Introduction About PRERABE L CAPSULE

PRERABE L CAPSULE is a combination of Levosulpiride and Rabeprazole which belongs to the group of medicines called Dopamine D2 antagonists and Proton-pump inhibitors respectively. PRERABE L CAPSULE is indicated for the management of Gastro-esophageal reflux disease (GERD). GERD is a chronic digestive disease in which the stomach acid frequently flows into the esophagus leading to irritation and inflammation of lining of food pipe. Symptoms include heartburn, chest pain, nausea, sensation of lump in throat and stomach discomfort.

PRERABE L CAPSULE can also be used to manage peptic ulcer (painful sores in the gut), Zollinger-Ellison syndrome (tumors in pancreas causing the stomach to secrete more acid), functional dyspepsia (recurrent signs and symptoms of indigestion without an obvious cause) and diabetic gastroparesis (delayed gastric emptying caused due to diabetes).

Levosulpiride is a dopamine D2 antagonist that reduces acid reflux by enhancing gastric emptying (propulsion of food from the stomach to the intestines) and bowel movements and rabeprazole is a proton pump inhibitor that inhibits the secretions of stomach acid, thus leading to healing of ulcers and inflammatory lesions in the stomach and in the intestines.

Take PRERABE L CAPSULE preferably on an empty stomach. Avoid consumption of alcohol while taking PRERABE L CAPSULE as it could potentiate the CNS depressive side effects. Patients receiving long-term management (>1 year) with PRERABE L CAPSULE should be kept on regular surveillance, because it can increase the risk of bone fracture (i.e., in the hip, wrist, or spine) which is more predominant in the patients having osteoporosis or taking corticosteroids.

Before taking PRERABE L CAPSULE, inform your doctor if you have any heart, kidney, or liver disease as a precaution. PRERABE L CAPSULE is not recommended for use in pregnant or breastfeeding women and in children (below 18 years. The most common side effects of taking PRERABE L CAPSULE are nausea, vomiting, stomach pain, diarrhea, constipation, infections, cough, sore throat, or fatigue. Consult your doctor if any of these symptoms worsen.

Uses Of PRERABE L CAPSULE

• Manage Gastro-Esophageal Reflux Disease (GERD)
• Manage function dyspepsia
• Manage peptic ulcer
• Manage Zollinger-Ellison syndrome
• Manage diabetic gastroparesis

How PRERABE L CAPSULE Works

PRERABE L CAPSULE reduces stomach ulcers, nausea, and acid reflux, where rabeprazole acts by inhibiting the secretions of stomach acid by blocking the proton pump (H+ K+ ATPase) at the secretory surface of gastric parietal cells and levosulpiride acts by blocking the dopamine D2 receptors in the CTZ (area in medulla oblongata that causes vomiting when stimulated) and in the gut, thus facilitating the movement of food from the stomach into the intestines followed by healing of ulcers or inflammatory lesions in the stomach and in the esophagus.

How to use PRERABE L CAPSULE

Take PRERABE L CAPSULE on an empty stomach or as advised by your physician. Swallow PRERABE L CAPSULE as a whole and 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.

Side Effects Of PRERABE L CAPSULE

How To Manage Side Effects

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.

Diarrhea

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

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.

Headache

Rest and relax. Drink lot 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.

Indigestion

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

Loss Of Appetite

Eat when you are hungry. Try to eat smaller meals more often than usual. Snack only when you're hungry. Try to have a nutritious snack that is rich in calories and protein, such as dried fruit and nuts.

Skin rash Or Itching

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.

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-manage on your own and consult your doctor if the symptom did not improve on its own.

Warning & Precautions

Pregnancy

Contraindicated

PRERABE L CAPSULE is not recommended for use in pregnant women. Consult your doctor before taking PRERABE L CAPSULE.

Breastfeeding

Contraindicated

PRERABE L CAPSULE is strictly not recommended for use in breastfeeding women. Consult your doctor before taking PRERABE L CAPSULE.

Driving and Using Machines

Use with Caution

Do not drive or operate any heavy tools or machines if you experience dizziness, drowsiness, or sleepiness after taking PRERABE L CAPSULE. 

Alcohol

Consult your doctor

Avoid consumption of alcohol while taking PRERABE L CAPSULE, as it could cause CNS depression (characterized by confusion, attention impairment, and anxiety), dizziness and/or drowsiness. Consult your doctor before taking PRERABE L CAPSULE.

