Rasagiline EG
Italy
Table of Contents
Package leaflet: Information for the user
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 give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Rasagilina EG is and what it is used for
- What you need to know before taking Rasagilina EG
- How to take Rasagilina EG
- Possible side effects
- How to store Rasagilina EG
- Contents of the pack and other information
1. What Rasagilina EG is and what it is 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).
In Parkinson's disease, there is a loss of dopamine-producing cells in the
brain. Dopamine is a chemical in the brain involved in the control of movement.
Rasagilina EG helps increase and maintain stable 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 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 Rasagilina EG:
- monoamine oxidase inhibitors (MAOIs) (used, for example, for the treatment of depression or Parkinson's disease or for any other indication), including non-prescription medicines and natural products such as St. John’s wort
- meperidine (a strong analgesic)
Wait at least 14 days after stopping treatment with Rasagilina EG before starting treatment with MAO inhibitors or meperidine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rasagilina EG if:
- you have mild to moderate liver problems
- you notice any suspicious changes in 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:
- 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 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.
Inform your doctor if you, your family members, or your caregiver 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 you or others. These behaviors are known as impulse control disorders. In patients taking Rasagilina EG and/or other medicines used to treat Parkinson’s disease, behaviors such as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviors, and abnormally increased sexual desire or increased sexual thoughts or desires have been observed. Your doctor may need to adjust your dose or discontinue treatment.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No studies have been conducted regarding the effects on the ability to drive vehicles or use machinery. Ask your doctor for advice before driving or operating machinery.
3. How to take Rasagilina EG
Take this medicine exactly as your doctor has told you. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose of Rasagilina EG is 1 tablet of 1 mg taken orally once daily.
For oral use.
Rasagilina EG may be taken with or without food.
If you take more Rasagilina EG than you should
If you think you have taken more tablets of Rasagilina EG than you should, contact your
doctor or pharmacist immediately. Take the Rasagilina EG package with you to show the
doctor or pharmacist.
If you forget to take Rasagilina EG
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 Rasagilina EG
Do not stop taking Rasagilina EG without first talking to your doctor.
If you have any questions about the use of this medicine, consult 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 in placebo-controlled clinical studies.
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)
- drop in blood pressure when standing up, with symptoms such as dizziness/mental confusion (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)
- loss of body weight
- abnormal dreams
- difficulty in muscle coordination (balance disorders)
- depression
- dizziness (vertigo)
- prolonged muscle contractions (dystonia)
- runny nose (rhinitis)
- skin irritation (dermatitis)
- skin rash
- red eyes (conjunctivitis)
- urinary urgency
Uncommon (may affect up to 1 in 100 people):
- stroke (cerebrovascular accident)
- heart attack (myocardial infarction)
- skin rash with blisters (vesiculobullous rash)
Additionally, in placebo-controlled clinical studies, skin cancer was reported in approximately 1% of patients. However, scientific evidence suggests that Parkinson's disease itself, rather than any specific medicine, is associated with a higher risk of skin cancer (not limited to melanoma). Please talk to your doctor about any suspicious changes in your skin.
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.
Cases have been reported of patients, while taking one or more medicines for the treatment of Parkinson's disease, being unable to resist the impulse, desire or temptation to carry out an action that could be harmful to themselves or others.
These behaviours are known as impulse control disorders. The following behaviours have been observed in patients taking rasagiline and/or other medicines used to treat Parkinson's disease:
- obsessive thoughts or impulsive behaviours;
- strong urge to gamble excessively despite serious personal or family consequences;
- altered or increased sexual interest and behaviours significantly concerning to themselves or others, for example increased sexual drive;
- uncontrolled and excessive spending or shopping.
Inform your doctor if any of these behaviours occur; they will discuss with you how to manage or reduce the symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 stated on the carton and blister pack. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Rasagilina EG contains
- The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).
- The other components are microcrystalline cellulose, anhydrous colloidal silica, sodium carboxymethyl starch type A, povidone K30, phosphoric acid, stearic acid.
Description of the appearance of Rasagilina EG and the contents of the pack
Rasagilina EG tablets are white, round, 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 Milano, Italy
Manufacturers:
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, 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 European Economic Area (EEA) Member States under the following names:
Austria Rasagilin STADA 1 mg Tabletten
Belgium Rasagiline EG 1mg tabletten
Germany Rasagilin AL 1 mg Tabletten
Denmark Rasagilin Stada Arzneimittel AG
Spain Rasagilina STADA 1 mg comprimidos EFG
Finland Rasagilin Stada Arzneimittel AG 1 mg tabletti
France RASAGILINE EG 1 mg, comprimé
Croatia Razagilin STADA 1 mg tablete
Hungary Rasagiline Stada 1 mg tabletta
Ireland Rasagiline Clonmel 1 mg tablets
Italy Rasagilina EG
Luxembourg Rasagiline EG 1mg comprimés
Netherlands Rasagiline CF 1 mg, tabletten
Portugal Rasagilina Ciclum
Sweden Rasagilin Stada Arzneimittel AG 1 mg tablett
Slovenia Razagilin STADA 1 mg tablete
Slovakia Rasagiline Stada