Pantopi 20 mg 20 tablets
El-Obour
El-Obour
Composition
Active ingredient
Pantoprazole sodium sesquihydrate, equivalent to 20 mg pantoprazole.
Excipients
Sodium carbonate decahydrate, Mannitol, Crospovidone (Type XL), Povidone (K90), Calcium stearate, Hydroxypropyl methylcellulose, Povidone (K25), Titanium dioxide, Iron oxide yellow, Propylene glycol, Methacrylic acid copolymer, Triethyl citrate.
Description
Pantopi 20 mg is a proton pump inhibitor that suppresses gastric acid secretion.
It is used for symptomatic GERD, long-term management of reflux esophagitis, and prevention of NSAID-induced gastroduodenal ulcers.
Indications for Use
Pantopi 20 mg is indicated in adults and adolescents ≥12 years for:
- Symptomatic gastro-oesophageal reflux disease
- Long-term management and prevention of relapse in reflux esophagitis.
In adults
- Prevention of gastroduodenal ulcers induced by non-selective NSAIDs in patients at risk requiring continuous NSAID therapy.
Directions for Use
Oral use.
Do not chew or crush; swallow whole 1 hour before meals.
- Adults and adolescents ≥12 years
- Symptomatic GERD
20 mg once daily; improvement usually within 2-4 weeks.
- Long-term management of reflux esophagitis
20 mg once daily; if relapse occurs, increase to 40 mg daily, then return to 20 mg after healing.
- NSAID-induced ulcer prevention
20 mg once daily.
- Hepatic impairment
Do not exceed 20 mg daily in severe impairment.
Contraindications
- Hypersensitivity to pantoprazole, substituted benzimidazoles, or any excipient.
- Children under 12 years.
Precautions
- Monitor liver enzymes in severe hepatic impairment; discontinue if elevated.
- Exclude gastric malignancy before starting treatment.
- Use cautiously with NSAIDs in at-risk patients.
- Long-term therapy may reduce vitamin B12 absorption.
- Long-term PPI use may increase risk of bacterial GI infections.
- Risk of hypomagnesemia with prolonged treatment (>3 months).
- Rare: Subacute cutaneous lupus erythematosus (SCLE).
- Increased Chromogranin A may interfere with neuroendocrine tumor diagnosis-stop 5 days before testing.
Side Effects
Most common
Diarrhea and headache
Common
Fundic gland polyps (benign)
Uncommon
Sleep disorders, headache, dizziness, diarrhea, nausea/vomiting, abdominal pain, constipation, dry mouth, increased liver enzymes, rash, pruritus, bone fractures, fatigue.
Rare
Agranulocytosis, hypersensitivity reactions (incl. anaphylaxis), hyperlipidemia, weight changes, depression, taste disturbances, blurred vision, increased bilirubin, urticaria, angioedema, arthralgia, myalgia, gynecomastia, fever, peripheral edema.
Very rare
Thrombocytopenia, leukopenia, disorientation.
Pregnancy and Breastfeeding
- Moderate data show no malformations, but use is not preferred during pregnancy.
- Pantoprazole is excreted in breast milk; breastfeeding should be discontinued or therapy avoided.
Storage Conditions
Store below 30°C in a dry place.
Keep out of reach of children.
Packaging
Carton box containing 2 strips of 10 tablets with an inner leaflet.