RASAGILINE 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Rasagiline Accord, 1 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Rasagiline Accord and what is it used for
4. Important information before taking Rasagiline Accord
   1. When not to take Rasagiline Accord
   2. Warnings and precautions
   3. Children and adolescents
   4. Rasagiline Accord with other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Rasagiline Accord contains sodium
5. How to take Rasagiline Accord
   1. Adults
   2. If you take more Rasagiline Accord than you should
   3. If you forget to take Rasagiline Accord
   4. If you stop taking Rasagiline Accord
6. Possible side effects
   1. Reporting side effects
7. How to store Rasagiline Accord
8. Contents of the pack and other information
   1. What Rasagiline Accord contains
   2. What Rasagiline Accord looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Rasagiline Accord has been authorized in the Member States of the European Economic Area (EEA) under the following names:
   6. Date of last revision of the package leaflet: December 2022

Package Leaflet: Information for the User

Rasagiline Accord, 1 mg, tablets

Rasagiline

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• Ask your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse (see section 4).

Table of Contents of the Package Leaflet

• 1. What is Rasagiline Accord and what is it used for
• 2. Important information 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 is Rasagiline Accord and what is it used for

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

2. Important information before taking Rasagiline Accord

When not to take Rasagiline 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.

While taking Rasagiline Accord, you must nottake the following medicines:

• monoamine oxidase inhibitors (MAOIs) (used for example to treat depression that occurs in Parkinson's disease or for other conditions), including medicines and herbal products available without prescription, such as St. John's Wort;
• pethidine (a strong painkiller).

There must be at least 14 days between stopping Rasagiline Accord and starting MAOIs or pethidine.

Warnings and precautions

You should talk to your doctor before taking Rasagiline Accord:

• if you have any liver problems;
• you should tell your doctor about any worrying changes in your skin. Treatment with Rasagiline Accord may increase the risk of skin cancer.

Tell your doctor if you or your family/carer notice that you are developing unusual behaviors such as compulsions, obsessive thoughts, or urges, which are difficult to control. These behaviors are called impulse control disorders. In patients taking Rasagiline Accord and/or other medicines for Parkinson's disease, there have been reports of such behaviors as: compulsions, obsessive thoughts, pathological gambling, excessive shopping, or spending, impulsive behavior, increased libido, or hypersexuality. Your doctor may need to adjust or stop your treatment (see section 4).
Rasagiline Accord may cause drowsiness and sudden sleep onset, especially when taken with other dopaminergic medicines (used to treat Parkinson's disease). For more information, see the section "Driving and using machines".

Children and adolescents

Rasagiline Accord should not be used in children and adolescents. It is not recommended to use Rasagiline Accord in patients under 18 years of age.

Rasagiline Accord with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about any medicines you plan to take.
In particular, tell your doctor if you are taking any of the following medicines:

• certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, tricyclic, or tetracyclic antidepressants);
• ciprofloxacin - an antibiotic used in infections;
• dextromethorphan - a cough medicine;
• sympathomimetics, such as those found in eye drops, nasal decongestants, and oral decongestants, and cold medicines containing ephedrine or pseudoephedrine.

Avoid taking Rasagiline Accord with antidepressants containing fluoxetine or fluvoxamine.
Do not start taking Rasagiline Accord until at least 5 weeks after stopping fluoxetine.
Do not start taking fluoxetine or fluvoxamine until at least 14 days after stopping Rasagiline Accord.
Tell your doctor or pharmacist if you smoke or intend to stop smoking. Smoking may decrease the amount of Rasagiline Accord in your blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, you should avoid taking Rasagiline Accord, as it is not known whether the medicine could harm the unborn baby.

Driving and using machines

Ask your doctor for advice before driving or using machines, as Parkinson's disease and Rasagiline Accord may affect your ability to perform these activities. Rasagiline Accord may cause dizziness or drowsiness.
It may also cause sudden sleep onset.
These effects may be more pronounced when taking other medicines for Parkinson's disease symptoms or other medicines that cause drowsiness, or if you drink alcohol while taking Rasagiline Accord. Patients who have experienced drowsiness and/or sudden sleep onset before or while taking Rasagiline Accord should not drive or use machines (see section 2).

Rasagiline Accord contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Rasagiline Accord

Adults

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose of Rasagiline Accord is 1 tablet of 1 mg taken by mouth once a day. Rasagiline Accord can be taken with or without food.

If you take more Rasagiline Accord than you should

If you think you have taken more tablets than you should, contact your doctor or pharmacist immediately. Take the carton/blisters or bottle of Rasagiline Accord with you to show the doctor or pharmacist.
Reported symptoms after overdose of Rasagiline Accord included: mildly euphoric mood (mild mania), severely high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagiline Accord

Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time.

If you stop taking Rasagiline Accord

Do not stop taking Rasagiline 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, Rasagiline Accord can cause side effects, although not everybody gets them.
If you experience any of the following side effects, contact your doctor immediately.You may need urgent medical attention or treatment:

• if you experience unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behavior, increased libido, or hypersexuality (impulse control disorders, see section 2).
• if you see or hear things that are not there (hallucinations).
• if you experience any of the following symptoms: hallucinations, fever, agitation, tremor, and sweating (serotonin syndrome).

Consult your doctorif you notice any suspicious changes in your skin, as treatment with Rasagiline Accord may increase the risk of skin cancer (melanoma) (see section 2).
Other side effects

Very common(affecting more than 1 in 10 people):

• involuntary movements (dyskinesia)
• headache

Common(affecting up to 1 in 10 people):

• abdominal pain
• falls
• allergic reactions
• fever
• flu-like symptoms
• weakness (asthenia)
• neck pain
• chest pain (angina pectoris)
• low blood pressure when standing up, with symptoms similar to dizziness (orthostatic hypotension)
• decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• flatulence
• abnormal blood test results (leukopenia)
• joint pain
• musculoskeletal pain (musculoskeletal pain)
• arthritis
• numbness and weakness of the hand (carpal tunnel syndrome)
• weight loss
• nightmares
• difficulty coordinating muscle groups (balance disorders)
• depression
• vertigo
• prolonged muscle contractions (dystonia)
• runny nose (rhinitis)
• skin irritation (dermatitis)
• rash
• eye redness (conjunctivitis)
• sudden need to urinate

Uncommon(affecting up to 1 in 100 people):

• stroke
• heart attack
• blistering rash (vesiculobullous rash)

Unknown(frequency cannot be estimated from available data)

• high blood pressure
• excessive drowsiness
• sudden sleep onset

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization 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 which is stated on the carton, bottle, or blister after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Rasagiline Accord contains

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).
• The other ingredients are: microcrystalline cellulose, corn starch, pregelatinized starch (corn), 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 beveled edges.
Rasagiline Accord is packaged in aluminum/aluminum blisters or PVC/PE/PVdC/aluminum blisters in a cardboard box, or HDPE bottles in a cardboard box.
Available pack sizes:
Blisters: 7, 10, 28, 30, 60, 100, or 112 tablets and single-dose blisters containing 7x1, 10x1, 28x1, 30x1, 60x1, 100x1, or 112x1 tablets.
HDPE container: 30 tablets
The HDPE container is closed with a child-resistant cap.
The container contains a desiccant (silica gel), which maintains the appropriate humidity. Do not swallow it.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 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

Rasagiline Accord has been authorized in the Member States of the European Economic Area (EEA) under the following names:

Date of last revision of the package leaflet: December 2022