Tiptipot Novimol

/ CTS

The preparation is given from the age of 0 and weight of at
least 3 kg.
The generally accepted dosage is: The dosage according to the child’s weight is calculated as 15 mg/kg of the child’s weight, per dose. In other words, 0.15 ml for every kg of the child’s body weight.
Only if the child’s weight is not known – the dosage will be determined according to age, as shown in the age table (at the attached doctor’s leaflet) indicating dosage according to the child’s age only.
Doses should be taken/administered in intervals of at least 4 hours, as necessary, up to 5 doses in 24 hours.
Method of use: Shake well before use.
See prescribing information for full details.

Analgesic and antipyretic.

* Hypersensitivity to the active substance or any of its excipients
* Patients suffering from severe haemolytic anaemia
* Severe hepatocellular insufficiency

* In rare cases of allergic reactions, administration should be discontinued and appropriate treatment should be instituted.
* Use with caution in cases of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolaemia.
* Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert’s syndrome), severe hepatic impairment (Child-Pugh >9), acute hepatitis, under concomitant treatment with medicinal products that alter liver function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia.
* High or prolonged doses of the product may lead to kidney and blood alterations, some of which severe; therefore, the administration in subjects with renal impairment should only be carried out if actually necessary and under direct medical supervision.
* In the case of prolonged use, it is advisable to monitor hepatic and renal function and blood crasis.
* Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
* This medical product contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take/ be given this medicine.

See prescribing information for full details.

* The oral absorption of paracetamol depends on the rate of gastric emptying. Therefore, concomitant administration of medicinal products that slow (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or increase in the bioavailability of the product, respectively.
* Concomitant administration of cholestyramine reduces the absorption of paracetamol.
* The simultaneous intake of paracetamol and chloramphenicol can induce an increase in the half-life of chloramphenicol, with the risk of elevating its toxicity.
* The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce slight variations in the INR values. In these cases, more frequent monitoring of INR values must be conducted during concomitant use and after its discontinuation.
* Use with extreme caution and under strict supervision during chronic treatment with medicinal products that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine). The same is true in cases of alcoholism and in patients treated with zidovudine.
* Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors.
* The administration of paracetamol can interfere with the determination of uricaemia (by the phosphotungstic acid method) and with that of blood sugar (by the glucose-oxidase-peroxidase method).

There is a risk of intoxication, especially in patients with hepatic disease, in chronic alcoholism, in patients suffering from chronic malnutrition, and in patients receiving enzyme inducers. In such cases, overdose can be fatal.
Symptoms
In case of accidental intake of very high doses of paracetamol, acute intoxication is manifested by anorexia, nausea and vomiting, followed by a profound deterioration of the general condition; these symptoms usually appear within the first 24 hours. In case of overdose, paracetamol can cause hepatic cytolysis which can evolve towards massive and irreversible necrosis, with consequent hepatocellular insufficiency, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in the levels of hepatic transaminases, lactate dehydrogenase, and bilirubinaemia, and a reduction in prothrombin levels are observed, which can occur in the 12-48 hours following ingestion.
Treatment
The measures to be taken consist of early gastric emptying and hospitalization for appropriate treatment, by administering, as early as possible, N-acetylcysteine as an antidote: the dosage is 150 mg/kg i.v. in glucose solution in 15 minutes, then 50 mg/kg in the following 4 hours and 100 mg/kg in the following 16 hours, for a total of 300 mg/kg in 20 hours.

15 ml bottle may be used up to 6 months after the first opening. 50 ml bottle may be used up to the expiration date.