1 mg rasagiline tablets
What Rasagiline Bluefish is and what it is used for
Rasagiline Bluefish 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 Bluefish helps increase and maintain dopamine levels in the brain.
Rasagiline contained in Rasagiline Bluefish 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 take Rasagiline Bluefish
Do not take Rasagiline Bluefish:
- 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 Bluefish:
- 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 Bluefish treatment before starting treatment with an MAOI or pethidine.
Warnings and cautions
Talk to your doctor before taking Rasagiline Bluefish
- if you have liver problems
- or if you have any kind of suspected skin change. Treatment with Rasagiline Bluefish 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 Bluefish 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 Bluefish 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 Bluefish in children and adolescents. Rasagiline Bluefish is therefore not recommended for use under 18 years of age.
Other medicines and Rasagiline Bluefish
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 Bluefish in combination with antidepressant drugs containing fluoxetine or fluvoxamine should be avoided. If you start treatment with Rasagiline Bluefish, 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 Bluefish treatment.
Tell your doctor or pharmacist if you smoke or plan to quit smoking. Smoking can reduce the amount of Rasagiline Bluefish 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 Rasagiline Bluefish is not known to affect pregnancy and the unborn baby, you should avoid taking Rasagiline Bluefish 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 Bluefish may affect your ability to do so. Rasagiline Bluefish may make you feel dizzy and drowsy. It can also cause sudden sleep attacks. This can be aggravated 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 Bluefish. If you have experienced drowsiness ( somnolence ) and/or sudden sleep attacks before or in connection with taking Rasagiline Bluefish, do not drive or use machines (see section 2).
This medicine contains less than 1 mmol sodium ( 23 mg ) per 1 mg tablet, ie essentially ‘sodium-free ‘.
How to take Rasagiline Bluefish
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 of Rasagiline Bluefish is 1 tablet of 1 mg daily, taken orally. Rasagiline Bluefish can be taken with or without food.
If you take more Rasagiline Bluefish than you should
If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor or hospital for risk assessment and advice. Bring the carton/blister pack or jar of Rasagiline Bluefish to see a doctor or pharmacist.
Reported symptoms due to overdose of Rasagiline Bluefish 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 Bluefish
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 Bluefish
Do not stop taking Rasagiline Bluefish without first talking to your doctor.
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)
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 Rasagiline Bluefish
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, jar, or blister after “EXP”. The expiration date is the last day of the specified month.
This medicine does not require any 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 1 mg rasagiline (as rasagiline tartrate).
- The other ingredients are microcrystalline cellulose, maize starch, pregelatinized maize starch, talc, and sodium stearyl fumarate.
What the medicine looks like and the contents of the pack
Rasagiline Bluefish are white to off-white, round, flat, beveled tablets (6.5 mm).
Pack sizes of 7, 10, 28, 30, 60, 84, 98, 100 or 112 tablets in blisters
Pack sizes 30, and 100 tablets in jars with child-resistant screw caps containing desiccant (silica gel). The desiccant is used to keep the tablets dry. The desiccant must not be swallowed.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
PO Box 49013
100 28 Stockholm
Manufacturer
DELORIS PHARMACEUTICALS LTD
17 Athinon Street, Ergates Industrial Area,
2643 Ergates
Nicosia
Cyprus
Iberfar – Indústria Pharmacêutica, SA
Rua Consiglieri Pedroso, no. 121-123
Queluz de Baixo, 2734-501 Barcarena
Portugal
This medicinal product is authorized under the European Economic Area under the names:
| Member State | The name of the drug |
| THE | Rasagiline Bluefish 1 mg Tabletten |
| AT | Rasagiline Bluefish 1 mg Tabletten |
| ES | Rasagiline Bluefish 1 mg compresses EFG |
| PT | Rasagiline Bluefish 1 mg compressed |
| SEE | Rasagiline Bluefish |