Description

Solpadeine is a capsule medication containing three active ingredients: paracetamol, codeine phosphate, and caffeine. The combination of these substances allows Solpadeine to exert its multifaceted effects. The medication has analgesic, antipyretic, and antitussive effects. Caffeine enhances the analgesic effect. This medicinal product is intended for short-term relief of pain symptoms such as headaches, toothaches, neuralgia, rheumatism, and fever.

Composition

The active substances of the drug are: paracetamol, codeine phosphate and caffeine ( Paracetamolum, Codeini phosphas, Coffeinum ).

1 capsule contains 500 mg of paracetamol, 8 mg of codeine phosphate and 30 mg of caffeine.

Excipients: magnesium stearate, corn starch, capsule shell bottom: titanium dioxide, gelatin, capsule shell top: erythrosine (E127), patent blue V (E131), quinoline yellow (E104), titanium dioxide (E171), gelatin; printing ink: shellac, black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide.

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 without consulting a doctor.
• Do not use other medicinal products containing paracetamol, caffeine or codeine simultaneously.

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

The onset of action of the drug occurs 30 to 60 minutes after taking it and the total duration of action is up to 4 hours.

Action

The healing properties of Solpadeine are the sum of the combined action of three active substances:

• Paracetamol has analgesic and antipyretic effects.
• Caffeine enhances the analgesic effect of paracetamol and stimulates the central nervous system.
• Codeine has analgesic and antitussive effects. Codeine belongs to the group of opioid analgesics, relieving pain.

Indications

• Headaches, migraines, painful menstruation, toothaches, neuralgia, rheumatic pains, sore throat,
• flu and cold symptoms, fever.

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

Codeine can be used in children aged 12 years and older for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen taken alone.

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.

The medicine may cause constipation.

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.

Other possible side effects:

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

• difficulty urinating,

Frequency unknown:

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

Warnings and precautions

Consuming coffee or tea while taking this medicine may cause feelings of tension and irritability, insomnia, anxiety, headaches, stomach and intestinal disorders, unusually rapid heart rate or sensations of irregular heartbeat.

The drug should be used short-term due to the addictive potential of codeine.

The medicine contains the dyes: erythrosine (E127), patent blue V (E131) and quinoline yellow (E104), so it may cause allergic reactions.

You should discuss the use of Solpadeine with your doctor if:

• hypertension,
• liver or kidney failure,
• use of drugs that depress the central nervous system,
• respiratory disorders,
• head injuries and increased intracranial pressure,
• enlargement of the prostate gland or obstructed urine flow,
• hypothyroidism,
• adrenal insufficiency,
• old age,
• acute abdominal symptoms,
• inflammatory or obstructive intestinal diseases,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase),
• diseases of the biliary tract (cholelithiasis) and after surgical procedures in the biliary tract.

Storage tips:

• the medicine should be kept 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.

You should consult your doctor if you are taking the following medications:

• metoclopramide, domperidone,
• cholestyramine,
• anticoagulants (e.g. warfarin) if long-term use of painkillers is necessary,
• substances causing drowsiness, i.e. sleeping pills, sedatives, tricyclic antidepressants (TCAs), phenothiazine antipsychotics, alcohol,
• antiepileptic drugs,
• rifampicin,
• MAO inhibitors (used to treat depression),
• probenecid,
• estrogens and progesterone (sex hormones),
• lithium salts,
• disulfiram (used, among others, to treat alcoholism),
• non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and ibuprofen.

Solpadeine may interact with:

• chloramphenicol,
• other opioid drugs,
• cholinolytics,
• sleeping pills and sedatives.

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

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.

The medicine should not be used during pregnancy.

Codeine should not be taken while breastfeeding. Codeine and morphine pass into breast milk.

Impact on laboratory tests

The use of paracetamol may cause false results in some laboratory tests (e.g. blood glucose testing).

Use of the drug in children and adolescents

Do not give this medicine to 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.