OCABILE 10 Tablet 10's
Key Information
Generic Name
Generic Name Obeticholic Acid 10 mg
Manufacturer
Torrent Pharmaceuticals Ltd
Variant
10 Tablet(s) in a Strip
Country of Origin
India
Detailed Information
Introduction
INTRODUCTIONOCABILE 10 contains Obeticholic acid which belongs to the group of medicines called Farnesoid X receptor agonists. It is used to manage primary biliary cholangitis (also known as primary biliary cirrhosis) in adults, either by itself or together with other medicine (called ursodeoxycholic acid). Primary biliary cholangitis is a chronic disorder in which the bile ducts in your liver are slowly destroyed. When these ducts are destroyed, bile (fluid that aids in digestion and absorption of vitamins) builds up in the liver leading to inflammation and scarring. It is also known as primary biliary cirrhosis. OCABILE 10 is not recommended for use in pregnant women and consult your doctor before taking OCABILE 10 if you are breast-feeding women. OCABILE 10 is not recommended for use in children and adolescents (under 18 years of age) and should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking OCABILE 10. Prior to management with OCABILE 10 your doctor may advice you to take blood test to understand your existing condition like liver function. The most common
Uses
OF OCABILE 10 Manages primary biliary cholangitis in adults
How It Works
OCABILE 10 works by reducing the production and build-up of bile in the liver and also reduces the inflammation of the liver. Therefore, as a result it helps to improve liver function.
Directions for Use
Take OCABILE 10 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 for you depending upon your age, body weight and disease condition.
Side Effects
taking OCABILE 10 are stomach pain, tiredness, dizziness, constipation, dry skin and fast or irregular heartbeat. Consult your doctor if any of the symptom worsens. USES OF OCABILE 10 Manages primary biliary cholangitis in adults HOW OCABILE 10 WORKSOCABILE 10 works by reducing the production and build-up of bile in the liver and also reduces the inflammation of the liver. Therefore, as a result it helps to improve liver function. DIRECTIONS FOR USETake OCABILE 10 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 for you depending upon your age, body weight and disease condition. SIDE EFFECTS OF OCABILE 10COMMON stomach pain feeling tired itching of skin thyroid hormone irregularity dizziness fast or irregular heartbeat (palpitations) pain in the mouth and throat constipation dry skin dryness, irritation, redness, crusting or drainage of the skin (eczema) rash pain in joints swelling in the hands and feet fever RAREStop taking OCABILE 10 and contact your physician immediately if you experience any of the following side effects: severe itching (pruritus) worsening of liver problems (symptoms include swelling of stomach-area due to fluid build-up, yellowing of your skin or white of the eyes, black, tarry, or bloody stools, coughing up or vomiting blood, or your vomit looks like coffee grounds, mental changes such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality) severe symptoms such as stomach-area pain, nausea, vomiting, diarrhoea, loss of appetite or weight loss, new or worsening fatigue, weakness, fever, and chills, light-headedness, less frequent urination
Warnings & Precautions
& PRECAUTIONSPREGNANCYOCABILE 10 is not recommended for use in pregnant women. Consult your doctor before taking OCABILE 10. BREASTFEEDINGIt is not known whether OCABILE 10 passes through breast milk. Consult your doctor before taking OCABILE 10. DRIVING AND USING MACHINESOCABILE 10 has no or negligible influence on your ability to drive or use machines. LIVEROCABILE 10 is not recommended for use in patients with complete blockage of the biliary tract (liver, gall bladder and bile ducts). Consult your doctor before taking OCABILE 10. ALLERGYDo not take OCABILE 10 if you are allergic to Obeticholic acid or any of the other ingredients of this medicine. OTHERSBefore taking OCABILE 10 inform your doctor if you: have itching that is difficult to tolerate Use in paediatrics: OCABILE 10 is not recommended for use in children and adolescents. Consult child’s doctor for advice. Use in geriatrics: OCABILE 10 should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking OCABILE 10.
Drug Interactions
SA. Drug-Drug interactions: Before taking OCABILE 10, inform your doctor if you are taking any of the following medicines: bile acid binding resins such as cholestyramine, colestipol, colesevelam (used to lower blood cholesterol levels) theophylline (used to prevent and manage wheezing) tizanidine (used to relieve the stiffness and restriction of muscles) warfarin (used to prevent and manage blood clots) Overdosage: If you or anyone else accidentally take too much of OCABILE 10, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage include yellowing of the skin. SYNOPSIS Drug : Obeticholic acid Pharmacological Category : Farnesoid X-receptor agonist Therapeutic Indication : Primary Biliary Cholangitis Dosage Forms : Tablet MORE INFORMATION Keep OCABILE 10 out of reach of children Store at room temperature