1 mg rasagiline tablets
What Rasagiline Mylan is and what it is used for
Rasagiline Mylan contains the active substance rasagiline and is used to treat 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 lack of cells that produce dopamine in the brain. Dopamine is a substance in the brain involved in movement control. Rasagiline Mylan helps increase and maintain dopamine levels in the brain.
What you need to know before you take Rasagiline Mylan
Do not take Rasagiline Mylan:
- 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 Rasagiline Mylan:
- monoamine oxidase (MAO) inhibitors (medicines for the treatment of depression or Parkinson’s disease or any other indication), including herbal medicines and over-the-counter medicines, e.g. St. John’s wort.
- pethidine (a powerful painkiller).
You must wait at least 14 days after stopping Rasagiline Mylan treatment before starting treatment with an MAOI or pethidine.
Warnings and cautions
Talk to your doctor before taking Rasagiline Mylan.
- if you have liver problems
- if you have any kind of suspected skin change. Treatment with Rasagiline Mylan may increase the risk of skin cancer.
Tell your doctor if you or your family/caregiver notice that you are developing unusual behavior where you can not resist impulses urges or temptations to engage in certain activities that may harm yourself or others. This behavior is called impulse control disorder. In patients taking Rasagiline Mylan and/or other medicines for Parkinson’s disease, obsessive-compulsive behavior, obsessive-compulsive disorder, gambling addiction, excessive spending, impulsive behavior, and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust your dose or stop treatment (see section 4).
Rasagiline Mylan can cause drowsiness and cause you to suddenly fall asleep in connection with everyday activities during the day. This is especially true if you are also taking other dopaminergic medicines (used to treat Parkinson’s disease ). For further information, see the section Driving and using machines.
Children and young people
It is not relevant to use Rasagiline Mylan in children and adolescents. Rasagiline Mylan is therefore not recommended for use under 18 years of age.
Other medicines and Rasagiline Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor before taking Rasagiline Mylan with any of the following medicines:
- Certain antidepressant drugs (selective serotonin reuptake inhibitors, selective serotonin noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants)
- antibiotic drug ciprofloxacin for infection _
- the antitussive dextromethorphan
- sympathomimetics of the type found in eye drops, decongestants for the nose and throat, and cold medicines containing ephedrine or pseudoephedrine.
The use of Rasagiline Mylan in combination with antidepressants containing fluoxetine or fluvoxamine should be avoided. If you start treatment with Rasagiline Mylan, you should wait at least five weeks after stopping treatment with fluoxetine . If you start treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline Mylan treatment.
Tell your doctor or pharmacist if you smoke or plan to quit smoking. Smoking can reduce the amount of Rasagiline Mylan in the blood.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
As Rasagaline Mylan is not known to affect pregnancy and the unborn baby, you should avoid taking Rasagaline Mylan if you are pregnant.
Driving and using machines
Consult a physician before driving or using machines, as both Parkinson’s disease itself and treatment with Rasagaline Mylan may affect your ability to do so. Rasagiline Mylan can make you feel dizzy and drowsy. It can also cause sudden sleep attacks.
This may be worse if you are taking other medicines to treat the symptoms of Parkinson’s disease , if you are taking medicines that may cause drowsiness or if you drink alcohol while taking Rasagiline Mylan. If you have experienced drowsiness ( somnolence ) and / or sudden sleep attacks before or in connection with taking Rasagaline Mylan, do not drive or use machines (see section 2).
How to take Rasagiline Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 tablet of 1 mg daily, taken orally. Rasagiline Mylan can be taken with or without food.
If you take more Rasagiline Mylan than you should
If you think you have taken too many Rasagiline Mylan tablets, contact your doctor or pharmacist immediately. Bring the carton / blister pack of Rasagiline Mylan to see your doctor or pharmacist.
Reported symptoms due to overdose of Rasagaline Mylan include mild euphoric mood (a mild form of mania), extremely high blood pressure and serotonergic syndrome (see section 4).
If you forget to take Rasagiline Mylan
Do not take a double dose to make up for a forgotten dose . Take the next dose as usual, when it’s time to take it.
If you stop taking Rasagiline Mylan
Do not stop taking Rasagiline Mylan without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you notice any of the following symptoms. You may need urgent medical advice or treatment:
- if you develop abnormal behavior such as obsessive-compulsive behavior, obsessive-compulsive disorder, gambling addiction, excessive shopping or spending, impulsive behavior, and abnormally high sexual drive or increase in sexual thoughts (impulse control disorders) (see section 2)
- if you see or hear things that do not exist (hallucinations)
- if you experience hallucinations, fever, restlessness, tremors and sweating in any combination (serotonergic syndrome)
Contact your doctor if you notice any suspected skin change as there may be an increased risk of skin cancer ( melanoma ) when using this medicine (see section 2).
Other side effects ar
Very common (may affect more than 1 user in 10)
- Involuntary movements ( dyskinesia )
- Headache
Common (may affect up to 1 in 10 people)
- Stomach pain
- Case
- Allergy
- Fever
- Influenza
- Feeling sick
- Nackont
- Chest pain (angina)
- Drop in blood pressure when getting up with symptoms such as dizziness ( orthostatic hypotension )
- Decreased appetite
- Constipation
- Dry mouth
- Nausea and vomiting
- Gases in the stomach ( flatulence )
- Abnormal blood test results ( leukopenia )
- Joint pain ( arthralgia )
- Muscle / skeletal pain
- Arthritis ( arthritis )
- Numbness and weakening of the muscles in the hand ( carpal tunnel syndrome )
- Reduced weight
- Dream disorders
- Difficulty co- ordinating muscles (balance disorder)
- Depression
- Dizziness (fraud)
- Abnormal muscle tension ( dystonia )
- Rinnsnuva ( rhinitis )
- Irritated skin ( dermatitis )
- Rash
- Eye inflammation ( conjunctivitis )
- Urination
Uncommon (may affect up to 1 in 100 people)
- Stroke ( cerebrovascular event)
- Heart attack (heart attack)
- Skin rash with blisters (vesicular bullous rash)
Has been reported (occurs in an unknown number of users)
- High blood pressure
- Excessive drowsiness
- Sudden sleep attack
How to store Rasagiline Mylan
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 carton or blister after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is rasagiline. Each tablet contains rasagiline tartrate equivalent to 1 mg rasagiline.
- The other ingredients are microcrystalline cellulose, tartaric acid, corn starch, pregelatinized corn starch, talc, stearic acid.
What the medicine looks like and the contents of the pack
Rasagiline tablets are white to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets marked “R9SE” on one side and “1” on the other side.
The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets and in perforated unit dose blisters containing 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 and 112 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland
Manufacturer
Mylan Hungary Kft,
Mylan UTC 1
H-2900 Komárom
Hungary.
Synthon Hispania SL,
C / Castelló no1, Pol. Las Salinas,
08830, Sant Boi de Llobregat, Barcelona,
Spain
Synthon sro,
Brněnská 32 / čp. 597
678 01 Blansko
The Czech Republic