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What is SAGILIA and what it is 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).
In Parkinson's disease there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical involved in traffic control. SAGILIA helps increase and maintain levels of dopamine in the brain.
2. What 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 until you have taken SAGLIA:
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, for example St John's wort;
pethidine (very painkiller).
There must be at least 14 days between stopping treatment with SAGIIA and starting 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 all suspected skin changes.
Children and adolescents
SAGLIA is not recommended for use in children below 18 years of age.
Other medicines and SAGLIA
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 / 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 SAGLIUM and antidepressants containing fluoxetine or fluvoxamine should be avoided.
If you start treatment with SAGLIA you should wait at least 5 weeks after stopping treatment with fluoxetine.
If you start treatment with fluoxetine or fluvoxamine, you should wait for at least 14 days after stopping treatment with SAGILIA.
Tell your doctor if you or your family / carer notice that you develop unusual behavior where you can not resist the impulse, urge, or irresistible urge to do certain harmful or detrimental actions to yourself or others . These are called impulse control disorders. Patients who take rasagiline and / or other medicines to treat Parkinson's disease have behaved as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behavior and unusually intense 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 are breast-feeding, think you may be pregnant or plan 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 performed. Ask your doctor before driving or operating 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 1 mg once a day.
Sagiil can be taken with or without food.
If you take more than the necessary dose of SAGLIA
If you think you may have taken too many SAGILIA tablets, contact your doctor or pharmacist immediately. Take the SAGLIA bottle / bottle with you to show it to your doctor or pharmacist.
If you forget to take SAGILIA
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 SAGLIA 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 have been 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):
general feeling of being unwell (fatigue);
chest pain (angina pectoris);
low blood pressure when standing up with symptoms such as dizziness / vertigo (orthostatic hypotension);
nausea and vomiting;
disturbances in blood test results (leucopenia);
joint pain (arthralgia);
inflammation of the joints (arthritis);
stiffness and weakness in the arm muscles (carpal tunnel syndrome);
difficulty muscle coordination (disturbed balance);
prolonged muscle relaxation time (dystonia);
runny nose (rhinitis);
skin irritation (dermatitis);
eye redness (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 such as hallucinations and confusion.
In post-marketing experience, these symptoms have also been observed in patients with Parkinson's disease who are being treated with SAGIIA.
Patients have been reported who have been unable to withstand impulse, urge, or temptation to take action that may harm them or others while taking one or more of the drugs to treat Parkinson's disease. These are called impulse control disorders. Patients taking SAGLIUM and / or other medicines to treat Parkinson's disease have experienced:
obsessive thoughts or impulsive behavior;
a strong impulse 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;
uncontrolled excessive shopping or spending.
Tell your doctor if you experience any of these conditions; he or she will discuss with you ways to cope or reduce these symptoms.
How to Store Sagillaria
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 sewage system 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 SAGLIA contains
The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as rasagiline tartrate).
The other ingredients are: microcrystalline cellulose; cornstarch; pregelatinised starch (maize); talc; sodium stearyl fumarate.
What the SAGILIA looks like and what the package contains
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.
There is a pack containing 30 tablets 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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