RASAGILINE ACCORD

Package leaflet: Information for the user

Rasagiline Accord, 1 mg, tablets
Rasagilinum
Read the entire leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor, pharmacist, or nurse if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If any side effects occur, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse (see section 4).

Leaflet contents

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

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

Rasagiline Accord contains the active substance rasagiline and is used in adults to treat
Parkinson's disease. It may be given in combination with levodopa (another medicine used to treat
Parkinson's disease) or without levodopa.
In Parkinson's disease, there is a loss of cells that produce dopamine in the brain. Dopamine
acts in the brain as a neurotransmitter involved in controlling movement. Rasagiline Accord
increases and maintains dopamine levels in these areas of the brain.

2. Important information before using Rasagiline Accord

When not to use Rasagiline Accord

• if the patient is allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe impairment of liver function.

During treatment with Rasagiline Accord, do not take the following medicines:

• monoamine oxidase inhibitors (MAO inhibitors) (used, for example, in the treatment of depression associated with Parkinson's disease or in any other indication), including over-the-counter medicines and herbal remedies such as St John's wort;
• pethidine (a strong painkiller).

At least 14 days must elapse between stopping Rasagiline Accord and starting treatment with MAO inhibitors or pethidine.
Warnings and precautions
Talk to your doctor before taking Rasagiline Accord:

• if the patient has any liver function disorders;
• the patient should inform their doctor about any unusual skin changes. Treatment with Rasagiline Accord may increase the risk of developing skin cancer.

Inform your doctor if the patient or their family notice any unusual behaviour resulting from an uncontrollable impulse, compulsion or desire to perform certain actions, which may be harmful to the patient or others. These behaviours are known as impulse control disorders. Such behaviours have been observed in patients treated with Rasagiline Accord and/or other medicines used in the treatment of Parkinson's disease, including obsessions, obsessive thoughts, pathological gambling, compulsive spending, impulsive actions, increased sexual drive or intensified sexual thoughts and feelings. Your doctor may decide to adjust the dose or discontinue treatment (see section 4).
Rasagiline Accord may cause drowsiness and sudden episodes of falling asleep during normal daily activities, particularly when taken together with other dopaminergic medicines (used in the treatment of Parkinson's disease). Further information is provided in the section: Driving and using machines.
Children and adolescents
Rasagiline Accord should not be used in children and adolescents. Rasagiline Accord is not recommended for patients under 18 years of age.
Rasagiline Accord and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking any of the following medicines:

• certain antidepressants (selective serotonin reuptake inhibitors, serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants);
• ciprofloxacin – an antibiotic used to treat infections;
• dextromethorphan – a cough suppressant;
• sympathomimetics, such as those contained in eye drops, nasal decongestants (administered nasally or orally), and cold remedies containing ephedrine or pseudoephedrine.

Avoid taking Rasagiline Accord together with antidepressants containing fluoxetine or fluvoxamine.
Rasagiline Accord may be started at least 5 weeks after stopping fluoxetine.
Fluoxetine or fluvoxamine may be started at least 14 days after stopping Rasagiline Accord.
Inform your doctor or pharmacist if the patient smokes or intends to stop smoking. Smoking may reduce the amount of Rasagiline Accord in the blood.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
If the patient is pregnant, she should avoid taking Rasagiline Accord, as the effects of Rasagiline Accord on pregnancy and the unborn child are unknown.
Driving and using machines
Consult your doctor before driving or operating machinery, as Parkinson's disease and treatment with Rasagiline Accord may affect the ability to perform these activities. Rasagiline Accord may cause dizziness or drowsiness.
It may also cause sudden sleep episodes.
These effects may be more pronounced when taking other medicines used to treat symptoms of Parkinson's disease or other medicines that cause drowsiness, or if the patient consumes alcohol while taking Rasagiline Accord. Patients who experience drowsiness and/or sudden sleep episodes before or during treatment with Rasagiline Accord should not drive or operate machinery (see section 2).
Rasagiline Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is considered "sodium-free".

