Description

Solpadeine Max is an effervescent painkiller tablet containing three active ingredients. Paracetamol and codeine provide the analgesic effect, while caffeine enhances the analgesic effect of paracetamol. It is used to relieve pain that requires more potent action than single-ingredient over-the-counter painkillers, such as migraines, sciatica, and sprains. Solpadeine Max can be administered short-term to children over 12 years of age and adults.

Composition

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

1 effervescent tablet contains: 500 mg of paracetamol, 30 mg of caffeine and 12.8 mg of codeine phosphate hemihydrate.

Excipients: sorbitol (E420), sodium saccharin, sodium bicarbonate, sodium lauryl sulfate, anhydrous citric acid, anhydrous sodium carbonate, povidone K-25 and dimethicone 350.

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 Max is administered orally, after dissolving the appropriate number of effervescent tablets in at least half a glass of water (200 ml).

While taking this medicine, you should not consume too much caffeine, which is found in beverages such as coffee or tea.

Do not use Solpadeine Max for more than 3 days without consulting your doctor.

Your doctor may recommend a different dosage, especially in: elderly people, adults and adolescents weighing less than 50 kg; patients with mild to moderate kidney and liver disease; people with Gilbert's syndrome (familial non-hemolytic jaundice); people with chronic alcoholism, malnutrition or dehydration.

Action

Solpadeine Max has an analgesic effect, containing 3 active substances: paracetamol - in addition to the analgesic effect, it also has an antipyretic effect; codeine - belongs to opioid analgesics; caffeine - enhances the effect of paracetamol.

Indications

Solpadeine Max is used for: headaches, migraines with or without aura, toothache (also after tooth extraction), painful periods, neuralgia, pain associated with strain injuries and sprains, back pain, bone and joint pain associated with arthritis and rheumatism, sciatica.

Contraindications

Do not use Solpadeine Max: if you have ever had an allergic reaction to paracetamol, codeine, caffeine or any of the other ingredients of this medicine; if you are taking other medicines containing paracetamol and codeine; if you are breastfeeding; if you have breathing difficulties; if you have chronic constipation; in children and adolescents up to 18 years of age during pain after removal of your palatine or pharyngeal tonsils; if you are known to metabolise codeine to morphine very quickly.

Side effects

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

You should stop taking this medicine if you experience any of the following symptoms: slow or shallow breathing, confusion, drowsiness, small pupils, nausea or vomiting, constipation, loss of appetite; dry mouth, nausea and vomiting if you have recently had your gallbladder removed; acute pancreatitis (inflammation of the pancreas), which can result in severe stomach pain; allergic reactions, which may be severe and include skin rash or mouth ulcers, sometimes with flu-like symptoms or itching, sometimes with swelling of the lips or face or shortness of breath, peeling skin; breathing problems. These symptoms are more likely to occur if you have experienced these symptoms before when taking other painkillers such as ibuprofen and aspirin; unexplained bruising or bleeding; sudden weight loss, yellowing of the eyes and skin; difficulty passing urine; cloudy urine.

Other side effects: nervousness and dizziness; constipation.

Very rare cases of severe skin reactions have been reported.

How can a patient know if he or she is addicted?
If you take this medicine according to the dosing instructions, the chance of becoming dependent on it is very small. However, it is important to talk to your doctor in the following situations: • If you need to take the medicine for a long time. • If you need to take a higher dose than recommended. • If you do not feel well when you stop taking the medicine, but you feel better when you start taking it again.

Warnings and precautions

Before taking this medicine, consult your doctor or pharmacist if: you have liver or kidney disease, alcoholic liver disease, or Gilbert's syndrome (familial non-hemolytic jaundice); you have intestinal problems, including intestinal obstruction; you have had your gallbladder removed; you have asthma and are hypersensitive to aspirin; you have low blood pressure, hypothyroidism, head trauma, or increased intracranial pressure.

Solpadeine Max contains codeine, which may be addictive if taken continuously for more than 3 days, and withdrawal symptoms may occur when stopping use.
Codeine is converted by liver enzymes into the pain-relieving morphine. Some people have a different enzyme, and this can cause differences in the amount of morphine produced, and consequently, the strength of the pain-relieving effect and side effects.

Solpadeine Max contains 427 mg of sodium per tablet. Patients on a sodium-restricted diet should take this into account.

Solpadeine Max contains sorbitol, so if you are intolerant to some sugars, consult your doctor before using the product.

Keep this medicine out of the sight and reach of children. Store below 25°C. Store in the original packaging to protect the product from moisture.

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 Max may interact with: metoclopramide, domperidone, cholestyramine, monoamine oxidase inhibitors (also if taken within the last two weeks), blood thinning drugs (also known as anticoagulants), probenecid, sedatives and decongestants - caffeine may increase their effect.

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.

Solpadeine Max should not be used during breastfeeding and pregnancy.

Use of the drug in children and adolescents

Solpadeine Max should not be used in children and adolescents after removal of the palatine or pharyngeal tonsils due to obstructive sleep apnea syndrome or in case of breathing disorders.

Do not give Solpadeine Max to children under 12 years of age.

Driving and operating machinery

If you feel dizzy or overly sedated while taking Solpadeine Max, you should not drive or operate machinery.