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INTRODUCTION
SOMIFIZ L CAPSULE is a combination of Esomeprazole and Levosulpiride which belongs to the group of medicines called Proton-pump inhibitors and Dopamine D2 antagonists respectively. SOMIFIZ L CAPSULE is indicated for the treatment of Gastro-esophageal reflux disease (GERD) among patients who do not adequately respond to proton-pump inhibitors alone (Ex. pantoprazole, rabeprazole, esomeprazole, omeprazole).
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.
SOMIFIZ L CAPSULE can also be used to treat peptic ulcer caused by H. pylori infection or NSAID 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 SOMIFIZ L CAPSULE eat less spicy food and drink plenty of water or fluids as advised by your physician. Avoid consumption of alcohol as it could aggravate your existing disease conditions.
Patients receiving long-term treatment with SOMIFIZ L CAPSULE should be kept on regular surveillance to rule out the risk of bone fractures (hip, wrist or spine), predominantly in patients taking corticosteroids and in patients with other recognized risk factors like osteoporosis. Before taking SOMIFIZ L CAPSULE, inform your doctor if you have any heart, kidney or liver disease as a precaution.
SOMIFIZ L CAPSULE is not recommended for use in pregnant or breastfeeding women, including children and adolescents (aged below 18 years) due to lack of safety and effectiveness. SOMIFIZ L CAPSULE should be used with caution in elderly patients (aged 65 years or above).
The most common side effects of taking SOMIFIZ L CAPSULE are headache, nausea, vomiting, stomach pain, diarrhea or constipation. Consult your doctor if any of the side effects worsen.
USES OF SOMIFIZ L CAPSULE
- Treats Gastro-esophageal reflux disease (GERD) among patients who do not respond to proton-pump inhibitors (Ex. pantoprazole, rabeprazole, esomeprazole, omeprazole) alone
- Treats peptic ulcer
HOW SOMIFIZ L CAPSULE WORKS
SOMIFIZ L CAPSULE reduces peptic ulcers 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 gut which promotes the secretions of acetylcholine, thus facilitating gastric emptying and healing of ulcers and/or esophageal lesions.
DIRECTIONS FOR USE
Take SOMIFIZ L CAPSULE as advised by your physician. Swallow SOMIFIZ L 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 SOMIFIZ L CAPSULE
COMMON
- headache
- nausea or vomiting
- diarrhea, stomach pain, constipation, flatulence
- benign polyps in stomach
UNCOMMON
- swollen ankles and feet
- insomnia (lack of sleep)
- dizziness
- pins and needles (tingling sensation in the body)
- sleepiness
- vertigo (spinning sensation)
- dry mouth
- skin rash, lumpy rash (hives) and itching
- fracture of wrist, hip or spine
RARE
- agitation, confusion, depression, aggression
- blurred vision
- changes in taste
- bronchospasm (difficulty in breathing)
- mouth sores
- fungal infection (Ex. thrush)
- hair loss
- skin sensitivity (skin rash following sun exposure)
- joint pain or muscle pains
- tiredness or lack of energy
- increased sweating
- abnormal heart rhythm
Stop taking SOMIFIZ L CAPSULE and contact your doctor immediately if you experience the following side effects:
- signs of severe allergic reactions (such as skin rash, sudden wheezing, swelling of the lips, tongue and throat or body, fainting or difficulty in swallowing)
- signs of severe allergic skin reactions (such as skin redness with severe blisters or peeling, bleeding in the eyes, lips, mouth, nose or genitals associated with a high fever and joint pains)
- signs of liver problems (such as yellowing of the skin, dark urine and tiredness)
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Stick to simple meals. Avoid eating oil rich, fried or spicy food. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom did not improve.
Diarrhoea:
Drink lot 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 forehead 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, 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
PREGNANCY
SOMIFIZ L CAPSULE is not recommended for use in pregnant women. Consult your doctor before taking SOMIFIZ L CAPSULE.
BREASTFEEDING
SOMIFIZ L CAPSULE is not recommended for use in breastfeeding women. Consult your doctor before taking SOMIFIZ L CAPSULE.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines if you experience dizziness, drowsiness or blurred vision after taking SOMIFIZ L CAPSULE.
ALCOHOL
Avoid consumption of alcohol while taking SOMIFIZ L CAPSULE, as it could aggravate your existing disease condition.
KIDNEY
SOMIFIZ L CAPSULE is not recommended for use in patients with severe kidney disease. Consult your doctor before taking SOMIFIZ L CAPSULE.
LIVER
SOMIFIZ L CAPSULE is not recommended for use in patients with severe liver disease. Consult your doctor before taking SOMIFIZ L CAPSULE.
