EFFER-PARALMAX® 325

DOSAGE

Children over 12 years old: 2 sachets every 4 – 6 hours, not exceeding 12 sachets per 24 hours.

Children 6 – 12 years old: 1 sachet every 4 – 6 hours, not more than 5 sachets per 24 hours.

This product is not recommended for children under 6 years old because the doses are not guaranteed accurate.

ADMINISTRATION

EFFER-PARALMAX 325 is administered orally. Dissolve the granules with about 200 ml of water, drink after effervescing completely.

CONTRAINDICATIONS

This product is contraindicated:

- In patient with hypersensitivity to paracetamol or to the excipients.

- In patients with G6PD enzyme deficiency.

WARNINGS AND PRECAUTIONS

Patients should be advised that paracetamol may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occur, they should stop use and seek medical assistance right away.

Doctor should warn the patients about the signs of serious skin side-effects such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysic (TEN) or Lyell syndrome, acute generalized exanthematous pustulosis (AGEP).

Thrombocytopenia, leukopenia, reducing whole blood were occurred when use the p-aminophenol derivatives, especially use the prolongation of large dose. Decreasing neutrophil and hemorrhage have been reported after using paracetamol. Agranulocytosis was happened. Caution for patients with anemia.

Drink alcohol too much and using paracetamol for long time may increase the risk of liver toxicity. Patient should avoid using alcohol.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment.

Do not take with any other products containing paracetamol.

This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Each of sachet contains 156.55 mg sodium so should pay attention to the need of daily diet in case the patient has been appointed salt diet.

PREGNANCY AND LACTATION

Pregnancy

Epidemiological studies in human pregnancy have shown no adverse effects due to paracetamol when used in the recommended dosage, but patients should follow the advices of the doctor regarding its use.

Lactation

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

None report.

SHELF-LIFE

36 months from the manufacturing date. Do not use after the expiry date.

Box of 30 sachets x 1.5 g.