Ralzyo^® contains the active substance rasagiline and it is used for the treatment of Parkinson’s disease in adults. It can be used together with or without Levodopa (another medicine that is used to treat Parkinson’s disease).

With Parkinson’s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain involved in movement control. Ralzyo^® helps to increase and sustain levels of dopamine in the brain.

Do not take Ralzyo^®

• 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 while taking Ralzyo^®:

• Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson’s disease, or used for any other indication), including medicinal and natural products without prescription e.g. St. John’s Wort.

• Pethidine (a strong pain killer).

You must wait at least 14 days after stopping Ralzyo^® treatment before starting treatment with MAO inhibitors or pethidine.

Warning and precautions

Talk to your doctor before taking Ralzyo^®

• If you have any liver problems

• You should speak with your doctor about any suspicious skin changes. Treatment with Ralzyo^® may possibly increase the risk of skin cancer.

Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to yourself or others. These are called impulse control disorders. In patients taking Ralzyo^® and/or other medicines used to treat Parkinson’s disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Ralzyo^® may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson’s disease). For further information please refer to section driving and using machines.

Children and adolescents

There is no relevant use of Ralzyo^® in children and adolescents. Therefore, Ralzyo^® is not recommended for use under the age of 18.

Other medicines and Ralzyo^®

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:

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)

• The antibiotic ciprofloxacin used against infections

• The cough suppressant dextromethorphan

• Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine

The use of Ralzyo^® together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Ralzyo^®, you should wait at least 5 weeks after stopping fluoxetine treatment.

If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Ralzyo^® treatment.

Tell your doctor or pharmacist if you are smoking or intend to stop smoking. Smoking could decrease the amount of Ralzyo^® in the blood.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should avoid taking Ralzyo^® if you are pregnant, as the effects of rasagiline on pregnancy and the unborn child are not known

Driving and using machines

Ask your doctor for advice before you drive and operate machines, since Parkinson’s disease itself as well as the treatment with Ralzyo^® may influence your ability to do so. Ralzyo^® can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.

This might be enhanced if you take other medicines to treat the symptoms of your Parkinson’s disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking Ralzyo^®. If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking Ralzyo^® do not drive or operate machinery (see section 2).

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose of Ralzyo^® is 1 tablet of 1 mg taken by mouth once daily. Ralzyo^® may be taken with or without food.

If you take more Ralzyo^® than you should

If you think that you may have taken too many Ralzyo^® tablets, contact your doctor or pharmacist immediately. Take the Ralzyo^® carton or bottle with you to show the doctor or pharmacist.

Symptoms reported following overdose of Ralzyo^® included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).

If you forget to take Ralzyo^®

Do not take a double dose to make up for a forgotten dose. Take the next dose normally, when it is time to take it.

If you stop taking Ralzyo^®

Do not stop taking Ralzyo^® without first talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor right away if you notice any of the following symptoms. You may need urgent

medical advice or treatment:

• If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).

• If you see or hear things which are not there (hallucinations).

• Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome)

Contact your doctor if you notice any suspicious skin changes because there may be an increased risk of skin cancer (melanoma) 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

• Fall

• Allergy

• Fever

• Flu (influenza)

• General feeling of being unwell (malaise)

• Neck pain

• Chest pain (angina pectoris)

• Low blood pressure when rising to a standing position with symptoms like dizziness/light-headedness (orthostatic hypotension)

• Decreased appetite

• Constipation

• Dry mouth

• Nausea and vomiting

• Flatulence

• Abnormal results of blood tests (leucopenia)

• Joint pain (arthralgia)

• Musculoskeletal pain

• Joint inflammation (arthritis)

• Numbness and muscle weakness of the hand (carpal tunnel syndrome)

• Decreased weight

• Abnormal dreams

• Difficulty in muscular coordination (balance disorder)

• Depression

• Dizziness (vertigo)

• Prolonged muscle contractions (dystonia)

• Runny nose (rhinitis)

• Irritation of the skin (dermatitis)

• Rash

• Bloodshot eyes (conjunctivitis)

• Urinary urgency

Uncommon (may affect up to 1 in 100 people):

• Stroke (cerebrovascular accident)

• Heart attack (myocardial infarction)

• Blistering rash (vesiculobullous rash)

• Not known: frequency cannot be estimated from the available data

• Elevated blood pressure

• Excessive drowsiness

• Sudden onset of sleep

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

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 and bottle. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.