Azilect 1 mg comprimidos

Product Information for the User

AZILECT 1 mg Tablets

Rasagiline

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

-Keep this leaflet because 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 give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What AZILECT is and what it is used for

2.What you need to know before you start taking AZILECT

3.How to take AZILECT

4.Possible side effects

5.Storage of AZILECT

6.Contents of the pack and additional information

AZILECT contains the active ingredient rasagilina and is indicated for the treatment of Parkinson's disease in adults. It may be used with or without levodopa (another medication 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 brain chemical involved in the control of movement. AZILECT helps to increase and maintain dopamine levels in the brain.

Do not take AZILECT

-If you are allergic to rasagiline or any of the other components of this medication (including those listed in section6).

-If you have severe liver problems.

Do not take the following medications while taking AZILECT:

• Monamine oxidase inhibitors (MAO) (e.g., for the treatment of depression or Parkinson's disease, or for another indication) including medications and natural products without a prescription, e.g., St. John's Wort.
• Pethidine (a potent analgesic).

You should wait at least 14days after stopping treatment with AZILECT and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Consult your doctor before starting to take AZILECT

-If you have any liver problems.

-You should talk to your doctor about any suspicious changes in your skin.The treatment with AZILECT may possibly increase the risk of skin cancer.

Inform your doctor if you or your family/caregiver notice that you are exhibiting abnormal behaviors in which you cannot resist the impulse, the urgent need or the craving to perform certain harmful or detrimental activities for yourself or for others. These are known as impulse control disorders. In patients taking AZILECT and/or other medications used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, ludomania, excessive spending, impulsive behavior, and an abnormally high or increased sexual impulse or thoughts have been observed. Your doctor may need to adjust or discontinue your dose (see section4).

AZILECT may cause drowsiness and make you fall asleep suddenly while performing daily activities, especially if you are taking other dopaminergic medications (used to treat Parkinson's disease). If you want more information, see the section “Driving and operating machines”.

Children and adolescents

The use of AZILECT in children and adolescents is not relevant. Therefore, AZILECT is not recommended for minors under 18years.

Other medications and AZILECT

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor especially if you are taking any of the following medications:

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

-Ciprofloxacin, an antibiotic used against infections.

-Dextromethorphan, a cough suppressant.

-Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and anticholinergic medications containing ephedrine or pseudoephedrine.

Avoid using AZILECT with antidepressants containing fluoxetine or fluvoxamine. If you are starting treatment with AZILECT, wait at least 5weeks since stopping treatment with fluoxetine.

If you are starting treatment with fluoxetine or fluvoxamine, wait at least 14days since stopping treatment with AZILECT.

Inform your doctor or pharmacist if you smoke or plan to quit smoking. Smoking may decrease the amount of AZILECT in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Avoid taking AZILECT if you are pregnant, as the effects of AZILECT on pregnancy and the fetus are unknown.

Driving and operating machines

Consult your doctor before driving or operating machines, as both Parkinson's disease and treatment with AZILECT may affect your ability to perform these activities. AZILECT may cause dizziness or drowsiness, as well as sudden sleep episodes.

This may increase if you take other medications for Parkinson's disease symptoms, if you take medications that can cause drowsiness, or if you consume alcohol during AZILECT treatment. If you have experienced drowsiness and/or sudden sleep episodes before or during AZILECT treatment, do not drive or operate machines (see section2).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

If you take more AZILECT than you should

If you think you have taken more AZILECT tablets than you should, inform your doctor or pharmacist immediately. Bring the AZILECT box/pouch or bottle with you to show to your doctor or pharmacist.

The symptoms reported after an AZILECT overdose were mildly euphoric mood (mild mania), very high blood pressure, and serotonin syndrome (see section4).

If you forget to take AZILECT

Do not take a double dose to make up for the missed dose. Take the next scheduled dose normally.

If you stop taking AZILECT

Do not stop taking AZILECT without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

Immediately contact your doctorif you experience any of the following symptoms. You may need treatment or urgent medical attention:

• If you experience unusual behaviors such as, for example, compulsions, obsessive thoughts, compulsive gambling, excessive spending or purchases, impulsive behavior, and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremors, and sweating (serotonin syndrome).

Contact your doctorif you observe any suspicious changes in your skin, as there may be an increased risk of skin cancer (melanoma) with the use of this medicine (see section2).

Other side effects

Very common (may affect more than 1 in 10people)

-Unintentional movements (dyskinesia).

-Headache.

Common (may affect up to 1 in 10people)

-Abdominal pain.

-Falls.

-Allergy.

-Fever.

-Flu (influenza).

-General feeling of being unwell.

-Neck pain.

-Chest pain (angina).

-Low blood pressure when standing with symptoms such as dizziness/dizziness (orthostatic hypotension).

-Decreased appetite.

-Constipation.

-Dry mouth.

-Nausea and vomiting.

-Flatulence.

-Alteration of blood test results (leucopenia).

-Joint pain (arthralgia).

-Musculoskeletal pain.

-Arthritis.

-Hand numbness and weakness (carpal tunnel syndrome).

-Weight loss.

-Abnormal dreams.

-Difficulty with muscle coordination (balance disorder).

-Depression.

-Dizziness (vertigo).

-Prolonged muscle contractions (dystonia).

-Nasal discharge (rhinitis).

-Skin irritation (dermatitis).

-Rash.

-Eye redness (conjunctivitis).

-Urgency to urinate.

Uncommon (may affect up to 1 in 100people)

-Stroke (cerebrovascular accident).

-Heart attack (myocardial infarction).

-Herpes zoster (shingles).

Frequency not known: cannot be estimated from available data

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

Reporting of side effects

If you experience any type of side effect, consult your doctororpharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, bottle or blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of AZILECT

-The active ingredient is rasagiline. Each tablet contains 1 mg of rasagiline (as mesylate).

-The other components are mannitol, anhydrous colloidal silica, cornstarch, pregelatinized cornstarch, stearic acid, and talc.

Appearance of the product and contents of the package

AZILECT tablets are presented in the form of white or off-white, round, flat, and bisected tablets, with the inscription in relief “GIL” and “1” 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 or in a bottle with 30 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

Teva Pharmaceuticals Europe B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Pliva Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

Teva Operations Poland Sp.z o.o.

ul. Mogilska 80

31-546 Krakow

Poland

For more information about this medication, please contact the local representative of the marketing authorization holder:

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