INTRODUCTION

RABIPRAZ D CAPSULE is a combination of Domperidone and Rabeprazole which belongs to the group of medicines called Dopamine Antagonists and Proton pump inhibitors respectively. RABIPRAZ D CAPSULE is used to treat Gastro-Esophageal Reflux Disease (GERD) among patients who have not responded adequately to rabeprazole alone.

GERD is a chronic digestive disease in which the stomach acid 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.

RABIPRAZ D CAPSULE can also be used to treat peptic ulcers caused by H. pylori infection or NSAIDs use. Peptic ulcers are painful sores that develop on the linings of the stomach, esophagus or intestines. Symptoms include stomach pain, flatulence, indigestion, vomiting and fatigue.

Along treatment with RABIPRAZ D CAPSULE, try to eat less spicy foods and drink plenty of water or fluids. Avoid smoking or alcohol consumption as it may aggravate your existing condition.

Patients receiving long-term treatment with RABIPRAZ D CAPSULE should be kept on regular surveillance to rule out the risk of hypomagnesaemia (decreased magnesium levels in blood) and bone fracture, predominantly in the elderly patients and in patients with other recognized risk factors. Before taking RABIPRAZ D CAPSULE inform your doctor if you have any liver, kidney or heart problems. Your doctor may reduce the dose or suggest an alternative therapy.

RABIPRAZ D CAPSULE is not recommended for use in pregnant or breastfeeding women and in children (aged less than 18 years). It should be used with caution in elderly patients (above 65 years of age).

The most common side effects of taking RABIPRAZ D CAPSULE are nausea, vomiting, stomach pain, diarrhea or constipation. Consult your doctor if any of these symptoms worsen.

USES OF RABIPRAZ D CAPSULE

• Treats peptic ulcer
• Treats Gastro-Esophageal Reflux Disease (GERD) (not responding to therapy with rabeprazole alone)

HOW RABIPRAZ D CAPSULE WORKS

RABIPRAZ D CAPSULE reduces stomach ulcers and acid reflux, where rabeprazole acts by inhibiting the secretions of stomach acid and domperidone acts by increasing bowel movements and facilitating gastric emptying, thus leading to rapid symptom relief and healing of stomach ulcers and esophageal lesions.

DIRECTIONS FOR USE

Take RABIPRAZ D CAPSULE as advised by your physician. Swallow RABIPRAZ D CAPSULE with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF RABIPRAZ D CAPSULE

HOW TO MANAGE SIDE EFFECTS

Diarrhea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom did not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.

Flatulence:

Eat smaller and frequent meals. Eat and drink slowly and exercise regularly. Consult your doctor if the symptom did not improve.

Constipation:

Eat fiber rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Try to exercise more regularly. Consult your doctor if the symptom did not improve on its own.

Stomach pain:

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking RABIPRAZ D CAPSULE inform to your doctor, if you are taking any of these medicines:

• other medicines used to treat gastrointestinal problems (Ex. cisapride, dolasetron, prucalopride, diphemanil)
• medicines used to treat heart problems or hypertension (Ex. digoxin, apomorphine, disopyramide, hydroquinidine, quinidine, amiodarone, dofetilide, dronedarone, ibutilide, sotalol, diltiazem or verapamil)
• medicines used to treat HIV infection (Ex. atazanavir, nelfinavir, saquinavir)
• medicines used to treat hepatitis C (Ex. telaprevir)
• antipsychotics (used to treat mental illness) Ex. haloperidol, pimozide, sertindole
• antidepressants (used to treat depression) Ex. escitalopram or citalopram
• 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)
• bepridil (used to treat hypertension)
• methadone (used to relieve pain)
• iron salts (used to treat iron deficiency anemia)
• tacrolimus or mycophenolate mofetil (used to prevent graft rejection)
• ketoconazole and itraconazole (used to treat fungal infection)
• pentamidine (used to treat parasite infections)
• warfarin (used to treat and prevent clots)

Overdosage:

If you or anyone else take too much of RABIPRAZ D CAPSULE, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of RABIPRAZ D CAPSULE might include altered consciousness, agitation, convulsions, disorientation, sleepiness and extrapyramidal reactions (such as rigidity, tremor, drooling etc.).

SYNOPSIS

MORE INFORMATION

• Keep RABIPRAZ D CAPSULE out of reach of children
• Store RABIPRAZ D CAPSULE at room temperature

FAQs ABOUT RABIPRAZ D CAPSULE

Can RABIPRAZ D CAPSULE cause diarrhea?

Yes. RABIPRAZ D CAPSULE can cause diarrhea in some individuals. Keep yourself hydrated by drinking plenty of fluids, oral electrolytes and juices. Do not self-treat diarrhea if it persists for a longer period. Contact your doctor for advice.

Can RABIPRAZ D CAPSULE cause acid reflux?

No. RABIPRAZ D CAPSULE is used to treat Gastro-Esophageal Reflux Disease (GERD) and does not cause acid reflux. If you experience any unusual symptoms after taking RABIPRAZ D CAPSULE, kindly consult your doctor.

Can RABIPRAZ D CAPSULE cause kidney damage?

RABIPRAZ D CAPSULE may rarely cause damage to your kidneys (Ex. interstitial nephritis). However, inform your doctor immediately if you experience any signs of kidney damage such as dark urine, blood in urine, painful urination or lower abdominal discomfort during treatment with RABIPRAZ D CAPSULE. Your doctor might reduce the dose or suggest an alternative therapy.

When and how should I take RABIPRAZ D CAPSULE?

Take RABIPRAZ D CAPSULE on an empty stomach or as advised by your physician. Swallow the medicine as a whole and do not crush or chew the medicine. Your doctor will decide the correct dose of RABIPRAZ D CAPSULE and duration of therapy for you, depending upon your age, body weight and health condition.

Can RABIPRAZ D CAPSULE be used in children?

No. RABIPRAZ D CAPSULE is not recommended for use in children and adolescents (below 18 years) due to lack of safety and effectiveness. Kindly consult child’s doctor if your child experiences any symptoms of gastro-esophageal reflux disease or peptic ulcer (such as nausea, vomiting, discomfort in upper stomach, stomach pain, heartburn, burping, etc.).

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 & 1317-1320

3. Gerald G. Briggs and Roger K. Freeman. D. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 1232 & -3337

4. Janssen Research & Development, LLC. A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in Newborn Infants with Gastroesophageal Reflux Disease (GERD). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in April 2013] [Accessed on 1st October 2021] https://clinicaltrials.gov/ct2/show/NCT00855361

5. Savita Shahani, Prabha Sawant, Pareen Dabholkar. Rabeprazole plus domperidone: the answer for gastro-esophageal reflux disease. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. April 2008. [Accessed on 1st October 2021] https://pubmed.ncbi.nlm.nih.gov/18828350/

6. K Semmanaselvan, Qayum I Mukaddam, Manoj Naik. An Open Label, Prospective, Single Centre Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Rabeprazole (Enteric-Coated, EC) 20 mg + Domperidone (Sustained Release, SR) 30 mg Capsule in Treatment of Patients with Laryngopharyngeal Reflux Disease. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. July 2015. [Accessed on 1st October 2021] https://pubmed.ncbi.nlm.nih.gov/26731824/

7. Cipla Ltd. Rabicip D Capsules (Rabeprazole sodium + Domperidone). Ciplamed.com. [Revised in January 2020] [Accessed on 1st October 2021] https://www.ciplamed.com/content/rabicip-d-capsules