“Description
Solpadeine is a medicinal product containing 3 active substances: paracetamol, codeine and caffeine. It has analgesic, antipyretic and antitussive properties.
Composition
The active substances of the drug are: paracetamol, codeine and 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 as described in the package leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The medicine should be taken orally.
Do not use more than the recommended dose.
The medicine should not be taken for longer than 3 days. If the pain does not subside after 3 days, seek medical advice.
Adults: 1-2 effervescent tablets, administered up to 4 times a day. Do not take a dose more often than every 6 hours or take more than 8 effervescent tablets in a day.
If necessary, children aged 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 properties. Codeine belongs to a group of medicines called opioid analgesics, which relieve pain.
Indications
headaches;
migraine;
painful menstruation;
toothache;
neuralgia;
rheumatic pains;
sore throat;
flu and cold symptoms;
fever.
Contraindications
When not to use Solpadeine
in people who are hypersensitive (allergic) to paracetamol, caffeine, codeine, other opioid painkillers 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 (MAOIs) – drugs used in 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 adenoids due to obstructive sleep apnea syndrome,
in a patient who metabolizes codeine to morphine very quickly,
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.
Very rare side effects (less than 1 in 10,000 patients):
difficulty urinating
Frequency unknown:
nervousness,
dizziness,
indigestion,
dry mouth,
drowsiness,
itching,
sweating,
difficult urination.
Drinking coffee or tea while taking this medicine may cause tension, irritability, insomnia, anxiety, headaches, stomach and intestinal problems, an unusually fast heart rate or irregular heart rhythm.
Warnings and precautions
The medicine contains codeine, which is addictive.
The 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 medicinal product.
The medicine contains 398 mg of sodium per tablet. This should be taken into account in patients with reduced renal function and in patients on a controlled sodium diet.
Storage:
Keep the medicine out of the sight and reach of children.
Store at temperatures below 25°C.”
