FEVADOL 500 MG 30 TABLETS

Indications

Approved Uses

Temporary relief of mild to moderate pain and reduction of fever (e.g., headache, dental pain, musculoskeletal aches, dysmenorrhea, sore throat/cold & flu aches).

Off-Label Uses

None relevant/established for this OTC paracetamol + sodium bicarbonate tablet.

Dosage & Administration

Dosing by Condition

Adults: 1-2 tablets every 4-6 hours as needed for pain/fever; maximum 8 tablets (4 g paracetamol) in 24 hours.

Initial Dose

1-2 tablets (500mg-1000mg paracetamol) as a single dose

Maintenance Dose

1-2 tablets every 4-6 hours as needed

Maximum Dose

4 g paracetamol per 24 hours (8 tablets)

Children's Dosage

For children 12 years and over, adult dosing applies. For children under 12, use of this specific combination product is not recommended; pediatric paracetamol formulations should be used at a dose of 10-15 mg/kg every 4 to 6 hours, with a maximum of 4 doses in 24 hours.

Dose Adjustment Notes

Use the lowest effective dose; do not exceed 4 g/day of paracetamol in adults, and consider a lower maximum daily dose in hepatic impairment, chronic alcohol use, malnutrition/low body weight, or frail elderly; use caution in renal impairment.

How to Take

Oral use: swallow the tablet(s) with water; may be taken with or without food.

Side Effects

Common Side Effects

Uncommon: nausea, abdominal discomfort. Uncommon: belching/flatulence (from sodium bicarbonate). Rare: rash/urticaria (hypersensitivity).

Side Effect Frequency

Uncommon: nausea, abdominal discomfort; belching/flatulence. Rare: hypersensitivity reactions (rash/urticaria). Very rare/serious: severe cutaneous adverse reactions (SJS/TEN/AGEP), blood dyscrasias; liver injury with overdose or prolonged high-dose use.

Safety & Warnings

Contraindications

Known hypersensitivity to paracetamol or sodium bicarbonate (or any excipients); severe hepatic impairment/active liver disease.

Warnings & Precautions

Do not exceed recommended dose; avoid concurrent use with other paracetamol-containing products; seek medical advice if symptoms persist (commonly >3 days for fever or >5 days for pain); use caution in hepatic disease, chronic alcohol use, malnutrition/low body weight, and severe renal impairment; consider sodium load-caution in sodium-restricted diets, hypertension, heart failure, and renal impairment due to sodium bicarbonate; prolonged regular use should be medically supervised.

Age Restriction

Not recommended for children under 12 years (unless specifically directed by a clinician).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Warfarin/coumarins (increased INR with regular/prolonged paracetamol use); enzyme-inducing anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital) and other hepatotoxic drugs or chronic alcohol (increased hepatotoxicity risk); isoniazid (increased hepatotoxicity risk); cholestyramine (reduced paracetamol absorption if given close together); metoclopramide/domperidone (increased absorption rate); sodium bicarbonate may alter absorption/urinary excretion of some oral drugs by increasing gastric/urine pH.

Interaction Severity

MAJOR: Chronic/heavy alcohol use (increased hepatotoxicity risk). MODERATE: Warfarin with regular paracetamol use (may increase INR/bleeding risk); enzyme inducers (e.g., carbamazepine, phenytoin, phenobarbital) and isoniazid (increased hepatotoxicity risk). MINOR/ADMINISTRATION: Metoclopramide/domperidone (faster absorption); cholestyramine (reduced absorption if taken close); sodium bicarbonate may reduce absorption of pH-dependent drugs (e.g., tetracyclines/fluoroquinolones) if co-administered.

Food Interaction

No food restriction; food may slow onset (rate of absorption) but not overall effect.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

FDA Category B; use only if clearly needed (Australian Category A)

Breastfeeding

Safe

Children

For children 12 years and over, adult dosing applies. For children under 12, use of this specific combination product is not recommended; pediatric paracetamol formulations should be used at a dose of 10-15 mg/kg every 4 to 6 hours, with a maximum of 4 doses in 24 hours.

Elderly

Standard adult dosing; however, maximum 3g/day recommended in frail elderly patients. Monitor renal and hepatic function.

Kidney Impairment

No specific adjustment required; use with caution in severe renal impairment (CrCl <30 mL/min) due to paracetamol accumulation risk and sodium content.

Liver Impairment

Severe hepatic impairment/active liver disease: avoid/contraindicated; mild-moderate hepatic impairment or chronic alcohol use/malnutrition: use with caution and reduce total daily dose (commonly max 2-3 g/day) and/or extend dosing interval.

Storage & Patient Advice

Storage Conditions

Store below 25°C, in a dry place, away from light. Keep out of reach of children.

Missed Dose

If used regularly and a dose is missed, take it when remembered unless it is close to the next dose; do not double. (If used PRN, simply take the next dose when needed within maximum daily limits.)

Stopping the Medicine

Can be stopped abruptly when no longer needed; no tapering required. Avoid prolonged continuous use without medical advice.

Overdose

Early symptoms may be absent or include nausea, vomiting, anorexia, pallor and abdominal pain within 24 hours; serious hepatotoxicity can develop 24-72 hours (and later) with possible acute liver failure; management is urgent medical assessment, activated charcoal if within ~1-2 hours of ingestion, and prompt N-acetylcysteine (NAC) guided by nomogram/time since ingestion plus supportive care-do not delay treatment.

Patient Counseling

Adults and adolescents ≥12 years: 1-2 tablets (paracetamol 500 mg each) every 4-6 hours as needed; do not exceed 8 tablets (4 g paracetamol) in 24 hours. Do not use with any other paracetamol/acetaminophen-containing products; avoid alcohol. Seek urgent medical help immediately if an overdose is taken, even if you feel well. This product contains sodium bicarbonate (sodium load): use caution/consult a clinician if on a sodium-restricted diet or with uncontrolled hypertension, heart failure, or significant renal disease. If symptoms persist (fever >3 days or pain >3-5 days) or worsen, seek medical advice. Store below 25°C and keep out of reach of children.

Monitoring Requirements

No routine monitoring for short-term OTC use; consider liver function monitoring if prolonged/high-dose use or in patients with hepatic risk factors.

Pharmacology

Mechanism of Action

Paracetamol provides analgesia/antipyresis primarily via central prostaglandin synthesis inhibition; sodium bicarbonate buffers gastric acid (raises gastric pH), improving tablet dissolution and potentially speeding paracetamol absorption/onset.

Onset of Action

Typically ~15-30 minutes; this buffered formulation may have a faster onset than standard paracetamol tablets.

Duration of Effect

4-6 hours.

Half-Life

Approximately 2 hours in healthy adults (typical range ~1-3 hours).

Bioavailability

Paracetamol oral bioavailability is variable, typically ~60-90% (often cited ~70-90%) due to first-pass metabolism; sodium bicarbonate may speed absorption/onset but does not reliably change overall bioavailability.

Metabolism

Hepatic metabolism primarily via glucuronidation and sulfation; a minor fraction undergoes CYP-mediated oxidation (mainly CYP2E1) to NAPQI, which is detoxified by glutathione.

Excretion

Renal excretion predominates: >90% of a dose is excreted in urine mainly as glucuronide and sulfate conjugates; only ~2-5% is excreted unchanged.

Protein Binding

Low protein binding at therapeutic concentrations (~10-25%, often <20%); increases at higher/toxic concentrations.

Product Information

Available Dosage Forms

Tablet (oral).

Composition per Dose

Each tablet: Paracetamol 500mg + Sodium Bicarbonate 630mg

Generic Availability

Yes

OTC Alternatives

Paracetamol (standard formulations), ibuprofen, or aspirin (where appropriate).

Pain Type

General

Nsaid

No

Opioid

No

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