3. How to use Rasagiline Accord

Use in adults
This medicine should always be taken according to the instructions given by the doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
The usual dose of Rasagiline Accord is 1 tablet of 1 mg taken orally once daily. Rasagiline Accord may be taken with food or independently of meals.
Taking more Rasagiline Accord than recommended
If a patient thinks they have taken more tablets of Rasagiline Accord than recommended, they should contact a doctor or pharmacist immediately.
The carton/foil or bottle of Rasagiline Accord should be brought along to show the doctor or pharmacist.
Symptoms reported following overdose of Rasagiline Accord include: slightly euphoric mood (a mild form of mania), extremely high blood pressure, and serotonin syndrome (see section 4).
Missing a dose of Rasagiline Accord
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time.
Stopping Rasagiline Accord
Do not stop taking Rasagiline Accord without first talking to your doctor.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, contact a doctor immediately.
The patient may require urgent medical advice or treatment:

• if they experience unusual behaviour such as compulsions, obsessive thoughts, gambling addiction, uncontrollable shopping or spending, impulsive behaviour, excessive sexual drive or increased sexual thoughts (impulse control disorders, see section 2).
• if they see or hear things that are not there (hallucinations).
• if any of the following symptoms occur together: hallucinations, fever, agitation, tremor and sweating (serotonin syndrome).

Contact a doctor if the patient notices suspicious skin changes, as there may be an increased risk of skin cancer (melanoma) during treatment with this medicine (see section 2).

Other adverse reactions
Very common (affects more than 1 in 10 people):

• involuntary body movements (dyskinesia)
• headache

Common (affects less than 1 in 10 people):

• abdominal pain
• fall
• allergy
• fever
• influenza-like symptoms
• malaise (weakness)
• neck pain
• chest pain (angina pectoris)
• low blood pressure upon standing, with symptoms resembling dizziness (orthostatic hypotension)
• decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• bloating with gas release
• abnormal blood test results (leukopenia)
• joint pain
• musculoskeletal pain (muscle and bone pain)
• arthritis
• numbness and weakness in the hand (carpal tunnel syndrome)
• weight loss
• nightmares
• impaired coordination of muscle groups (balance disorders)
• depression
• vertigo
• prolonged muscle tension (dystonia)
• runny nose (rhinitis)
• skin irritation (dermatitis)
• rash
• eye congestion (conjunctivitis)
• sudden urge to urinate

Uncommon (affects less than 1 in 100 people):

• stroke
• myocardial infarction
• blistering rash (vesiculobullous rash)

Not known (frequency cannot be determined from available data):

• increased blood pressure
• excessive sleepiness
• sudden sleep attacks

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Rasagiline Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle or blister pack after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Rasagiline Accord contains

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline hydrogen tartrate).
• The other ingredients are: microcrystalline cellulose, maize starch, pregelatinized starch (maize), talc, sodium stearyl fumarate.

What Rasagiline Accord looks like and contents of the pack
Rasagiline Accord is a white or almost white, round, flat tablet with bevelled edges.
Rasagiline Accord is packed in blisters made of Aluminium/Aluminium or PVC/PE/PVdC/Aluminium in a cardboard box, or in HDPE bottles in a cardboard box.
Available pack sizes:
Blisters: 7, 10, 28, 30, 60, 100 or 112 tablets and unit dose blisters containing 7x1, 10x1, 28x1, 30x1, 60x1, 100x1 or 112x1 tablets.
HDPE bottle: 30 tablets
The HDPE bottle is closed with a child-resistant cap.
The container contains a desiccant (silica gel) to maintain appropriate moisture levels. This must not be swallowed.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00
Manufacturer
Delorbis Pharmaceuticals LTD
17 Athinon Street, Ergates Industrial Area
2643 Ergates, Lefkosia
Cyprus
Iberfar – Indústria Farmacêutica, S.A.
Rua Consiglieri Pedroso, no. 121-123
Queluz de Baixo, Barcarena
2734-501
Portugal
This medicinal product is authorised in the European Economic Area (EEA) member states under the following names: