1 mg rasagiline tablets
What Rasagiline Krka is and what it is used for
Rasagiline Krka 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 Krka helps increase and maintain dopamine levels in the brain.
Rasagiline contained in Rasagiline Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Krka
Do not use Rasagiline Krka
- 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 Rasagilin Krka:
- 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, such as St. John’s wort.
- pethidine (a powerful painkiller).
You must wait at least 14 days after stopping Rasagiline Krka treatment before starting treatment with an MAOI or pethidine.
Warnings and cautions
Talk to your doctor before taking Rasagilin Krka
- if you have liver problems
- or if you have any kind of suspected skin change. Treatment with Rasagiline Krka 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 Krka 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 Krka 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 Krka in children and adolescents. Rasagiline Krka is therefore not recommended for use in children and adolescents under 18 years of age.
Other medicines and Rasagilin Krka
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)
- 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 Krka in combination with antidepressant drugs containing fluoxetine or fluvoxamine should be avoided.
If you start treatment with Rasagiline Krka, 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 treatment with Rasagiline Krka.
Tell your doctor or pharmacist if you smoke or plan to quit smoking. Smoking can reduce the amount of Rasagiline Krka in the blood.
Rasagilin Krka with food, drink, and alcohol
Rasagiline Krka 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 Rasagilin Krka is not known to affect the pregnancy and the unborn baby, you should avoid taking Rasagilin Krka 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 Krka may affect your ability to do so. Rasagiline Krka may make you feel dizzy and drowsy. It can also cause sudden sleep attacks. This can be aggravated if you take other medicines to treat the symptoms of Parkinson’s disease, if you take medicines that can cause drowsiness or if you drink alcohol while taking Rasagilin Krka. If you have experienced drowsiness ( somnolence ) and/or sudden sleep attacks before or in connection with taking Rasagilin Krka, 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.
How to use Rasagiline Krka
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Rasagiline Krka is 1 tablet of 1 mg daily, taken orally. Rasagiline Krka can be taken with or without food.
If you use more Rasagilin Krka than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice. Bring the carton/blister pack Rasagilin Krka.
Reported symptoms due to overdose of Rasagiline Krka include mild euphoric mood (a mild form of mania), extremely high blood pressure, and serotonergic syndrome (see section 4).
If you forget to use Rasagiline Krka
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 Rasagiline Krka
Do not stop taking Rasagilin Krka 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, an 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)
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) :
- abdominal pain
- case
- allergy
- fever
- influenza
- feeling sick
- 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
- flatulence
- 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
- dream disorders
- 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 Krka
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 blister and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store in the original package. Moisture sensitive.
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 1 mg rasagiline (as rasagiline hemitartrate).
- The other ingredients are microcrystalline cellulose (E460), pregelatinized maize starch (type 1500), colloidal anhydrous silica (E551), talc (E553b), and stearic acid.
What the medicine looks like and the contents of the pack
The tablets are white to almost white, round, slightly biconvex, 7 mm in diameter, with beveled edges, and possibly dark dots may be visible.
Rasagilin Krka is available in cartons containing:
- 14, 15, 28, 30 or 112 tablets in blisters
- 14 x 1, 15 x 1, 28 x 1, 30 x 1 or 112 x 1 tablets in perforated unit dose blisters.
- 14 x 1, 15 x 1, 28 x 1, 30 x 1, or 112 x 1 tablet in perforated unit dose blisters with the names of the days of the week ( calendar pack )
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany