INTRODUCTION

IZUMEP CAPSULE is a combination of Domperidone and Esomeprazole which belongs to the group of medicines called Prokinetic Drugs and Proton pump inhibitors respectively. It is used in adults to treat peptic ulcers, gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome (tumors in pancreas causing the stomach to secrete more acid).

Peptic ulcers are painful sores that develop on the linings of the stomach, esophagus and/or intestines. It causes severe stomach pain with sensation of flatulence, indigestion, vomiting and fatigue.

IZUMEP CAPSULE is effective in treating peptic ulcer caused either due to stomach infection (H. pylori infection) or due to prolong use of non-steroidal anti-inflammatory drugs (such as ibuprofen, Aceclofenac etc.). It can also be used to prevent re-bleeding from the ulcers.

GERD is a chronic digestive disease in which the acid from the stomach frequently flows into the esophagus leading to irritation of lining of the food pipe. Symptoms include heartburn, chest pain, nausea, sensation of a lump in the throat and stomach discomfort.

IZUMEP CAPSULE acts by reducing the production of gastric acid. It also speeds up the movement of food from the stomach to the intestines, thereby reducing the signs of nausea, vomiting and acid reflux. Due to these actions, it can also reduce the unpleasant signs of the GI tract such as nausea, vomiting, indigestion, burping, bloating, acidity or heartburn.

IZUMEP CAPSULE is suitable for use both in adults and in children (aged 12 years or above weighing 35 kg or more). It should be taken at least 30 minutes before meals. During treatment with IZUMEP CAPSULE, your doctor will closely monitor your kidney functions, liver functions and blood magnesium levels to avoid the risk of unwanted side effects.

Before taking IZUMEP CAPSULE inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have any blockage or tears in the gut or have weak bones.

IZUMEP CAPSULE is not recommended for use in patients having bleeding from the gut. Consult your doctor before taking IZUMEP CAPSULE if you are pregnant or breastfeeding. The most common side effects of taking IZUMEP CAPSULE are dryness of mouth, constipation and flatulence. Consult your doctor if any of these side effects bother you.

You must also inform your doctor immediately if you experience any abnormal signs such as unusual tiredness, abnormal muscle movements, dizziness, confusion, disorientation, irregular heartbeat, fragile bones, bloody stools or vomits or sudden weight loss.

USES OF IZUMEP CAPSULE

It is used in adults and in children (aged 12 years or older weighing 35 kg or more) to treat:

• Peptic ulcers
• Gastrointestinal Reflux disease (GERD)
• Zollinger-Ellison syndrome (tumors in the pancreas causing the stomach to secrete more acid)
• Nausea and Vomiting
• Acidity, Heartburn, Indigestion, Burping, Bloating

HOW IZUMEP CAPSULE WORKS

IZUMEP CAPSULE contains two medicines namely domperidone and esomeprazole. Domperidone is a prokinetic medicine with anti-emetic properties. It works by blocking the actions of a chemical messenger called dopamine in the gut and across the brain and spinal cord.

This action stimulates the gut, reduces acid reflux and speeds up the movements of food from the stomach into the intestines. It also blocks the transmission of nerve signals between the vomiting centers and the brain which reduces the onset of nausea and vomiting.

Esomeprazole is a proton pump inhibitor. It reduces gastric acid secretion by blocking the actions of a protein membrane called H+K+Atpase (proton pump) present in the lining of the stomach.

By reducing stomach acid production, IZUMEP CAPSULE prevents the worsening of ulcers, heals the existing ulcers and esophageal lesions and provides relief from the unpleasant symptoms of the GI tract (such as acidity, bloating, burping and indigestion).

DIRECTIONS FOR USE

Take IZUMEP CAPSULE 30 minutes to 1 hour before meals or as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Do not stop taking IZUMEP CAPSULE unless your doctor advises you to stop.

