Algostase Mono 500 mg
Manufacturer
SMB Technology S.A. – Belgium
Applicant company
TV Pharmaceutical Trade Promotion and Investment Co., Ltd.
Active ingredient
Paracetamol
Content
500 mg
Shelf life
24 months
Dosage Form
Effervescent tablets
Package
Box of 1 tube x 16 tablets
Visa Number
540100430425
Issuing Date
October 20, 2025
Expiration Date
October 20, 2030
Therapeutic area
Analgesics and antipyretics
Indication
This medicinal product is indicated for:
- Fever reduction.
- Relief of mild to moderate pain, such as headache, flu-like symptoms, toothache, myalgia, and dysmenorrhea.
Dosage
DOSING MUST BE CALCULATED BASED ON THE CHILD'S BODY WEIGHT. The corresponding age ranges provided below are for reference only. To prevent the risk of overdose, verify that concomitant medications (both prescription and over-the-counter) do not contain paracetamol.
This pharmaceutical form is intended only for adults and children weighing more than 17 kg (approximately 5 years of age and older).
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Pediatric Population:
The daily dose of paracetamol must be calculated according to the child's body weight; age is for reference and guidance purposes only. If the child's weight is unknown, the child should be weighed to determine the most appropriate dosage.
Paracetamol is available in various dosage strengths and formulations to enable appropriate dosing tailored to each child's body weight.
The recommended daily pediatric dose of paracetamol depends on the child's body weight: approximately 60 mg/kg/day, administered in 4 to 6 divided doses, corresponding to approximately 15 mg/kg every 6 hours, or 10 mg/kg every 4 hours. The maximum daily dose must not exceed 3 g.
Do not swallow the tablet whole. Dissolve the tablet completely in a glass of water before oral administration.
| Body Weight (kg) | Approximate Age* | Paracetamol Dose / Administration (mg) | Number of Effervescent Tablets / Dose | Minimum Dosing Interval (hours) | Maximum Daily Dose (tablets) |
|---|---|---|---|---|---|
| 17 - < 25 | 5 - < 7 | 250 | 0,5 | 6 | 2 (1000 mg) |
| 25 - < 33 | 7 - < 10 | 250 | 0,5 | 4 | 3 (1500 mg) |
| 33 - < 50 | 10 - < 12 | 500 | 1 | 6 | 4 (2000 mg) |
| ≥ 50 | ≥ 12 | 500 | 1 | 4 to 6 | 6 (3000 mg) |
Generally, it is not necessary to exceed 3000 mg of paracetamol per day (approximately 6 tablets per day). However, in cases of severe pain and upon medical advice, the total daily dose may be increased up to 4000 mg per day (approximately 8 tablets per day).
However:
- Doses exceeding 3000 mg of paracetamol per day require medical evaluation and consultation.
- NEVER EXCEED 4000 MG OF PARACETAMOL PER DAY (taking into account all paracetamol-containing medications).
- The minimum dosing interval between administrations must be at least 4 hours.
Renal Impairment:
In patients with severe renal impairment, the minimum dosing interval should be adjusted according to the following table:
| Creatinine Clearance | Dosing Interval |
|---|---|
| Cl ≥ 50 mL/min | 4 hours |
| Cl: 10 – 50 mL/min | 6 hours |
| Cl < 10 mL/min | 8 hours |
In patients with hepatic impairment, the dose must be reduced or the dosing interval prolonged. The maximum daily dose should not exceed 60 mg/kg/day (not to exceed 2 g/day) in the following circumstances:
- Adults weighing less than 50 kg.
- Chronic or active compensated hepatic disease, particularly in patients with mild to moderate hepatocellular insufficiency.
- Gilbert's syndrome (familial non-hemolytic jaundice).
- Chronic alcoholism.
- Chronic malnutrition (low hepatic glutathione reserves).
- Dehydration.
Elderly Patients:
No dose adjustment is required in elderly patients.
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