The composition of the drug:
active substance: 1 tablet contains 500 mg of paracetamol, 30 mg caffeine and 8 mg codeine phosphate;
excipients: corn starch, starch is first romanized, potassium sorbate, polyvidone, talc purified, magnesium stearate, microcrystalline cellulose, stearic acid;
ink inscription: ethanol, water, ethyl cellulose gdocsopen, carmoisine (E 122).
Dosage form. Pills.
White pills with round shape and a size of 8.4 mm × 15.8 mm with a red inscription “Solpadeine“ on one side.
The name and location of manufacturer.
“GlaxoSmithKline Dungarvan Limited”, Ireland. Applicant: "GlaxoSmithKline Consumer, Helser", UK.
Address of the manufacturer: "GlaxoSmithKline Dungarvan limited", Nocbreak, Dungarvan, County Waterford, Ireland. The address of the applicant: “GlaxoSmithKline consumer, helser”, Brentford, TW8 9GS, UK.
Analgesics and antipyretics. ATC code N02B E51.
The pharmacological properties. Paracetamol is an analgesic-antipiretic. Caffeine increases the efficiency of analgesia with buguljma effect on the Central nervous system. Codeine phosphate is a moderate analgesic and has weak cough action.
Pharmacokinetics. Paracetamol is well absorbed in the digestive tract. Concerts peak in plasma occurs within 30 - 60 min, and the half of elimination from plasma is 1 - 4 hours. Metabolized in liver and excreted almost exclusively by the kidneys as conjugated metabolites. After oral intake of caffeine is absorbed rapidly. The maximum concentration in plasma achieved within 1 hours, while removing the floor, about 3.5 hours 65 - 80% of caffeine is excreted in the urine in the form of 1-methyl uric acid 1-metilksantina. Codeine phosphate is well absorbed after oral administration. Approximately 86 % of the oral dose excreted in urine within 24 hours.
Indications for use.
For fast pain relief of moderate to severe intensity (headache, migraine, backache, toothache, neuralgia, rheumatical pain, muscle pain, and recurrent pain during menstruation) and reduce symptoms of colds, sinusitis, flu.
Hypersensitivity to any component of the drug.
Severe liver or kidney disease, bronchial asthma, respiratory depression, head injury, increased cranial pressure internally, the period after surgery on the biliary tract.
Children up to age 12 years.
Appropriate security measures when using.
Recommended with caution to prescribe the drug to patients with impaired renal function or liver. The risk of overdose is higher in patients with netissime alcoholic liver disease.
Also it should be carefully prescribed to patients in the States that can be degraded by the use of opioids, in particular those who are treated for depression or diseases associated with respiratory failure, patients with prostatic hypertrophy, inflammatory or obstructive diseases of the stomach.
Do not take at the same time other drugs containing paracetamol and Solpadeine.
Do not exceed the dose. In case of overdose you should immediately contact your doctor.
If the headache becomes persistent, you should consult with your doctor. If the symptoms persist more than 3 days, consult a doctor.
Use during pregnancy or breast-feeding.
Epidemiological studies have not revealed any undesirable effects of paracetamol or caffeine when they are pregnant women at the recommended doses. There are insufficient data on the safety of codeine during pregnancy. The drug can be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
Paracetamol and caffeine are excreted in breast milk in quantities that have no clinical significance.
Codeine passes into breast milk in small amounts. Available published data do not indicate the contraindications of the drug during lactation period. Pregnant women and mothers who breast-feed should adhere to doctor's recommendations regarding treatment.
The ability to influence the rate of reaction at management of motor transport or operating other mechanisms.
During application of the drug may experience drowsiness, dizziness, excitation. This should be considered in patients who are driving or working with complex mechanisms, requiring concentration.
It is not recommended to appoint drug children up to 12 years.
Method of application and doses.
The drug is administered orally.
Adults and children over 12 years take 2 tablets 3 - 4 times a day, if necessary, but not more often than every 4 hours. No more than 8 tablets per day.
The duration of treatment should not exceed 3 days.
Symptoms of paracetamol overdose in the first 24 hours: pallor, nausea, vomiting, anorexia and abdominal pain. Symptoms of liver damage may appear within 12 to 48 hours after the overdose. May have abnormal glucose metabolism and metabolic acidosis. In severe intoxication, hepatic failure may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Also noted cardiac arrhythmia. Liver damage is possible in adults who took 10 g or more of paracetamol in children who took more than 150 mg/kg of body weight. Overdose necessary emergency medical care. The purpose of oral methionine or acetyl cysteine internally tively can have a positive effect within 48 hours after the overdose. It is also necessary to apply symptomatic therapy. Overdose of caffeine may cause nervousness, anxiety, insomnia, agitation, diuretic effect, tides blood to a person, muscle cramps, impaired digestive tract, tachycardia or cardiac arrhythmia, “incoherence” of thought and speech, psychomotor agitation, or periods of “restlessness”.
The use of high doses of codeine may cause miosis, hypotension, respiratory depression; specific antidote is naloxone.
The therapy is symptomatic.
Possible rash, urticaria, angio neurotic edema, constipation, nausea, dizziness, drowsiness (depending on dose and individual sensitivity), insomnia, arousal due to stimulation of the Central nervous system.
Long-term use may be hepatotoxic effects.
Interaction with other medicinal products and other forms of interaction.
The rate of absorption of paracetamol may be increased by concomitant use with metoklopramidom and domperon, and suction can be reduced when applying holestiraminom. Noah anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol (increased risk of bleeding). Patients taking monoamine oxidase inhibitors should be used with caution codeine. Codeine may potentiate the effects of oppressive Central nervous system (including alcohol), however, this interaction has no clinical significance in the application of recommended doses of the drug.
The expiration date. 5 years.
The storage conditions. Store at temperature below 25 °C. Keep out of reach of children.