INTRODUCTION

DIGIPAN 40 contains Pantoprazole which belongs to the group of medicines called proton pump inhibitors. It is used to treat reflux oesophagitis (inflammation of oesophagus with regurgitation of stomach acid) in adults and in children aged 12 years or above. It is also used to treat stomach and duodenal ulcers, Zollinger-Ellison-Syndrome and other conditions where, too much acid are produced in the stomach in adults. It can also be used in the treatment of Helicobacter pylori infection in adult patients with duodenal or stomach ulcers in combination with other antibiotics (eradication therapy).

Pantoprazole decreases stomach acid production by inhibiting the proton pump (H+ K+ ATPase). Along with this treatment, your doctor might recommend you, to take enough rest and drink plenty of fluids. Sticking to simple meals and avoiding rich or spicy food can also be beneficial. Avoid smoking and consumption of alcohol during this therapy, as it may reduce the chances of healing and worsen the ulcers.

Always take this medicine as directed by your physician, because long-term use of pantoprazole may reduce your blood magnesium levels, affect liver function or increase the risk of bone fracture. To avoid this, regular monitoring of bone functions, liver enzymes and blood magnesium levels are required during the course of treatment. This medicine must be taken 1 hour before meals. The most common side effects of this medicine are vomiting, stomach pain and diarrhea. Contact your doctor if any of these symptoms bothers you. Before taking this medicine, inform your doctor if you have any kidney or liver disease. If you are pregnant or breast-feeding, consult your doctor for advice before taking this medicine.

USES OF DIGIPAN 40

• Treats reflux oesophagitis in adults and in children aged 12 years or above
• Treat stomach and duodenal ulcers in adults
• Treats Zollinger-Ellison Syndrome in adults
• Treats H. pylori infection in adult patients with duodenal or stomach ulcers in combination with other antibiotics (eradication therapy)

HOW DIGIPAN 40 WORKS

Following oral administration, pantoprazole binds to and irreversibly inhibits the enzyme called H+ K+ ATPase (proton pump) in the parietal cells of the stomach, which decreases gastric acid secretions.

DIRECTIONS FOR USE

Take DIGIPAN 40 as directed by your physician. It should be taken one hour before meals. Swallow the medicine as whole with a sip of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, weight and health condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF DIGIPAN 40

HOW TO MANAGE SIDE EFFECTS

Skin rash:

Avoid hot showers because hot water can irritate the skin. Do not rub or scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use moisturizers to soothe and hydrate the affected area. If it does not get better, speak to your doctor.

Vomiting:

Try taking this medicine with, or just after meals. Stick to simple meals. Do not eat rich or spicy food.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole and posaconazole)
• medicines used to thin your blood (e.g. warfarin and phenprocoumon)
• medicines used to treat HIV-infection (e.g. atazanavir)
• corticosteroids (used to treat inflammation or allergies) e.g. prednisone, dexamethasone, beclomethasone
• erlotinib (used to treat cancer)
• methotrexate (used to treat cancer, psoriasis or rheumatoid arthritis)
• fluvoxamine (used to treat depression and other psychiatric illness)
• rifampicin (used to treat tuberculosis infection)
• St John’s wort (used to treat depression)

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT DIGIPAN 40

Can DIGIPAN 40 be taken twice a day?

Yes. It can be taken twice a day if required. However, your doctor will decide the correct dose and duration for you depending upon your age, weight and health condition. Try to take this medicine 1 hour before meals.

Can DIGIPAN 40 be taken at night?

Yes. It can be taken at night. However, consult your doctor before taking. Try to take this medicine one hour before meals.

How long does it take for DIGIPAN 40 to work?

It will generally take up to 2-3 days to show its effects and make you feel better. It may also take up to four weeks for some individuals depending upon their severity of disease.

REFERENCES

1. KD. Tripathi. Drugs for Peptic ulcer and Gastroesophageal Reflux Disease. Essentials of medical pharmacology. Seventh edition. 2013. Page – 651-653.

2. John L. Wallace and Keith A. Sharkey. Pharmacotherapy of Gastric acidity, Peptic ulcer and Gastroesophageal Reflux disease. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1311-1313.

3. Gerald G. Briggs and Roger K. Freeman. R. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 2960-2965.

4. Wyeth is now a wholly owned subsidiary of Pfizer. Study Evaluating Pantoprazole in Children with Gastroesophageal Reflux Disease (GERD). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on May 2010] [Accessed 24th November 2020] https://clinicaltrials.gov/ct2/show/NCT00300755

5. Takeda. Long-term Pantoprazole Trial in Patients with Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on May 2012] [Accessed 24th November 2020] https://clinicaltrials.gov/ct2/show/NCT00261300

6. Andrzej Dabrowski, Borut Štabuc, and Leonid Lazebnik. Meta-analysis of the efficacy and safety of pantoprazole in the treatment and symptom relief of patients with gastroesophageal reflux disease – PAN-STAR. NCBI; PMC US National Library of Medicine, National Institute of Health. March 2018. [Accessed 24th November 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5894447/

7. Takeda GmbH. Electronic Medicines Compendium (EMC); [Revised on February 2020] [Accessed 24th November 2020] https://www.medicines.org.uk/emc/files/pil.484.pdf

8. Pharma Pack Hungary Ltd. Heads of Medical Agency (HMA); [Revised on December 2016] [Accessed 24th November 2020] http://mri.cts-mrp.eu/download/NL_H_2751_002_FinalPL_1of2.pdf

9. Pfizer. U.S. Food & Drug Administration. [Revised on May 2012] [Accessed 24th November 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s045lbl.pdf

USEFUL DIAGNOSTIC TESTS

• Abdominal ultrasound
• Endoscopy