Properties
What is it?
What Paracetamol Sopharma Syrup Contains - Active substance: 120 mg paracetamol in 5 ml syrup. - Other ingredients: sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, aspartame, propylene glycol, sodium citrate dihydrate, citric acid monohydrate, macrogol 400, sodium hydrogensulphate solution, "Exotic" liquid essence, purified water. Description and packaging content of Paracetamol Sopharma Syrup A clear, viscous liquid, colorless to pale yellow, with a specific fruity aroma and sweet taste. 125 ml syrup in dark polyethylene terephthalate bottles with a plastic cap, a measuring cup, and an insert leaflet in a cardboard box. What Paracetamol Sopharma is and what it is used for Paracetamol Sopharma syrup contains the active substance paracetamol, which has pronounced analgesic and antipyretic effects. Paracetamol Sopharma syrup is intended for children under 12 years of age. It is used to treat elevated body temperature and pain in the following cases: acute inflammatory diseases of the upper respiratory tract; flu; infectious diseases such as chickenpox, measles, mumps; teething pain; to reduce elevated body temperature after immunization. Before taking Paracetamol Sopharma - Do not take Paracetamol Sopharma syrup - if your child is allergic (hypersensitive) to the active substance or any of the other ingredients. - if your child suffers from severe liver diseases. Take special care when using Paracetamol Sopharma syrup - if the child has severe liver or kidney disease; - when pain or elevated temperature lasts for more than 3 days, or symptoms worsen, or other symptoms develop, do not continue treatment without consulting a doctor. - this medicinal product contains paracetamol. Other medicinal products also contain this active substance. To avoid exceeding the recommended daily dose, do not use such medicinal products in combination. Use of other medicinal products Please inform your doctor or pharmacist if your child is taking or has recently taken any other medicinal products, including those obtained without a prescription. With limited use in children and administration according to the recommended regimen, no clinically significant drug interactions are observed. Prolonged use of high doses of paracetamol may affect treatment and increase the risk of side effects if your child is simultaneously taking: - coumarin-type anticoagulants (medicinal products that reduce blood clotting); - aspirin and other non-steroidal anti-inflammatory drugs (with anti-inflammatory action); - anti-emetic medicinal products (metoclopramide, domperidone); - anti-epileptic medicinal products (phenytoin, carbamazepine, phenobarbital); - antibacterial medicinal products (isoniazid, rifampicin, chloramphenicol); - cholestyramine (for high cholesterol levels) and antacids (which affect stomach acidity). If your doctor orders a uric acid or blood sugar test, you should inform him that your child is taking paracetamol. Taking Paracetamol Sopharma with food and drink The syrup is intended for children. Alcohol consumption is not recommended during paracetamol treatment due to the increased risk of liver damage. Pregnancy and breastfeeding Consult your doctor or pharmacist before using any medicinal product. This medicinal product is intended for use in children. The use of paracetamol is not recommended during the first three months of pregnancy. During breastfeeding, the product can be used if the daily dose and duration of treatment are carefully observed. Driving and operating machinery Paracetamol Sopharma syrup is intended for use in children. Important information about some ingredients of Paracetamol Sopharma syrup - the medicinal product contains sorbitol 1.5 g/5 ml. If your doctor has told you that your child has an intolerance to some types of sugar, consult him before using this product. - the syrup contains methyl and propyl parahydroxybenzoates, which can cause allergic reactions (possibly delayed type). - the product contains aspartame, which is a source of phenylalanine and may be harmful to people with phenylketonuria. - the syrup contains propylene glycol, which can cause alcohol-like symptoms (in amounts greater than 200 mg/kg in children). How to take Paracetamol Sopharma Take Paracetamol Sopharma syrup as described in this leaflet. If you are unsure about anything, ask your doctor or pharmacist. Paracetamol Sopharma syrup is taken orally. The medicinal product is intended for use in pediatric practice in children under 12 years of age. The recommended daily dose depends on your child's weight. It is 60 mg/kg/24h, divided into 4 doses, or approximately 15 mg/kg every 6 hours. If you have any doubts, consult your doctor. The medicinal form is not suitable for dosing in infants under 3 months of age. Children from 3 months to 1 year old 2.5-5 ml (60-120 mg) 3-4 times a day. Children from 1 to 6 years old 5-10 ml (120-240 mg) 3-4 times a day. Children from 6 to 12 years old 10-20 ml (240-480 mg) 3-4 times a day. If necessary, the syrup can be taken every 4 hours, but no more than 4 doses in 24 hours. In case of severe kidney disease, the interval between 2 doses should be at least 8 hours. In children, the course of treatment should not exceed 3 days without consulting a doctor. The total daily dose of paracetamol for children under 12 years of age should not exceed 80 mg/kg. If you have taken more than the recommended dose of Paracetamol Sopharma syrup If you have taken a high dose of the medicinal product, consult a doctor immediately, even if your child feels well. If you have missed a dose of Paracetamol Sopharma syrup If you have missed a dose, give it to your child as soon as possible. If it is almost time for the next dose, give it as usual. Do not use a double dose to compensate for a missed dose. If you have any further questions about the use of this medicinal product, ask your doctor or pharmacist. Possible side effects Like all medicinal products, Paracetamol Sopharma syrup can cause side effects, although not everyone gets them. Several cases of reduced platelet count, reduced white blood cell count, agranulocytosis (a severe illness characterized by severe fever, skin lesions, and a decrease in granular white blood cells in the blood), anemia (unusual fatigue or weakness, and paleness) have been reported. In rare cases, hypersensitivity reactions are observed, more often on the skin – itching and various types of rash, urticaria. Respiratory system: very rarely – difficulty breathing in predisposed patients, allergic to aspirin and other non-steroidal anti-inflammatory drugs. In rare cases, mild gastrointestinal symptoms may occur (nausea, vomiting, abdominal pain, diarrhea). In case of high doses, kidney function may be impaired. Prolonged use of high doses can cause liver damage (toxic hepatitis), with early symptoms being nausea, vomiting, sweating, and general malaise. If any side effect becomes serious, or if you notice any other symptoms not mentioned in this leaflet, please inform your doctor or pharmacist. How to store Paracetamol Sopharma In the original packaging, in a dry place protected from light, at a temperature not exceeding 25°C. Keep out of reach of children. After opening the bottle, the syrup can be used for up to 1 month. Do not use Paracetamol Sopharma syrup after the expiry date indicated on the packaging. Expiry date: 3 years The expiry date corresponds to the last day of the indicated month. It is not recommended to dispose of medicinal products down the drain or in household waste containers. Ask your pharmacist how to dispose of unwanted medicinal products. These measures will help protect the environment. Dispensing category: Pharmaceutical product group III (dispensing regime: without prescription)
