Pantopi 20 mg 20 tablets

Пантопи 20 мг 20 таблеток

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.