Aspirin du Rhone, 500mg, Tablet, Box of 50

1. NAME OF DRUG Aspirin du Rhone, 500mg, tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Acetylsalicylic acid ................................................................. 500 mg Per tablet. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment for light to moderate pain and/or fever. 4.2. Dosage and how to use How to use Orally. Swallow tablets with a drink (for example water, milk, fruit juice), preferably at mealtimes. Keep tablet out of reach of children under 6 years of age due to risk of swallowing and choking. Use another form. Dosage Light to moderate pain and/or fever: Suitable for adults and children over 30 kg (9-15 years old). For adults and children weighing more than 50kg (from the age of 15 years old): The maximum recommended daily dose is 3g of aspirin (6 tablets per day). The usual dosage is 1x500mg tablets each time, and depending on the level of pain they can be taken minimum every 4 hours. For more intense pain or fever: 2x500mg tablets, and depending on the level of pain they can be taken minimum every 4 hours without exceeding 6 tablets per day. - Elderly patients: The maximum recommended daily dose is 2 g of aspirin (4 tablets per day). The usual dosage is 1x500mg tablets each time, and depending on the level of pain they can be taken minimum every 4 hours. For more intense pain or fever: 2x500mg tablets, and depending on the level of pain they can be taken minimum every 4 hours without exceeding 4 tablets per day. - Children between 30-50kg (9-15 years old): For children it is important to follow the recommended doses depending on the weight of the child. Approximate ages according to weight are given as an indication. The recommended daily dose of acetylsalicylic acid depends on the weight of the child: approximately 60mg/kg per day, to be taken 4-6 times, either 15mg/kg every 6 hours or 10mg/kg every 4 hours. · For children weighing between 30-40kg (approximately 9-13 years old) the dosage is 1 500mg tablet every 6 hours. Do not take more than 4 tablets in any 24 hours. · For children weighing between 41-50kg (approximately 12-15 years old) the dosage is 1 500mg tablet every 4 hours. Do not take more than 6 tablets in any 24 hours. Frequency of dose Regular doses avoid pain and fever fluctuations. For children (30-50kg, 9-15 years old): doses need to be spaced out including during the night, preferably 6 hours and at least 4 hours: follow the dose instructions below above. Adults: dose must be spaced out every 4 hours. Length of treatment You should not take acetylsalicylic acid for more than 3 days with a fever and 5 days with pain without medical advice. 4.3. Contraindications This drug is not recommended in the following cases: - Over-sensitivity to acetylsalicylic acid or one of its dilutants. - History of asthma from taking similar non-steroidal anti-inflammatory drugs. - from the 24th week of amenorrhea (5 months) for doses higher than 100mg per day (see section 4.6). - an evolving gastroduodenal ulcer. - any constitutional or acquired haemorrhagic disease. - haemorrhagic risk. - Severe hepatic failure. - Severe renal failure. - severe cardiac insufficiency. - In combination with methotrexate used at doses greater than 20 mg / week (see section 4.5) and for anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g daily), or for analgesic or Antipyretic acid (≥ 500 mg per dose and / or