Description

Solpadeine is a medicinal product containing three active ingredients: paracetamol, codeine, and caffeine. It has analgesic, antipyretic, and antitussive properties.

Composition

The active substances of the drug are: paracetamol, codeine and caffeine.

One effervescent tablet contains 500 mg of paracetamol ( Paracetamolum ), 8 mg of codeine phosphate ( Codeini phosphas ) ​​and 30 mg of caffeine ( Coffeinum ).

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 questions, ask your doctor or pharmacist.

The medicine should be taken orally.

Do not use more than the recommended dose.

This medicine should not be taken for longer than 3 days. If pain does not subside after 3 days, consult a doctor.

Adults: 1-2 effervescent tablets, up to 4 times daily. Do not take a dose more often than every 6 hours or take more than 8 effervescent tablets in 24 hours.

As needed, children 12 years and older: 1-2 effervescent tablets every 6 hours. Do not take more than 8 effervescent tablets in 24 hours.

Action

Paracetamol has an analgesic and antipyretic effect.

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

Codeine has analgesic and antitussive effects. Codeine belongs to a group of drugs called opioid analgesics, which relieve pain.

Indications

Indications for use: headaches; migraine; painful menstruation; toothache; neuralgia; rheumatic pain; sore throat; flu and cold symptoms; fever.

Contraindications

Solpadeine should not be used: in people with hypersensitivity (allergic) to paracetamol, caffeine, codeine, other opioid analgesics or any of the other ingredients of this medicine; in people with alcoholism; in people with severe liver or kidney failure; in people with respiratory failure and depression; in people with bronchial asthma; in people taking monoamine oxidase inhibitors (MAO) - medicines used for depression and for up to 2 weeks after their discontinuation; in people suffering from chronic constipation; in children under 12 years of age; to relieve pain in children and adolescents (aged 0 to 18 years) after removal of palatine or pharyngeal tonsils due to obstructive sleep apnea syndrome; in a patient who metabolizes codeine very quickly to morphine; in pregnant women and while breastfeeding; in patients addicted to opioids.

Side effects

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

Taking Solpadeine may cause:

Rare (more than 1 in 10,000 patients but not less than 1 in 1,000 patients): allergies (without angioedema).

Very rare (affecting less than 1 in 10,000 patients): difficulty in passing urine, anaphylaxis, bronchospasm in patients allergic to aspirin and other NSAIDs, liver function abnormalities, skin hypersensitivity reactions including skin rashes, pruritus, sweating, purpura, urticaria and angioedema, cases of serious skin reactions; toxic epidermal necrolysis, drug-induced dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, sterile pyuria (cloudy urine), thrombocytopenia.

Unknown frequency (frequency cannot be estimated based on the available data): nervousness, dizziness, constipation, nausea, vomiting, dyspepsia, dry mouth, acute pancreatitis in patients after cholecystectomy (removal of the gallbladder) in the history, worsening of headache in case of prolonged use, drowsiness, difficulty urinating, in case of prolonged use of codeine in higher doses, drug dependence may occur, a serious condition that may cause acidification of the blood (so-called metabolic acidosis), in patients with a serious illness taking paracetamol.

Consuming coffee or tea while taking this medicine may cause tension, irritability, insomnia, anxiety, headaches, stomach and intestinal disorders, unusually fast heart rate or irregular heart rhythm.

Warnings and precautions

The medicine contains codeine, which is addictive.

This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains 398 mg of sodium per tablet. This should be taken into account by patients with reduced kidney function and those on a controlled sodium diet.

Storage:

Keep this 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 are planning to take, including medicines obtained without a prescription.

Do not use other medicines containing paracetamol, codeine or caffeine at the same time.

You should consult your doctor if you are taking the following medicines: metoclopramide, domperidone (used against nausea and vomiting); cholestyramine (used to lower high blood cholesterol); anticoagulants (e.g. warfarin) if you need to take painkillers long-term; agents that cause drowsiness, such as sleeping pills, sedatives, tricyclic antidepressants, phenothiazine antipsychotics, alcohol; antiepileptic medicines; rifampicin (an antituberculosis medicine); MAO inhibitors (used to treat depression); probenecid (a diuretic); estrogens and progesterone (sex hormones); lithium salts (used, among other things, for depression and mania); disulfiram (used, among other things, to treat alcoholism); non-steroidal anti-inflammatory drugs (including acetylsalicylic acid).

Taking the medicine with food and drink

While taking this medicine, avoid excessive caffeine intake (e.g., from coffee, tea, or some beverages). Excessive coffee or tea consumption while taking this medicine may cause feelings of tension and irritability.

Alcohol should not be consumed while taking this medication due to the increased risk of liver damage and the potentiation of codeine's effects. Patients who are fasting and regularly drink alcohol are at particular risk of liver damage.

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 for advice before taking this medicine.

Do not use this medicine during pregnancy or breastfeeding. Codeine and morphine pass into breast milk.

Use of the drug in children and adolescents

Do not use in adolescents and children under 12 years of age.

Driving and operating machinery

This medicine may cause dizziness and drowsiness. If you experience these symptoms, do not drive or operate machinery.