Pantoprazole Sodium

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• PANTOPRAZOLE SODIUM DESCRIPTION
• CLINICAL PHARMACOLOGY
• USE IN SPECIFIC POPULATIONS
• PHARMACODYNAMICS
• CLINICAL STUDIES
• INDICATIONS & USAGE
• PANTOPRAZOLE SODIUM CONTRAINDICATIONS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• PANTOPRAZOLE SODIUM ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• INFORMATION FOR PATIENTS
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

PANTOPRAZOLE SODIUM DESCRIPTION

CLINICAL PHARMACOLOGY

USE IN SPECIFIC POPULATIONS

PHARMACODYNAMICS

CLINICAL STUDIES

INDICATIONS & USAGE

PANTOPRAZOLE SODIUM CONTRAINDICATIONS

PRECAUTIONS

INFORMATION FOR PATIENTS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

PANTOPRAZOLE SODIUM ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

INFORMATION FOR PATIENTS

• ●     Caution patients that pantoprazole sodium delayed-release tablets, should not be split, crushed, or chewed.

• ●     Tell patients that pantoprazole sodium delayed-release tablets, USP should be swallowed whole, with or without food in the stomach.

• ●     Let patients know that concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets, USP.

• ●     Up to 8 weeks for short-term treatment of acid-related damage to the lining of the esophagus (erosive esophagitis) caused by gastroesophageal reflux disease (GERD). If needed, your doctor may prescribe an additional 8 weeks of pantoprazole sodium delayed-release tablets.

• ●     Maintain healing of acid-related damage to the lining of the esophagus and helps prevent return of heartburn symptoms caused by GERD. Pantoprazole sodium delayed-release tablets have not been studied for treatment lasting longer than 1 year

• ●     Treating a rare condition called Zollinger-Ellison Syndrome, where the stomach makes more than the normal amount of acid

• ●     allergic to any of the ingredients in pantoprazole sodium delayed-release tablets. See the end of this leaflet for a complete list of ingredients in pantoprazole sodium delayed-release tablets.

• ●     allergic to any proton pump inhibitor (PPI). If you do not know if your medicines are PPIs, please ask your doctor.

• ●     pregnant, think you may be pregnant, or are planning to become pregnant. It is not known if pantoprazole sodium delayed-release tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

• ●     breastfeeding or planning to breastfeed. Pantoprazole sodium delayed-release tablets may pass into your milk. Talk with your doctor about the best way to feed your baby if you take pantoprazole sodium delayed-release tablets.

• ●     Warfarin (CoumadinAthrombin -KJantovenPanwarfin

• ●     Ketoconazole (Nizoral

• ●     Atazanavir (ReyatazNelfinavir (Viracept

• ●     Iron supplements

• ●     Ampicillin antibiotics

• ●     Take pantoprazole sodium delayed-release tablets exactly as prescribed by your doctor.

• ●     Do not change your dose or stop pantoprazole sodium delayed-release tablets without talking to your doctor.

• ●     If you forget to take a dose of pantoprazole sodium delayed-release tablets, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take two doses to try to make up for a missed dose.

• ●     If you take too much pantoprazole sodium delayed-release tablets, call your doctor right away.

• ●     See the Patient Instructions for Use at the end of this leaflet for detailed instructions about:

• ●               how to take pantoprazole sodium delayed-release tablets .

• ●     Stomach lining weakening with long-term use

• ●     Vitamin B-12 deficiency

• ●     Serious allergic reactions. Tell your doctor if you get any of the following symptoms with pantoprazole sodium delayed-release tablets

• ●               rash

• ●               face swelling

• ●               throat tightness

• ●               difficult breathing

• ●     Store pantoprazole sodium delayed-release tablets at 20(68

• ●     Keep pantoprazole sodium delayed-release tablets and all medicines out of the reach of children.

• ●     You can take pantoprazole sodium delayed-release tablets with food or on an empty stomach.

• ●     Swallow pantoprazole sodium delayed-release tablets whole.

• ●     If you have trouble swallowing a pantoprazole sodium delayed-release tablet 40 mg tablet, you can take two 20 mg tablets instead.

• ●     Do not split, chew or crush pantoprazole sodium delayed-release tablets.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION