RASAGILINE RATIO 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Rasagiline ratio 1 mg tablets EFG

rasagiline

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Rasagiline ratio contains the active substance rasagiline and is indicated for the treatment of Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine used to treat Parkinson's disease).

In Parkinson's disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a brain chemical involved in controlling movement. Rasagiline ratio helps to increase and maintain dopamine levels in the brain.

2. What you need to know before you take Rasagiline ratio

Do not take Rasagiline ratio

• 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 rasagiline:

• Monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including non-prescription medicines and natural products, e.g. St. John's Wort.
• Pethidine (a strong painkiller).

You should wait at least 14 days after stopping treatment with rasagiline before starting treatment with MAOIs or pethidine.

Warnings and precautions

Consult your doctor before taking Rasagiline ratio

• If you have any liver problems.
• You should discuss with your doctor any suspicious changes in your skin. Treatment with rasagiline may possibly increase the risk of skin cancer.

Tell your doctor if you or your family/caregiver notice that you are developing unusual behaviours where you cannot resist the impulse, urge or temptation to perform certain harmful or hazardous activities to yourself or others. These are called impulse control disorders. In patients taking rasagiline or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour, and an abnormally high sexual drive or increased sexual thoughts and feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagiline ratio may cause you to feel dizzy or sleepy, or to suddenly fall asleep during everyday activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). If you would like more information, see the section “Driving and using machines”.

Children and adolescents

The use of Rasagiline ratio in children and adolescents is not appropriate. Therefore, Rasagiline ratio is not recommended for people under 18 years of age.

Other medicines and Rasagiline ratio

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor especially if you are taking any of the following medicines:

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin and noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants).
• The antibiotic ciprofloxacin used against infections.
• The cough suppressant dextromethorphan.
• Sympathomimetics such as those found in eye drops, nasal decongestants, and oral and anti-cough medicines that contain ephedrine or pseudoephedrine.

The use of rasagiline with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you are starting treatment with rasagiline, you should wait at least 5 weeks after stopping treatment with fluoxetine. If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping treatment with rasagiline.

Tell your doctor or pharmacist if you smoke or intend to stop smoking. Smoking may decrease the amount of Rasagiline ratio 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.

You should avoid taking Rasagiline ratio if you are pregnant, as the effects of rasagiline on pregnancy and the fetus are unknown.

Driving and using machines

Consult your doctor before driving or using machines, as both Parkinson's disease and treatment with rasagiline may affect your ability to perform these activities. Rasagiline may cause you to feel dizzy or sleepy, as well as sudden episodes of sleepiness.

This may increase if you take other medicines for treating the symptoms of Parkinson's disease, if you take medicines that may cause you to feel sleepy, or if you consume alcohol during treatment with rasagiline. If you have experienced sleepiness and/or sudden episodes of sleepiness before or during treatment with Rasagiline ratio, do not drive or use machines (see section 2).

3. How to take Rasagiline ratio

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended dose of Rasagiline ratio is one 1 mg tablet taken by mouth, once a day. Rasagiline ratio can be taken with or without food.

If you take more Rasagiline ratio than you should

If you think you have taken more tablets of Rasagiline ratio than you should, tell your doctor or pharmacist immediately. Take the package leaflet and/or the bottle of Rasagiline ratio with you to show the doctor or pharmacist.

The symptoms reported after an overdose of rasagiline were mildly euphoric mood (a mild form of mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take Rasagiline ratio

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 ratio

Do not stop taking Rasagiline ratio without talking to your doctor first.

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

4. Possible side effects

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

Seek immediate medical attentionif you experience any of the following symptoms. You may need urgent medical treatment:

• If you experience unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour, and an abnormally high sexual drive or increased sexual thoughts and feelings (impulse control disorders) (see section 2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremors, and sweating (serotonin syndrome).
• Tell your doctorif you notice any suspicious changes in your skin, as 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.
• Falls.
• Allergic reactions.
• Fever.
• Flu (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing up with symptoms such as dizziness/lightheadedness (orthostatic hypotension)
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Abnormal blood test results (leucopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint inflammation (arthritis).
• Numbness and muscle weakness in the hand (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Muscle coordination problems (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urinary urgency.

Uncommon (may affect up to 1 in 100 people)

• Stroke (cerebrovascular accident).
• Heart attack (myocardial infarction).
• Blistering rash (vesiculobullous rash).

Frequency not known: cannot be estimated from the available data

• High blood pressure.
• Excessive sleepiness.
• Sudden sleepiness.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rasagiline ratio

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 the month shown.

Do not store above 30°C.

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

Composition of Rasagiline ratio

• The active substance is rasagiline (as mesylate). Each tablet contains rasagiline mesylate equivalent to 1 mg of rasagiline.
• The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, and talc.

Appearance and packaging of the product

Rasagiline ratio tablets are presented as white or almost white, round, flat, and bevelled tablets with a diameter of 8 mm, with the inscription "GIL" and "1" in relief on the lower part of one face and smooth on the other face.

The tablets are presented in blister packs of 7, 10, 28, 30, 100, and 112 tablets, single-dose blister packs of 10x1, 30x1, and 100x1, or in a bottle with 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas 28108 Madrid

Spain

Manufacturer

Pliva Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

Or

Teva Operations Poland Sp.zo.o

80 Mogilska Str.

31-546 Krakow

Poland

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain: Rasagilina ratio 1 mg tablets EFG

Sweden: Rasagiline ratio

Date of last revision of this leaflet: January 2021