ALLERGY
Do not take SOMIFIZ L CAPSULE if you are allergic to Levosulpiride, Esomeprazole or other proton pump inhibitors (Ex. pantoprazole, rabeprazole, omeprazole).
HEART DISEASE
SOMIFIZ L CAPSULE should be used with caution in patients with prolongation of QTc interval (irregular electrical activity of the heart), stroke and cardiac insufficiency. Consult your doctor before taking SOMIFIZ L CAPSULE.
OTHERS
SOMIFIZ L CAPSULE is not recommended for use if you:
- have parkinson’s disease
- have history of epilepsy
- have porphyria (a rare blood disorder)
- have breast cancer or non-cancerous tumor in breast
- have alcohol intoxication (drinking too much alcohol in short period)
- have certain tumors like phaeochromocytoma (tumor in adrenal glands) or pituitary prolactinoma (tumors of pituitary gland)
- have hypokalemia (low blood potassium levels)
- have bleeding or perforation in the stomach or intestines
- have manic states (abnormally elevated mood)
Before taking SOMIFIZ L CAPSULE, inform your physician if you:
- are due to have a specific blood test (Chromogranin A)
- reduced vitamin B12 levels in body
- osteoporosis
Use in pediatrics:
SOMIFIZ L CAPSULE is not recommended for use in children and adolescents (aged below 18 years) due to lack of safety and effectiveness. Consult your child’s doctor for advice.
Use in geriatrics:
SOMIFIZ L CAPSULE should be used with caution in elderly patients (aged 65 years or above). Consult your doctor before taking SOMIFIZ L CAPSULE.
INTERACTIONS
A. Drug-Drug interactions:
Before taking SOMIFIZ L CAPSULE inform to your doctor, if you are taking any of these medicines:
- medicines used to treat HIV infection (Ex. nelfinavir, atazanavir)
- medicines used to treat fungal infections (Ex. ketoconazole, itraconazole or voriconazole)
- medicines used to treat depression (Ex. citalopram, imipramine, clomipramine, rasagiline, selegiline, phenelzine, or St. John’s wort)
- anticholinergics (used to reduce gastrointestinal movements) such as atropine, biperiden or hyoscine butylbromide
- narcotic analgesics (used to provide pain relief) Ex. morphine, pethidine, fentanyl
- medicines that can make you feel sleepy or drowsy such as sedatives or hypnotics (Ex. phenobarbital) or tranquilizers (Ex. diazepam, clonazepam, lorazepam)
- clopidogrel (an antiplatelet medicine used to prevent blood clots)
- erlotinib (used to treat cancer)
- phenytoin (used to treat epilepsy)
- medicines used for blood thinning (Ex. warfarin)
- cilostazol (a medicine used to treat intermittent claudication (pain in legs))
- cisapride (used to treat heartburn or indigestion)
- digoxin (used to treat abnormal heart rhythm)
- methotrexate (a medicine used to treat cancer or other auto-immune disease)
- tacrolimus (used to suppress immune function and prevent graft rejection)
- rifampicin (used to treat tuberculosis)
- diuretics (used to reduce blood pressure by increasing urine output) Ex. furosemide, hydrochlorothiazide
B. Drug-Food interaction:
SOMIFIZ L CAPSULE can be taken with food or on an empty stomach. Try to take this medicine at least one hour before meals to maximize the efficacy. However, consult your doctor before taking SOMIFIZ L CAPSULE.
Overdosage:
If you or anyone else accidentally take too much of SOMIFIZ L CAPSULE, contact your doctor immediately or go to a hospital straight away.
SYNOPSIS
| Drug | : | Esomeprazole, Levosulpiride |
| Pharmacological Category | : | Proton pump inhibitors, Dopamine D2 antagonists |
| Therapeutic Indication | : | Gastro-esophageal reflux disease (GERD), Peptic ulcer |
| Dosage Forms | : | Tablet, Capsule |
MORE INFORMATION
- Keep SOMIFIZ L CAPSULE out of reach of children
- Store at room temperature
FAQs ABOUT SOMIFIZ L CAPSULE
Can SOMIFIZ L CAPSULE be used in children?
SOMIFIZ L CAPSULE is generally not recommended for use in children and adolescents (aged below 18 years) due to lack of safety and effectiveness. Kindly consult your child’s doctor for advice.
Can SOMIFIZ L CAPSULE be used during pregnancy?
No, SOMIFIZ L CAPSULE is generally not recommended for use in pregnant women. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking SOMIFIZ L CAPSULE.
Can SOMIFIZ L CAPSULE cause depression?
