RASAGILINA 1 mg Tabletka

Treść ulotki

1. RASAGILINA DOC Generici 1 mg tablets
   1. What is RASAGILINA DOC Generici and what it is used for
   2. What you need to know before taking RASAGILINA DOC Generici
2. RASAGILINA DOC Generici may cause drowsiness and may cause you to fall asleep suddenly
   1. How to take RASAGILINA DOC Generici
   2. Possible side effects
   3. How to store RASAGILINA DOC Generici
   4. Contents of the pack and other information

RASAGILINA DOC Generici 1 mg tablets

Generic medicine

Read this leaflet carefully before 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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

RASAGILINA DOC Generici is used for the treatment of Parkinson's disease in
adults. It can be used with or without levodopa (another medicine used to treat Parkinson's disease).
With Parkinson's disease, there is a loss of dopaminergic cells in certain areas of the
brain. Dopamine is a brain substance responsible for controlling movements.
RASAGILINA DOC Generici helps to increase and maintain constant 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 any of the other ingredientsof this medicine (listed in section 6).
• if you suffer from severe hepatic impairment .

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

• monoamine oxidase inhibitors (MAOIs)(used as antidepressants, for the treatment of Parkinson's disease or for any other indication), including medicines and herbal products available without a prescription, such as St. John's Wort.
• pethidine(a strong painkiller).

Wait at least 14 days after stopping treatment with RASAGILINA DOC Generici before
starting treatment with MAOIs or pethidine.

Warnings and precautions
Talk to your doctor before taking RASAGILINA DOC Generici.

• in case of any liver function problems .
• Consult your 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 urge, stimulus or desire to perform certain activities that are dangerous or harmful to you or others. These behaviors are called impulse control disorders. In patients taking RASAGILINA DOC Generici and/or other

medicines used to treat Parkinson's disease, behaviors such as
compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviors and an abnormally high sexual desire or an increase in sexual thoughts or desires have been observed. Your
doctor may need to adjust the dose or stop 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 for the
treatment of Parkinson's disease). For further information, please refer to the Driving and using
machines section.

Children and adolescents
There is no indication for 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
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 antibioticused 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 the 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.
Tell your doctor or pharmacist if you are a smoker or intend to quit 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, 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 DOC Generici if you are pregnant, because the effects of
RASAGILINA DOC Generici on pregnancy and the fetus are unknown.

Driving and using machines
. Ask your doctor for advice before driving and using machines, as Parkinson's disease itself as well as
treatment with RASAGILINA DOC Generici can affect your ability
to do so. RASAGILINA DOC Generici may make you feel dizzy and drowsy; it may
also cause episodes of sudden onset of sleep
This may be enhanced 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 DOC Generici. If you have experienced drowsiness and/or episodes of sudden
onset of sleep in the past or during the taking of RASAGILINA DOC Generici, do not drive or
use machines (see section 2).

3. How to take RASAGILINA DOC Generici

Take this medicine following exactly the instructions of 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 by mouth
once a day. RASAGILINA DOC Generici can 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. Bring with you the package of RASAGILINA DOC
Generici to show to the doctor or pharmacist.
Symptoms reported after an overdose of RASAGILINA DOC Generici 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 DOC Generici
Do not take a double dose to make up for the missed tablet. Take the next
dose as normal, when it is time to take it.

If you stop taking RASAGILINA DOC Generici
Do not stop taking RASAGILINA DOC Generici 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.

Contact your doctor immediatelyif you notice any of the following symptoms. You may need immediate medical attention or treatment:

• If you develop unusual behaviour such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour and an abnormally increased sexual desire 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, because patients with Parkinson’s disease have a higher 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
• allergy
• fever
• flu-like illness (influenza)
• general feeling of being unwell (malaise)
• neck pain
• chest pain (angina pectoris)
• Reduced blood pressure when getting up from a sitting or lying position accompanied by symptoms such as dizziness/lightheadedness (orthostatic hypotension)
• decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• flatulence
• abnormal blood test results (leucopenia)
• joint pain (arthralgia)
• musculoskeletal pain
• joint inflammation (arthritis)
• numbness and weakness of the hand muscle (carpal tunnel syndrome)
• weight loss
• 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)
• urgent need to urinate.

Uncommon (may affect up to 1 in 100 people)

• stroke (cerebrovascular accident)
• heart attack (myocardial infarction)
• blisters (bullous and blistering rash).

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-avverseBy 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 which is stated on the package or blister after
Exp. 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 wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RASAGILINA DOC Generici 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 DOC Generici and contents of the pack
The tablets of RASAGILINA DOC Generici 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 of 28 tablets.

Marketing Authorisation 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
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: RASAGILINA DOC Generici
Netherlands: Rasagiline DOC Generici