ROLDAP 1 mg Tabletka

Treść ulotki

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

ROLDAP 1 mg tablets

rasagiline
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 ROLDAP is and what it is used for
• 2. What you need to know before you take 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 is ROLDAP and what is it 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, there is a loss of dopaminergic cells in certain areas of the brain. Dopamine is a substance in the brain responsible for controlling movements.
ROLDAP helps to increase and maintain constant levels of dopamine in the brain.

2. What you need to know before you take ROLDAP

Do not take ROLDAP

• If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from severe hepatic insufficiency.

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 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 ROLDAP before starting treatment with MAOIs or pethidine.

Warnings and precautions
Talk to your doctor before taking ROLDAP,

• If you have any problems with liver function
• Consult your trusted doctor in case of 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 behaviours that make you unable to resist the urge, drive or desire to perform certain activities that are dangerous or harmful to you or others. These behaviours are called impulse control disorders. Patients taking ROLDAP and/or other medicines used to treat Parkinson's disease have been observed to exhibit 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. Your doctor may need to adjust the dose or stop treatment (see section 4).

ROLDAP can cause drowsiness and may cause you to fall asleep suddenly during the day, especially if you are taking other dopaminergic medicines (used to treat 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 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.
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 the 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. Tell your doctor or pharmacist if you are a smoker or intend to quit smoking. Smoking may reduce the amount of ROLDAP in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking ROLDAP if you are pregnant, because the effects of ROLDAP on pregnancy and the foetus 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 ROLDAP can affect your ability to do so. ROLDAP can make you feel dizzy and drowsy; it can also cause sudden onset of sleep.
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 ROLDAP. If you have experienced drowsiness and/or sudden onset of sleep in the past or during the intake of ROLDAP, do not drive or use machines (see section 2).

3. How to take ROLDAP

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.
The recommended dose of ROLDAP is 1 tablet of 1 mg taken by mouth, once a day.
ROLDAP can 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. Bring with you the carton/blister of ROLDAP to show to the doctor or pharmacist.
Symptoms reported after an overdose of ROLDAP included slightly euphoric mood
(mild form of mania), extremely high blood pressure and serotonin syndrome (see
paragraph 4).

If you forget to take ROLDAP
Do not take a double dose to make up for the missed tablet. Take the next
dose normally, when it is time to take it.

If you stop taking ROLDAP
Do not stop taking ROLDAP without first talking to your doctor.
If you have any questions about using this medicine, ask your doctor or pharmacist.
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 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 paragraph 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 doctorif you notice suspicious skin changes, because the risk of skin cancer
(melanoma) may increase with the use of this medicine (see paragraph 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)
• Decrease in blood pressure when standing up accompanied by symptoms such as dizziness/lightheadedness (orthostatic hypotension)
• Decreased appetite
• Constipation
• Dry mouth
• Nausea and vomiting
• Flatulence
• Abnormalities in 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)
• 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).

Not known: frequency cannot be estimated from available data

• High blood pressure
• Excessive sleepiness
• Sudden onset of sleep Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 ROLDAP

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

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

Description of the appearance of ROLDAP and contents of the pack
ROLDAP is presented as white-whitish, round, flat tablets with bevelled edges
bearing “1” embossed on one side, with a diameter of 8 mm.
The tablets are available in blisters of 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the member states of the European Economic Area
under the following denominations:
Italy: ROLDAP