Each sachet of oral powder contains:
Active ingredient:
Paracetamol | 325 mg |
Chlorpheniramine maleate | 2 mg |
Thiamine nitrate | 10 mg |
Excipients: Povidone K30, aspartame, saccharin sodium, sucrose, sodium benzoate, sunset yellow, orange flavour.
Each sachet of oral powder contains:
Active ingredient:
Paracetamol | 325 mg |
Chlorpheniramine maleate | 2 mg |
Thiamine nitrate | 10 mg |
Excipients: Povidone K30, aspartame, saccharin sodium, sucrose, sodium benzoate, sunset yellow, orange flavour.
ADMINISTRATION AND DOSAGE
Dissolve the powder in boiled and cooled water then use orally.
Dosage
Adults and children 12 years and over: 2 sachets every 4 – 6 hourly. Maximum daily dose: 8 sachets in any 24 hours.
Children aged 6 – 12 years: 1 sachet every 4 – 6 hourly. Maximum daily dose: 4 sachets in any 24 hours.
Children aged 2 – 6 years: ½ sachet every 4 – 6 hourly. Maximum daily dose: 2 sachets in any 24 hours.
Children aged 1 – 2 years: ½ sachet twice daily. The minimum interval between doses should be 4 hours.
Not recommended for children below 1 year.
CONTRAINDICATIONS
This product is contraindicated in patients:
Hypersensitivity to any components of the drug.
Patients with severe renal or hepatic impairment or glucose-6-phosphate dehydrogenase deficiency.
Patients taking or have taken monoamine oxidase inhibitors (MAOIs) in the last two weeks.
Patients with breathing problem such as emphysema or chronic bronchitis.
Glaucoma.
Patients with trouble urinating due to an enlarged prostate gland.
WARNINGS AND PRECAUTIONS
Paracetamol should be given with care to patients with alcohol dependence, impaired kidney or liver function.
Paracetamol may cause liver damage if you consume more alcoholic drinks. Furthermore, the effects of alcohol may be increased by chlorpheniramine maleate. Therefore concurrent use with alcohol should be avoided.
For paracetamol-containing drugs, the physician should warn patients of serious signs of skin reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell syndrome, acute generalized exanthematous pustulosis (AGEP).
Chlorpheniramine, in common with other drugs having anticholinergic effects, should be used with caution in epilepsy; raised intra-ocular pressure including glaucoma; prostatic hypertrophy; severe hypertension or cardiovascular disease; bronchitis, bronchiectasis or asthma; hepatic impairment; renal impairment. Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (eg. increased energy, restlessness, nervousness).
The anticholinergic properties of chlorpheniramine may cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients which may seriously affect ability to drive and use machinery.
Avoid concurrent administration with the drugs containing paracetamol and other antihistamine containing products, including antihistamine containing cough and cold medicines.In the case of severe renal insufficiency, desloratadine should be used with caution.
PREGNANCY AND LACTATION
Pregnancy
Human and animal studies with paracetamol have not identified any risk to paracetamol and thiamine in pregnancy or embryo-foetal development. While there are no adequate data from the use of chlorpheniramine maleate in pregnant women. The potential risk for humans is unknown. Use during the third trimester may result in reactions in the newborn or premature neonates. As a result, this drug should not be used during pregnancy unless considered essentially by a physician.
Lactation
This product should not be used while breast-feeding without medical advice.
Human studies with paracetamol at the recommended dosed have not identified any risk to lactation or the breastfed offspring. Chlorpheniramine maleate and other antihistamine may inhibit lactation and may be secreted in breast milk. Therefore, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
The anticholinergic properties of chlorpheniramine maleate may cause drowsiness, dizziness, blurred vision and psychomotor impairment, which can seriously hamper the patients' ability to drive and use machinery.
STORAGE CONDITION
In a dry place, below 30°C, protect from light.
SHELF-LIFE
36 months from the manufacturing date. Do not use after the expiry date.