Rasagiline Ratio 1 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Rasagilina ratio 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could 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 Rasagilina ratio is and what it is used for
- What you need to know before taking Rasagilina ratio
- How to take Rasagilina ratio
- Possible side effects
- How to store Rasagilina ratio
- Contents of the pack and other information
1. What Rasagilina ratio is and what it is used for
Rasagilina ratio contains the active substance rasagilina and is indicated for the treatment of Parkinson's disease in adults. It can be used either in combination 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 compound in the brain involved in the control of movement. Rasagilina ratio helps increase and maintain dopamine levels in the brain.
2. What you need to know before taking Rasagilina ratio
Do not take Rasagilina ratio
- If you are allergic to rasagilina 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:
- 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 such as St. John's wort.
- Pethidine (a strong painkiller).
You must wait at least 14 days after stopping rasagilina before starting treatment with MAO inhibitors or pethidine.
Warnings and precautions
Talk to your doctor before taking Rasagilina ratio
- If you have any liver problems.
- You should speak to your doctor about any suspicious changes in your skin. Treatment with rasagilina may possibly increase the risk of skin cancer.
Tell your doctor if you or your family/caregiver notice that you are developing unusual behaviours that you cannot resist the impulse, drive, or urge to carry out actions that could be harmful to yourself or others. These are called impulse control disorders. In patients taking rasagilina or other medicines used to treat Parkinson's disease, such behaviours as compulsions, obsessive thoughts, gambling, excessive spending, impulsive behaviour, and abnormally high sex drive or increased thoughts or feelings about sex have been observed. Your doctor may need to adjust or stop your dose (see section 4).
Rasagilina ratio may cause drowsiness and may cause you to fall asleep suddenly while performing everyday activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). For further information, see the section “Driving and use of machines”.
Children and adolescents
The use of Rasagilina ratio in children and adolescents is not appropriate. Therefore, Rasagilina ratio is not recommended for patients under 18 years of age.
Other medicines and Rasagilina ratio
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-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants).
- The antibiotic ciprofloxacin used to treat 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 rasagilina together with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you are starting treatment with rasagilina, 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 rasagilina.
Tell your doctor or pharmacist if you smoke or intend to stop smoking. Smoking may reduce the amount of Rasagilina ratio in your blood.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
You should avoid taking Rasagilina ratio if you are pregnant, as the effects of rasagilina on pregnancy and the unborn baby are unknown.
Driving and use of machines
Talk to your doctor before driving or operating machinery, as both Parkinson's disease and treatment with rasagilina may affect your ability to perform these activities. Rasagilina may cause dizziness or drowsiness, as well as sudden episodes of falling asleep.
This risk may increase if you are taking other medicines to treat symptoms of Parkinson's disease, if you are taking medicines that may cause drowsiness, or if you consume alcohol during treatment with rasagilina. If you have experienced drowsiness and/or sudden episodes of falling asleep before or during treatment with Rasagilina ratio, do not drive or operate machinery (see section 2).
3. How to take Rasagilina ratio
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose of Rasagilina ratio is one 1 mg tablet taken orally once daily. Rasagilina ratio may be taken with or without food.
If you take more Rasagilina ratio than you should
If you think you have taken more tablets of Rasagilina ratio than you should, inform your doctor or pharmacist immediately. Take the pack/blister or bottle of Rasagilina ratio with you to show to the doctor or pharmacist.
Symptoms reported following an overdose of 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 Rasagilina ratio
Do not take a double dose to make up for forgotten doses. Take the next dose as scheduled.
If you stop taking Rasagilina ratio
Do not stop treatment with Rasagilina ratio without first consulting your doctor.
If you have any further questions about 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 everyone will experience them.
Contact your doctor immediately if you experience any of the following symptoms. You may need urgent medical treatment or care:
- If you display 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 do not exist (hallucinations).
- Any combination of hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome).
- Contact your doctor if you notice any suspicious changes in the skin, as there may be an increased risk of skin cancer (melanoma) with the use of this medicine (see section 2).
Other side effects
Very common (may affect more than 1 in 10 people)
- Involuntary movements (dyskinesia).
- Headache.
Common (may affect up to 1 in 10 people)
- Abdominal pain.
- Falls.
- Allergic reaction.
- Fever.
- Flu (influenza).
- General discomfort.
- Neck pain.
- Chest pain (angina pectoris).
- Low blood pressure upon standing, with symptoms such as dizziness or lightheadedness (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 (may 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.
Reporting of side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Rasagiline ratio
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container, vial, or blister pack after EXP or CAD. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rasagilina ratio
- The active substance is rasagiline (as mesilate). Each tablet contains rasagiline mesilate equivalent to 1 mg of rasagiline.
- The other components are mannitol, anhydrous colloidal silicon dioxide, maize starch, pregelatinized maize starch, stearic acid and talc.
Nature of the product and contents of the container
Rasagilina ratio tablets are white or almost white, round, flat, bevelled tablets, 8 mm in diameter, with the embossed inscription “GIL” and “1” on the lower part of one side and smooth on the other side.
The tablets are supplied in blister packs of 7, 10, 28, 30, 100 and 112 tablets, perforated unit-dose blister packs of 10x1, 30x1 and 100x1, or in a bottle containing 30 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas 28108 Madrid
Spain
Manufacturer
Pliva Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
Or
Teva Operations Poland Sp.zo.o
80 Mogilska Str.
31-546 Krakow
Poland
This medicinal product is authorized in the European Economic Area member states under the following names:
Spain: Rasagilina ratio 1 mg tablets EFG
Sweden: Rasagiline ratio
Date of the most recent review of this leaflet: January 2021