RASAGILINA 1 mg Tabletka

Treść ulotki

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

Rasagilina EG 1 mg tablets

Generic medicine

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 Rasagilina EG is and what it is used for
• 2. What you need to know before you take Rasagilina EG
• 3. How to take Rasagilina EG
• 4. Possible side effects
• 5. How to store Rasagilina EG
• 6. Contents of the pack and other information

1. What is Rasagilina EG and what is it used for

Rasagilina EG is used in the treatment of Parkinson's disease. It can be used with
or without levodopa (another medicine 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 chemical substance in the brain involved in the control of movements.
Rasagilina EG helps to increase and maintain constant levels of dopamine in the brain.

2. What you need to know before taking Rasagilina EG

Do not take Rasagilina EG:

• 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 Rasagilina EG:

• 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 available without a prescription, such as St John's Wort
• pethidine (a strong painkiller)

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Rasagilina EG.

• if you suffer from mild to moderate liver problems
• if you notice any suspicious changes to your skin.

Children and adolescents
The use of Rasagilina EG is not recommended in children and adolescents under 18 years of age.

Other medicines and Rasagilina EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, or if you are a smoker or if you intend to stop smoking.
Ask your doctor for advice before taking any of the following medicines together with Rasagilina EG:

• some antidepressants (selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
• ciprofloxacin, an antibiotic used 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 Rasagilina EG with antidepressants containing fluoxetine or fluvoxamine.
Before starting treatment with Rasagilina EG, you must wait at least five weeks after stopping treatment with fluoxetine.
Before starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with Rasagilina EG.
Tell your doctor if you, your family members or caregivers notice that you are developing unusual behaviours that make you unable to resist the impulse, urge or desire to carry out certain activities that are dangerous or harmful to you or others. These behaviours are called impulse control disorders. In patients taking Rasagilina EG and/or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviours and an abnormally high sexual desire or increased sexual thoughts or desires have been observed. Your doctor may need to adjust the dose or stop treatment.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No studies have been conducted regarding the effects on the ability to drive and operate machinery. Ask your doctor for advice before driving and using machines.

3. How to take Rasagilina EG

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

If you take more Rasagilina EG than you should
If you think you have taken more Rasagilina EG tablets than you should, contact
your doctor or pharmacist immediately. Bring the package of Rasagilina EG with you to
show to the doctor or pharmacist.

If you forget to take Rasagilina EG
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 Rasagilina EG
Do not stop taking Rasagilina EG 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.
The following side effects have been reported during controlled clinical studies versus placebo.
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 syndrome (influenza)
• general feeling of being unwell (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 results in blood tests (leucopenia)
• 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 (vertigo)
• 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)
• blistering rash (bullous erythema)

In addition, in controlled clinical studies versus placebo, skin cancer was reported in approximately 1% of patients. However, scientific evidence suggests that Parkinson's disease, and not a particular medicine, is associated with an increased risk of skin cancer (not exclusively melanoma). Talk to your doctor about any suspicious skin changes.
Parkinson's disease is associated with symptoms such as hallucinations and confusion. In post-marketing experience, these symptoms have also been observed in patients with Parkinson's disease treated with rasagiline.
There have been reports of patients who, while taking one or more medicines for the treatment of Parkinson's disease, have been unable to resist the urge, the desire, or the temptation to perform an action that could be harmful to themselves or others.
These behaviors are called impulse control disorders. In patients taking rasagiline and/or other medicines used to treat Parkinson's disease, the following behaviors have been observed:

• obsessive thoughts or compulsive behaviors;
• strong urge to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and behaviors that are significantly disturbing to oneself or others, for example, an increase in sexual impulse;
• uncontrollable and excessive spending or shopping.

Tell your doctor if you experience any of these behaviors; they will discuss with you how to manage or reduce the symptoms.

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
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported during controlled clinical studies versus placebo.
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 syndrome (influenza)
• general feeling of being unwell (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 results in blood tests (leucopenia)
• 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 (vertigo)
• 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)
• blistering rash (bullous erythema)

In addition, in controlled clinical studies versus placebo, skin cancer was reported in approximately 1% of patients. However, scientific evidence suggests that Parkinson's disease, and not a particular medicine, is associated with an increased risk of skin cancer (not exclusively melanoma). Talk to your doctor about any suspicious skin changes.
Parkinson's disease is associated with symptoms such as hallucinations and confusion. In post-marketing experience, these symptoms have also been observed in patients with Parkinson's disease treated with rasagiline.
There have been reports of patients who, while taking one or more medicines for the treatment of Parkinson's disease, have been unable to resist the urge, the desire, or the temptation to perform an action that could be harmful to themselves or others.
These behaviors are called impulse control disorders. In patients taking rasagiline and/or other medicines used to treat Parkinson's disease, the following behaviors have been observed:

• obsessive thoughts or compulsive behaviors;
• strong urge to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and behaviors that are significantly disturbing to oneself or others, for example, an increase in sexual impulse;
• uncontrollable and excessive spending or shopping.

Tell your doctor if you experience any of these behaviors; they will discuss with you how to manage or reduce the symptoms.

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
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rasagilina EG

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 and on the blister. The
expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
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 Rasagilina EG contains

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).
• The other ingredients are microcrystalline cellulose, anhydrous colloidal silicon dioxide, sodium carboxymethylcellulose type A, povidone K30, phosphoric acid, stearic acid.

Description of the appearance of Rasagilina EG and contents of the pack
Rasagilina EG tablets are presented in the form of round, white, biconvex tablets with a
diameter of 6 mm.
The tablets are available in blister packs containing 7, 10, 14, 28, 30, 56, 60, 84, 90, 98,
100, 112, 140, 168 and 180 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milan
Manufacturer
STADA Arzneimittel AG, Stadastrasse 2 – 18 61118 Bad Vilbel – Germany
STADA Arzneimittel GmbH, Muthgasse 36/2 1190 Vienna – Austria
Centrafarm Services B.V., Nieuwe Donk 9 NL- 4879 AC Etten-Leur – Netherlands
Clonmel Healthcare Ltd., Waterford Road Clonmel, Co. Tipperary – Ireland
STADA Nordic ApS, Marielundvej 46° 2730 Herlev – Denmark

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria Rasagilin STADA 1 mg Tablets
Belgium Rasagiline EG 1mg tablets
Germany Rasagilin AL 1 mg Tablets
Denmark Rasagilin Stada Arzneimittel AG
Spain Rasagilina STADA 1 mg comprimidos EFG
Finland Rasagilin Stada Arzneimittel AG 1 mg tablet
France RASAGILINE EG 1 mg, coated tablet
Croatia Razagilin STADA 1 mg tablets
Hungary Rasagiline Stada 1 mg tablet
Ireland Rasagiline Clonmel 1 mg tablets
Italy Rasagilina EG
Luxembourg Rasagiline EG 1mg comprimés
Netherlands Rasagiline CF 1 mg, tablets
Portugal Rasagilina Ciclum
Sweden Rasagilin Stada Arzneimittel AG 1 mg tablet
Slovenia Razagilin STADA 1 mg tablete
Slovakia Rasagiline Stada