AIDEX 1 mg Tablet

Зміст інструкції

1. Aidex 1 mg tablets
   1. What is Aidex and what is it 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

Aidex 1 mg tablets

Rasagiline
Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Aidex and what is it 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 cells that produce dopamine in certain areas of the brain. Dopamine is a chemical substance in the brain involved in controlling movements. Aidex helps to increase and maintain constant 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 any of the other ingredientsof this medicine (listed in section 6).
• if you have severe liver problems.

Do not take the following medicines while taking Aidex:

• monoamine oxidase inhibitors (MAOIs)(used for example for the treatment of depression or Parkinson's disease or for any other indication), including medicines and herbal products without a prescription, such as St. John's Wort.
• pethidine(a strong painkiller).

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

Warnings and precautions
Talk to your doctor before taking Aidex.

• if you have mild to moderate liver problems.
• Talk to your doctor if you notice any suspicious skin changes. Tell your doctor if you, your family members or your caregivers notice that you are developing unusual behaviours that make you unable to resist the impulse, urge or desire to perform certain activities that are dangerous or harmful to you or others. These behaviours are called impulse control disorders. Patients taking Aidex and/or other medicines used to treat Parkinson's disease have been observed to exhibit behaviours such as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviours and an abnormally increased sexual desire or an increase in sexual thoughts or desires. Your doctor may need to adjust the dose or stop treatment (see section 4).

Aidex can cause drowsiness and may cause you to fall asleep suddenly during the day, especially if you are taking other dopaminergic medicines (used for the treatment of Parkinson's disease). For further information, refer to the section “Driving and using machines”.

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

Other medicines and Aidex
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:

• some antidepressants(selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants);
• the antibiotic ciprofloxacinused to treat infections;
• dextromethorphan, a medicine used for cough;
• sympathomimetics such as those found in eye drops, nasal and oral decongestants and cold medicines 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.
Tell your doctor or pharmacist if you are a smoker or intend to quit smoking. Smoking may reduce the amount of Aidex in the blood.

Aidex with food and drink
Aidex can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking any medicine.
Avoid taking Aidex if you are pregnant, because the effects of Aidex on pregnancy and the foetus are unknown.

Driving and using machines
Ask your doctor for advice before driving and using machines, as both Parkinson's disease itself and treatment with Aidex can affect your ability to do so. Aidex can make you feel dizzy and drowsy; it can also cause sudden episodes of sleepiness.
This may be increased if you are taking other medicines to treat the symptoms of Parkinson's disease or if you are taking medicines that can make you feel sleepy, or if you drink alcohol while taking Aidex. If you have experienced drowsiness and/or sudden episodes of sleepiness in the past or during the taking of Aidex, do not drive or use machines (see section 2).

3. How to take Aidex

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose of Aidex is 1 mg tablet by mouth once a day. Aidex can
be taken with or without food.

If you take more Aidex than you should
If you think you have taken more Aidex tablets than you should, seek medical advice immediately
or contact your pharmacist. Bring the Aidex package with you to show to the doctor or pharmacist.
Symptoms reported after an overdose of Aidex included a slightly euphoric mood
(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 a missed tablet. Take the next
dose as normal, when it is time to take it.

If you stop taking Aidex
Do not stop taking Aidex without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediatelyif you notice any of the following symptoms. You may need immediate medical attention or treatment:

• If you develop unusual behaviour such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour and an abnormally increased sexual desire or increased sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that are not there (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin

syndrome).

Contact your doctorif you notice suspicious skin changes, because 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 symptoms (influenza)
• general feeling of being unwell (malaise)
• neck pain
• chest pain (angina pectoris)
• low blood pressure when standing up, accompanied by symptoms such as dizziness/lightheadedness (orthostatic hypotension)
• decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• flatulence
• abnormal blood test results (leukopenia)
• joint pain (arthralgia)
• musculoskeletal pain
• joint inflammation (arthritis)
• numbness and weakness of the hand muscle (carpal tunnel syndrome)
• weight loss
• abnormal dreams
• difficulty with muscle coordination (balance disorders)
• depression
• dizziness
• prolonged muscle contractions (dystonia)
• runny nose (rhinitis)
• skin irritation (dermatitis)
• rash
• red eyes (conjunctivitis)
• urgent need to urinate

Uncommon (may affect up to 1 in 100 people)

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

Not known: frequency cannot be estimated from available data

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

Reporting of side effects
If you get 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 through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help 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 which is stated on the package or blister. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aidex contains

• The active ingredient is rasagiline. Each tablet contains 1 mg of rasagiline (as mesylate).
• The other ingredients are microcrystalline cellulose, tartaric acid, corn starch, pregelatinized corn 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 by 6 mm),
biconvex, with “R9SE” imprinted on one side and “1” on the other side.
The tablets are available in packs of 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 Milan (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
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
IT:AIDEX