Rodlap

Package leaflet: Information for the user

ROLDAP 1 mg tablets

rasagiline
Equivalent medicine
Please read all of 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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What ROLDAP is and what it is used for

ROLDAP contains the active substance rasagiline and 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).
In Parkinson's disease, dopaminergic cells are lost in certain areas of the
brain. Dopamine is a substance in the brain responsible for controlling movement.
ROLDAP helps increase and maintain stable levels of dopamine in the brain.

2. What you need to know before taking ROLDAP

Do not take ROLDAP

• 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 ROLDAP:

• Monoamine oxidase inhibitors (MAOIs) (used as antidepressants, for the treatment of Parkinson's disease, or for any other indication), including medicines and natural products available without prescription, such as St. John's wort.
• Meperidine (a strong analgesic). Wait at least 14 days after stopping treatment with ROLDAP before starting treatment with MAO inhibitors or meperidine.

Warnings and precautions
Talk to your doctor before taking ROLDAP,

• If you have any liver function problems.
• Consult your trusted doctor if you notice any suspicious skin changes. Treatment with ROLDAP may increase the risk of skin cancer. 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 could be dangerous or harmful to yourself or others. These behaviors are known as impulse control disorders. In patients taking ROLDAP 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 sexual desire or increased sexual thoughts or urges have been observed. Your doctor may need to adjust the dose or discontinue treatment (see section 4).

ROLDAP 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 ROLDAP in children and adolescents. Therefore, the use of ROLDAP is not recommended in patients under 18 years of age.

Other medicines and ROLDAP
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 concomitant use of ROLDAP and antidepressants containing fluoxetine or fluvoxamine. Before starting treatment with ROLDAP, wait at least five weeks after stopping treatment with fluoxetine. Before starting treatment with fluoxetine or fluvoxamine, wait at least 14 days after stopping treatment with ROLDAP.

Inform your doctor or pharmacist if you are a smoker or plan to stop smoking. Smoking may reduce the amount of ROLDAP 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 ROLDAP if you are pregnant, as the effects of ROLDAP on pregnancy and the fetus are unknown.

Driving and use of machines
Ask your doctor for advice before driving or operating machinery, as Parkinson's disease itself and treatment with ROLDAP may affect your ability to do so. ROLDAP 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 other medicines that cause drowsiness, or if you drink alcohol while taking ROLDAP. If you have previously experienced drowsiness and/or sudden episodes of falling asleep, either before or during treatment with ROLDAP, do not drive or operate machinery (see section 2).

3. How to take ROLDAP

Take this medicine exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
The recommended dose of ROLDAP is 1 tablet of 1 mg taken orally once daily.
ROLDAP may be taken with or without food.

If you take more ROLDAP than you should
If you think you have taken more ROLDAP tablets than you should, contact your doctor or pharmacist immediately.
Take the ROLDAP packaging/blister pack with you to show to the doctor or pharmacist.
Symptoms reported after an overdose of ROLDAP include slightly euphoric mood (a mild form of mania), extremely high blood pressure, and serotonin syndrome (see section 4).

If you forget to take ROLDAP
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 ROLDAP
Do not stop taking ROLDAP 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 everyone gets them.
Contact your doctor immediately if you experience 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, abnormally increased sex drive, 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).

Contact your doctor if you notice suspicious skin changes, as the risk of skin cancer (melanoma)
may increase with the use of this medicine (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
• Influenza-like illness (influenza)
• General feeling of being unwell (malaise)
• Neck pain
• Chest pain (angina pectoris)
• Drop in blood pressure when standing up, accompanied by symptoms such as dizziness/light-headedness (orthostatic hypotension)
• Decreased appetite
• Constipation
• Dry mouth
• Nausea and vomiting
• Flatulence
• Abnormal 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)
• Erythema
• Red eyes (conjunctivitis)
• Urinary urgency.

Uncommon (may affect up to 1 in 100 people)

• Stroke (cerebrovascular accident)
• Confusion
• Heart attack (myocardial infarction)
• Skin blisters (bullous erythema).

Frequency 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 ROLDAP

Keep ROLDAP out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the
original packaging to protect the medicine from light.
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 ROLDAP contains

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as emitharate).
• The other components are microcrystalline cellulose, pregelatinized (partially) maize starch, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of ROLDAP and package contents
ROLDAP is available as white to off-white, round, flat tablets with bevelled edges, marked with "1" on one side, and with a diameter of 8 mm.
The tablets are available in blisters containing 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori – Strada 6 – Edificio L – Rozzano, Milan

Manufacturer
Genepharm S.A.
18 km Marathon Avenue
153 51 Pallini
Greece

This medicinal product is authorized in the European Economic Area member states
under the following trade names:
Italy: ROLDAP