Product Overview
[Drug Name]
Trade Name: Hailing
English Name: Omeprazole Enteric Capsules
Chinese Pinyin: Aomeilazuo Jiaonang
[Ingredients]
Omeprazole.
[Properties]
Capsules containing small, off-white enteric-coated granules.
[Indications]
Indicated for peptic ulcers (gastric and duodenal ulcers), reflux esophagitis, and gastrinoma. Also indicated for stress ulcers, hyperacidity gastritis, and acute gastric mucosal bleeding.
[Dosage and Administration]
Oral. Adults: 1 capsule once daily (every 24 hours). Take an additional capsule as needed with warm water.
This tablet must be swallowed whole. Do not chew or crush. Do not crush this tablet with food.
[Adverse Reactions]
Common adverse reactions to this product include headache, diarrhea, nausea, vomiting, constipation, abdominal pain, and bloating. Occasionally, dizziness, drowsiness, fatigue, sleep disturbances, paresthesias, rash, itching, urticaria, and abnormal liver function tests may occur. Rarely, hyperhidrosis, peripheral angioedema, hyponatremia; angioedema, fever, and anaphylactic shock; leukopenia, thrombocytopenia, granulocytosis, and pancytopenia; reversible confusion, irritability, depression, aggression, and hallucinations; gynecomastia; dry mouth, dysgeusia, stomatitis, and candidiasis; alopecia, photosensitivity, and erythema multiforme; hepatic encephalopathy (in patients with preexisting severe liver disease), icteric or non-icteric hepatitis, and liver failure; bronchospasm; arthralgia, myalgia, and muscle fatigue; interstitial nephritis; and blurred vision.
[Contraindications]
This product is contraindicated in patients with allergies, severe renal impairment, and infants and young children.
[Precautions]
1. Do not use for more than 7 days. If symptoms persist or disappear, consult a doctor or pharmacist. 2. Do not use again within 2 months. If symptoms recur, consult a doctor immediately. 3. Do not use this product if: you experience difficulty or pain swallowing; vomiting blood; or bloody or black stools. These may be signs of a serious condition; consult a doctor. 4. Patients with liver dysfunction or abnormal blood counts should use this product under the guidance of a doctor. 5. If heartburn persists or worsens, discontinue use and seek medical attention. 6. Children should only use this product under the guidance of a doctor. 7. Use with caution in pregnant or breastfeeding women. 8. In case of overdose or serious adverse reactions, consult a doctor immediately. 9. Do not use if you are allergic to this product. Use with caution if you have allergies. 10. Do not use if the properties of this product change. 11. Keep this product out of reach of children. 12. Children must be supervised by an adult when using this product. 13. If you are using other medications, consult a doctor or pharmacist before using this product.
[Use in Special Populations]
Precautions for Children:
Contraindicated for use in infants and young children.
Precautions for Pregnancy and Lactation:
Although this product has not been shown to cause teratogenicity in animal studies, it should generally not be used in pregnant women, and should be used with caution in lactating women.
Precautions for Elderly:
Unclear information available.
[Drug Interactions]
1. Avoid concomitant use with oral imidazole antifungals such as ketoconazole, itraconazole, miconazole, and fluconazole.
2. Concomitant use of omeprazole and clarithromycin may increase the incidence of central nervous system (primarily headache) and gastrointestinal adverse reactions.
3. Avoid concomitant use with diazepam (Valium), phenytoin, warfarin, nifedipine, digoxin, cisapride, quinidine, cyclosporine, caffeine, and theophylline.
4. Concomitant use with other medications may cause drug interactions. Please consult your physician or pharmacist for details.
[Pharmacological Action]
H+, K+-ATPase (acid pump) inhibitor, significantly inhibits gastric acid secretion. Rapid onset of action. A single dose each morning can suppress gastric acid secretion, with effects lasting approximately 24 hours.
[Storage]
Store in a dry, airtight container protected from light.
[Strength]
20 mg
[Packaging Size]
20 mg x 14 sachets
[Expiry Life]
24 months.
[Approval Number]
National Medicine Standard H10920092
[Manufacturer]
Hainan Hailing Chemical Pharmaceutical Co., Ltd.
