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What is SAGILIA and what is it used for?
SAGILIA is used to treat Parkinson's disease. It can be used alone or together with levodopa (another medicine to treat Parkinson's disease).
With Parkinson's disease there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain that is involved in traffic control. SAGILIA helps to increase and maintain dopamine levels in the brain.
2. What do you need to know before taking SAGILIA?
Do not take SAGILIA
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 SAGILIA
Monoamine oxidase (MAO) inhibitors (e.g., for the treatment of depression or Parkinson's disease or any other indication), including non-prescription drug and natural products, e.g., St. John's Wort;
Pethidine (very painkiller). There must be at least 14 days between stopping treatment with SAGIIA and initiating treatment with MAO inhibitors or pethidine.
Warnings and precautions
Talk to your doctor or pharmacist before taking SAGILIA:
If you have mild to moderate liver problems.
You should talk to your doctor about any suspicious skin changes.
Children and adolescents
SAGLIUM is not recommended for use in children below 18 years of age.
Other medications and SAGILIA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines or if you are a smoker or if you intend to stop smoking.
Ask your doctor before taking any of the following medicines along with a SAGLI:
Some antidepressants (selective serotonin reuptake inhibitors, selective serotonin / noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants);
The antibiotic ciprofloxacin used against infections;
Cough-suppressing drug dextromethorphan;
Sympathomimetics such as those contained in eye drops, nasal and oral decongestants, and cold medicines that contain ephedrine or pseudoephedrine.
The co-administration of SAGILIA and antidepressants containing fluoxetine or fluvoxamine should be avoided.
If you start treatment with SAGILIA you should wait at least 5 weeks after stopping treatment with fluoxetine.
If you start treatment with fluoxetine or fluvoxamine, wait at least 14 days after stopping treatment with SAGILIA
Tell your doctor if you or your family / carer notice that you develop abnormal behavior where you can not resist impulse, urge, or irresistible urge to do certain harmful or detrimental actions to yourself or others . These are called pulse control disorders. Patients who take rasagiline and / or other medicines to treat Parkinson's have behaved as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behavior and unusually strong sexual attraction or increased sexual thoughts or feelings. Your doctor may need to change the dose or stop the medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been conducted. Ask your doctor before driving or using machines.
3. How to take SAGILIA?
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of SAGILIA is 1 tablet of 1 mg once a day.
Sagiil can be taken with or without food.
If you take more than the necessary dose of SAGILIA
If you think you may have taken too many SAGLI tablets, talk to your doctor or pharmacist immediately. Take the SAGILIA bottle / bottle with you to show it to your doctor or pharmacist. Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
If you stop taking SAGILIA
Do not stop taking Sagliya before talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. The following undesirable effects were reported in placebo-controlled clinical trials:
Very common (may affect more than 1 in 10 people):
- unusual movements (dyskinesia);
Common (may affect up to 1 in 10 people):
- stomach ache;
- influenza (influenza);
- Common feeling of feeling unwell (fatigue)
- neck pain;
- chest pain (angina pectoris);
- low blood pressure when standing up with symptoms such as dizziness / vertigo (orthostatic hypotension);
- decreased appetite;
- dry mouth;
- nausea and vomiting;
- gas release (flatulence);
- disturbances in blood test results (leucopenia);
- joint pain (arthralgia);
- musculoskeletal pain;
- inflammation of the joints (arthritis);
- stiffness and weakness in the arm muscles (carpal tunnel syndrome);
- weight loss;
- bright dreams;
- difficulty in muscle coordination (disturbed balance);
- dizziness (vertigo);
- prolonged muscle relaxation time (dystonia);
- runny nose (rhinitis);
- skin irritation (dermatitis);
- redness of the eye (conjunctivitis);
- frequent urination urgency.
Uncommon (may affect more than 1 in 100 people):
Stroke (cerebrovascular accident);
- heart attack (myocardial infarction);
- rash with blisters (vesiculobullous rash).
In addition, skin cancer was reported in about 1% of patients in the placebo-controlled trials. Nevertheless, scientific evidence suggests that Parkinson's disease, not a specific drug, is associated with a higher risk of skin cancer (not just melanoma). You should talk to your doctor about any questionable skin changes.
Parkinson's disease is associated with symptoms like hallucinations and confusion.
In post-marketing experience these symptoms have also been observed in patients with Parkinson's disease who are being treated with SAGILIA.
There have been reports of patients who, while taking one or more of the drugs to treat Parkinson's disease, have been unable to resist impulse, urge, or temptation to perform actions that may harm them or others. These are called pulse control disorders. Patients taking SAGLIUM and / or other medicines to treat Parkinson's disease have experienced:
- obsessive thoughts or impulsive behavior;
- a strong impetus for excessive gambling regardless of personal or family consequences;
- changed or increased sexual interest and behavior that seriously worries you or others, for example, increased sexual desire;
- uncontrollable excessive shopping or spending.
How to store SAGILIA?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton, the tablet container and the blister. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What does SAGILIA have?
The active substance is rasagilme. Each tablet contains 1 mg rasagiline (as rasagiline tartrate).
The other ingredients are: microcrystalline cellulose; cornstarch; Pregelatinised starch (maize); Talc; Sodium stearyl fumarate.
What does it look like and what does it contain?
SAGILIA are white to off-white, round, flat, tapered tablets (6.5 mm).
Packs containing 7, 10, 28, 30, 60, 100 tablets packed in blisters are available.
A pack containing 30 tablets is packed in a screw-cap screw container (silica gel). The drier is used to keep the tablets dry, should not be swallowed.
Not all pack sizes may be marketed.
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