1 mg rasagiline tablets
What Rasagiline STADA is and what it is used for
Rasagiline Stada 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 Stada helps increase and maintain dopamine levels in the brain.
Rasagiline contained in Rasagilin Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Rasagiline STADA
Do not take Rasagiline STADA:
- 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 Stada:
- monoamine oxidase (MAO) inhibitors (medicines used to treat 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 Stada treatment before starting treatment with an MAOI or pethidine.
Warnings and cautions
Talk to your doctor before taking Rasagilin Stada
- if you have liver problems
- You should talk to your doctor about any suspected skin changes.
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 and/or other drugs 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 Stada 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 Rasagilin Stada in children and adolescents. Rasagiline Stada is therefore not recommended for use under 18 years of age.
Other medicines and Rasagilin STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are taking any of the following medicines:
- certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants)
- the antibiotic ciprofloxacin against infection er
- 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 Stada in combination with antidepressant drugs containing fluoxetine or fluvoxamine should be avoided.
If you start treatment with Rasagiline Stada, 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 Stada treatment.
Tell your doctor or pharmacist if you smoke or plan to quit smoking. Smoking may reduce the amount of Rasagiline Stada in the blood.
Rasagiline STADA with food, drink, and alcohol
Rasagiline Stada can 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.
As it is not known how Rasagilin Stada affects your pregnancy and your unborn baby, you should avoid taking Rasagilin Stada 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 Rasagiline Stada may affect your ability to do so. Rasagiline Stada may 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 Stada. If you have experienced drowsiness ( somnolence ) and/or sudden sleep attacks before or in connection with taking Rasagilin Stada, do not drive or use machines (see section 2).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rasagiline STADA contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Rasagiline STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Rasagiline Stada is 1 tablet of 1 mg daily, taken orally. Rasagiline Stada can be taken with or without food.
If you use more Rasagilin STADA than you should
If you think you have taken too many Rasagilin Stada tablets, contact your doctor or pharmacist immediately. Bring the carton or jar of Rasagilin Stada to your doctor or pharmacist.
Reported symptoms due to overdose of Rasagiline Stada include mild euphoric mood (a mild form of mania), extremely high blood pressure, and serotonergic syndrome (see section 4).
If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Do this even if you / the child does not notice any symptoms.
If you forget to use Rasagiline STADA
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 using Rasagilin STADA
Do not stop taking Rasagiline Stada 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 sex 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)
- if you notice any kind of suspected skin change (because there is an increased risk of skin cancer, not just melanoma ) in patients with Parkinson’s disease ) (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):
- abdominal pain
- case
- allergy
- fever
- influenza
- malaise
- account
- 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
- gas in the stomach
- abnormal results on blood tests ( leukopenia )
- joint pain ( arthralgia )
- muscle / skeletal pain
- joint inflammation ( arthritis )
- numbness and weakening of the muscles in the hand ( carpal tunnel syndrome )
- reduced weight
- abnormal dreams
- difficulty coordinating muscles (balance disorder)
- Depression
- dizziness (fraud)
- abnormal muscle tension ( dystonia )
- rinnsnuva ( rinit )
- irritated skin ( dermatitis )
- rash
- eye inflammation ( conjunctivitis )
- urinary incontinence.
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 Rasagilin STADA
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.
No special storage instructions.
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 tartar equivalent to 1 mg of rasagiline.
The other ingredients are microcrystalline cellulose, silica colloidal anhydrous, sodium starch glycolate, povidone, phosphoric acid, and stearic acid.
What the medicine looks like and the contents of the pack
Rasagiline Stada is a white round, biplane tablet.
The tablets are available in blister packs of 28 or 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
STADA Nordic ApS
Marielundvej 46A
2430 Herlev
Denmark
Local representative
STADA Nordic ApS
Marielundvej 46A
2430 Herlev
Denmark