JAZOFEN 400/MG TAB 30/TAB

Indications

Approved Uses

OTC symptomatic relief of mild to moderate pain (e.g., headache, dental pain, musculoskeletal pain, backache), dysmenorrhea, and reduction of fever; anti-inflammatory use for arthritis is generally a prescription/physician-directed indication at higher doses.

Off-Label Uses

Acute gout flares; acute pericarditis (as an anti-inflammatory option).

Dosage & Administration

Dosing by Condition

Adults/≥12 years (OTC pain/fever/dysmenorrhea): 200-400 mg every 4-6 hours as needed; maximum 1200 mg/day OTC unless directed by a clinician. Prescription/physician-directed anti-inflammatory dosing (e.g., OA/RA): 1200-3200 mg/day in divided doses (max 3200 mg/day).

Initial Dose

400mg as a single dose

Maintenance Dose

400mg every 4 to 6 hours as needed.

Maximum Dose

OTC maximum: 1200 mg/day; prescription/medical supervision maximum: up to 3200 mg/day in divided doses.

Children's Dosage

Children 6 months to 12 years: 5-10mg/kg every 6-8 hours, max 40mg/kg/day; use weight-appropriate formulation (suspension preferred). Not recommended under 6 months of age

Dose Adjustment Notes

No formal dose adjustment is defined, but use the lowest effective dose for the shortest duration; use caution in elderly and in mild-moderate renal/hepatic impairment; avoid in severe renal impairment and in severe hepatic impairment, and avoid use in advanced dehydration/volume depletion.

How to Take

Swallow the tablet with a full glass of water; take with food or milk if stomach upset occurs; do not crush/chew unless needed for administration; remain upright is not required (but avoid taking immediately before lying down if it causes reflux).

Side Effects

Common Side Effects

Nausea, dyspepsia, abdominal pain, diarrhea, constipation, headache, dizziness, flatulence, heartburn, vomiting

Side Effect Frequency

Ibuprofen 400 mg oral tablet (ATC M01AE01) adverse-effect frequency (typical SmPC/label ranges): Very common (≥10%): dyspepsia/heartburn, nausea. Common (1-10%): abdominal pain/epigastric pain, diarrhea, flatulence, constipation, vomiting, headache, dizziness, rash/pruritus, fluid retention/edema, mild transaminase elevations. Uncommon (0.1-1%): gastritis, peptic ulcer, hypersensitivity reactions (e.g., urticaria), tinnitus, somnolence. Rare (<0.1%): gastrointestinal bleeding/perforation, severe cutaneous reactions, bronchospasm (esp. aspirin-sensitive asthma), renal impairment (incl. interstitial nephritis), hypertension/heart failure exacerbation.

Safety & Warnings

Contraindications

Hypersensitivity to ibuprofen/other NSAIDs (including aspirin-induced asthma/urticaria); active GI bleeding or active peptic ulcer; history of NSAID-related GI bleeding/perforation; perioperative pain in CABG surgery; severe renal failure (e.g., CrCl <30 mL/min) and severe hepatic failure are generally avoided/contraindicated; pregnancy: contraindicated in 3rd trimester.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; increased risk of CV thrombotic events and GI bleeding/ulceration; caution in elderly, history of ulcer/GI bleed, concomitant anticoagulants/antiplatelets/SSRIs/corticosteroids; caution in hypertension, heart failure, edema; monitor/avoid in renal impairment or dehydration; avoid in aspirin-sensitive asthma; may mask fever/infection; avoid combining with other NSAIDs and consider timing with low-dose aspirin.

Age Restriction

OTC 400 mg ibuprofen tablets are generally for adults and adolescents ≥12 years; do not use in children <12 years unless directed by a clinician. Ibuprofen is not recommended in infants <6 months unless specifically prescribed.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Clinically significant interactions include: anticoagulants (e.g., warfarin) and antiplatelets (incl. aspirin) ↑ bleeding; SSRIs/SNRIs ↑ GI bleeding; corticosteroids ↑ GI ulcer/bleed; ACE inhibitors/ARBs and diuretics ↑ AKI risk/↓ antihypertensive/diuretic effect; lithium ↑ levels; methotrexate ↑ toxicity; cyclosporine/tacrolimus ↑ nephrotoxicity; other NSAIDs ↑ additive toxicity; aspirin cardioprotection may be reduced if ibuprofen is taken near aspirin dosing.

Interaction Severity

MAJOR/clinically significant: anticoagulants/antiplatelets (e.g., warfarin, DOACs, clopidogrel) ↑ bleeding; methotrexate (especially high-dose) ↑ toxicity; lithium ↑ levels/toxicity; ACEI/ARB + diuretic ("triple whammy") ↑ AKI risk; other NSAIDs/aspirin ↑ GI bleeding (and ibuprofen can blunt low-dose aspirin antiplatelet effect if timed improperly). MODERATE: SSRIs/SNRIs and corticosteroids ↑ GI bleeding; cyclosporine/tacrolimus ↑ nephrotoxicity; diuretics/antihypertensives may have reduced effect. MINOR: antacids may slightly alter absorption rate.

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Use with caution; small amounts excreted in breast milk, generally compatible with breastfeeding but avoid high doses/long-term use; monitor infant for GI irritation.

Children

Children 6 months to 12 years: 5-10mg/kg every 6-8 hours, max 40mg/kg/day; use weight-appropriate formulation (suspension preferred). Not recommended under 6 months of age

Elderly

Use lowest effective dose for shortest duration; increased risk of GI bleeding, renal impairment, and cardiovascular events; monitor renal function and blood pressure regularly

Kidney Impairment

Mild-moderate renal impairment: use with caution, lowest effective dose, monitor renal function; severe renal impairment (e.g., CrCl <30 mL/min) or progressive kidney disease: avoid/contraindicated.

Liver Impairment

Mild-moderate hepatic impairment: use with caution at the lowest effective dose; severe hepatic impairment/failure: avoid (often treated as contraindicated).

Storage & Patient Advice

Storage Conditions

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

Missed Dose

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose.

Stopping the Medicine

Safe to stop anytime; no tapering required for short-term use

Overdose

Overdose may cause nausea/vomiting/abdominal pain, dizziness/drowsiness, headache, tinnitus; severe toxicity can include metabolic acidosis, hypotension, seizures, coma, acute kidney injury; management is urgent medical evaluation, activated charcoal if early/appropriate, and supportive care with monitoring (renal function, acid-base status).

Patient Counseling

Take with food/milk if it upsets your stomach; use the lowest effective dose and do not exceed 1200 mg/day OTC; avoid combining with other NSAIDs and limit alcohol; stop and seek care for signs of GI bleeding (black stools/vomiting blood), severe allergic reaction, chest pain/SOB, or swelling; consult a clinician if pain lasts >10 days or fever >3 days; avoid in 3rd-trimester pregnancy and use caution with kidney disease, ulcers/bleeding history, cardiovascular disease, or asthma.

Monitoring Requirements

For long-term use, periodic monitoring of renal function, liver function, and complete blood count may be recommended. For short-term OTC use, no routine monitoring is required.

Pharmacology

Mechanism of Action

Reversible, nonselective inhibition of COX-1 and COX-2, decreasing prostaglandin synthesis to reduce pain, fever, and inflammation.

Onset of Action

30-60 minutes.

Duration of Effect

4-6 hours.

Half-Life

Approximately 2 hours (typical range ~1.8-2.5 hours in healthy adults).

Bioavailability

Approximately 80-100% (commonly cited ~80-90%).

Metabolism

Hepatic metabolism primarily via CYP2C9 to inactive hydroxylated and carboxylated metabolites (then conjugation).

Excretion

Primarily renal (>90%) as metabolites and conjugates; minimal unchanged drug and minor fecal excretion.

Protein Binding

>99%

Product Information

Available Dosage Forms

For this product: oral tablet (400 mg). (Ibuprofen in general is also available in capsules, oral suspension/drops, chewable tablets, topical gel, and IV formulations in some markets.)

Composition per Dose

Each tablet: 400mg ibuprofen

Generic Availability

Yes

OTC Alternatives

Paracetamol (acetaminophen) and naproxen sodium (where available OTC); aspirin is an alternative in some settings but is generally avoided in children/teens and in many patients due to bleeding risk.

Pain Type

General, Muscular, Joint

Nsaid

Yes

Opioid

No

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