Recommended dose (Adults):
20 mg once daily or as directed by the physician.
Capsules should be swallowed whole, preferably before meals.
Do not crush, chew, or open the capsule.
Duration of therapy depends on the condition being treated and medical advice.
Gastro-esophageal Reflux Disease (GERD):
20 mg once daily for 4–8 weeks.
Duodenal Ulcer:
20 mg once daily for 2–4 weeks.
Gastric Ulcer:
20 mg once daily for 4–8 weeks.
NSAID-induced Ulcer (treatment or prevention):
20 mg once daily.
Zollinger-Ellison Syndrome:
Starting dose 60 mg daily (dose adjustment as directed by physician).
No dosage adjustment is generally required.
Dose adjustment may be required. Use under medical supervision.
No dosage adjustment is usually necessary.
Dose and duration should be determined by a physician based on age and body weight.
If a dose is missed, take it as soon as remembered.
If it is almost time for the next dose, skip the missed dose.
Do not take a double dose.
Symptoms may include nausea, vomiting, dizziness, abdominal pain, or confusion.
In case of overdose, seek immediate medical attention.
⚠️ Dosage may vary in children, elderly patients, or patients with liver impairment and should be determined by a healthcare professional.
Omeprazole is a proton pump inhibitor (PPI).
It acts by irreversibly inhibiting the H⁺/K⁺-ATPase enzyme (proton pump) in the gastric parietal cells, thereby reducing gastric acid secretion and promoting healing of acid-related disorders.
Gastro-esophageal reflux disease (GERD)
Peptic ulcer disease (gastric and duodenal ulcers)
Zollinger-Ellison syndrome
Acid-related dyspepsia
Prevention of NSAID-induced ulcers (as prescribed)
Known hypersensitivity to omeprazole, substituted benzimidazoles, or any component of the formulation
History of allergic reactions to proton pump inhibitors (PPIs)
Concomitant use with nelfinavir, as it may significantly reduce its plasma concentration
Patients with severe hypersensitivity reactions such as anaphylaxis, angioedema, or severe cutaneous adverse reactions associated with omeprazole or other PPIs
Gastric malignancy:
Symptomatic response to omeprazole does not exclude the presence of gastric malignancy. Appropriate investigations should be carried out in patients with alarm symptoms.
Long-term use:
Prolonged use may be associated with an increased risk of Vitamin B12 deficiency, hypomagnesemia, and bone fractures, particularly in elderly patients or those on high doses.
Hypomagnesemia:
Severe hypomagnesemia has been reported in patients treated for prolonged periods. Magnesium levels should be monitored if treatment is extended.
Hepatic impairment:
Omeprazole should be used with caution in patients with liver disease, as metabolism may be reduced.
Clostridioides difficile–associated diarrhea:
Proton pump inhibitors may increase the risk of gastrointestinal infections. Discontinue therapy if severe or persistent diarrhea occurs.
Renal effects:
Cases of acute interstitial nephritis have been reported. Discontinue treatment if renal impairment is suspected.
Drug interactions:
Caution is advised when used with medicines such as clopidogrel, warfarin, phenytoin, diazepam, and other drugs metabolized via CYP2C19.
Pregnancy and lactation:
Use during pregnancy and breastfeeding should be only if clearly needed and under medical supervision.
Pediatric use:
Safety and dosage should be determined by a healthcare professional based on age and body weight.
Consult a healthcare professional if symptoms persist or worsen.
The following adverse reactions have been reported with the use of Omeprazole. Adverse effects are generally mild and reversible on discontinuation of therapy.
Common (≥1/100 to <1/10)
Headache
Abdominal pain
Nausea
Diarrhea
Constipation
Flatulence
Uncommon (≥1/1,000 to <1/100)
Dizziness
Insomnia
Paresthesia
Dry mouth
Skin rash, pruritus, urticaria
Elevated liver enzymes
Rare (≥1/10,000 to <1/1,000)
Taste disturbances
Visual disturbances
Hepatitis (with or without jaundice)
Alopecia
Photosensitivity
Muscle pain or joint pain
Very Rare (<1/10,000) / Serious
Hypomagnesemia (especially with long-term use)
Vitamin B12 deficiency (prolonged therapy)
Severe allergic reactions (anaphylaxis, angioedema)
Severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome)
Interstitial nephritis
Serious (Seek medical attention immediately):
Severe allergic reactions (rash, swelling, difficulty breathing)
Severe diarrhea
Unusual fatigue or muscle spasms
⦁ Mild effects: Usually resolve on their own; continue therapy unless advised otherwise.
⦁ Persistent or worsening symptoms: Consult a doctor.
⦁ Severe or allergic reactions: Discontinue immediately and seek medical help.
⦁ Do not self-adjust dose without medical advice.
⦁ Store below 25°C
⦁ Protect from moisture and light
⦁ Keep out of reach of children
⦁ Do not use after expiry date
⦁ Rx Only / Prescription Drug
⦁ To be sold by retail on the prescription of a Registered Medical Practitioner only
⦁ This leaflet is for informational purposes and does not replace professional medical advice.
⦁ Do not exceed the prescribed dose.
⦁ Keep medicines out of reach of children.
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