Trade name of the drug: Kupen

Active ingredients (INN): paracetamol, sodium diclofenac

Dosage form: tablets

Composition:

Each tablet contains:

active substances:

Paracetamol 500 mg

Diclofenac sodium 50 mg

excipients: starch, gelatin, purified talc, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, Sunset Yellow FCF dye, anhydrous colloidal silicon dioxide, purified water (sufficient amount).

Description : White-orange, two-layer, round, biconvex tablet. Smooth (not serrated) on both sides

Pharmacotherapeutic group: A nalgesic-Antipyretic

ATX code: N02BE51

 

Pharmacological properties

Kupen tablets   contain 2 substances from the NSAID group – paracetamol and diclofenac sodium. Both agents inhibit the activity of cyclooxygenase, which promotes the formation of cyclic endoperoxides from arachidonic acid. Cyclic endoperoxides are the starting material in the formation of prostaglandins involved in the development of inflammation and its clinical manifestations – pain, edema, fever.

Diclofenac inhibits the formation of prostaglandins by inhibiting the activity of both types of cyclooxygenase. Thus, it has a pronounced analgesic and anti-inflammatory effect. The antipyretic effect is moderate. The central mechanism of the analgesic effect of diclofenac is associated with inhibition of the formation of prostaglandins in the nervous system.

Paracetamol has a predominantly central effect, inhibiting the formation of prostaglandins in the nervous system. It is a strong analgesic and antipyretic. The anti-inflammatory effect is weak.

 

Pharmacokinetics

Diclofenac is well absorbed from the digestive tract. The absorption rate slows down slightly with simultaneous food intake. Able to penetrate into synovial fluid. Metabolism is carried out mainly in the liver. Some of the metabolites are pharmacologically active. Excretion of metabolites is carried out mainly by the kidneys, partly with bile. About 1% of diclofenac is excreted unchanged by the kidneys.

Absorption of paracetamol in the digestive tract occurs quickly, mainly in the small intestine. Paracetamol metabolism occurs in the liver. Metabolic products are excreted by the kidneys. In unchanged form, the kidneys excrete 5% of the drug.

 

Indications for use

Recommended for the symptomatic treatment of colds (anti-inflammatory, antipyretic), headache, neuralgia, toothache, lumbago, osteoarthritis, sciatica, rheumatoid arthritis, sciatica, febrile conditions, bursitis, tendinitis, myositis, dysmenorrhea, postoperative pain, and sports accidental damage.

 

Method of administration and dosage

For oral use.

Do not use in children under 12 years of age.

Adults and children over 12 years old: 1 tablet 2 – 3 times a day after meals.

Or as prescribed by your doctor.

Swallow the tablets whole without chewing.

 

Side effects

– Anorexia, constipation, nausea, abdominal pain, diarrhea;

– ulcers of the digestive tract with a possible complication of bleeding (as a rule, they occur only with prolonged use);

– depression, drowsiness, headache;

– hematuria, nephrotic syndrome, acute renal failure, proteinuria;

– thrombocytopenia, anemia;

– allergic reactions.

The symptoms of side effects (if any) should subside after the medication is discontinued. If symptoms persist, see your doctor.

 

Contraindications

Contraindicated in

– exacerbation of peptic ulcer;

– pregnancy;

– kidney disease;

– during lactation;

– “aspirin triad” (combination of nasal polyposis and paranasal sinuses, NSAID intolerance and bronchial asthma);

– children under 12 years old ..

 

Drug interactions

Kupen   reduces the clinical effects of furosemide and antihypertensive drugs, potentiates the effect of potassium-sparing diuretics. Increases the content of digoxin in plasma. Concomitant administration of corticosteroids increases the risk of gastrointestinal ulcers. Increases the toxic effects of methotrexate. Enhances the nephrotoxic effect of cyclosporine. Potentiation of the action of anticoagulants is possible.

 

special instructions

Care must be taken when using the drug in patients with impaired renal and hepatic function. Check the expiration date on the package and do not use the drug after the expiration date.

Pregnancy and lactation

Do not use if pregnant or nursing. Use during pregnancy only if the potential benefit to the patient outweighs the potential risk to the fetus.

 

Overdose

Symptoms: renal failure, arterial hypotension, convulsions, dyspeptic symptoms, breathing disorders.

Treatment is symptomatic.

 

Release form

10 tablets in a blister pack, 10 blister packs in a cardboard box with instructions for use.

 

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25ºC

Keep out of the reach of children.

 

Shelf life

4 years.

Do not use after the expiration date.

 

Conditions of dispensing from pharmacies

Prescribed by a doctor.