Product Description:

• Esopole Capsule is used for the short-term treatment and maintenance of inflammation of the food pipe.


• This medicine works by decreasing the amount of acid in the stomach.


• This medicine helps by relieving the symptoms of hyperacidity.


• Esopole is also used for the short-term treatment of backflow of stomach acid into esophagus, to reduce the occurrence of stomach ulcers related to the repeated use of NSAID's in patients, for the long-term treatment of overproduction of acid in the stomach, to reduce the risk of rebleeding in patients with stomach or intestinal ulcers who are undergoing endoscopy procedure, and to treat the patients with H.


• pylori bacterial infection and intestinal ulcers.


• Esopole Capsule may also be used together with other medicines to treat certain conditions as recommended by the doctor.


• It is used in combination with Amoxicillin, or Clarithromycin to treat the patients with H.


• pylori bacterial infection and intestinal ulcers.

Proton Pump Inhibitors :

• Esopole is a prescription medicine that belongs to a class of medicines called Proton Pump Inhibitors.


• Proton-pump inhibitors (PPIs) are a group of medicines that significantly reduce stomach acid production.


• Excess acid production causes diseases related to the stomach and intestines.


• PPIs are used to treat such disorders.

How to use:

• Esopole Capsule is used with food.


• Patients are advised to mix the granules with food, and the granules should only be mixed with applesauce.


• This medicine should be taken at least one hour before a meal.


• Do not crush or chew the capsules.

Typical Dosage :

• The typical dose of Esopole is 20 mg or 40 mg once daily for 4 to 8 weeks.


• The maximum adult dose of Esopole is 40 mg in a day.


• This medicine is typically used for a period of 4 to 8 weeks for inflammation of the food pipe, 6 months for the occurrence of stomach ulcers related to the repeated use of NSAID's in patients, 4 weeks for backflow of stomach acid into esophagus, and 10 days for H.


• pylori bacterial infection and intestinal ulcers.


• Esopole is commonly used at the same time every day.


• It takes 1 hour for this medicine to start to work.

Special Instructions:

Capsule

• Patients are advised to mix the granules with food, and the granules should only be mixed with applesauce.


• If the applesauce or granules mixture is not used entirely, the remaining mixture should not be used.


• Do not ingest the granules if they have disintegrated or dissolved

Caution & Warnings:

Interference with diagnostic investigations

• Blood chromogranin A levels may lead to an increased drug-induced decrease in stomach acidity.


• The elevated blood chromogranin A levels may cause false positive results in diagnosis for neuroendocrine tumors.


• Esopole therapy should be stopped temporarily before assessing blood chromogranin A levels and consider repeating the test if initial blood chromogranin A levels are high.


• The same practical lab should be used for testing (monitoring) of chromogranin A levels in the blood.

Use of Esopole strontium with rifampin:

• Drugs which induce CYP3A4 or CYP2C19 (such as St.


• John’s Wort or rifampin) can essentially decrease Esopole levels.


• Avoid combined use of Esopole strontium with rifampin or St.


• John’s Wort.

Low levels of magnesium:

• Patients using proton pump inhibitors including Esopole for at least three months and after a year of therapy are at an increased risk of low levels of magnesium characterized by adverse events such as involuntary contraction of muscles (tetany), irregular heartbeat, and seizures.


• Proper monitoring of magnesium levels is required before starting therapy with proton pump inhibitors.

Increased risk of bone fractures:

• Patients who are using high-dose, defined as multiple daily doses, and long-term treatment with proton pump inhibitors are at an increased risk.


• Studies suggest that proton pump inhibitor (PPI) including Esopole therapy may be associated with an enhanced risk for osteoporosis-related fractures of the hip, spine, or wrist.


• Such patients should use the lowest dose and shortest duration of proton pump inhibitors therapy appropriate to the suitable condition.

Interaction with clopidogrel:

• The metabolism of clopidogrel can be worsened by combined use with medicines, such as Esom, that block CYP2C19 activity.


• The combined use of clopidogrel with Esopole 40 mg reduces the pharmacological action of clopidogrel.


• Avoid the combined use of Esopole strontium with clopidogrel, which is a prodrug.


• Blockage of platelet aggregation by clopidogrel is entirely due to an active metabolite.


• When using Esopole strontium, consider other alternative anti-platelet therapy.

Inflammation of the colon:

• Hospitalized patients who are on proton pump inhibitors therapy are at an increased risk when using this medicine.


• Studies suggest that PPI therapy like Esopole strontium is related to an increased risk of diarrhea associated with Clostridium difficile bacteria infection.


• Proper diagnosis should be considered in patients with the worsening condition of diarrhea associated with inflammation of the colon (Clostridium difficile bacteria infection).

Vitamin B-12 deficiency:

• Regular therapy with any acid-suppressing medicines over a prolonged period (longer than three years) may lead to a deficiency of vitamin B-12 caused by the absence of hydrochloric acid from the gastric juice (achlorhydria).


• A diagnostic approach should be followed if any clinical symptoms consistent with vitamin-B12 deficiency are observed.

Swelling in between the kidney tubules:

• Patients using proton pump inhibitors including Esopole are at an increased risk.


• Swelling in between the kidney tubules may happen during proton pump inhibitors treatment and is generally associated with a severe allergic reaction without any known cause.


• Discontinue the use of Esopole if acute interstitial nephritis develops.

The Inflammatory mucous membrane of the stomach:

• Patients who are on long-term treatment with omeprazole are at an increased risk.


• Such patients may suffer from an increased risk of inflammation of the mucous membrane of the stomach (atrophic gastritis).


• Stomach cancer (concurrent gastric malignancy)


• Response according to the symptoms of treatment with Esopole strontium does not prevent the presence of stomach cancer.

The combined use of Esopole strontium with methotrexate:

• The combined use of PPIs with methotrexate (primarily at high dose) may raise and progress blood levels of methotrexate or its metabolite, probably leading to the condition of harmful effects of the methotrexate.


• In high-dose methotrexate ingestion, a short-term withdrawal of the proton pump inhibitors including Esopole should be considered in such patients.

Non scaring skin lesions:

• Use of proton pump inhibitors including Esopole may lead to an increased risk of development of skin lesions in sun-exposed areas.


• The patient should seek medical help promptly, and discontinue the use of Esopole after consultation with the health care professional.

Stomach and intestinal infections:

• Therapy with proton pump inhibitors including Esopole may lead to increased risk of stomach and intestinal infections such as infections caused by bacteria Campylobacter and Salmonella.

Ingredients:

• Esomeprazole