Aidex

Package leaflet: Information for the user

Aidex 1 mg tablets

Rasagiline
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Aidex is and what it is used for

Aidex contains the active substance rasagiline and is used in the treatment of Parkinson's disease in adults. It can be used with or without levodopa (another medicine used to treat Parkinson's disease).
In Parkinson's disease, there is a loss of dopamine-producing cells in certain areas of the brain. Dopamine is a chemical in the brain involved in controlling movement. Aidex helps increase and maintain stable levels of dopamine in the brain.

2. What you need to know before taking Aidex

Do not take Aidex:

• if you are allergic to rasagiline or to 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 Aidex:

• monoamine oxidase inhibitors (MAO inhibitors) (used, for example, to treat depression or Parkinson's disease, or for any other indication), including medicines and non-prescription natural products such as St. John’s wort.
• pethidine (a strong painkiller).

Wait at least 14 days after stopping treatment with Aidex before starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Talk to your doctor before taking Aidex:

• if you have mild to moderate liver problems.
• if you notice any suspected changes in your skin. Inform your doctor if you, your family members, or caregivers notice that you are developing unusual behaviors that make you unable to resist the impulse, urge, or desire to carry out certain activities that may be dangerous or harmful to yourself or others. These behaviors are known as impulse control disorders. In patients taking Aidex and/or other medicines used to treat Parkinson’s disease, such behaviors as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviors, abnormally increased sex drive, or increased sexual thoughts or desires have been observed. Your doctor may need to adjust your dose or stop treatment (see section 4).

Aidex may cause drowsiness and may cause you to fall asleep suddenly during daytime activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson’s disease). For further information, refer to the section “Driving and use of machines”.

Children and adolescents

There is no indication for the use of Aidex in children and adolescents. Therefore, the use of Aidex is not recommended in patients under 18 years of age.

Other medicines and Aidex

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

In particular, inform your doctor if you are taking any of the following medicines:

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

Avoid using Aidex with antidepressants containing fluoxetine or fluvoxamine.

Before starting treatment with Aidex, you must wait at least 5 weeks after stopping treatment with fluoxetine.

Before starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with Aidex.

Inform your doctor or pharmacist if you are a smoker or plan to stop smoking. Smoking may reduce the amount of Aidex in your blood.

Aidex with food and drink

Aidex may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking any medicine.

Avoid taking Aidex during pregnancy, as the effects of Aidex on pregnancy and the unborn baby are unknown.

Driving and use of machines

Ask your doctor for advice before driving or using machines, as Parkinson’s disease itself and treatment with Aidex may affect your ability to do so. Aidex may cause dizziness and drowsiness; it may also cause sudden episodes of falling asleep.

This effect may be increased if you are taking other medicines to treat symptoms of Parkinson’s disease, or if you are taking other medicines that may cause drowsiness, or if you drink alcohol while taking Aidex. If you have previously experienced drowsiness and/or sudden episodes of falling asleep, either in the past or during treatment with Aidex, do not drive or operate machinery (see section 2).

3. How to take Aidex

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Aidex is 1 tablet of 1 mg taken orally once daily. Aidex may be taken with or without food.
If you take more Aidex than you should
If you think you have taken more tablets of Aidex than you should, contact your doctor or pharmacist immediately. Take the pack of Aidex with you to show the doctor or pharmacist.
Symptoms reported following an overdose of Aidex included slightly elevated mood (a mild form of mania), extremely high blood pressure, and serotonin syndrome (see section 4).
If you forget to take Aidex
Do not take a double dose to make up for the forgotten tablet. Take the next dose as scheduled, at the usual time.
If you stop taking Aidex
Do not stop taking Aidex without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following symptoms. You may need
urgent medical advice or treatment:

• If you develop unusual behaviour such as compulsions, obsessive thoughts, gambling addiction, excessive shopping or spending, impulsive behaviours, abnormally increased sexual desire or increased sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that are not real (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome).
  Contact your doctor if you notice suspicious skin changes, as the risk of skin cancer (melanoma) may increase with the use of this medicine (see section 2).

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

• abnormal movements (dyskinesia)
• headache

Common (may affect up to 1 in 10 people)

• abdominal pain
• falls
• allergy
• fever
• flu-like illness (influenza)
• general feeling of being unwell (malaise)
• neck pain
• chest pain (angina pectoris)
• decrease in blood pressure when standing up, accompanied by symptoms such as dizziness/light-headedness (orthostatic hypotension)
• decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• flatulence
• abnormal results in blood tests (leucopenia)
• joint pain (arthralgia)
• musculoskeletal pain
• inflammation of the joints (arthritis)
• numbness and weakness of the hand muscle (carpal tunnel syndrome)
• loss of body weight
• abnormal dreams
• difficulty with muscle coordination (balance disorders)
• depression
• dizziness
• prolonged muscle contractions (dystonia)
• runny nose (rhinitis)
• skin irritation (dermatitis)
• rash
• red eyes (conjunctivitis)
• urgency to urinate

Uncommon (may affect up to 1 in 100 people)

• stroke (cerebrovascular accident)
• heart attack (myocardial infarction)
• skin blisters (erythema bullous)

Not known: frequency cannot be estimated from the available data

• high blood pressure
• excessive sleepiness
• sudden onset of sleep

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Aidex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Aidex contains

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as tartrate).
• The other components are microcrystalline cellulose, tartaric acid, maize starch, pregelatinized maize starch, talc, stearic acid.

Description of the appearance of Aidex and contents of the pack
Aidex tablets are white to off-white, oblong (approximately 11.5 mm x 6 mm), biconvex, with "R9SE" engraved on one side and "1" on the other side.
The tablets are available in packs containing 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder:
Ecupharma S.r.l. - Via Mazzini 20 - 20123 Milano (Italy).

Manufacturers:
Synthon Hispania S.L.
C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat, Barcelona
Spain
Synthon s.r.o.
Brněnská 32/čp.597, Blansko
678 01 Czech Republic
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
IT: AIDEX