CLARADOL CAFFEINE 16 EFFERVESCENT TABLETS

Paracetamol 500 mg, Caffeine 50 mg.

Excipients: Citric acid anhydrous, Sodium bicarbonate, Sodium carbonate anhydrous, Saccharin sodium, Lemon flavour, (Lemon essential oil, Maltodextrin, Sucrose), Blackcurrant flavour, (Palmarosa essence, Propylene glycol, Benzyl alcohol, Vanillin, Acetic aldehyde, Para-hydroxybenzylacetone, Jasmone, Ethyl butyrate, Ethyl citrate, Methyl sulfide, Glyceryl triacetate, Maltodextrin), Sodium docusate, Simethicone 30%, Sodium benzoate, qsp 1 effervescent tablet.

Excipient: sodium, sucrose

Method of administration:

Oral use.

Drink immediately after complete dissolution of the effervescent tablet in a large glass of water.

Dosage:

RESTRICTED TO ADULTS AND CHILDREN OVER 50 kg (from 15 years of age) due to the presence of caffeine.

- The usual dosage is 1 to 2 effervescent tablets of 500 mg, to be repeated if necessary after at least 4 hours.

- It is generally not necessary to exceed 3 grams of paracetamol per day, i.e. 6 effervescent tablets. However, in case of more intense pain, the maximum dosage can be increased to 4 grams per day, i.e. 8 effervescent tablets per day.

Always respect an interval of 4 hours between doses.

Warnings: - To avoid the risk of overdose, check the absence of paracetamol in the composition of other drugs. - Maximum recommended doses: in adults and children weighing more than 50 kg (from 15 years of age), THE TOTAL DOSE OF PARACETAMOL SHOULD NOT EXCEED 4 GRAMS PER DAY (see overdose section).

- Due to the presence of sucrose, this medicine is contraindicated in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.

- Due to the presence of maltodextrin (source of glucose), this drug is contraindicated in cases of glucose and galactose malabsorption syndrome.

Precautions for use: - In case of salt-free or low salt diet, take into account the amount of sodium: 422 mg per effervescent tablet.

- Due to the presence of caffeine, this medicine may cause insomnia, it should not be taken at the end of the day.

- Pregnancy: epidemiological studies do not show an increased risk of malformations due to caffeine. At the end of pregnancy, high doses of caffeine may cause fetal or neonatal cardiac arrhythmia. Consequently, the use of caffeine should be considered during pregnancy only if necessary.

- Breastfeeding: caffeine passes into breast milk and the maximum concentration is observed 1 to 2 hours after intake. The half-life of caffeine is considerably increased in breast-fed infants, by a factor of about 15. Repeated large doses of caffeine may cause the development of restlessness and irritability in the breastfed infant. The maximum dose of caffeine that may not affect the child is approximately 100 to 200 mg per day (one to two cups of coffee). Consequently: if the intake of this medicine appears essential, it is advisable not to exceed this dose, including food intake, while spacing out the doses as much as possible; the medicine should be taken just after the feeding.

Pregnancy and Lactation: Pregnancy:

- Data on paracetamol: Studies in animals have not demonstrated a teratogenic or fetotoxic effect of paracetamol. Clinically, the results of epidemiological studies appear to exclude a specific malformative or fetotoxic effect of paracetamol.

- Caffeine-Related Data: Epidemiological studies do not show an increased malformational risk due to caffeine. In late pregnancy, high doses of caffeine may cause fetal or neonatal cardiac arrhythmia. Therefore, the use of caffeine should be considered during pregnancy only if necessary.

Breastfeeding: Caffeine passes into breast milk and the maximum concentration is observed 1 to 2 hours after intake. The half-life of caffeine is significantly increased in breast-fed infants by a factor of about 15. Repeated large doses of caffeine may cause the development of restlessness and irritability in the breastfed infant. The maximum dose of caffeine, which is not likely to affect the child, is approximately 100 to 200 mg per day (i.e. one to two cups of coffee). Consequently: - if the intake of this medicine appears to be indispensable, this dose should not be exceeded, including food intake, while spacing out the doses as much as possible; - the medicine should be taken just after the feed.