Kidney

Use with Caution

PRERABE L CAPSULE should be taken with caution in patients with kidney disease. Consult your doctor before taking PRERABE L CAPSULE.

Liver

Use with Caution

PRERABE L CAPSULE should be taken with caution in patients with a previous history of liver problems. Consult your doctor before taking PRERABE L CAPSULE.

Allergy

Contraindicated

Do not take PRERABE L CAPSULE if you are allergic to Levosulpiride, Rabeprazole, or other proton-pump inhibitors (Ex. pantoprazole, omeprazole, lansoprazole).

Lungs

Use with Caution

PRERABE L CAPSULE should be taken with caution in patients with asthma or other respiratory diseases. Consult your doctor before taking PRERABE L CAPSULE.

Heart Disease

Use with Caution

PRERABE L CAPSULE should be taken with caution in patients with heart disease. Consult your doctor before taking PRERABE L CAPSULE.

Use In Pediatrics

Contraindicated

PRERABE L CAPSULE is not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking PRERABE L CAPSULE.

Use In Geriatrics

Use with Caution

PRERABE L CAPSULE should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking PRERABE L CAPSULE. Proper dose adjustments and careful monitoring are required in such patients.

Interactions

A. Drug-Drug interactions:

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

• medicines used to manage HIV infection (Ex. atazanavir, nelfinavir, saquinavir, rilpivirine)
• antacids (used to neutralize stomach acid secretions) Ex. aluminium hydroxide, magnesium hydroxide
• sucralfate (used to manage duodenal ulcer)
• cisapride (used to manage heart burn in patients with gastroesophageal reflux disease)
• anticholinergics (medicines that causes smooth muscle relaxation and decreases body secretions) Ex. atropine, scopolamine, homatropine
• levodopa (used for Parkinson’s disease)
• medicines causing low levels of potassium in blood such as furosemide (used to manage edema), corticosteroids (used to manage inflammation) Ex. cortisol, laxatives such as bisacodyl (used to manage constipation)
• iron salts (used to manage iron deficiency) Ex. ferrous sulphate, ferric ammonium citrate
• medicines used to manage high blood pressure and other heart problems (Ex. captopril, enalapril, losartan, valsartan, diltiazem, digoxin, quinidine)
• atomoxetine (used to manage attention-deficit hyperactivity disorder)
• terfenadine (used to manage allergic conditions)
• chloroquine (used to manage or manage malaria)
• clarithromycin, or amoxicillin (used to manage bacterial infections)
• medicines used to manage cancer (Ex. erlotinib, dasatinib, nilotinib)
• methotrexate (used to manage cancer and auto-immune disease)
• tacrolimus or mycophenolate mofetil (used to manage graft rejection)
• ketoconazole, itraconazole (used to manage fungal infection)
• warfarin (used for blood thinning and management of heart problems)
• pregabalin (used to manage neuropathic pain)
• tramadol (used to manage pain)
• ipratropium (used to manage symptoms of COPD/asthma)

Overdosage:

If you or anyone else accidentally take too much of PRERABE L CAPSULE, contact your doctor immediately or go to a hospital straight away.  

Synopsis

More Information

• Keep PRERABE L CAPSULE out of reach of children
• Store PRERABE L CAPSULE at room temperature

FAQs About PRERABE L CAPSULE

Q: When and how should I take PRERABE L CAPSULE?

A: Take PRERABE L 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 PRERABE L CAPSULE and duration of therapy for you, depending upon your age, body weight and health condition.

Q: Can PRERABE L CAPSULE be used in children?

A: PRERABE L CAPSULE is not recommended for use in children and adolescents (aged below 18 years). Kindly consult child’s doctor if your child experiences any symptoms of gastro-esophageal reflux disease (such as nausea, discomfort in upper stomach, heartburn, burping, etc.)

Q: Can I consume alcohol while taking PRERABE L CAPSULE?

A: No. Avoid consumption of alcohol while taking PRERABE L CAPSULE, as it could cause CNS depression (characterized by confusion, attention impairment, and anxiety), dizziness and/or drowsiness. Also, if you are a chronic alcoholic or suffering from acute alcohol intoxication, please inform your doctor as a precaution before taking PRERABE L CAPSULE.  

Q: Can I drive while taking PRERABE L CAPSULE?

