Ketonal duo capsules 150mg №30

Indications

Symptomatic therapy of painful and inflammatory processes of various origins, including:

inflammatory and degenerative diseases of the musculoskeletal system:

- rheumatoid arthritis;

- seronegative arthritis (ankylosing spondylitis / Bechterew's disease /, psoriatic arthritis, reactive arthritis / Reiter's syndrome /);

- gout, pseudogout;

- osteoarthritis.

pain syndrome:

- headache;

- tendonitis, bursitis, myalgia, neuralgia, sciatica;

- post-traumatic pain;

- postoperative pain;

- Algomenorrhea;

- pain syndrome in oncological diseases.

Dosage and administration

Inside Standard dose of Ketonal ^® Duo for adults and children over 15 makes 150 mg / days. Capsules should be taken with or after meals with water or milk (the volume of the liquid should be at least 100 ml).

The maximum dose of Ketoprofen is 200 mg / day.

Adverse effects

The incidence of side effects is characterized as very common (> 10%), common (> 1% <10%), non-prevalent (> 0.1% <1%), rare (> 0.01% <0.1%) and very rare (<0.01% ).

Gastrointestinal: common - dyspepsia (nausea, diarrhea or constipation, flatulence, vomiting, decreased or increased appetite), abdominal pain, stomatitis,dry mouth; undistributed (with long-term use in large doses) - ulceration of the gastrointestinal mucosa, impaired liver function; rare - perforation of the digestive tract, exacerbation of Crohn's disease, melena, Gastrointestinal bleeding, transient increase in the level of liver enzymes.

From the side of the central nervous system: common - headache, dizziness, sleep disturbance, fatigue, nervousness, nightmares; rare - migraine, peripheral polyneuropathy; very rare - hallucinations, disorientation and speech disorder.

Special senses: rare - tinnitus, change in taste, blurred vision, conjunctivitis.

Cardiovascular: not common - tachycardia, arterial hypertension, peripheral edema.

Hemic and lymphatic: decreased platelet aggregation; rare - anemia, thrombocytopenia, agranulocytosis, purpura.

Urogenital: rare - impaired renal function, interstitial nephritis, nephrotic syndrome, hematuria (most often develop in people who take NSAIDs for a long time and diuretics).

Allergic reactions: common - skin reactions (itching, urticaria); not common - rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions.

Other: rare - hemoptysis, menometorrhagia.

Contraindications

- bronchial asthma, rhinitis, urticaria in history, caused by taking Acetylsalicylic acid or other NSAIDs;

- peptic ulcer of the stomach and duodenum in the acute phase;

- UC, Crohn's disease in the acute phase, inflammatory bowel disease in the acute stage;

- hemophilia and other bleeding disorders;

- severe liver failure;

- severe renal failure;

- progressive kidney disease;

- decompensated heart failure;

- The postoperative period after coronary artery bypass surgery;

- gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding);

- chronic dyspepsia;

- children's age up to 15 years;

- III trimester of pregnancy;

- lactation period (breastfeeding);

- hypersensitivity to ketoprofen or other components of the drug, as well as salicylates or other NSAIDs.

WITH caution The drug should be prescribed for a history of peptic ulcer disease, a history of bronchial asthma, clinically significant cardiovascular, cerebrovascular diseases and diseases of the peripheral arteries, dyslipidemia, progressive liver diseases, hyperbilirubinemia, alcoholism, renal insufficiency, chronic heart failure, a non-nonparasitic, hemorrhagic urine, hyperbilirubinemia, alcoholism, renal insufficiency, chronic heart failure, a non-non-nonparasitic, hemorrhagic ulcer, cardiovascular diseases dehydration, diabetes, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, smoking, concomitant anti-coagulant therapy ntami (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid), oral GCS (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, sertraline), long-term use of NSAIDs.

Use during pregnancy and lactation

The use of ketoprofen in the third trimester of pregnancy is contraindicated. In the first and second trimesters of pregnancy, prescribing is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

When taking the drug during lactation should decide on the termination of breastfeeding.

Application for violations of the liver

The drug is contraindicated in severe liver failure.

Application for violations of kidney function

The drug is contraindicated in severe renal failure.

Use in children

Contraindicated in children and adolescents up to 15 years.

Special notes

With prolonged use of NSAIDs, it is necessary to monitor the state of the blood, as well as the function of the kidneys and liver, especially in elderly patients (over 65).

Care must be taken and more often to control blood pressure when using ketoprofen to treat patients with arterial hypertension, cardiovascular diseases that lead to fluid retention in the body.

Like other NSAIDs, ketoprofen can mask signs of infectious diseases.

Influence on ability to drive motor transport and control mechanisms

Evidence of adverse effects of ketonal^® Duo in the recommended doses on the ability to drive a car or work with mechanisms not. However, patients who notice non-standard effects when taking Ketonal^® Duo, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and psychomotor speed.

Overdosage

Symptoms: nausea, vomiting, abdominal pain, vomiting with blood, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function and renal failure.

Treatment: in case of overdose, gastric lavage and the use of Activated carbon are indicated. Symptomatic therapy is performed. The effect of ketoprofen on the gastrointestinal tract can be reduced with the help of histamine N blockers.₂-receptors, proton pump inhibitors and prostaglandins.

Drug interaction

Ketoprofen can weaken the effect of diuretics and antihypertensive drugs, and enhance the effect of oral hypoglycemic and some anticonvulsant drugs (phenytoin).

Combined use with other NSAIDs, salicylates, GCS, ethanol increases the risk of adverse effects from the gastrointestinal tract.

The simultaneous appointment with anticoagulants, thrombolytics, antiplatelet agents increases the risk of bleeding.

At the same time taking NSAIDs with diuretics or ACE inhibitors increases the risk of impaired renal function.

Increases plasma concentration of cardiac glycosides, slow Calcium channel blockers, lithium preparations, cyclosporine, Methotrexate .

NSAIDs may decrease the effectiveness of mifepristone.NSAID administration should begin no earlier than 8-12 days after the abolition of mifepristone.

Terms and conditions of storage

The drug should be stored out of the reach of children, protected from light at a temperature not higher than 25 ° C.