Raglysa 1 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Raglysa 1 mg tablets EFG
rasagiline
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Raglysa is and what it is used for
- What you need to know before taking Raglysa
- How to take Raglysa
- Possible side effects
- How to store Raglysa
- Contents of the pack and other information
1. What Raglysa is and what it is used for
Raglysa contains the active substance rasagiline and is indicated for 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 the brain. Dopamine is a chemical substance in the brain involved in the control of movement. Rasagiline helps increase and maintain dopamine levels in the brain.
2. What you need to know before taking Raglysa
Do not take Raglysa
- 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 rasagiline:
- Monoamine oxidase inhibitors (MAO inhibitors) (e.g. for the treatment of depression or Parkinson's disease, or for other indications), including prescription and non-prescription medicines and herbal products, e.g. St. John’s wort.
- Meperidine (a strong painkiller).
You must wait at least 14 days after stopping rasagiline before starting treatment with MAO inhibitors or meperidine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Raglysa:
- If you have any liver problems.
- You should speak with your doctor about any suspicious changes in your skin. Treatment with Raglysa might possibly increase the risk of skin cancer.
Tell your doctor if you or your family/carer notice any unusual behaviour where you cannot resist the impulse, urgent need, or desire to carry out certain harmful or damaging activities. These are known as impulse control disorders. In patients taking Raglysa and/or other medicines used to treat Parkinson’s disease, behaviours such as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behaviour, and abnormally increased sex drive or increased sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).
Raglysa may cause drowsiness and cause you to fall asleep suddenly during everyday activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson’s disease). For further information, see section “Driving and use of machines”.
Children and adolescents
The use of Raglysa in children and adolescents is not relevant. Therefore, Raglysa is not recommended for patients under 18 years of age.
Other medicines and Raglysa
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Tell your doctor especially 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 for infections.
- The cough suppressant dextromethorphan.
- Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine.
The use of rasagiline together with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you are starting treatment with rasagiline, you must wait at least 5 weeks after stopping treatment with fluoxetine.
If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with rasagiline.
Tell your doctor or pharmacist if you smoke or plan to stop smoking. Smoking may reduce the amount of Raglysa in your blood.
Taking Raglysa with food and drink
Rasagiline may be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
You should avoid taking Raglysa if you are pregnant, as the effects of Raglysa on pregnancy and the unborn baby are unknown.
Driving and use of machines
Consult your doctor before driving or operating machinery, as both Parkinson’s disease and treatment with Raglysa may affect your ability to perform these activities. Raglysa may cause dizziness or drowsiness, as well as sudden episodes of falling asleep. This risk may increase if you are taking other medicines for Parkinson’s disease symptoms, if you take medicines that may cause drowsiness, or if you consume alcohol during treatment with Raglysa. If you have experienced drowsiness and/or sudden sleep episodes before or during treatment with Raglysa, do not drive or operate machinery (see section 2).
3. How to take Raglysa
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.
The recommended dose of Raglysa is 1 tablet of 1 mg taken orally once daily. It can be taken with or without food.
If you take more Raglysa than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. Take the box or blister pack of rasagiline with you to show to the doctor or pharmacist.
Symptoms reported after overdose with rasagiline include slightly euphoric mood (a mild form of mania), very high blood pressure, and serotonin syndrome (see section 4).
If you forget to take Raglysa
Do not take a double dose to make up for missed doses. Take the next dose at the usual time.
If you stop taking Raglysa
Do not stop treatment with Raglysa without first consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Contact your doctor immediately if you experience any of the following symptoms. You may need urgent medical treatment or care:
- If you have unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour, or abnormally increased sex drive 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 doctor if you notice any suspicious changes in your skin, as there may be an increased risk of skin cancer (melanoma) with the use of this medicine (see section 2).
Other adverse effects
Very common adverse effects (affect more than 1 in 10 people):
- Involuntary movements (dyskinesia).
- Headache.
Common adverse effects (affect up to 1 in 10 people):
- Abdominal pain.
- Falls.
- Allergy.
- Fever.
- Flu (influenza).
- General malaise.
- Neck pain.
- Chest pain (angina pectoris).
- Low blood pressure upon standing, with symptoms such as dizziness/spinning sensation (orthostatic hypotension).
- Decreased appetite.
- Constipation.
- Dry mouth.
- Nausea and vomiting.
- Flatulence.
- Abnormal blood test results (leucopenia).
- Joint pain (arthralgia).
- Musculoskeletal pain.
- Joint inflammation (arthritis).
- Numbness and muscle weakness in the hand (carpal tunnel syndrome).
- Weight loss.
- Abnormal dreams.
- Difficulty with muscle coordination (balance disorder).
- Depression.
- Dizziness (vertigo).
- Prolonged muscle contractions (dystonia).
- Runny nose (rhinitis).
- Skin irritation (dermatitis).
- Rash.
- Redness of the eye (conjunctivitis).
- Urinary urgency.
Uncommon adverse effects (affect up to 1 in 100 people):
- Stroke (cerebrovascular accident).
- Heart attack (myocardial infarction).
- Blistering rash (vesiculobullous rash).
Frequency not known (cannot be estimated from available data):
- High blood pressure.
- Excessive sleepiness.
- Sudden sleep onset.
Reporting of adverse effects:
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Raglysa
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Raglysa
-
The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as rasagiline hemitartrate).
-
The other components are microcrystalline cellulose (E460), pregelatinized corn starch (type 1500), anhydrous colloidal silica (E551), talc (E553b) and stearic acid.
Appearance of the medicine and contents of the pack
This medicine is presented as white to almost white, round, slightly biconvex tablets, 7 mm in diameter, with bevelled edges and possible visible dark specks.
The tablets are available in boxes of 30 tablets in blisters.
Marketing Authorization Holder
KRKA, d.d., Novo mesto,
Šmarješka cesta 6,
8501 Novo mesto,
Slovenia
Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
or
TAD Pharma GmbH
Heinz-Lohmann – Straße 5
2742 Cuxhaven
Germany
For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:
KRKA Farmacéutica, S.L.
C/ Anabel Segura, 10,
28108 Alcobendas, Madrid
Spain
Date of the most recent review of this leaflet: June 2021
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/