TACHIPIRINA NEONATI 62, 5 MG SUPPOSITORIES 10 SUPPOSITORIES

Name
TACHIPIRINA

Active ingredients
TACHIPIRINA 500 mg tablets. Each tablet contains: active ingredient: paracetamol 500 mg. TACHIPIRINA 500 mg effervescent granules. Each sachet contains: active ingredient: paracetamol 500 mg. excipients with known effects: aspartame, maltitol, 12.3 mmol sodium per sachet TACHIPIRINA 125 mg effervescent granules. Each sachet contains: active ingredient: paracetamol 125 mg. excipients with known effects: aspartame, maltitol, 3.07 mmol sodium per sachet TACHIPIRINA Neonati 62.5 mg suppositories. Each suppository contains. active ingredient: paracetamol 62.5 mg TACHIPIRINA Prima Infanzia 125 mg suppositories. Each suppository contains: active ingredient: paracetamol 125 mg. TACHIPIRINA Children 250 mg suppositories. Each suppository contains: active ingredient: paracetamol 250 mg . TACHIPIRINA Children 500 mg suppositories. Each suppository contains: active ingredient: paracetamol 500 mg. TACHIPIRINA Adults 1000 mg suppositories. Each suppository contains: active ingredient: paracetamol 1000 mg. For the full list of excipients, see section 6.1.

Therapeutic indications
As an antipyretic: symptomatic treatment of febrile conditions such as influenza, exanthematous diseases, acute respiratory tract conditions, etc. As an analgesic: headaches, neuralgia, myalgia and other moderately severe painful conditions of various origins.

Dosage
For children, it is essential to respect the dosage defined according to their body weight, and therefore choose the appropriate formulation. The approximate ages according to body weight are given for information purposes only. In adults, the maximum oral dosage is 3000 mg and rectal dosage is 4000 mg of paracetamol per day (see section 4.9). The doctor must evaluate the need for treatments for more than 3 consecutive days. The dosage schedule of Tachipirina in relation to body weight and administration route is as follows: 500 mg tablets. • Children weighing between 21 and 25 kg (approximately between 6.5 and less than 8 years): ½ tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day (3 tablets). • Children weighing between 26 and 40 kg (approximately 8 and 11 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • Children weighing between 41 and 50 kg (approximately 12 and 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • Children weighing more than 50 kg (approximately over 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • Adults : 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. In case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after not less than 4 hours. Effervescent granules of 500 mg in sachets. Dissolve the effervescent granules in a glass of water. • Children weighing between 26 and 40 kg (approximately 8 to 11 years): 1 sachet at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • Children weighing between 41 and 50 kg (approximately 12 to 15 years): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • Children weighing more than 50 kg (approximately over 15 years): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • Adults : 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. In the case of severe pain or high fever, 2 sachets of 500 mg to be repeated if necessary after not less than 4 hours. 125 mg effervescent granules in sachets. Dissolve the effervescent granules in a glass of water. • Children weighing between 7 and 10 kg (approximately between 6 and 19 months): 1 sachet at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • Children weighing between 11 and 12 kg (approximately between 20 and 29 months): 1 sachet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. • Children weighing between 13 and 20 kg (approximately between 30 months and less than 6.5 years): 2 sachets at a time (corresponding to 250 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • Children weighing between 21 and 25 kg (approximately between 6.5 and less than 8 years): 2 sachets at a time (corresponding to 250 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. Newborn Suppositories 62.5 mg. • Children weighing between 3.2 and 5 kg (approximately between birth and 2 months): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. Early Childhood Suppositories 125 mg. • Children weighing between 6 and 7 kg (approximately between 3 and 5 months): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • Children weighing between 7 and 10 kg (approximately between 6 and 19 months): 1 suppository at a time, to be repeated if necessary after 4 - 6 hours, without exceeding 5 administrations per day. • Children weighing between 11 and 12 kg (approximately between 20 and 29 months): 1 suppository at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. Suppositories Children 250 mg. • Children weighing between 11 and 12 kg (approximately between 20 and 29 months): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 administrations per day. • Children weighing between 13 and 20 kg (approximately between 30 months and less than 6.5 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. Suppositories Children 500 mg. • Children weighing between 21 and 25 kg (approximately between 6.5 and less than 8 years): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 administrations per day. • Children weighing between 26 and 40 kg (approximately between 8 and 11 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. Suppositories Adults 1000 mg. • Children weighing between 41 and 50 kg (approximately 12 and 15 years): 1 suppository at a time, to be repeated if necessary after 8 hours, without exceeding 3 administrations per day. • Children weighing more than 50 kg (approximately over 15 years): 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. • Adults : 1 suppository at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations per day. Renal insufficiency. In case of severe renal insufficiency (creatinine clearance less than 10 ml/min), the interval between administrations must be at least 8 hours.

Conservation
Tablets and effervescent granules : no special precautions for storage. Suppositories: store at a temperature not exceeding 25°C.

Pregnancy and breastfeeding
Pregnancy: A large amount of data on pregnant women indicate neither malformative nor fetal/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and with the lowest possible frequency. Breastfeeding: It is recommended to administer the product only in cases of real need and under the direct supervision of a doctor.