“Description
Solpadeine Forte is a drug in the form of coated tablets with an analgesic effect that contains 2 active substances. Paracetamol and codeine are responsible for the analgesic effect. The drug is used to relieve pain that requires a stronger action than single-component analgesics available over the counter, such as migraine, sciatica, toothache or menstrual pain. Solpadeine Forte can be administered on a short-term basis to children over 12 years of age and adults.
Composition
The active substances are paracetamol and codeine.
One tablet contains 500 mg of paracetamol (Paracetamolum) and 12.8 mg of codeine phosphate hemihydrate (Codeini phosphas hemihydricus).
Excipients: pregelatinized corn starch, povidone K25, corn starch, talc, magnesium stearate, stearic acid, microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, macrogol 4000, quinoline yellow (E 104), erythrosine (E 127), titanium dioxide (E 171).
Dosage
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Adolescents from 12 to 15 years: one tablet up to 4 times a day. This dose should not be administered more frequently than every 6 hours. In adolescents aged 12-15 years, no more than 4 doses should be administered per day (equivalent to 2g of paracetamol and 51.2 mg of codeine phosphate hemihydrate).
Adolescents from 16 to 18 years: two tablets up to 4 times a day. This dose should not be administered more frequently than every 6 hours. No more than 4 doses (equivalent to 4 g of paracetamol and 102.4 mg of codeine phosphate hemihydrate) should be administered in any 24 hour period.
Adults: two tablets up to 4 times a day. This dose should not be administered more frequently than 4 to 6 hours apart. No more than 4 doses (equivalent to 4 g of paracetamol and 102.4 mg of codeine phosphate hemihydrate) should be administered in any 24 hour period.
Minimum interval between doses: 4 hours.
If pain or fever lasts longer than 3 days or worsening or other symptoms occur, treatment should be discontinued and a doctor should be consulted.
People with impaired renal and/or liver function may require a different dosage regimen. Consultation with a doctor is recommended.
Action
The drug has an analgesic and antipyretic effect.
Indications
Solpadeine Forte is indicated for the short-term relief of moderate pain, e.g. headaches, migraines, toothaches, pain in muscles, joints and bones following injuries and associated with inflammation, as well as in dysmenorrhea and sciatica.
Contraindications
The drug should not be used in case of hypersensitivity to any component of the drug or other opioid drugs, in breastfeeding women, in patients with rapid CYP2D6 metabolism, respiratory depression or suffering from chronic constipation. Use is contraindicated in pediatric patients (under 18 years of age) in the perioperative period of palatine and/or adenoids.”
