Sertofen tablets 25 mg No. 10




Sertofen tablets are used for the symptomatic treatment of mild to moderate pain, for example, musculoskeletal pain, painful menstruation (dysmenorrhea), and toothache.
Composition
The active substance is dexketoprofen (one film-coated tablet contains dexketoprofen (in the form of trometamol) 25 mg).
Excipients: microcrystalline cellulose (PH 101), microcrystalline cellulose (PH 102), corn starch, sodium starch glycolate (type A), glycerol distearate; film coating: Opadry white II 85F18422 (polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc).
Contraindication
hypersensitivity to dexketoprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs) or to other components of the drug; attacks of bronchial asthma, bronchospasm, acute rhinitis or development of nasal polyps, urticaria or angioedema as a result of the use of drugs with a similar mechanism of action, for example, acetylsalicylic acid and other NSAIDs; known phototoxic or photoallergic reactions when using ketoprofen or fibrates; active phase of peptic ulcer disease / bleeding in the digestive tract or history of bleeding in the digestive tract, ulcers, perforations; history of bleeding or perforation in the digestive tract associated with taking NSAIDs; other bleeding in the active phase or increased bleeding; hemorrhagic diathesis and other blood clotting disorders; chronic dyspepsia; Crohn's disease or nonspecific ulcerative colitis; severe heart failure; moderate or severe renal impairment (creatinine clearance <59 ml/minute); severe liver impairment (10-15 points on the Child-Pugh scale); severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake); III trimester of pregnancy; breastfeeding period.Method of application
The drug is intended for oral use. The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water). Simultaneous food intake reduces the rate of absorption of the active substance, therefore, in case of acute pain, it is recommended to take the drug at least 30 minutes before a meal.
Adverse drug reactions can be minimized by using the lowest effective dose for the shortest possible time necessary to relieve symptoms.
The drug is not intended for long-term therapy; treatment continues as long as symptoms persist.
Adults: Depending on the type and intensity of pain, the recommended dose is 12.5 mg (½ film-coated tablet) every 4-6 hours or 25 mg (one tablet) every 8 hours. The daily dose should not exceed 75 mg.
Application features
Pregnant women
The drug can be used in the I and II trimesters of pregnancy only if absolutely necessary. When prescribing dexketoprofen in the I and II trimesters of pregnancy, the lowest possible effective dose should be used for the shortest possible duration of treatment.
Children
The safety and efficacy of dexketoprofen in children under the age of 18 have not been established. The drug should not be used in this category of patients.
Drivers
When using dexketoprofen, dizziness, visual disturbances or drowsiness may occur, which may affect the ability to drive or use other mechanisms.
Overdose
Symptoms
Symptoms of overdose are unknown. Similar drugs cause disorders of the digestive tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, vertigo, disorientation, headache).
Treatment
In case of overdose, symptomatic therapy should be initiated immediately according to the patient's clinical condition. If an adult or child has taken a dose of 5 mg/kg body weight within the first hour, an adsorbent should be administered. Hemodialysis may be used to remove dexketoprofen.
Side effects
Gastrointestinal tract: often (≥ 1/100 to ˂ 1/10) - nausea and/or vomiting, abdominal pain, diarrhea, dyspepsia.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
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