Complaint
Before to use this medicinal product. inform your physician in case of:
History of asthma associated with a chronic rhinitis, with a chronic sinusitis and/or with polyps in the nose. The administration of this medicinal product may result in a respiratory discomfort or in a asthma attack , especially in some people who are allergic to aspirin or to a ASAID (see Contraindications) ,
Coagulation disorders, concomitant anticoagulant treatment or platelet aggregation inhibiting medicinal product treatment (see interaction with other medicinal products and other forms of interaction). Indeed , risks of gastrointestinal hemorrhages or of ulcers exist and are increased in those situations as well as in the elderly or in weakness or low body weight patients.
Congenital galactosemia , glucose or galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases) , due to the presence of lactose
DRIVING AND MACHINE USE
The use of this medicinal product may produce dizziness , drowsiness , Convulsions or visual disorders. It
is advisable not to drive or use machines if one of there symptoms occurs.
LIST OF EXCIPINENTS THESE LIABLETO PRODUCE SOME RISKS IN SOME PATIENTS
HOW SHOULD THIS MEDICINAL PRODUCT BE USED
In all cases, strictly follow the physician prescription.
Dosage
The dosage depends on the indication.
Short-term symptomatic treatment of acute exacerbations: 3 tablets per day , i.e. 300mg per day
Long-term symptomatic treament : 1 to 2 tablets per day , i.e. 100 to 200 me per day.
The daily dosage is to be divided into 1 to 3 intakes per day.
Method of administration
Oral route. The tablets must be take with a large glass of water , during meals.
Overdoes
The main signs of overdosage are headache , dizziness , drowsiness , nausea , vomiting , diarrhea, and abdominal pain. If you suffer of one of these symptoms, discontinue the treatment and consult immediately your physician. There is no specific antidote.
UNDESIRABLE EFFECTS.
Like any active substance , this medicinal product may induce , in some patients , undersirable effects to a greater or lesser degree.
Gastrointestinal disorders: Nausea , vomiting , diarrhea , constipation , stomach pains pain , gastrointestinal discomfort , gastritis ( inflammation of the gastricmucosa ), stomatitis ( inflammation of the mouth ) , more rarely colitis. The most serious undesirable effects are peptic ulcer, gastrointestinal hemorrhage ( see Warnings and precautions) which is more frequent with a high dosage and intestinal perforations.
Hypersensitivity reactions: Very rare cases of angioedema ( a severe condition characterized by the swelling of face , tongue , throat or larynx ) and anaphylactic shock ( a severe allergic reaction of sudden onset ) ; Skin allergies : Eruption , rash , pruritus ( itching ), urticaria ( skin eruption with itching wheals ), and exacerbation of chronic urticaria . Respiratory allergies : Asthma attack or bronchospasm ( respiratory discomfort ) may occur , particularly in people who are allergic to aspirin and to other NSAIDS.
Neuropsychic disorders : Headache , dizziness , drowsiness ; Exceptionally ; Convulsion and mood disturbances.
Skin reactions: Photosesitivity ( skin reactions following exposure to sunlight or U.V rays ) , alopecia (hair loss); Exceptionally : Stevens-Jonnson syndrome and Lyell's syndrome ( severe bullous skin reactions which may extend on all over the body).
Hearing and ocular disorders: Tinnitus ( noise in the ears ), blurred vision.
Renal and hepatic disorders : Acute renal impairment , increase in transaminase serum level (hepatic enzymes) ; Exceptionally : Interstitial nephritis , nephritic syndrome , hepatitis.
Haematological disorders: Thrombocytopenia ( abnormal low rate of platelets) , anemia (reduction in the number of read blood cells) due to a chronic hemorrhage , rare cases of leucopenia ( insufficient amount of white blood cells ) with possibility of agranulocytosis ( marked decrease in the number of certain white blood cells).
Heart disorders : Hypertension ( high blood pressure)
Other : Oederma.
Do not hesitate to ask your physician or pharmacist for advice and to report any undeesirable effect not mentioned in this leaflet.
EXPIRY DATE
Do not use later than the date of expiry indicated on the outer packaging.
STORAGE
100mg, film-coated tablets : Do not sore above 25ºC.
200mg, prolonged release coated tablets: Do not store above 30ºC.
Keep out of the reach of children.
