PACKAGE LEAFLET: INFORMATION FOR THE USER

RASAGILINA DOC Generici 1 mg tablets

Equivalent 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, consult 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What RASAGILINA DOC Generici is and what it is used for

RASAGILINA DOC Generici is used to treat Parkinson's disease in adults.
It can be used with or without levodopa (another medicine used to treat Parkinson's disease).
In Parkinson's disease, dopaminergic neurons are lost in certain areas of the brain. Dopamine is a substance in the brain responsible for controlling movement.
RASAGILINA DOC Generici helps increase and maintain stable levels of dopamine in the brain.

2. What you need to know before taking RASAGILINA DOC Generici

Do not take RASAGILINA DOC Generici:

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 impairment.

Do not take the following medicines in combination with RASAGILINA DOC Generici:

monoamine oxidase inhibitors (MAO inhibitors) (used as antidepressants, for the treatment of Parkinson's disease, or for any other indication), including medicinal products and non-prescription natural products such as St. John’s wort.
meperidine (a strong analgesic).

Wait at least 14 days after stopping treatment with RASAGILINA DOC Generici before starting treatment with MAO inhibitors or meperidine.
Warnings and precautions
Talk to your doctor before taking RASAGILINA DOC Generici:

if you have any liver function problems.
Consult your trusted doctor if you notice any suspicious skin changes. 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 treated with RASAGILINA DOC Generici and/or other medicines used to treat Parkinson’s disease, such behaviors as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviors, and abnormally increased sex drive or increased sexual thoughts or desires have been observed. Your doctor may need to adjust the dose or discontinue treatment (see section 4).
RASAGILINA DOC Generici 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 on Driving and use of machines.
Children and adolescents
There is no indication for the specific use of RASAGILINA DOC Generici in children and adolescents. Therefore, the use of RASAGILINA DOC Generici is not recommended in patients under 18 years of age.
Other medicines and RASAGILINA DOC Generici
Inform 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 and 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 concomitant use of RASAGILINA DOC Generici with antidepressants containing fluoxetine or fluvoxamine.
Before starting treatment with RASAGILINA DOC Generici, wait at least 5 weeks after stopping treatment with fluoxetine.
Before starting treatment with fluoxetine or fluvoxamine, wait at least 14 days after stopping treatment with RASAGILINA DOC Generici.
Inform your doctor or pharmacist if you are a smoker or intend to stop smoking. Smoking may reduce the amount of RASAGILINA DOC Generici in your blood.
RASAGILINA DOC Generici with food and drink
RASAGILINA DOC Generici can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Avoid taking RASAGILINA DOC Generici if you are pregnant, as the effects of RASAGILINA DOC Generici on pregnancy and the fetus are unknown.
Driving and use of machines
Consult your doctor before driving or operating machinery, as both Parkinson’s disease itself and treatment with RASAGILINA DOC Generici may affect your ability to do so. RASAGILINA DOC Generici 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, if you are taking medicines that cause drowsiness, or if you drink alcohol while taking RASAGILINA DOC Generici. If you have previously experienced drowsiness and/or sudden episodes of falling asleep while taking RASAGILINA DOC Generici, do not drive or operate machinery (see section 2).

3. How to take RASAGILINA DOC Generici

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose of RASAGILINA DOC Generici is 1 tablet of 1 mg taken orally
once daily. RASAGILINA DOC Generici may be taken with or without food.
If you take more RASAGILINA DOC Generici than you should
If you think you have taken more tablets of RASAGILINA DOC Generici than you should, contact
your doctor or pharmacist immediately. Take the pack of RASAGILINA DOC
Generici with you to show to the doctor or pharmacist.
Symptoms reported after overdose of RASAGILINA DOC Generici 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 DOC Generici
Do not take a double dose to make up for the missed tablet. Take the next dose
at the usual time.
If you stop taking RASAGILINA DOC Generici
Do not stop taking RASAGILINA DOC Generici without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following symptoms. You may need
urgent medical advice or treatment:

If you develop unusual behaviour such as compulsions, obsessive thoughts, gambling addiction, excessive shopping or spending, impulsive behaviours, or abnormally increased sexual desire or an increase in sexual thoughts (impulse control disorders) (see section 2).
If you see or hear things that are not real (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)
Drop in blood pressure upon standing, accompanied by symptoms such as dizziness/light-headedness (orthostatic hypotension)
decreased appetite
constipation
dry mouth
nausea and vomiting
flatulence
abnormalities in blood test results (leucopenia)
joint pain (arthralgia)
musculoskeletal pain
inflammation of the joints (arthritis)
numbness and weakness of the hand muscle (carpal tunnel syndrome)
loss of body weight
abnormal dreams
difficulty with muscle coordination (balance disorders)
depression
dizziness
prolonged muscle contractions (dystonia)
runny nose (rhinitis)
skin irritation (dermatitis)
skin rash
red eyes (conjunctivitis)
urinary urgency.

Uncommon (may affect up to 1 in 100 people)

stroke (cerebrovascular accident)
heart attack (myocardial infarction)
skin blisters (vesiculobullous skin rash).

Not known (Note: 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 effects, including those not listed in this leaflet, talk to 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 DOC Generici

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 pack, following
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 no longer required. This will help protect the environment.

6. Package contents and other information

What RASAGILINA DOC Generici 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 DOC Generici and package contents
RASAGILINA DOC Generici tablets are white to off-white, oblong (approximately 11.5 mm by 6 mm), biconvex, with "R9SE" engraved on one side and "1" on the other side.
The tablets are available in packs containing 28 tablets.

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano – Italy.

Manufacturer responsible for batch release
Synthon Hispania SL
C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon s.r.o.
Brněnská 32/čp. 597
678 01 Blansko
Czech Republic
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: RASAGILINA DOC Generici
The Netherlands: Rasagiline DOC Generici