Solpadeine (Tablets) Instructions for Use

ATC Code

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

Active Substances

Caffeine (Ph.Eur.)

Paracetamol (Rec.INN)

Clinical-Pharmacological Group

Analgesic-antipyretic

Pharmacotherapeutic Group

Analgesics; other analgesics and antipyretics; anilides

Pharmacological Action

A combined medicinal product.

Paracetamol is an analgesic-antipyretic. It has analgesic, antipyretic, and weak anti-inflammatory effects. The mechanism of action is associated with the inhibition of prostaglandin synthesis, with a predominant effect on the thermoregulation center in the hypothalamus. The lack of effect on prostaglandin synthesis in peripheral tissues explains the absence of a negative effect on water-salt metabolism (sodium and water retention) and the gastrointestinal mucosa.

Caffeine stimulates the psychomotor centers of the brain, has an analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, and increases physical and mental performance.

Pharmacokinetics

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract, with relatively uniform distribution in body fluids. The binding of paracetamol to plasma proteins is minimal at therapeutic concentrations.

Paracetamol is metabolized in the liver and excreted in the urine as glucuronide and sulfate metabolites – less than 5% is excreted unchanged. The T_1/2 after a therapeutic dose is 1-3 hours.

Caffeine is rapidly absorbed from the gastrointestinal tract and distributed throughout the body. Caffeine is almost completely metabolized in the liver by oxidation and demethylation into metabolites, which are excreted in the urine. The T_1/2 is 4-9 hours.

Indications

Pain syndrome (mild to moderate): headache; migraine; bone pain; myalgia; neuralgia; arthralgia; dysmenorrhea; toothache.

Symptomatic treatment of colds, influenza, including febrile syndrome.

ICD codes

Dosage Regimen

Administer orally with water.

For adults and adolescents over 12 years, take two tablets up to four times daily.

Maintain a minimum interval of 4 hours between doses.

Do not exceed the maximum daily dose of eight tablets.

The total duration of self-treatment without medical consultation must not exceed five days for pain and three days for fever.

The maximum overall treatment duration is ten days.

Adhere strictly to the recommended dosage to avoid the risk of serious liver damage from paracetamol overdose.

Reduce intake of other caffeine-containing beverages and foods during treatment.

Consult a physician if symptoms persist or if higher, more frequent, or prolonged dosing is required.

Adverse Reactions

Allergic reactions (skin rash, angioedema, urticaria), dyspeptic disorders (including nausea, epigastric pain).

In rare cases – hemolytic anemia, thrombocytopenia.

With long-term use in high doses – hepatotoxicity, nephrotoxicity, pancytopenia.

Contraindications

Severe hepatic and/or renal failure; epilepsy; arterial hypertension; glaucoma; sleep disorders; children under 12 years of age; hypersensitivity to the components of the combination.

With caution

Benign hyperbilirubinemias (including Gilbert’s syndrome), viral hepatitis, alcoholic liver disease, glucose-6-phosphate dehydrogenase deficiency, alcoholism.

Use in Pregnancy and Lactation

Should not be used during pregnancy and lactation (breastfeeding).

When taking caffeine, there is a high risk of having a child with low birth weight and a risk of spontaneous abortion.

Passing into breast milk, Caffeine can have a stimulating effect on the breastfed infant.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated in severe renal insufficiency.

Pediatric Use

Contraindicated for use in children under 12 years of age.

Special Precautions

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

With long-term (more than 1 week) treatment, monitoring of peripheral blood counts and liver functional state is necessary. Without consulting a doctor, take for no more than 3 days for the treatment of febrile syndrome and no more than 5 days for pain syndrome.

May alter the results of doping control tests in athletes.

Makes diagnosis difficult in the “acute abdomen” symptom complex.

Patients suffering from atopic bronchial asthma and hay fever have an increased risk of developing allergic reactions.

During treatment, ethanol consumption should be avoided (increased risk of hepatotoxicity).

Drug Interactions

Enhances the effect of MAO inhibitors.

Reduces the effectiveness of uricosuric drugs.

Caffeine accelerates the absorption of ergotamine.

Under the influence of paracetamol, the elimination time of chloramphenicol increases 5 times.

With long-term use, Paracetamol may enhance the effect of anticoagulants (dicoumarol derivatives).

Concomitant use of paracetamol and ethanol increases the risk of hepatotoxic effects and acute pancreatitis.

Barbiturates, phenytoin, ethanol, rifampicin, phenylbutazone, tricyclic antidepressants and other inducers of microsomal oxidation increase the production of hydroxylated active metabolites, creating the possibility of severe intoxication with small overdoses.

Inhibitors of microsomal oxidation (cimetidine) reduce the risk of hepatotoxic action.

When used concomitantly, metoclopramide and domperidone increase, and cholestyramine decreases absorption.

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.