RASAGILINA 1 mg Tabletka Powlekana

Treść ulotki

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

Rasagilina Accord 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 their symptoms are the same as yours because it could 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 Accord is and what it is used for
• 2. What you need to know before you take Rasagilina Accord
• 3. How to take Rasagilina Accord
• 4. Possible side effects
• 5. How to store Rasagilina Accord
• 6. Contents of the pack and other information

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

Rasagilina Accord contains the active substance rasagilina and is used in the treatment of 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, 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 Accord helps
to increase and maintain constant levels of dopamine in the brain.

2. What you need to know before you take Rasagilina Accord

Do not take Rasagilina Accord:

• 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 in combination with Rasagilina Accord:
• monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease or used for any other indication), including medicines and herbal products without a prescription, such as St. John's Wort.
• pethidine (a strong painkiller). You must wait at least 14 days after stopping treatment with Rasagilina Accord before starting treatment with MAOIs or pethidine.

Warnings and precautions
Tell your doctor or pharmacist before you take Rasagilina Accord

• In case of any liver problems.
• Contact 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 carry out
certain activities that are dangerous or harmful to you or to others. These behaviours are called impulse control disorders. In patients taking Rasagilina Accord and/or other medicines used to treat
Parkinson's disease, behaviours such as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviours and an abnormally high sexual drive or an increase in sexual thoughts or desires have been observed. Your doctor may need to adjust the dose or stop the
treatment (see section 4).
Rasagilina Accord can cause drowsiness and may cause you to fall asleep suddenly during daily activities, especially if you are taking other dopaminergic medicines (used for the treatment of
Parkinson's disease). For further information, please refer to the section Driving and using machines.

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

Other medicines and Rasagilina Accord
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 decongestants and oral decongestants and cold medicines containing ephedrine or pseudoephedrine.

Avoid the concomitant use of Rasagilina Accord and antidepressants containing fluoxetine or fluvoxamine.
If you are starting treatment with Rasagilina Accord you must wait at least five weeks
after stopping treatment with fluoxetine.
If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days
after stopping treatment with Rasagilina Accord.
Tell your doctor or pharmacist if you are a smoker or intend to stop smoking. Smoking can reduce the
amount of Rasagilina Accord in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be 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 Accord if you are pregnant, because the effects of Rasagilina Accord
on pregnancy and the fetus are unknown.

Driving and using machines
Ask your doctor for advice before driving vehicles and using machines, as Parkinson's disease itself as well as treatment with Rasagilina Accord can affect your ability to do so.
Rasagilina Accord 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 Accord. If you have experienced drowsiness and/or sudden episodes of
sleepiness in the past or while taking Rasagilina Accord, do not drive or use
machines (see section 2).

3. How to take Rasagilina Accord

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 Accord is 1 tablet of 1 mg taken by mouth, once a day.
Rasagilina Accord can be taken with or without food.

If you take more Rasagilina Accord than you should
If you think you have taken more Rasagilina Accord tablets than you should, contact your doctor
or pharmacist immediately. Bring with you the box/blister or bottle of Rasagilina Accord to show to the doctor or to the
pharmacist.
Symptoms reported after an overdose of rasagiline 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 Accord
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 Accord
Do not stop taking Rasagilina Accord without talking to your doctor first.
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 increased 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 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)
• low blood pressure when standing up, accompanied by symptoms such as dizziness/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 muscle coordination (balance disorders)
• depression
• dizziness
• 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)
• blisters (bullous erythema).

Not known: frequency cannot be estimated from 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 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 Accord

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, bottle or blister
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rasagilina Accord contains

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).
• The excipients are microcrystalline cellulose, corn starch, pregelatinized starch (from corn), talc, sodium stearyl fumarate.

Description of the appearance of Rasagilina Accord and contents of the pack
Rasagilina Accord tablets are white to off-white in colour, round, flat and bevelled (6.5
mm).
Packs of 7, 10, 28, 30, 60, 100 and 112 tablets in blisters.
Packs of 30 tablets are available in containers with child-resistant screw caps, containing
a desiccant (silica gel). The desiccant, used to keep the tablets dry, must not be
swallowed.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Delorbis Pharmaceuticals Ltd
17 Athinon Street, Ergates Industrial Area,
2643 Ergates Lefkosia,
Cyprus
Iberfar – Indústria Farmaĉeutica, S.A.
Rua Consiglieri Pedroso, no. 121-123
Queluz de Baixo, Barcarena,
Portugal
Sofarimex – Indústria Química e Farmacêutica, S.A.
Av. das Indústrias – Alto do Colaride, Cacém,
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the following
names: