Pepzol 40 mg 7 capsules

Pepzol 40 mg 7 capsules

Composition:

Each capsule contains Omeprazole 40 mg.
Excipients include:
sodium lauryl sulfate, sodium hydrogen sulfate, calcium carbonate, talc, hypromellose, and methacrylic acid copolymer.

Product Description:

Pepzol is an antiulcer medication that inhibits the enzyme responsible for gastric acid secretion within parietal cells of the stomach.
As a prodrug, it converts into its active sulfenamide form in the acidic environment of the secretory canaliculi.
This active metabolite binds to the hydrogen-potassium ATPase enzyme ("proton pump"), effectively blocking the final step of gastric acid production and delivering highly selective reduction of gastric acidity.

Indications for Use:

• Treatment and relapse prevention of gastric and duodenal ulcers (acute phase and maintenance therapy), including ulcers associated with Helicobacter pylori (as part of combination therapy).
• Gastroesophageal reflux disease (GERD), including erosive esophagitis.
• Pathological hypersecretory conditions, including Zollinger-Ellison syndrome, gastrointestinal stress ulcers, multiple endocrine adenomatosis, and systemic mastocytosis.
• Treatment and prevention of NSAID-associated gastropathy and mucosal lesions.

Method of Administration and Dosage:

• The product is intended for oral administration.
• Capsules should be taken in the morning shortly before meals, swallowed whole with a small amount of water, without chewing.
• For acute peptic ulcers, GERD, and NSAID-induced gastropathy, the standard dosage is 20 mg once daily. 
• In severe cases of reflux esophagitis, the dose may be increased to 40 mg once daily. 
• Duration of treatment is 2 to 4 weeks for duodenal ulcer, and 4 to 8 weeks for gastric ulcer, reflux esophagitis, and NSAID-associated mucosal lesions.

Contraindications:

• Pediatric patients (children and adolescents).
• Pregnancy.
• Breastfeeding (lactation) period.
• Known hypersensitivity to omeprazole or any of the excipients present in the formulation.

Precautions:

Caution should be exercised in patients with hepatic and/or renal impairment.
Prior to initiating therapy, malignancy must be excluded, particularly in patients with gastric ulcers, as symptomatic relief induced by treatment may delay accurate diagnosis.
Co-administration with food does not alter the overall efficacy of the drug.

Adverse Reactions / Side Effects:

Gastrointestinal Disorders: diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence.
Skin and Subcutaneous Tissue Disorders: rarely, skin rash, pruritus; in isolated cases, photosensitivity, erythema multiforme exudativum, alopecia.
Immune System Disorders: allergic reactions such as urticaria, angioedema, and fever.

Pregnancy and Lactation:

Pepzol is strictly contraindicated during pregnancy and breastfeeding.
If administration becomes necessary during lactation, breastfeeding must be discontinued.

Storage Conditions:

Store at a temperature not exceeding 25 °C in a dry place.
Keep out of reach of children.

Packaging:

The cardboard box contains 7 capsules and a medical instruction insert.