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Pharmacotherapeutic group – ATC code: A07XA04 (A: digestive system and metabolism). This medicine is an anti-diarrhoeal product Hidrasec is indicated in addition to oral rehydration for the symptomatic treatment of acute diarrhoea in infants. How to use Dosage The standard daily dose is established according to your child's body weight, based on 1.5 mg/kg per dose, with a loading dose, then three doses spread throughout the day. In practice: Number of sachet(s) per dose based on the infant's body weight: Infant more than 3 months old and weighing less than 9 kg: 1 sachet per dose. Infant weighing approximately 9 to 13 kg: 2 sachets per dose. Method of administration Oral route Dosing frequency Day 1: the starting dose, then, depending on the time of the first dose, up to a maximum of three divided daily doses, including the initial dose. The doses should preferably be taken at the start of the three main meals. On the following days: three divided daily doses, preferably at the start of the three main meals. Not more than three doses may be taken per day. Duration of treatment Treatment will be continued until the first two formed stools are produced. Do not administer for more than 7 days. Always administer as directed by your doctor. Consult your doctor or pharmacist if you are not sure. Warnings and precautions Do not administer Hidrasec 10 mg Infants, if: Your child is allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine listed in section 6. Warnings and precautions In infants, the onset of diarrhoea, i.e. an increase in the number of daily stools, warrants medical attention. In fact, the origin of the diarrhoea must be investigated and your child must take the oral rehydration solute prescribed. Breast-feeding should continue. For infants, it is essential to follow the instructions for use and the method used to reconstitute the oral rehydration solute which may be prescribed by your doctor. Dietary advice should also be followed. You must seek medical advice quickly in the following cases: Diarrhoea comprising more than 6 liquid stools per day or lasting for more than 24 hours, or accompanied by weight loss. Your doctor will decide whether an oral rehydration solution should be prescribed. Presence of blood or mucus in the stools and if your child's temperature rises. In the event of prolonged or uncontrolled vomiting; Renal or liver impairment (kidney or liver dysfunction) due to a lack of information. Side Effects You must stop giving Hidrasec 10 mg Infants to your child and must consult your doctor immediately if your child experiences any symptoms of angio-oedema such as: Swelling of the face, tongue or throat; Swallowing difficulties; Nettle rash (urticaria) and breathing difficulties. Uncommon side effects (affecting at least 1 in 1,000 patients but fewer than 1 in 100 patients): Rash and erythema Storage Information Store at temperature below 30°C. Store in the original packaging. Drug Interactions Tell your doctor or pharmacist if your child is taking, has recently taken or could be taking any other medicine, especially: An angiotensin converting enzyme inhibitor (e.g.: perindopril or ramipril) to lower blood pressure and help the heart to function properly. Angiotensin II antagonists (e.g.: candesartan or irbesartan) to treat high blood pressure and heart failure. Inform your doctor or pharmacist if you are giving or have recently given any other medicine to your child, including over-the-counter medicines. Ingredients The active substance is Racecadotril (10 mg). The other ingredients are: sucrose, anhydrous colloidal silica, polyacrylate dispersion 30%, apricot flavouring Specifications This medicine is available as white oral powder in a single-dose sachet, with the characteristic odour of apricot.
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