“Description
Solpadeine is a medicinal product containing paracetamol, codeine and caffeine. The therapeutic effect of Solpadeine is the sum of the combined action of the active substances. Solpadeine has multidirectional effects: analgesic, antipyretic, antitussive. Caffeine enhances the analgesic effect. Medicinal product for short-term relief of pain (headache, toothache, neuralgia, rheumatism, fever).
Composition
The active substances are: paracetamol, codeine phosphate, caffeine.
1 effervescent tablet contains 500 mg of paracetamol, 8 mg of codeine phosphate and 30 mg of caffeine.
Excipients: sorbitol powder, sodium saccharin, sodium bicarbonate, povidone, sodium lauryl sulfate, dimethicone, anhydrous citric acid, anhydrous sodium carbonate.
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.
Solpadeine is taken orally.
This medicine is used for a short period of time, no longer than 3 days.
Do not use other medicinal products containing paracetamol, caffeine or codeine at the same time.
Adults and adolescents over 12 years of age: 1-2 effervescent tablets up to 4 times a day. Do not take the medicine more often than every 6 hours, do not use more than 8 effervescent tablets in 24 hours.
Action
Solpadeine contains 3 active substances that complement each other in terms of the therapeutic effects of this drug.
Paracetamol has analgesic and antipyretic properties.
Caffeine enhances the analgesic effect of paracetamol and also has a stimulating effect on the CNS (central nervous system).
Codeine has analgesic and antitussive properties. Codeine belongs to the so-called opioid painkillers – a group of these drugs relieves pain.
Indications
pain (headache, toothache, rheumatic pain, throat pain, dysmenorrhea, neuralgia, migraine, cold and flu symptoms),
fever.
Solpadeine is indicated in the case of ineffectiveness of drugs containing paracetamol and ibuprofen (monotherapy).
Contraindications
When not to use Solpadeine:
in case of hypersensitivity (allergy) to paracetamol, caffeine, caffeine, other opioid painkillers or other ingredients of this medicine,
in people with the following ailments/diseases: alcoholism, severe kidney or liver failure, respiratory failure and respiratory depression, bronchial asthma, chronic constipation,
in the case of opioid addiction, people who quickly metabolize codeine to morphine,
during pregnancy and breastfeeding,
in children under 12 years of age, in children aged 0-18 years after removal of palatine/pharyngeal tonsils (risk of obstructive sleep apnea),
if you are taking monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks.
Side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects (less than 1 in 10,000 people):
difficulty urinating.
Frequency unknown:
dizziness,
nervousness, drowsiness,
indigestion,
itching,
sweating,
dry mouth.
The use of the medicine should be discontinued if the following symptoms occur:
severe abdominal pain, nausea, vomiting,
allergic reaction (rash, itchy skin, sweating, redness, difficulty breathing),
agranulocytosis,
breathing problems
bruises and bleeding of unknown origin,
symptoms of addiction.
Warnings and precautions
Solpadeine should be used short-term due to the addictive potential of codeine.
The use of the drug should be discussed with a doctor in the case of: hypertension, renal/liver failure, use of CNS depressing drugs, head injuries, increased intracranial pressure, hypothyroidism, adrenal insufficiency.
The medicine contains sorbitol – this should be taken into account in case of intolerance to some sugars.
The drug contains 398 mg of sodium in 1 tablet – this should be taken into account in reduced kidney function and people following a low-sodium diet.
Keep the medicine out of the sight and reach of children.
Store at temperatures below 25°C.
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Solpadeine may interact with:
metoclopramide,
anticoagulants (e.g. warfarin),
drugs that cause drowsiness (TCLs, hypnotics, phenothiazine antipsychotics, antiepileptic drugs),
MAO inhibitors,
lithium,
NSAIDs.”