About ESOPOLE DSR

Domperidone+Esomeprazole

NTRODUCTION

ESOPOLE D SR 30/40MG 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.

ESOPOLE D SR 30/40MG 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 food pipe. Symptoms include heartburn, chest pain, nausea, sensation of lump in throat and stomach discomfort.

ESOPOLE D SR 30/40MG 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 GI tract such as nausea, vomiting, indigestion, burping, bloating, acidity or heartburn.

ESOPOLE D SR 30/40MG CAPSULE should be taken at least 30 minutes before meals. During treatment with ESOPOLE D SR 30/40MG 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 ESOPOLE D SR 30/40MG 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.

ESOPOLE D SR 30/40MG CAPSULE is not recommended for use in patients having bleeding from the gut. Consult your doctor before taking ESOPOLE D SR 30/40MG CAPSULE if you are pregnant or breastfeeding. The most common side effects of taking ESOPOLE D SR 30/40MG CAPSULE are dryness of mouth, constipation and flatulence. Consult your doctor if any of these side effect bothers you.

USES OF ESOPOLE D SR 30/40MG CAPSULE

It is used in adults to treat:

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

HOW ESOPOLE D SR 30/40MG CAPSULE WORKS

ESOPOLE D SR 30/40MG 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 the 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, ESOPOLE D SR 30/40MG CAPSULE prevents the worsening of ulcers, heals the existing ulcers and esophageal lesions and provides relief from the unpleasant symptoms of GI tract (such as acidity, bloating, burping and indigestion).

DIRECTIONS FOR USE

Take ESOPOLE D SR 30/40MG 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 ESOPOLE D SR 30/40MG CAPSULE unless your doctor advice you to stop.

SIDE EFFECTS OF ESOPOLE D SR 30/40MG CAPSULE

COMMON

• Headache
• Diarrhea, stomach pain, constipation, flatulence
• Nausea, vomiting
• Benign polyps in the stomach

UNCOMMON

• Dry mouth
• Low sex drive
• Dizziness, drowsiness
• Anxiety, sleeplessness
• Skin rash or itchiness
• Breast enlargement in both men and in women
• Feeling weak
• Swelling of body parts (oedema)
• Fragile bones (risk of bone fracture)
• Abnormal liver function tests

RARE

• Low WBC or platelet counts in blood
• Signs of low sodium levels in blood (weakness, being sick and cramps)
• Mouth ulcers
• Hair loss
• Fungal infection of the gut (thrush)

Stop taking ESOPOLE D SR 30/40MG CAPSULE and inform your doctor immediately if you experience any of the following side effects such as:

• Severe allergic reactions (such as skin rash, itching, swelling of the lips, face or body and difficulty in breathing or swallowing)
• Signs of liver problems (yellowing of the skin and eyes, dark urine and tiredness)
• Severe skin reactions (such as redness, blistering, peeling of skin and bleeding in the lips, eyes, mouth, nose and genitals with fever)
• Chest pain, fast or irregular heartbeat, difficulty in breathing, feeling faint
• Fits
• Uncontrollable body movements (including eye and tongue), twisted neck and abnormal body posture
• Signs of low magnesium levels in blood (such as tiredness, abnormal muscle movements, dizziness, confusion, disorientation, irregular heartbeat)
• Skin rashes on sun exposed areas with or without joint pain
• Sudden weight loss, looking pale and weak (anemia)
• Signs of bleeding in the gut (such as bloody vomits/stools)

HOW TO MANAGE SIDE EFFECTS

Constipation

Taking ESOPOLE D SR 30/40MG 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.

Dizziness Or Drowsiness

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.

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.

Nausea And Vomiting

Try to take ESOPOLE  D SR 30/40MG CAPSULE with or just after meals. Stick to simple meals and avoid oil rich or spicy foods. Consult your doctor if nausea worsens.

