Description Apo-Napro Fast is a drug with analgesic, anti-inflammatory, and antipyretic effects. This medicinal product contains naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and can be used for the short-term treatment of mild to moderate pain. Composition The active substance is naproxen sodium. One capsule contains 220 mg of naproxen sodium. Excipients: macrogol 600; lactic acid; propylene glycol; povidone K-30. Capsule shell: gelatin; sorbitol, liquid, partially dehydrated; glycerol; purified water; patent blue V (E131); medium chain triglycerides of saturated fatty acids; isopropyl alcohol; lecithin. 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. Adults and children 12 years and older: Usually: 1 capsule every 8 to 12 hours. You can also take 2 capsules as an initial dose, and if symptoms persist, take another capsule 12 hours later. The maximum daily dose is 3 capsules per day. The medicine should be taken orally with plenty of water or milk, preferably after a meal. Action Apo-Napro Fast contains naproxen, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and has analgesic, anti-inflammatory and antipyretic properties. Indications Apo-Napro Fast soft capsules are used for mild to moderate pain, including headaches, toothaches, joint pain, muscle pain, and back pain, as well as for menstrual cramps. The medication can also be administered to reduce fever. Contraindications Do not use the drug if: you are hypersensitive to the active substance or to any of the excipients, you have had a hypersensitivity reaction such as bronchial asthma, rhinitis or urticaria after taking acetylsalicylic acid or other prostaglandin synthesis inhibitors, you have a gastrointestinal ulcer, congestive or atrophic gastritis, you have gastrointestinal bleeding or other bleeding, such as bleeding from cerebral blood vessels, you have a bleeding diathesis or are treated with anticoagulants, you have severe renal and/or hepatic impairment, you have severe heart failure. Side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common side effects (may affect more than 1 in 10 people): nausea, abdominal discomfort, constipation. Common side effects (may affect 1 to 10 people in 100): headache, visual disturbances, ringing or buzzing in the ears, swelling of the ankles and feet (oedema), heart problems, vomiting, rash. Uncommon side effects (may affect 1 to 10 people in 1,000): difficulty concentrating, difficulty sleeping (insomnia), difficulty concentrating or remembering (cognitive disorders), gastrointestinal bleeding and/or perforation, photosensitivity. Rare side effects (may affect 1 to 10 people in 10,000): reduction in red blood cells, which can turn the skin pale yellow and cause weakness and shortness of breath (hemolytic anemia), allergic reactions to medicines containing naproxen and naproxen sodium. Allergic reactions usually occur in patients with a known hypersensitivity to aspirin, other NSAIDs, and Apo-Napro Fast. However, they can also occur in patients with no history of such an allergy; high levels of potassium in the blood (hyperkalemia), hearing impairment, inflammation of blood vessels, inflammation of the lungs (eosinophilic pneumonia), mouth ulcers, life-threatening inflammation of the liver (fatal hepatitis), hair loss, reactions resulting from exposure to light such as dermatitis and bullous eruptions (porphyria cutanea tarda or epidermolysis bulloescens-like reactions). Very rare side effects (may affect up to 1 in 100,000 people): decreased white blood cell count (granulocytopenia), decreased platelet count (thrombocytopenia), seizures, non-infectious inflammation of the membranes surrounding the brain (aseptic meningitis), a slightly increased risk of heart attack (myocardial infarction or stroke). This risk is more likely in patients taking high doses during long-term treatment; Stevens-Johnson syndrome (blisters on the hands and feet), redness of the skin (erythema multiforme), blood in the urine (hematuria), kidney disorders including glomerulonephritis or interstitial nephritis, renal papillary necrosis (death of parts of the tissue in the kidney) and nephrotic syndrome (proteinuria). Not known: severe reduction in blood cells which can cause weakness, bruising or make infections more likely (aplastic anemia), gout, dizziness, high blood pressure, non-peptic ulcers of the digestive tract, peptic ulcers, inflammation of the large intestine, swelling of the neck and face (angioedema), peeling of the skin (epidermal necrosis), kidney failure, decreased fertility in women, mild swelling of the ankles and feet (mild peripheral oedema). Warnings and precautions Caution should be exercised in patients with: heart disorders, previous stroke or suspected risk of these disorders, blood clotting disorders, liver and/or kidney problems, elderly patients, gastrointestinal problems. Apo-Napro Fast contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Apo-Napro Fast contains lecithin derived from soybean oil. Store the medicine at room temperature. Keep the medicine out of the sight and reach of children. 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. Consultation with a doctor is recommended if you are taking the following medications: anticoagulants (heparin), diuretics, some oral antidiabetics, some antibiotics, some antiepileptics (phenytoin), some sulfonamides (sulfadoxine), some narcotics (thiopental), drugs to prevent blood clots (acetylsalicylic acid), methotrexate, beta-blockers, cyclosporine, lithium, or if you are taking other painkillers and anti-inflammatory drugs. 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. Apo-Napro Fast should not be used during the first and second trimesters of pregnancy unless absolutely necessary. Use during the third trimester is contraindicated. The medicinal product is not recommended for use in breastfeeding women. Use of the drug in children and adolescents Apo-Napro Fast cannot be given to adolescents under 12 years of age.