Product Overview

[Drug Name]
Pantoprazole Sodium Enteric-coated Capsules

[Ingredients]
Pantoprazole sodium.

[Properties]
This product is an enteric-coated capsule containing a white or off-white powder.

[Indications]
It is indicated for active peptic ulcers (gastric and duodenal ulcers), reflux esophagitis, and Zollinger-Ellison syndrome.

[Dosage and Administration]
This product should not be chewed or crushed. It should be taken whole with water one hour before breakfast.
1. For the treatment of mild reflux esophagitis and its associated symptoms (such as heartburn, acid reflux, and odynophagia): The recommended oral dose is 20 mg (one capsule) daily. Symptoms typically resolve within 2 to 4 weeks. A 4-week course of treatment is recommended to cure associated esophagitis. If the esophagitis is not cured within 4 weeks, an additional 4 weeks of treatment is usually required.
2. For long-term maintenance treatment of reflux esophagitis to prevent relapses: The recommended dose for long-term maintenance treatment is 20 mg (1 tablet) daily. If relapse occurs, the dose can be increased to 40 mg (2 tablets) daily. After relapse is resolved, the dose can be reduced to 20 mg. Because long-term safety data for this product are not yet available, the efficacy of long-term maintenance treatment should be extended beyond one year only after a thorough consideration of the risk/benefit ratio.
3. In patients with severe liver dysfunction, the daily dose should generally not exceed 20 mg.

[Adverse Reactions]
Clinical symptoms include occasional dizziness, insomnia, drowsiness, nausea, diarrhea and constipation, rash, and muscle pain.

[Contraindications]
Not yet known.

[Precautions]
1. This product is an enteric-coated formulation; do not chew it when taking it.
2. When gastric ulcers are suspected, the possibility of cancer should be ruled out first, as treatment with this product may alleviate symptoms and delay diagnosis.
3. Use with caution in patients with hepatic and renal impairment. In patients with severe liver disease, clearance of this product is delayed, and the dosage should be reduced.
4. To prevent excessive acid suppression, high doses and long-term use are not recommended for conditions other than Zollinger-Ellison syndrome, such as peptic ulcers. Please read the instructions carefully and follow your doctor's instructions.

[Use in Special Populations]
Precautions for Children:
Efficacy and safety data for this product in children have not been established. This product is contraindicated in infants and young children.

Precautions for Pregnancy and Lactation:
Unknown.

Precautions for Elderly:
No dose adjustment required.

[Drug Interactions]
Drug interactions may occur if used with other medications. Please consult your doctor or pharmacist for details.

[Pharmacological Actions]
Unknown.

[Storage]
Keep sealed.

[Strength]
20mg

[Packaging Size]
7 tablets per box

[Expiration Date]
24 months

[Approval Number]
National Medicine Standard H20090075

[Manufacturer]
Company Name: Hubei Weisen Pharmaceutical Co., Ltd.