WARNING & PRECAUTIONS

PREGNANCY

MONITORING REQUIRED

ESOPOLE D SR 30/40MG CAPSULE should be used in pregnant women only if it is considered necessary by the physician. Therefore, consult your doctor before taking it.

BREASTFEEDING

MONITORING REQUIRED

ESOPOLE D SR 30/40MG CAPSULE may pass through breast milk. Therefore, it is not recommended for use in breastfeeding women unless considered necessary by the physician.

DRIVING AND USING MACHINES

USE WITH CAUTION

ESOPOLE D SR 30/40MG CAPSULE does not affect your ability in driving or handling heavy tools or machines. However, do not drive or handle heavy tools or machines if your ability is affected by ESOPOLE D SR 30/40MG CAPSULE.

ALCOHOL

CONSULT YOUR DOCTOR

Avoid consumption of alcohol while taking ESOPOLE D SR 30/40MG CAPSULE, as it could aggravate your existing condition.

KIDNEY

USE WITH CAUTION

ESOPOLE D SR 30/40MG CAPSULE should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.

LIVER

CONSULT YOUR DOCTOR

ESOPOLE D SR 30/40MG CAPSULE is not recommended for use in patients with moderate or severe liver impairment. It should be used with caution in patients with other mild liver problems. Therefore, consult your doctor before taking it.

ALLERGY

CONTRAINDICATED

Do not take ESOPOLE D SR 30/40MG CAPSULE if you are allergic to Domperidone, esomeprazole or to any other proton pump inhibitors (such as rabeprazole, pantoprazole).

HEART DISEASE

CONTRAINDICATED

ESOPOLE D SR 30/40MG CAPSULE is not recommended for use in patients having heart problems (such as prolongation of QT wave, congestive heart failure or arrhythmia). Therefore, consult your doctor before taking it.

USE IN PEDIATRICS

CONTRAINDICATED

ESOPOLE D SR 30/40MG CAPSULE is not recommended for use in children and adolescents (aged below 18 years) due to lack of safety data. However, consult your doctor before taking it.

USE IN GERIATRICS

USE WITH CAUTION

ESOPOLE D SR 30/40MG CAPSULE should be used with caution in elderly patients (aged 65 years and above). Therefore, consult your doctor before taking it.

OTHERS

ESOPOLE D SR 30/40MG CAPSULE is not recommended for use if you:

• Have bloody stools or bleeding in the gut
• Have blockage or tear in the intestines
• Have severe fluid or electrolyte disturbances
• Have prolactinoma (a non-cancerous tumor of pituitary gland)
• Have low blood potassium or magnesium levels
• Have hyperkalemia (high blood potassium levels)

Before taking ESOPOLE D SR 30/40MG CAPSULE inform your doctor if you:

• Have osteoporosis
• Have vitamin B12 deficiency (sore tongue, mouth ulcers, pale skin, depression)
• Are going to test Chromogranin A level

INTERACTIONS

A. Drug-Drug interactions:

Before taking ESOPOLE D SR 30/40MG 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 ESOPOLE D SR 30/40MG 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 ESOPOLE D SR 30/40MG CAPSULE out of the sight and reach of children
• Store ESOPOLE D SR 30/40MG CAPSULE at room temperature

FAQs ABOUT ESOPOLE D SR 30/40MG CAPSULE

Q: What is ESOPOLE D SR 30/40MG CAPSULE used for?

A: ESOPOLE D SR 30/40MG 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.

Q: How and when to take ESOPOLE D SR 30/40MG CAPSULE?

A: Take ESOPOLE D SR 30/40MG CAPSULE at least 30 minutes to 1 hour before meals. Swallow the medicine with a glass of water. Do not cursh 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.

Q: How long should I take ESOPOLE D SR 30/40MG CAPSULE?

A: You need to take ESOPOLE D SR 30/40MG CAPSULE for the stipulated duration prescribed by your doctor. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

Q: What is the best time to take ESOPOLE D SR 30/40MG CAPSULE?

