IDENTIFICATION OF THE MEDICINAL PRODUCT
100mg film-coated tablets
Active substance : Ketoprofen 100mg for one film-coated tablet.
Excipients: Core : Lactose monohydrate , maize starch ,
pregeiatinised maize starch , croscarmellose sodium, magnesiu
stearate , anhydrous colloidal silica;
Coating : Hypromellose , macrogol 6000
WHEN SHOULD THIS MEDICINAL PRODUCT NOT BE USED (Contraindications)
100mg and 200mg must not be used in the following cases
● Starting from the 6th month of pregnancy.
● Hypersensitivity ( allergy ) to ketoprofen or to any of the
● History of asthma due to this medicinal product or to a related
medicinal product , in particular other non-steroidal
anti-inflammatory drugs (NSAIDS) including aspirin.
● Gastrointestinal hemorrhage , cerebrovascular hemorrhage or other
hemorrhage in progress.●
● Active stomach or intestine ulcer.
● Serious liver disease.
● Serious kidney disease.
● Serious hear disease.
In case of doubt you must consult your physician or pharmacist.
WARNINGS AND PRECAUTIONS
This medicinal product must be take under medical supervision only.
The transaminase serum level ( liver enzymes) should be monitored
in patients with disturbed hapatic function test or with history of
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
LIST OF EXCIPINENTS THESE LIABLETO PRODUCE SOME RISKS IN SOME
HOW SHOULD THIS MEDICINAL PRODUCT BE USED
In all cases, strictly follow the physician prescription.
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 ,
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.
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
● 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
● Hearing and ocular disorders: Tinnitus ( noise in the ears ),
● 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
● 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.
Do not use later than the date of expiry indicated on the outer
100mg, film-coated tablets : Do not sore above 25℃.
200mg, prolonged release coated tablets: Do not store above 30℃.
Keep out of the reach of children.