Femcomfort^® (Tablets) Instructions for Use

Marketing Authorization Holder

Alvils Patent, LLC (Russia)

Manufactured By

Styrolbiopharm LLC (Ukraine)

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Caffeine (Ph.Eur. European Pharmacopoeia)

Paracetamol (Rec.INN WHO Registered)

Propyphenazone (Rec.INN WHO Registered)

Dosage Form

Femcomfort®

Tablets 200 mg+200 mg+50 mg: 6, 12, 24, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets are white, round, with a biconvex surface, and a score on one side.

Excipients: granulate for direct compression (pregelatinized starch – 16.5 mg, povidone – 3.3 mg, croscarmellose sodium – 1.1 mg, stearic acid – 1.1 mg) – 22 mg, magnesium stearate – 7 mg, pregelatinized starch – 30 mg, lactose monohydrate – 15 mg, microcrystalline cellulose – 163 mg, croscarmellose sodium – 5 mg, colloidal silicon dioxide – 8 mg.

6 pcs. – blisters^× (1) – cardboard packs.
12 pcs. – blisters^× (1) – cardboard packs.
12 pcs. – blisters^× (2) – cardboard packs.
30 pcs. – containers (1) – cardboard packs.

^× supplied with or without a pocket for carrying the blister.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Combined analgesic agent (NSAID + non-narcotic analgesic agent + psychostimulant agent)

Pharmacological Action

Combined medicinal product. The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action.

Paracetamol and Propyphenazone have analgesic and antipyretic effects. Paracetamol is a non-narcotic analgesic. It blocks COX only in the CNS, affecting the centers of pain and thermoregulation (in inflamed tissues, cellular peroxidases neutralize the effect of paracetamol on COX), which explains the almost complete absence of an anti-inflammatory effect. The lack of effect on the synthesis of prostaglandins (PG) in peripheral tissues determines the absence of a negative effect on water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa.

Propyphenazone is a pyrazolone derivative. The mechanism of action is carried out by inhibiting COX, which is involved in the formation of prostaglandins from arachidonic acid.

Caffeine increases the reflex excitability of the spinal cord, excites the respiratory and vasomotor centers, dilates blood vessels of skeletal muscles, brain, heart, kidneys, reduces platelet aggregation; reduces drowsiness, feeling of fatigue. In this combination, Caffeine in a small dose has almost no stimulating effect on the CNS, but it helps regulate the tone of cerebral vessels, reduces drowsiness, and enhances the analgesic effect of other components of the drug.

Pharmacokinetics

Paracetamol

Absorption is high, plasma protein binding is 15%, T_max is 20-30 min. Penetrates the BBB. Less than 1% of the dose taken by a nursing mother passes into breast milk. The therapeutic effective concentration of paracetamol in plasma is achieved when administered at a dose of 10-15 mg/kg.

Metabolized in the liver: 80% undergoes conjugation with glucuronic and sulfuric acids to form inactive metabolites; 17% undergoes hydroxylation to form inactive metabolites, which conjugate with glutathione and form inactive metabolites. With a deficiency of glutathione, these metabolites can block the enzyme systems of hepatocytes and cause their necrosis. T_1/2 is 2-3 h. In elderly patients, the clearance of paracetamol decreases and the half-life increases. Excreted by the kidneys unchanged 3%.

Propyphenazone

C_max of propyphenazone in plasma is reached after 30 min. Metabolized in the liver. T_1/2 is 1-1.5 h. Combination with paracetamol increases its elimination time by 40%, which plays a significant role, as it allows reducing the number of drug doses per day. Excreted by the kidneys.

Caffeine

Time to reach C_max is 1 h; T_1/2 is 3.5 h; 65-80% of caffeine is excreted by the kidneys mainly in the form of 1-methylxanthine, 1-methyluric acid and acetylated uracil derivatives, a small amount is converted into theophylline and theobromine.

Indications

Relief of mild to moderate pain syndrome of various origins: headache; migraine; toothache; arthralgia; myalgia; primary dysmenorrhea.

As an antipyretic for febrile conditions against the background of infectious and inflammatory diseases (ARVI, including influenza, etc.).

