Description

Solpadeine Forte is a painkiller in the form of film-coated tablets containing two active ingredients. Paracetamol and codeine provide the analgesic effect. It is used to relieve pain that requires more potent action than single-ingredient over-the-counter painkillers, such as migraines, sciatica, toothache, or menstrual pain. Solpadeine Forte can be administered short-term to children over 12 years of age and adults.

Composition

The active substances are paracetamol and codeine ( Paracetamolum i Codeini phosphas hemihydricu s).

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 the package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist.

Adolescents 12 to 15 years: one tablet up to 4 times daily. This dose should not be administered more frequently than every 6 hours. In adolescents aged 12 to 15 years, no more than 4 doses per day should be administered (equivalent to 2g of paracetamol and 51.2mg of codeine phosphate hemihydrate).

Adolescents 16 to 18 years: two tablets up to 4 times daily. This dose should not be administered more frequently than 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 24 hours.

Adults: two tablets up to four times daily. This dose should not be administered more frequently than 4 to 6 hours apart. No more than four 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 worsens or other symptoms occur, treatment should be discontinued and a doctor should be consulted.

People with renal and/or hepatic impairment may require a different dosing regimen. Consultation with a physician 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. headache, migraine, toothache, muscle, joint and bone pain after injuries and associated with inflammation, as well as painful menstruation and sciatica.

Contraindications

This drug should not be used in cases of hypersensitivity to any of the drug's ingredients or other opioid medications, or in breastfeeding women, patients with CYP2D6 rapid metabolizers, respiratory depression, or chronic constipation. Use is contraindicated in pediatric patients (under 18 years of age) during the perioperative period of tonsil and/or pharyngeal tonsil surgery.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and tell your doctor immediately if you experience symptoms such as: dry mouth, nausea and vomiting if you have recently had your gallbladder removed; acute pancreatitis (inflammation of the pancreas), which can cause severe stomach pain; allergic reactions, which may be severe and include skin rash or mouth ulcers, sometimes with flu-like symptoms or itching, sometimes with swelling of the lips or face, or shortness of breath, peeling skin; breathing problems. These symptoms are more likely if you have experienced these symptoms before when taking other painkillers such as ibuprofen and aspirin; unexplained bruising or bleeding; nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin; difficulty urinating; cloudy urine.

Very rare side effects (affecting less than 1 in 10,000 patients): thrombocytopenia, anaphylactic shock, allergies, bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs), liver function abnormalities, cutaneous hypersensitivity reactions including skin rash, pruritus, sweating, purpura, urticaria and angioedema, toxic epidermal necrolysis (TEN), drug-induced dermatitis, Stevens-Johnson syndrome (SJS), cloudy urine.

Unknown frequency: nervousness, dizziness, constipation, nausea, vomiting, dyspepsia, dry mouth, acute pancreatitis in patients with a history of cholecystectomy, pruritus, sweating, difficulty in urination.

With prolonged use of codeine in higher doses, drug dependence may occur.

Warnings and precautions

Before taking this medicine, consult your doctor or pharmacist if: you have liver or kidney disease, alcoholic liver disease, or Gilbert's syndrome (familial nonhemolytic jaundice); you have intestinal problems, including intestinal obstruction; you have had gallbladder surgery; you have asthma and are hypersensitive to aspirin; you have hypotension, hypothyroidism, head trauma, or increased intracranial pressure. Caution should be exercised in dehydrated or chronically malnourished patients and those weighing less than 50 kg.

Solpadeine Forte contains codeine, which may be addictive if taken continuously for more than 3 days, and withdrawal symptoms may occur when stopping use.

This medicine should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

The medicine should be stored out of the sight and reach of children, at a temperature below 25°C, in the original packaging to protect the product from moisture.

Use of other medications

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including medicines obtained without a prescription.

Information is particularly important if the patient is taking: metoclopramide or domperidone, cholestyramine, antidepressants, sleeping pills and sedatives, anticoagulants, probenecid,

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Use during pregnancy is only possible on the advice of a doctor. This medication should not be used while breastfeeding.

Use of the drug in children and adolescents

Solpadeine Forte should not be used in children and adolescents after removal of the palatine or pharyngeal tonsils due to obstructive sleep apnea syndrome or in case of breathing disorders.

Do not give Solpadeine Forte to children under 12 years of age.

Driving and operating machinery

If you experience dizziness, excessive sedation or drowsiness, do not drive or operate machinery.