use of 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.
manifest.

Contact your doctor immediatelyif 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, excessive shopping or spending, impulsive behaviour and an abnormally high sexual desire or an increase in 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, because patients with Parkinson’s disease have a higher risk of skin cancer (not just 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
• Allergy
• Fever
• Flu-like illness (influenza)
• General feeling of being unwell (malaise)
• Neck pain
• Chest pain (angina pectoris)
• Low blood pressure when standing up, leading to symptoms such as dizziness or lightheadedness (orthostatic hypotension)
• Decreased appetite
• Constipation
• Dry mouth
• Nausea and vomiting
• Flatulence
• Abnormal blood test results (leukopenia)
• Joint pain (arthralgia)
• Musculoskeletal pain
• Joint inflammation (arthritis)
• Numbness and weakness of the hand muscle (carpal tunnel syndrome)
• Weight loss
• Abnormal dreams
• Difficulty in coordinating movements (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)
• Blistering rash (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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the package or blister after SCAD.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 ingredient is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The other ingredients are microcrystalline cellulose, tartaric acid, corn starch, pregelatinized corn 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 by 6
mm), biconvex, with “R9SE” imprinted on one side and “1” on the other side.
The tablets are available in packs of 28 tablets.
The tablets are 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)

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 Member States of the European Economic Area under the following
names:
Belgium Rasagiline AB 1 mg, tablets
Germany Rasagilin PUREN 1 mg Tablets
Spain Rasagilina Aurovitas Spain 1 mg coated tablets
Italy Rasagilina Aurobindo
Romania Rasagilina Aurobindo 1 mg tablets
Portugal Rasagilina Aurovitas
Netherlands Rasagiline Aurobindo 1 mg, tablets
United Kingdom Rasagiline Milpharm 1 mg tablets