Flamax capsules 50mg, No. 25

• Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic arthritis, Bechterew's disease (ankylosing spondylitis), gouty arthritis (with an acute attack of gout, fast-acting dosage forms are preferred), osteoarthritis.

• Pain syndrome: myalgia, ossalgia, neuralgia, tendonitis, arthralgia, bursitis, radiculitis, adnexitis, otitis media, headache and toothache, with cancer, post-traumatic and postoperative pain syndrome, accompanied by inflammation.

• Algodismenorrhea.

Inside, during meals. For rheumatic diseases 1 capsule in the morning, 1 in the afternoon and 2 in the evening, or 4 times a day, 1 capsule. Combined use of dosage forms is possible.
For patients with renal insufficiency, the dose is reduced to 33-50%; in elderly patients, the dose is adapted to age.
In the treatment of pain and algodismenorrhea, the dose, if necessary, is 25-50 mg of ketoprofen every 6-8 hours. The
maximum daily dose is 300 mg.

1 capsule contains 50 mg of ketoprofen,
excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, colloidal silicon dioxide.
Composition of the gelatin capsule: titanium dioxide, gelatin, indigo carmine FD&C blue.

- Hypersensitivity to ketoprofen or to any component of the drug;
- a history of bronchial asthma caused by ketoprofen, another non-steroidal anti-inflammatory drug, or acetisalicylic acid;
- Recurrent gastric ulcer and duodenal ulcer;
- peptic ulcer;
- severe liver failure;
- severe renal failure;
- failure of the circulatory system;
- gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding);
- pregnancy and lactation;
- children's age (up to 15 years old);
- hemophilia and other blood clotting disorders;
- ulcerative colitis, Crohn's disease, diverticulitis.

With care
Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis of the liver, hyperbilirubinemia, hepatic and renal (since the drug is mainly excreted by the kidneys) failure, diabetes mellitus, dehydration, sepsis, chronic heart failure, edema, arterial hypertension, ischemic heart disease, blood diseases (including leukopenia), stomatitis, childhood (over 15 years old), old age.
Pregnancy and lactation
The use of ketoprofen is contraindicated during pregnancy and lactation.

Trade name: Flamax

International Non-Proprietary Name (INN): ketoprofen

Chemical name: (2 RS) -2- (3-benzoylphenyl) propionic acid

Dosage form:

capsules

Composition:
1 capsule contains 50 mg of ketoprofen,
excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, colloidal silicon dioxide.
Composition of the gelatin capsule: titanium dioxide, gelatin, indigo carmine FD&C blue.

Description
Hard gelatin capsules No. 2 - white body with a blue lid. The contents of the capsules are a homogeneous white powder.

Pharmacological group: non-steroidal anti-inflammatory drug (NSAID).

Pharmacological properties

Pharmacodynamics
Nonsteroidal anti-inflammatory drug (NSAID), a derivative of propionic acid. It has anti-inflammatory, analgesic and antipyretic, antiaggregatory effects. Suppresses the activity of cyclooxygenases 1 and 2, which regulate the synthesis of prostaglandins. The analgesic effect is due to both central and peripheral mechanisms. Possesses anti-bradykinin activity, stabilizes lysosomal membranes.

Pharmacokinetics
Absorption - fast, bioavailability - 90%. Up to 99% of absorbed ketoprofen binds to plasma proteins, mainly albumin. The maximum concentration of the drug in plasma (Cmax) is reached quickly (0.5-2 hours after oral administration) due to the low volume of distribution (0.1-0.2 l / kg). The equilibrium concentration (Css) of ketoprofen in plasma is reached 24 hours after the start of its regular intake. Ketoprofen penetrates well into synovial fluid and connective tissues. The maximum concentration in the synovial fluid is 30% of the concentration in the serum, and 4-6 hours after administration it exceeds it. Ketoprofen crosses the blood-brain barrier. It is almost completely metabolized in the liver by glucuronidation, and has a 'first pass' effect through the liver.Excreted by the kidneys (mainly) and intestines (1-8%). The half-life of ketoprofen (T1 / 2) is 1.6-1.9 hours. In the elderly, the half-life increases to 3-5 hours, in patients with renal insufficiency (creatinine clearance 20-60 ml / min) is about 3.5 hours Does not cumulate.

Indications for use:
Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic arthritis, ankylosing spondylitis (ankylosing spondylitis), gouty arthritis (with an acute attack of gout, fast-acting dosage forms are preferred), osteoarthritis.
Pain syndrome: myalgia, ossalgia, neuralgia, tendonitis, arthralgia, bursitis, sciatica, adnexitis, otitis media, headache and toothache, with cancer, post-traumatic and postoperative pain syndrome, accompanied by inflammation. Algodismenorrhea.

Contraindications:
- hypersensitivity to ketoprofen or to any component of the drug;
- a history of bronchial asthma caused by ketoprofen, another non-steroidal anti-inflammatory drug, or acetisalicylic acid;
- Recurrent gastric ulcer and duodenal ulcer;
- peptic ulcer;
- severe liver failure;
- severe renal failure;
- failure of the circulatory system;
- gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding);
- pregnancy and lactation;
- children's age (up to 15 years old);
- hemophilia and other blood clotting disorders;
- ulcerative colitis, Crohn's disease, diverticulitis.

With care
Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis of the liver, hyperbilirubinemia, hepatic and renal (since the drug is mainly excreted by the kidneys) failure, diabetes mellitus, dehydration, sepsis, chronic heart failure, edema, arterial hypertension, ischemic heart disease, blood diseases (including leukopenia), stomatitis, childhood (over 15 years old), old age.
Pregnancy and lactation
The use of ketoprofen is contraindicated during pregnancy and lactation.

Method of administration and dosage
Inside, during meals. For rheumatic diseases 1 capsule in the morning, 1 in the afternoon and 2 in the evening, or 4 times a day, 1 capsule. Combined use of dosage forms is possible.
For patients with renal insufficiency, the dose is reduced to 33-50%; in elderly patients, the dose is adapted to age.
In the treatment of pain syndrome and algodismenorrhea, the dose, if necessary, is 25-50 mg of ketoprofen every 6-8 hours. The
maximum daily dose is 300 mg.

Side effect
- From the digestive system: NSAID-gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, loss of appetite, diarrhea), stomatitis; change in taste, ulceration and perforation of the mucous membrane of the gastrointestinal tract,
gingival, gastrointestinal, hemorrhoidal bleeding; increased activity of 'hepatic' transaminases in blood serum, hepatitis.
- From the nervous system: headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, asthenia, confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy.
- From the senses: noise or ringing in the ears, blurred vision, conjunctivitis, dryness of the mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, hearing loss, vertigo.
- From the side of the cardiovascular system: increased blood pressure, tachycardia.
- From the side of hematopoiesis: rarely - agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia.
- From the urinary system: edema syndrome, cystitis, urethritis, impaired renal function, interstitial nephritis, nephrotic syndrome, hematuria.
- On the part of the respiratory system: hemoptysis, dyspnea, bronchospasm, rhinitis, laryngeal edema, epistaxis, shortness of breath.
- On the part of the skin: skin rash, alopecia and eczema, exudative erythema, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), photodermatitis.
- Allergic reactions: skin rash (including erythematous, urticaria), itching of the skin, rhinitis, angioedema, exfoliative dermatitis, anaphylactic shock.
- Others: increased sweating, myalgia, muscle twitching, shortness of breath, thirst, vaginal bleeding.
Overdose
Symptoms: drowsiness, nausea, vomiting, abdominal pain, bleeding, liver and kidney dysfunction may occur.
Symptomatic treatment: gastric lavage and / or activated carbon and / or other sorbents. There is no specific antidote.

Interaction
Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of glucocorticosteroids and mineralocorticosteroids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics.
Co-administration with other NSAIDs, glucocorticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, to an increase in the risk of developing renal dysfunction.
The simultaneous administration of oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandol and cefotetan increases the risk of bleeding.
Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is required).
Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.
Co-administration with sodium valproate causes impaired platelet aggregation.
Increases plasma concentration of verapamil and nifedipine, lithium preparations, methotrexate.
Antacids and cholestyramine reduce absorption.
Myelotoxic drugs increase the manifestations of the drug's hematotoxicity.

Special instructions
With the simultaneous use of ketoprofen and warfarin, as well as coumarin anticoagulants or lithium salts, patients should be under strict medical supervision.
Care must be taken when prescribing the drug to patients with a history of gastrointestinal ulcers, renal or hepatic insufficiency. During treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys. In case of impaired renal and liver function (an increase in ALT activity is the most sensitive indicator of NSAID-induced liver dysfunction), dose reduction and careful monitoring are necessary.
If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.
Like other drugs in this group, it can mask the signs of an infectious disease.
With the development of violations of the organs of vision, consultation with an ophthalmologist is necessary.
During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form
Capsules containing 50 mg of ketoprofen. 25 capsules in a plastic container with a screw cap, with tamper evident. 1 plastic container with instructions for use in a cardboard box.

Shelf life is
3 years. Do not use after the expiration date printed on the package.
Storage
conditions Store in a dry, dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Terms of dispensing
By prescription.