Description

Solpadeine is a medicinal product containing paracetamol, codeine, and caffeine. Solpadeine's therapeutic effects are the combined effects of its active ingredients. Solpadeine exhibits multifaceted effects: analgesic, antipyretic, and antitussive. Caffeine enhances the analgesic effect. This medicinal product is intended 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 the package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist.

• Solpadeine is taken orally.
• This medicine is used for a short period of time, not longer than 3 days.
• Do not use other medicinal products containing paracetamol, caffeine or codeine simultaneously.

Adults and adolescents over 12 years: 1-2 effervescent tablets up to 4 times daily. Do not take this medicine more often than every 6 hours and do not take more than 8 effervescent tablets in 24 hours.

Action

Solpadeine contains 3 active substances that complement each other in the therapeutic effect of this drug.

Paracetamol has analgesic and antipyretic effects.

Caffeine enhances the analgesic effect of paracetamol and also has a stimulating effect on the CNS (central nervous system).

Codeine has analgesic and antitussive effects. Codeine belongs to the so-called opioid analgesics, a group of drugs that relieve pain.

Indications

• pain (headache, toothache, rheumatic pain, sore throat, painful menstruation, neuralgia, migraine, cold and flu symptoms),
• fever.

Solpadeine is indicated in case of ineffectiveness of drugs containing paracetamol and ibuprofen (in monotherapy).

Contraindications

When not to use Solpadeine:

• in case of hypersensitivity (allergy) to paracetamol, caffeine, other opioid painkillers or any of the other ingredients of this medicine,
• in people with the following ailments/diseases: alcoholism, severe renal or hepatic failure, respiratory failure and respiratory depression, bronchial asthma, chronic constipation,
• in the case of opioid addiction, people who rapidly 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 two weeks.

Side effects

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

Very rare side effects (affecting less than 1 in 10,000 people):

• difficulty urinating.

Frequency unknown:

• dizziness,
• nervousness, drowsiness,
• indigestion,
• itching,
• sweating,
• dry mouth.

The drug should be discontinued if the following symptoms occur:

• acute 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 codeine's addictive potential.
• The use of the drug should be discussed with a doctor in case of: hypertension, renal/liver failure, use of drugs that depress CNS function, 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 on a low-sodium diet.
• Keep the medicine out of the sight and reach of children.
• Store below 25°C.

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.

Solpadeine may interact with:

• metoclopramide,
• anticoagulants (e.g. warfarin),
• drugs causing drowsiness (TCAs, hypnotics, phenothiazine antipsychotics, antiepileptic drugs),
• MAO inhibitors,
• lithium,
• NSAIDs.

Taking the medicine with food and drink

Alcohol should be avoided while taking this medicine (risk of liver damage, intensification of the effects of codeine).

The medicine contains caffeine, which is also found in coffee and tea - too much of it may cause feelings of irritability and tension.

Pregnancy and breastfeeding

The use of Solpadeine during pregnancy and breastfeeding is contraindicated.

Impact on laboratory tests

The paracetamol contained in Solpadeine may affect the results of some tests, e.g. blood glucose testing.

Use of the drug in children and adolescents

Do not use in children under 12 years of age due to the risk of severe breathing disorders.

Do not use in children under 18 years of age after removal of the palatine or pharyngeal tonsils.

Driving and operating machinery

Solpadeine may cause drowsiness and dizziness. Do not drive or operate machinery if you experience these symptoms.