Fleksen

General characteristics. Structure:

Active agent: ketoprofen - 50 mg Excipients: vegetable oil, soybeans the oil hydrated the vegetable oil hydrogenated beeswax, lecithin soy.

Structure of the capsule: 
gelatin, глицерол, sorbitol, titanium dioxide, ethylparahydroxysodium benzoate, пропилпарагидроксибензоат sodium.

Description: 
Opaque oblong soft gelatin capsules of pale yellow color. Contents of capsules – oily suspension of cream color.

Pharmacological properties:

FLEKSEN renders antiinflammatory, analgeziruyushchy and febrifugal, anti-aggregation actions. Suppresses activity of the cyclooxygenases 1 and 2 regulating synthesis of prostaglandins. Analgeziruyushchy action is caused, both central, and peripheral by mechanisms. Has antibradikininovy activity, stabilizes lizosomalny membranes.

Pharmacokinetics. At intake bioavailability – to 90% is soaked up quickly. Contacts proteins of a blood plasma for 99%. Time of achievement of the maximum concentration in a blood plasma – 0,5 – 2,0 h.
The average level of concentration in a blood plasma makes 0,45 – 5,62 mkg/ml after reception of a dose of 50 mg 4 times a day. Equilibrium concentration in plasma is reached in 24 h after the beginning of regular reception. Therapeutic concentration in synovial fluid remains 6-8 h. It is metabolized in a liver by a glyukuronirovaniye.
Also 1-8% through intestines are removed, mainly, by kidneys. The elimination half-life makes 1,6 – 1,9 h. Does not kumulirut.

Indications to use:

Symptomatic treatment of an acute pain syndrome at inflammatory processes of various origin: the osteoarthrosis ankylosing a spondylitis, gouty arthritis (at a bad attack of gout high-speed dosage forms are preferable), a pseudorheumatism, psoriasis arthritis; the bursitis, tendosinovit; ischialgia, mialgiya, neuralgia, dorsalgiya, radiculitis; bruises and muscle strain; adnexitis, otitis; head and dentagra; a pain syndrome at oncological diseases; posttraumatic and postoperative pain syndrome; альгодисменорея.

Route of administration and doses:

Capsules accept without chewing with enough water after meal. Appoint usually adult on 1-2 capsules on 50 mg 2-3 times a day. The maximum daily dose of drug should not exceed 300 mg.

Features of use:

At simultaneous use of ketoprofen and warfarin, and also coumarinic anticoagulants or salts of lithium patients have to be under strict observation of the doctor.
It is necessary to be careful at purpose of drug the patient with ulcer diseases of digestive tract in the anamnesis, a renal and liver failure.
During treatment control of a picture of peripheral blood and a functional condition of a liver and kidneys is necessary. At a renal failure and a liver (increase in activity of ALT is the liver dysfunction NPVP-indutsirovannoy indicator) the dose decline and careful observation of the doctor is necessary. In need of definition of 17 ketosteroids drug should be cancelled for 48 h prior to a research. To avoid reception of alcoholic drinks!
At development of disturbances from organs of sight consultation of the ophthalmologist is necessary. During treatment it is necessary to be careful when driving motor transport and occupations other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

From the alimentary system: NPVP-gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, meteorism, loss of appetite, diarrhea), stomatitis; taste change, ulceration and perforation of a mucous membrane of digestive tract, gingival, gastrointestinal, hemorrhoidal bleeding; increase in activity of "hepatic" transaminases in blood serum, hepatitis.

From a nervous system: headache, dizziness, sleeplessness, excitement, nervousness, drowsiness, depression, adynamy, confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy.

From sense bodys: noise or a ring in ears, a sight illegibility, conjunctivitis, dryness of a mucous membrane of an eye, eye pain, a conjunctiva hyperemia, decrease in hearing, вертиго.
From cardiovascular system: increase in arterial pressure, tachycardia. From bodies of a hemopoiesis: seldom – an agranulocytosis, anemia, hemolitic anemia, thrombocytopenia, a leukopenia.
From an urinary system: edematous syndrome, cystitis, urethritis, renal failure, intersticial nephrite, nephrotic syndrome, hamaturia.

From a respiratory organs: диспноэ, bronchospasm, rhinitis, throat hypostasis, nasal bleeding, pneumorrhagia, asthma.

From integuments: alopecia, eczema, mnogoformny exudative erythema, including Stephens-Johnson's syndrome, toxic epidermal necrolysis (Lyell's disease), photodermatitis.
Allergic reactions: skin rash (including erythematic, small tortoiseshell), skin itch, Quincke's disease, exfoliative dermatitis, acute anaphylaxis.

Others: sweating strengthening, mialgiya, muscular twitchings, thirst, vaginal bleeding.

Interaction with other medicines:

Reduces efficiency of uricosuric medicines, strengthens effect of anticoagulants, antiagregant, fibrinolitik, ethanol, side effects of glucocorticosteroids and mineralokortikosteroid, estrogen; reduces efficiency of hypotensive medicines and diuretics. Joint reception with other NPVP, glucocorticosteroids, ethanol, corticotropin can lead to formation of ulcers and development of gastrointestinal bleedings, to increase in risk of development of disturbances of functions of kidneys.
Co-administration with peroral anticoagulants, heparin, trombolitika, antiagregant, tsefoperazony, tsefamandoly and tsefatetany increases risk of development of bleedings.
Increases hypoglycemic effect of insulin and peroral hypoglycemic medicines (recalculation of a dose is necessary). Inductors of a microsomal oxidation in a liver (Phenytoinum, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase products of hydroxylated active metabolites. Joint appointment with Valproatum of sodium causes disturbance of aggregation of thrombocytes.
Increases concentration in plasma of verapamil and nifedipine, drugs of lithium, a methotrexate. Antacids and Colestyraminum reduce absorption. Myelotoxic medicines strengthen manifestations of a gematotoksichnost of drug.

Contraindications:

• individual hypersensitivity to ketoprofen, acetylsalicylic acid or other NPVP (including instructions in the anamnesis on the bronchospasm, urticaria or rhinitis caused by reception of acetylsalicylic acid);
• digestive tract diseases in an aggravation phase;
• gastrointestinal bleedings and perforation in the anamnesis;
• the expressed renal failures and a liver;
• disturbances from blood (a leukopenia, thrombocytopenia, disturbances of hemocoagulation, hemophilia);
• stopping of a pain syndrome just before or right after operational treatment of cardiovascular system;
• the expressed heart failure;
• pregnancy and feeding by a breast;
• children's age (up to 15 years);

With care: It is necessary to use with care drug at patients: with abnormal liver functions and/or kidneys, gastrointestinal diseases in the anamnesis; bronchial asthma, rhinitis, small tortoiseshell, polyps mucous nose; hypertensia and/or with cardiovascular diseases, cerebrovascular diseases; diseases of blood, anemia; alcoholism, alcoholic cirrhosis, a hyperbilirubinemia, diabetes, dehydration, smoking, sepsis and at patients of advanced age.

Overdose:

Symptoms: emergence of drowsiness, nausea, vomiting, abdominal pains, bleedings, abnormal liver functions and kidneys is possible. Symptomatic treatment: gastric lavage and/or absorbent carbon and/or other sorbents. There is no specific antidote.

Storage conditions:

To store at a temperature not over 25 ºС. To store in the place, unavailable to children. Period of validity: 5 years. Drug should not be used after a period of validity!

Issue conditions:

According to the recipe

Packaging:

Capsules of 50 mg. On 10 capsules in a blister strip packaging from PVC / Aluminum foil (blister). On 2 or 3 blisters together with the application instruction in a cardboard pack.