SIDE EFFECTS OF IZUMEP CAPSULE

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try to take IZUMEP CAPSULE with or just after meals. Stick to simple meals and avoid oil-rich or spicy foods. Consult your doctor if the nausea worsens.

Headache:  

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Constipation:

Taking IZUMEP CAPSULE with meals may reduce the chances of constipation. However, if you experience constipation, eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking IZUMEP CAPSULE inform your doctor if you are taking any of the following medicines such as:

• other medicines used to treat gastrointestinal problems (Ex. cisapride, dolasetron, prucalopride, diphemanil, bepridil, methadone, omeprazole, lansoprazole, rabeprazole, ranitidine, famotidine)
• medicines used to treat arrhythmia or other heart problems (Ex. digoxin, apomorphine, disopyramide, hydroquinidine, quinidine, amiodarone, dofetilide, dronedarone, ibutilide, sotalol, diltiazem, or verapamil)
• medicines used to treat HIV infection (Ex. atazanavir, nelfinavir, saquinavir)
• antipsychotics (used to treat mental illness) Ex. haloperidol, pimozide, sertindole
• antidepressants (used to treat depression) Ex. escitalopram, citalopram, imipramine, St. John’s Wort
• antibiotics (used to treat bacterial infections) Ex. moxifloxacin, erythromycin, levofloxacin, clarithromycin, telithromycin, or amoxicillin
• medicines used to treat malaria (Ex. halofantrine, lumefantrine)
• antihistamines (used to treat allergies) Ex. mizolastine, mequitazine
• medicines used to treat cancer (Ex. toremifene, vandetanib, vincamine, erlotinib, dasatinib, nilotinib)
• methotrexate (used to treat cancer and auto-immune disease)
• tacrolimus (used to prevent graft rejection)
• ketoconazole, itraconazole or voriconazole (used to treat fungal infection)
• rifampicin (used to treat tuberculosis)
• apomorphine (used to treat Parkinson’s disease)
• diazepam (used to treat anxiety)
• phenytoin (used to treat epilepsy)
• cilostazol (used to treat pain in legs)
• warfarin (used for blood thinning)
• clopidogrel (used to treat or prevent blood clots)

B. Drug-Food interaction:

Try to take this medicine before meals to achieve maximum efficacy.

Overdosage:

If you or anyone else accidentally took more IZUMEP CAPSULE, contact your doctor immediately or go to a hospital straight away. Symptoms of overdosage might include sleepiness, confusion, uncontrollable body movements (including eye and tongue), twisted neck and abnormal posture.

SYNOPSIS

MORE INFORMATION

• Keep IZUMEP CAPSULE out of the sight and reach of children
• Store IZUMEP CAPSULE at room temperature

FAQs ABOUT IZUMEP CAPSULE

What is IZUMEP CAPSULE used for?

IZUMEP CAPSULE is used to treat peptic ulcers, GERD and Zollinger Ellison Syndrome. It can also be used to treat nausea, vomiting, bloating, burping, acidity and heartburn.

How and when to take IZUMEP CAPSULE?

Take IZUMEP CAPSULE at least 30 minutes to 1 hour before meals. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight and disease condition.

How long should I take IZUMEP CAPSULE?

You need to take IZUMEP CAPSULE for the stipulated duration prescribed by your doctor. Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight and disease condition

What is the best time to take IZUMEP CAPSULE?

IZUMEP CAPSULE must be taken before meals to avoid gastrointestinal side effects.

What to do if I forgot to take a dose of IZUMEP CAPSULE?

If you forgot to take a dose of IZUMEP CAPSULE, take it as soon as you remember. However, if it is time for the next dose of IZUMEP CAPSULE, skip the missed dose and take the next one regularly. Do not take a double dose of IZUMEP CAPSULE to compensate the missed ones.

What are the most common side effects of taking IZUMEP CAPSULE?

The most common side effects of taking IZUMEP CAPSULE are dryness of mouth, constipation and flatulence. Consult your doctor if any of these side effect bothers you.