Yes, SOMIFIZ L CAPSULE can rarely cause depression in some individuals. If you experience any signs of depression such as feeling extremely sad, solitary attitude, lack of social connectivity, please contact your doctor immediately.
Can SOMIFIZ L CAPSULE be taken for long term?
SOMIFIZ L CAPSULE can be taken as a long-term therapy for gastrointestinal disorders. However, consult your doctor before taking SOMIFIZ L CAPSULE. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and health condition. Do not stop taking SOMIFIZ L CAPSULE abruptly or take for a longer period than prescribed without consulting your doctor.
Can SOMIFIZ L CAPSULE cause black stools?
Yes, SOMIFIZ L CAPSULE can rarely cause black stools or blood-stained stools in some individuals. If you experience black stools or blood-stained stools with or without stomach pain or indigestion, stop taking SOMIFIZ L CAPSULE and consult your doctor immediately.
Is SOMIFIZ L CAPSULE safe to use in patients with heart problems?
SOMIFIZ L CAPSULE should be used with caution in patients with prolongation of QTc interval (irregular electrical activity of the heart), stroke and cardiac insufficiency. Consult your doctor before taking SOMIFIZ L CAPSULE.
REFERENCES
1. KD. Tripathi. Drugs for Peptic Ulcer and Gastroesophageal Reflux Disease. Essentials of medical pharmacology. Seventh edition. 2013. Page – 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. E. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 1427 & -2775.
4. Evangelos Kalaitzakis and Einar Bjornsson. A review of esomeprazole in the treatment of gastroesophageal reflux disease (GERD). NCBI; PMC US National Library of Medicine, National Institute of Health. August 2007. [Accessed on 29th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2374928/
5. Caroline M den Hoed, Ernst J Kuipers. Esomeprazole for the treatment of peptic ulcer bleeding. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. December 2010. [Accessed on 29th October 2022] https://pubmed.ncbi.nlm.nih.gov/21108587/
6. Syed Ibrahim Hassan, Syed Mohd Akbar Hassan. Comparison of Safety and Efficacy of Levosulpiride and Itopride in Treatment of Gastroesophageal Reflux Disease. Journal of Evidence based medicine and healthcare. January 2017. [Accessed on 29th October 2022] https://jebmh.com/latest_articles/95552
7. 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 Sandi and H Burgos Quiros. 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 29th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1936295/
8. Chi-Wook Song, Hoon-Jae Chun, Chang-Duck Kim, Ho-Sang Ryu, Jae-Gol Choe, and Jin-Hai Hyun. Effects of Levosulpiride in Patients with Functional Dyspepsia Accompanied by Delayed Gastric Emptying. NCBI; PMC US National Library of Medicine, National Institute of Health. February 1998. [Accessed on 29th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4531935/
9. Torrent Pharmaceuticals Ltd. Nexpro L Esomeprazole DR and Levosulpiride ER Capsules. Torrentian.com. [Revised in June 2020]. [Accessed on 29th October 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2500.pdf
10. Cipla Ltd. Esomac-L Capsules (Esomeprazole magnesium + Levosulpiride). Ciplamed.com. [Revised in July 2020]. [Accessed on 29th October 2022] https://www.ciplamed.com/content/esomac-l-capsules
11. Soigner Pharma. Esomeprazole & Levosulpiride Capsules. [Accessed on 29th October 2022] https://www.soignerpharma.com/product/esperam-ls/
12. Alniche Life Science Pvt Ltd. Gastroenterology. [Accessed on 29th October 2022] https://www.alniche.com/product/esobiz-dsr-l/
13. Steris Healthcare Pvt Ltd. Esomeprazole+ Levosulpiride. [Accessed on 29th October 2022] https://www.sterisindia.com/latest-update/esomeprazole-levosu/1111
14. Aelida Healthcare. Esomeprazole 40 Mg +levosulpiride 75 Mg Sustain Release Caps. [Accessed on 29th October 2022] http://www.aelidahealthcare.in/esomeprazole-40-mg-levosulpiride-75-mg-sustain-release-caps-6423328.html
15. Mits Healthcare Private Limited. Esomeprazole sodium and levosulpiride capsule. [Accessed on 29th October 2022] https://www.mitshealthcare.in/product/esomeprazole-sodium-and-levosulpiride-capsule-manufacturers-and-suppliers
16. Vibcare Pharma Pvt. Ltd. Esovib L. [Accessed on 29th October 2022] https://vibcare.co.in/esomeprazole-levosulpiride/#!/INDICATION
USEFUL DIAGNOSTIC TESTS
- Helicobacter Pylori IgA
- Helicobacter Pylori IgG
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