ICD codes

Dosage Regimen

Take orally with a sufficient amount of water.

For adults and adolescents over 12 years of age, the single dose is one tablet.

If pain or fever persists, take a second tablet after a minimum interval of 4 hours.

Do not exceed the maximum daily dose of four tablets (equivalent to 800 mg paracetamol, 800 mg propyphenazone, and 200 mg caffeine).

Limit the duration of self-treatment to three to five days for pain relief and two to three days for fever reduction.

Discontinue use and consult a physician if symptoms persist beyond these recommended durations.

For patients with benign hyperbilirubinemia (e.g., Gilbert’s syndrome) or elderly patients, use the same regimen but with increased caution and only after medical consultation.

Avoid concomitant intake of other products containing paracetamol, propyphenazone, or caffeine to prevent overdose.

Do not use in children under 12 years of age.

Adverse Reactions

From the nervous system: dizziness, insomnia.

From the gastrointestinal tract: nausea, vomiting, heaviness and discomfort in the stomach area.

From the hematopoietic system: thrombocytopenia, agranulocytosis, hemolytic anemia.

Allergic reactions: skin rash, itching, urticaria, angioedema, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

Contraindications

Hypersensitivity to the components of the drug; severe renal and/or hepatic insufficiency; deficiency of the enzyme glucose-6-phosphate dehydrogenase; bone marrow depression (leukopenia, anemia, including hemolytic); acute hematoporphyria; complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to NSAIDs (including history); conditions accompanied by respiratory depression; intracranial hypertension; acute myocardial infarction; coronary artery disease; arrhythmias; arterial hypertension; peptic ulcer of the stomach and duodenum; glaucoma; insomnia; pregnancy; lactation period; children under 12 years of age.

With caution: benign hyperbilirubinemias (including Gilbert’s, Dubin-Johnson, Rotor syndromes), elderly age, alcoholism, epilepsy and tendency to convulsive seizures.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal insufficiency.

Pediatric Use

Contraindication: children under 12 years.

Geriatric Use

With caution: elderly age.

Special Precautions

With long-term use (more than 5 days), monitoring of the peripheral blood picture and functional state of the liver is necessary.

During treatment, one should refrain from consuming alcoholic beverages (increased risk of gastrointestinal bleeding).

Excessive consumption of caffeine-containing products (coffee, tea) during treatment may cause overdose symptoms.

Taking the drug may complicate the diagnosis in acute abdominal pain syndrome.

Influence on the ability to drive vehicles and mechanisms

During the intake period, caution should be exercised when driving vehicles and engaging in other activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

The effectiveness of this combination may decrease with simultaneous use with cholestyramine, anticholinergics, antidepressants, and alkaline substances.

With simultaneous use with barbiturates, anticonvulsants, and ethanol, the hepatotoxic effect is significantly increased.

Metoclopramide accelerates the absorption of paracetamol.

Under the influence of paracetamol, the half-life of chloramphenicol increases 5 times.

Simultaneous use of paracetamol in high doses enhances the effect of anticoagulants.

Myelotoxic agents enhance the manifestations of hematotoxicity of paracetamol.

Caffeine accelerates the absorption of ergotamine; reduces the absorption of calcium preparations; reduces the effect of narcotic and hypnotic agents, increases the excretion of lithium preparations; accelerates the absorption and enhances the action of cardiac glycosides, increases their toxicity.

Simultaneous use of caffeine with beta-blockers may lead to mutual suppression of therapeutic effects, with beta-agonists to additional stimulation of the CNS and other toxic effects.

Caffeine may reduce the clearance of theophylline, and possibly other xanthines, increasing the possibility of additive pharmacodynamic and other toxic effects.

MAO inhibitors, furazolidone, procarbazine, selegiline and large doses of caffeine can cause the development of dangerous cardiac arrhythmias or a pronounced increase in blood pressure.

Nicotine increases the rate of caffeine excretion.

Caffeine is an antagonist of adenosine.

Propyphenazone may enhance the action of oral hypolipidemic agents, sulfonamide drugs, anticoagulants, the ulcerogenic effect of glucocorticosteroids, and reduces the effectiveness of potassium-sparing diuretics.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.