A: PRERABE L CAPSULE may cause dizziness in some individuals and so avoid driving or operating any tools or machines while you are feeling dizzy. Try to rest and relax. Get enough sleep. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor before taking PRERABE L CAPSULE

Q: Can prolong use of PRERABE L CAPSULE cause bone fractures?

A: Yes. Prolonged use of PRERABE L CAPSULE can increase the risk of bone fracture (particularly in the hips, wrist, or spine), particularly in the elderly patients and in patients with other risk factors such as having osteoporosis or taking corticosteroids. Consult your doctor before taking PRERABE L CAPSULE. During management with PRERABE L CAPSULE your doctor may monitor to rule out the risk of fractures. Do not take PRERABE L CAPSULE for a prolonged period without consulting your doctor.    

Q: What to do If I forget to take PRERABE L CAPSULE?

A: You should take PRERABE L CAPSULE immediately when you remember. If it is time for your next dose of PRERABE L CAPSULE skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.

Q: What are the common side effects of PRERABE L CAPSULE?

A: The most common side effects of taking PRERABE L CAPSULE are nausea, vomiting, stomach pain, diarrhea, constipation, infections, cough, sore throat, or headache. Consult your doctor if any of these symptoms worsen.

References

1.  KD. Tripathi. Drugs for Peptic Ulcer and Gastroesophageal Reflux Disease. Essentials of medical pharmacology. Seventh edition. 2013. Page – 651-654.

2. Gerald G. Briggs and Roger K. Freeman. P. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 3337 & -2775.

3. E. Distrutti, S. Fiorucci, S. K. Hauer, M. O. Pensi, M. Vanasia, A. Morelli. Effect of acute and chronic levosulpiride administration on gastric tone and perception in functional dyspepsia. Alimentary Pharmacology and Therapeutics. September 2002. [Accessed on 28th October 2022] https://onlinelibrary.wiley.com/doi/epdf/10.1046/j.1365-2036.2002.01180.x

4. Ratnani IJ, Panchal BN, Gandhi RR, Vala AU and Mandal K. Role of Levosulpiride in the Management of Functional Dyspepsia. Journal of Family medicine. 2015. [Accessed on 28th October 2022] https://austinpublishinggroup.com/family-medicine/fulltext/jfm-v2-id1034.php

5. R Lozano, MG Peralta Concha, A Montealegre, L de Leon, J Ortiz Villalba, HO Lee Esteban, M Cromeyer, JA Rivas García, A Brossa, G Lluberes, E Izquierdo Sandí and H Burgos Quirós. Effectiveness and safety of levosulpiride in the treatment of dysmotility-like functional dyspepsia. NCBI; PMC US National Library of Medicine, National Institute of Health. March 2007. [Accessed on 28th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1936295/

6. C Mansi, V Savarino, S Vigneri, D Perilli, P Melga, L Sciabà, D De Martini, G S Mela. Gastrokinetic effects of levosulpiride in dyspeptic patients with diabetic gastroparesis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. November 1995. [Accessed on 28th October 2022] https://pubmed.ncbi.nlm.nih.gov/7485007/

7. P W Y Lim, K L Goh. Review article: efficacy and safety of rabeprazole in treating gastroesophageal reflux disease. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. September 2004. [Accessed on 28th October 2022] https://pubmed.ncbi.nlm.nih.gov/15324384/

8. Torrent pharmaceuticals Ltd. Veloz L. Torrentian.com. [Revised in Match 2020]. [Accessed on 28th October 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2425.pdf

9. Cipla Ltd. Rabicip L Capsules (Rabeprazole sodium + Levosulpiride). Ciplamed.com [Revised in January 2020]. [Accessed on 28th October 2022] https://www.ciplamed.com/content/rabicip-l-capsules

10. Accord Healthcare Ltd. Electronic Medicines Compendium (EMC). [Revised in March 2020] [Accessed on 28th October 2022] https://www.medicines.org.uk/emc/files/pil.2843.pdf

11. Eisai R&D Management Co., Ltd. Aciphex. U. S. Food and administration. [Revised in December 2014]. [Accessed on 28th October 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf

12. Akesiss Pharma Pvt Ltd. Rabipot LS. [Accessed on 28th October 2022] https://akesiss.com/divisions/glyvo-life/rabipot-ls/

Useful Diagnostic Tests

• Anti-Saccharomyces Cerevisiae (ASCA), IgA
• Anti-Saccharomyces Cerevisiae (ASCA), IgG
• Complete Blood Count
• Helicobacter Pylori IgA
• Helicobacter Pylori IgG