Prospect: Information for the user

ANAXIRA 1 mg tablets EFG

Rasagilina

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

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

1.What Anaxira is and for what it is used

2.What you need to know before starting to take Anaxira

3.How to take Anaxira

4.Possible adverse effects

5.Storage of Anaxira

6.Contents of the package and additional information

Anaxira 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. Rasagilina helps to increase and maintain dopamine levels in the brain.

Do not take Anaxira

-if you are allergic to rasagilina or any of the other components of this medication (listed in section 6).

-if you have severe liver problems.

Do not take the following medications while taking rasagilina:

-monoamine 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.

-petidina (a potent analgesic).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take rasagilina.

-If you have any liver problems.

-You should talk to your doctor about any suspicious changes in your skin.

Inform your doctor if you or your family/caregiver notice that you are exhibiting unusual behaviors that you cannot resist, an urgent need or an intense desire to perform certain activities that are harmful or detrimental to yourself or others. These are known as impulse control disorders. In patients taking rasagilina 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 section 4).

Rasagilina 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 rasagilina in children and adolescents is not relevant. Therefore, rasagilina is not recommended for minors under 18 years old.

Use of Anaxira with other medications

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).

-the antibiotic ciprofloxacin used against infections.

-the antitussive dextromethorphan.

-sympathomimetics such as those found in eye drops, nasal and oral decongestants, and medications for cataracts containing ephedrine or pseudoephedrine.

You should avoid using rasagilina with antidepressants containing fluoxetine or fluvoxamine. If you are starting your treatment with rasagilina, you should wait at least 5 weeks since the interruption of treatment with fluoxetine.

If you are starting your treatment with fluoxetine or fluvoxamine, you should wait at least 14 days since the interruption of treatment with rasagilina.

Inform your doctor if you smoke or intend to quit smoking. Smoking may decrease the amount of rasagilina in the blood.

TakingAnaxirawith food and drinks

Anaxira can be taken with or without food.

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.

You should avoid taking rasagilina if you are pregnant, as the effects of rasagilina 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 rasagilina may affect your ability to perform these activities. Rasagilina may cause dizziness or drowsiness, as well as sudden episodes of sleep.

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 treatment with rasagilina. If you have experienced drowsiness and/or sudden episodes of sleep before or during treatment with rasagilina, do not drive or operate machines (see section 2).

Anaxira contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

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 rasagilina is 1 tablet of 1 mg taken by mouth, once a day. Rasagilina can be taken with or without food.

If you take more Anaxira than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging of rasagilina to show to your doctor or pharmacist.

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

If you forgot to take Anaxira

Do not take a double dose to compensate for the missed doses.

Take the next regular dose when it is due.

If you interrupt treatment with Anaxira

Do not stop taking rasagilina 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 medicine may 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 behavior, 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).
• If you notice any suspicious changes in the skin, as there is a higher risk of skin cancer (not exclusively melanoma) in patients with Parkinson's disease (see section2).

Other side effects

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

-Unintentional movements (dyskinesia)

-Headache

Common(may affect up to 1 in 10 people):

-Abdominal pain

-Fall

-Allergy

-Fever

-Flu-like syndrome

-General malaise

-Neck pain

-Chest pain (angina pectoris)

-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

-Muscle coordination disorder (balance disorder)

-Depression

-Dizziness (vertigo)

-Prolonged muscle contractions (dystonia)

-Nasal discharge (rhinitis)

-Skin irritation (dermatitis)

-Rash

-Conjunctivitis (red eye)

-Urgency to urinate

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

-Stroke (cerebrovascular accident)

-Heart attack (myocardial infarction)

-Wart-like rash (vesiculobullous rash)

Unknown frequency(cannot be estimated from available data)

-High blood pressure.

-Excessive somnolence.

-Sudden sleep

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. 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 after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Anaxira

-The active principle is rasagilina. Each tablet contains 1 mg of rasagilina (as tartrate).

-The other components are microcrystalline cellulose, anhydrous colloidal silica, sodium starch glycolate type A, povidone K30, phosphoric acid, and stearic acid.

Appearance of the product and contents of the packaging

Anaxira 1 mg tablets are presented in the form of white, round, and flat tablets.

The tablets are presented in blister packs of 30 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible manufacturer:

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Last review date of this leaflet: January 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/