1 mg rasagiline tablets
What Rasagiline Glenmark is and what it is used for
Rasagiline Glenmark 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 chemical substance in the brain that is involved in movement control. Rasagiline Glenmark helps increase and maintain dopamine levels in the brain.
Rasagiline contained in Rasagiline Glenmark 1 mg tablets 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 Glenmark
Do not take Rasagiline Glenmark
- 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 Glenmark :
- Monoamine oxidase (MAO) inhibitors (eg for the treatment of depression or Parkinson’s disease or for any other indication), including over-the-counter medicines and herbal medicines, e.g. St. John’s wort .
- Pethidine (a powerful painkiller).
You must wait at least 14 days after stopping treatment with Rasagiline Glenmark before starting treatment with MAOIs or pethidine.
Warnings and cautions
Talk to your doctor before taking Rasagilin Glenmark
- if you have liver problems
- Talk to your doctor about any suspected skin changes. Treatment with Rasagiline Glenmark may increase the risk of skin cancer.
Tell your doctor if you or your family / carer notice that you are developing an unusual behavior where you can not resist impulses, urges or temptations to perform certain activities that may harm yourself or others. These are called impulse control disorders. In patients taking Rasagiline Glenmark and / or other Parkinson’s drugs , obsessive-compulsive behavior, obsessive-compulsive disorder, gambling addiction, excessive spending, impulsive behavior, and abnormally high sexual drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust your dose or stop your treatment (see section 4).
Rasagiline Glenmark 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 Glenmark in children and adolescents. Rasagiline Glenmark is therefore not recommended for use in children and adolescents below 18 years.
Other medicines and Rasagiline Glenmark
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important that you tell your doctor if you are taking any of the following medicines:
- Certain antidepressant drugs (selective serotonin reuptake inhibitors, selective serotonin ornoradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants)
- Antibiotic drug ciprofloxacin for infection _
- The antitussive drug 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 Glenmark in combination with antidepressants containing fluoxetine or fluvoxamine should be avoided.
If you start treatment with Rasagilin Glenmark, you should wait at least 5 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 Rasagilin Glenmark.
Tell your doctor or pharmacist if you smoke or plan to quit smoking. Smoking may reduce the amount of Rasagiline Glenmark in the blood.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, 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 Glenmark affects pregnancy and the unborn baby, you should avoid taking Rasagilin Glenmark if you are pregnant.
Driving and using machines
Talk to your doctor before driving or using machines, as both Parkinson’s disease itself and treatment with Rasagiline Glenmark may affect your ability to do so. Rasagiline Glenmark 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 Rasagilin Glenmark. If you have experienced drowsiness ( somnolence ) and / or sudden sleep attacks before or in connection with taking Rasagilin Glenmark, 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 take Rasagiline Glenmark
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 Glenmark is 1 tablet of 1 mg, once daily, taken orally.
Rasagiline Glenmark can be taken with or without food.
If you take more Rasagilin Glenmark than you should
If you have ingested too much Rasagilin Glenmark or if e.g. If a child has ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice. Bring the carton / blister or jar of Rasagilin Glenmark and show it to your doctor or pharmacist.
Reported symptoms due to overdose of Rasagiline Glenmark 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 Glenmark
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 Rasagilin Glenmark
Do not stop taking Rasagilin Glenmark without first consulting 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 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):
- Abdominal pain
- Case
- Allergy
- Fever
- Influenza
- General malaise
- Neck pain
- Chest pain (angina)
- Drop-in blood pressure when you get up with symptoms such as dizziness/feeling of instability ( orthostatic hypotension )
- Reduced appetite
- Constipation
- Dry mouth
- Nausea and vomiting
- Gas formation
- Abnormal blood test results ( leukopenia )
- Joint pain ( arthralgia )
- Muscle / skeletal pain
- Arthritis ( arthritis )
- Numbness and muscle weakness in the hand ( carpal tunnel syndrome )
- Weight loss
- Abnormal dream balance problems
- Depression
- Dizziness (fraud)
- Abnormal muscle tension ( dystonia )
- Rinnsnuva ( rhinitis )
- Skin irritation ( dermatitis )
- Rash
- Eye inflammation ( conjunctivitis )
- Urination
Uncommon (may affect up to 1 in 100 people) :
- Stroke _ _
- Heart attack (heart attack)
- Skin rash with blistering (vesicle bullous rash)
Has been reported (occurs in an unknown number of users) :
- High blood pressure
- Excessive drowsiness
- Sudden sleep attack
How to store Rasagilin Glenmark
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 and can or carton/blister, after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Only the jar
Shelf life after first opening: 2 months
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. One tablet contains 1 mg rasagiline (as rasagiline tartrate).
- The other ingredients are microcrystalline cellulose, citric acid, pregelatinized corn starch, colloidal anhydrous silica, stearic acid, and talc.
What the medicine looks like and the contents of the pack
Rasagiline Glenmark is white to off-white, round, flat tablets with “771” debossed on one side and “G” on the other side, approximately 8 mm in diameter.
The tablets are available in blisters of 7, 10, 28, 30, 60, 100, and 112 tablets or a jar with or without a child-resistant lid containing 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holder of a marketing authorization
Glenmark Arzneimittel GmbH
Industriestr. 31, 82194 Gröbenzell,
Germany
Manufacturer
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park, Croxley Green, WD18 8YA, UK
Glenmark Pharmaceuticals sro
Fibichova 143, 566 17 Vysoké Mýto
Czech Republic
This medicinal product is authorized under the European Economic Area under the names:
| Germany | Rasagiline Glenmark 1 Mg Tablets |
| Sweden | Rasagiline Glenmark 1 mg tablets |
| Denmark | Rasagilin Glenmark |
| Spain | Rasagilina Viso Pharmacéutica 1 mg compresses EFG |
| Slovakia | Rasagiline Glenmark 1 mg tablets |