Description

Solpadeine Max is an effervescent painkiller tablet containing three active ingredients. Paracetamol and codeine provide the analgesic effect, enhanced by caffeine. 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). Solpadeine Max should not be used for longer than 3 days without consulting a doctor.

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

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

Action

The analgesic effect of Solpadeine Max is due to the complementary action of three active ingredients. Paracetamol, in addition to reducing pain, also has an antipyretic effect, and its effect is enhanced by caffeine. Codeine, a member of the opioid analgesic group, also reduces pain.

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 medication. Contraindications to Solpadeine Max also include: taking other medications containing paracetamol and codeine, breastfeeding, breathing difficulties, chronic constipation, or very rapid metabolism of codeine to morphine.

Do not administer to children and adolescents under 18 years of age in case of pain following removal of palatine or pharyngeal tonsils.

Side effects

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

The drug should be discontinued if the following symptoms occur:

• slow or shallow breathing, confusion, drowsiness, small pupils, nausea or vomiting, constipation, loss of appetite,
• dry mouth, nausea and vomiting in case of recent gallbladder removal surgery,
• acute pancreatitis (inflammation of the pancreas), which can result in severe stomach pain,
• allergic reactions, which may be severe and may 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 of the skin,
• breathing problems. These symptoms are more likely if you have experienced them before while taking other painkillers, such as ibuprofen and aspirin,
• unexplained bruising or bleeding,
• sudden weight loss, yellowing of the eyes and skin,
• difficulty urinating,
• cloudy urine.

Rare side effects (affecting 1 to 10 people in 10,000): allergies.

Very rare side effects (affecting less than 1 in 10,000 patients): thrombocytopenia, anaphylactic shock, bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs), liver function abnormalities, cutaneous hypersensitivity reactions including skin rash, pruritus, sweating, purpura, urticaria and angioedema, toxic epidermal necrolysis (TEN), drug-induced dermatitis, Stevens-Johnson syndrome (SJS), cloudy urine.

Unknown frequency: nervousness, dizziness, constipation, nausea, vomiting, dyspepsia, dry mouth, acute pancreatitis in patients with a history of cholecystectomy, pruritus, sweating, difficulty in urination.

With prolonged use of codeine in higher doses, drug dependence may occur.

Warnings and precautions

Before taking this medicine, talk to your doctor or pharmacist if:

• you have liver or kidney disease, alcoholic liver disease, or Gilbert's syndrome (familial non-hemolytic jaundice),
• the patient has intestinal problems, including intestinal obstruction,
• in people after gallbladder removal surgery,
• the patient suffers from asthma and is hypersensitive to aspirin,
• the patient has hypotension, hypothyroidism, head injury 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 above 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 medications (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.