INTRODUCTION ABOUT SOMPRAZ L CAPSULE

SOMPRAZ 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. SOMPRAZ L CAPSULE is indicated for the management 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.    

SOMPRAZ L CAPSULE can also be used to manage 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 management with SOMPRAZ 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 management with SOMPRAZ 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 SOMPRAZ L CAPSULE, inform your doctor if you have any heart, kidney or liver disease as a precaution.  

SOMPRAZ 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.  SOMPRAZ L CAPSULE should be used with caution in elderly patients (aged 65 years or above).

The most common side effects of taking SOMPRAZ L CAPSULE are headache, nausea, vomiting, stomach pain, diarrhea or constipation. Consult your doctor if any of the side effects worsen.

USES OF SOMPRAZ L CAPSULE

• Manage Gastro-esophageal reflux disease (GERD) among patients who do not respond to proton-pump inhibitors (Ex. pantoprazole, rabeprazole, esomeprazole, omeprazole) alone
• Manage peptic ulcer
  

HOW SOMPRAZ L CAPSULE WORKS

SOMPRAZ 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 SOMPRAZ L CAPSULE as advised by your physician. Swallow SOMPRAZ 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 SOMPRAZ L CAPSULE

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 managing 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-manage 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 SOMPRAZ L CAPSULE inform to your doctor, if you are taking any of these medicines:

• medicines used to manage HIV infection (Ex. nelfinavir, atazanavir)
• medicines used to manage fungal infections (Ex. ketoconazole, itraconazole or voriconazole)
• medicines used to manage 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 manage blood clots)
• erlotinib (used to manage cancer)
• phenytoin (used to manage epilepsy)
• medicines used for blood thinning (Ex. warfarin)
• cilostazol (a medicine used to manage intermittent claudication (pain in legs))
• cisapride (used to manage heartburn or indigestion)
• digoxin (used to manage abnormal heart rhythm)
• methotrexate (a medicine used to manage cancer or other auto-immune disease)
• tacrolimus (used to suppress immune function and manage graft rejection)
• rifampicin (used to manage tuberculosis)
• diuretics (used to reduce blood pressure by increasing urine output) Ex. furosemide, hydrochlorothiazide

B. Drug-Food interaction:

SOMPRAZ 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 SOMPRAZ L CAPSULE.

Overdosage:

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

SYNOPSIS

MORE INFORMATION

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