Can I stop taking IZUMEP CAPSULE without consulting your doctor?

No. You should not stop taking IZUMEP CAPSULE without consulting your doctor because it may lead to a reversal of symptoms. If you feel better after using IZUMEP CAPSULE, consult your doctor for advice.

Will taking a higher dose of IZUMEP CAPSULE be more effective?

No, taking a higher dose of IZUMEP CAPSULE will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.

What precautions do I need to follow while taking IZUMEP CAPSULE?

Make sure to take IZUMEP CAPSULE 30 minutes before meals. Before taking IZUMEP CAPSULE inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have any blockage or tears in the gut or have weak bones. Consult your doctor before taking IZUMEP CAPSULE if you are pregnant or breastfeeding. Regularly visit your doctor and take all the blood tests recommended by your doctor without fail.

Can I take medication for high blood pressure along with IZUMEP CAPSULE?

It is not advisable to take medicines to control blood pressure while taking IZUMEP CAPSULE without consulting your doctor as they have known interactions with IZUMEP CAPSULE.

Can IZUMEP CAPSULE be used in pregnant women?

IZUMEP CAPSULE should be used in pregnant women only if it is considered necessary by the physician. Therefore, consult your doctor before taking it.

How to take IZUMEP CAPSULE?

You must take IZUMEP CAPSULE as advised by your physician. Try to take IZUMEP CAPSULE 30 minutes before and swallow it with a glass of water. Do not crush or chew the medicine.

How much IZUMEP CAPSULE should I take?

IZUMEP CAPSULE should be used only under medical supervision. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body condition and severity of the disease condition.

Can IZUMEP CAPSULE cause constipation?

Yes. Constipation is a common side effect of using IZUMEP CAPSULE. Eat plenty of fiber-rich foods such as fresh fruits, vegetables, cereals as well as drink plenty of water and exercise more regularly when taking this medicine. Contact your doctor if this side effect bothers you.

Can IZUMEP CAPSULE cause dry mouth?

Yes. Dry mouth is an uncommon side effect of using IZUMEP CAPSULE. Contact your doctor if this side effect bothers you.

REFERENCES

1. KD. Tripathi. Antiemetic, Prokinetic and Digestant drugs & Drugs for Peptic Ulcer and Gastroesophageal Reflux Disease. Essentials of medical pharmacology. Seventh edition. 2013. Page – 666 & 651-653.

2. Keith A. Sharkey and John L. Wallace. Treatment of disorders of bowel motility and water flux; Antiemetics; Agents used in biliary and pancreatic disease and 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 – 1326 & 1311-1313.

3. Gerald G. Briggs and Roger K. Freeman. D & E. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 1232 & 1427-1431.

4. KY Marakhouski, GA Karaseva, DN Ulasivich and Y Kh Marakhouski. Omeprazole-Domperidone Fixed Dose Combination vs Omeprazole Monotherapy: A Phase 4, Open-Label, Comparative, Parallel Randomized Controlled Study in Mild to Moderate Gastroesophageal Reflux Disease. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. May 2017. [Accessed on 3rd November 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5457029/

5. Kentaro Sugano, Yoshikazu Kinoshita, Hiroto Miwa and Tsutomu Takeuchi. Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs. BMC Gastroenterology. March 2013. [Accessed on 3rd November 2022]. https://bmcgastroenterol.biomedcentral.com/articles/10.1186/1471-230X-13-54

6. Sun Pharmaceutical Industries Europe B.V., and Terapia SA. Electronic Medicines Compendium (EMC). [Revised in July 2022] [Accessed on 3rd November 2022]. https://www.medicines.org.uk/emc/files/pil.2326.pdf

7. Milpharm Limited, APL Swift Services (Malta) Ltd. Electronic Medicines Compendium (EMC). [Revised in March 2021] [Accessed on 3rd November 2022]. https://www.medicines.org.uk/emc/files/pil.556.pdf