A: ESOPOLE D SR 30/40MG CAPSULE must be taken before meals to avoid gastrointestinal side effects.

Q: What to do if I forgot to take a dose of ESOPOLE D SR 30/40MG CAPSULE?

A: If you forgot to take a dose of ESOPOLE D SR 30/40MG CAPSULE, take it as soon as you remember. However, if it is time for the next dose of ESOPOLE D SR 30/40MG CAPSULE, skip the missed dose and take the next one regularly. Do not take a double dose of ESOPOLE D SR 30/40MG CAPSULE to compensate the missed ones.

Q: What are the most common side effects of taking ESOPOLE D SR 30/40MG CAPSULE?

A: The most common side effects of taking ESOPOLE D SR 30/40MG CAPSULE are dryness of mouth, constipation and flatulence. Consult your doctor if any of these side effect bothers you.

Q: Can I stop taking ESOPOLE D SR 30/40MG CAPSULE without consulting your doctor?

A: No. You should not stop taking ESOPOLE D SR 30/40MG CAPSULE without consulting your doctor because it may lead to reversal of symptoms. If you feel better after using ESOPOLE D SR 30/40MG CAPSULE, consult your doctor for advice.

Q: Will taking a higher dose of ESOPOLE D SR 30/40MG CAPSULE be more effective?

A: No, taking a higher dose of ESOPOLE D SR 30/40MG 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.

Q: What precautions do I need to follow while taking ESOPOLE D SR 30/40MG CAPSULE?

A: Make sure to take ESOPOLE D SR 30/40MG CAPSULE 30 minutes before meals. Before taking ESOPOLE D SR 30/40MG 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 ESOPOLE D SR 30/40MG CAPSULE if you are pregnant or breastfeeding. Regularly visit your doctor and take all the blood tests recommended by your doctor without fail.

Q: Can I take medication for high blood pressure along with ESOPOLE D SR 30/40MG CAPSULE?

A: It is not advisable to take medicines to control blood pressure while taking ESOPOLE D SR 30/40MG CAPSULE without consulting your doctor as they have known interactions with ESOPOLE D SR 30/40MG CAPSULE.

Q: Can ESOPOLE D SR 30/40MG CAPSULE be used in pregnant women?

A: ESOPOLE D SR 30/40MG CAPSULE should be used in pregnant women only if it is considered necessary by the physician. Therefore, consult your doctor before taking it.

Q: How to take ESOPOLE D SR 30/40MG CAPSULE?

A: You must take ESOPOLE D SR 30/40MG CAPSULE as advised by your physician. Try to take ESOPOLE D SR 30/40MG CAPSULE 30 minutes before and swallow it with a glass of water. Do not crush or chew the medicine.

Q: How much ESOPOLE D SR 30/40MG CAPSULE should I take?

A: ESOPOLE D SR 30/40MG 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.

Q: Can ESOPOLE D SR 30/40MG CAPSULE cause constipation?

A: Yes. Constipation is a common side effect of using ESOPOLE D SR 30/40MG 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.

Q: Can ESOPOLE D SR 30/40MG CAPSULE cause dry mouth?

A: Yes. Dry mouth is an uncommon side effect of using ESOPOLE D SR 30/40MG 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. TORRENT PHARMACEUTICALS LTD. IZRA D. Torrentian.com. [Revised in February 2022]. [Accessed on 3rd November 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2977.pdf

6. Cipla Ltd. ESOMAC-D Capsules (Esomeprazole magnesium + Domperidone).  Ciplamed. [Revised in April 2020]. [Accessed on 3rd November 2022] https://www.ciplamed.com/content/esomac-d-capsules

7. 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

8. Vibcare Pharma Pvt Ltd. ESOVIB DSR. [Accessed on 3rd November 2022] https://vibcare.co.in/esomeprazole-domperidone-sr/#!/INDICATION