OCAFIB 10MG TABLET

Introduction:

Ocafib 10mg Tablet contains Obeticholic acid. It is used to treat primary biliary cholangitis (also known as primary biliary cirrhosis). Primary biliary cholangitis is a chronic disorder in which the bile ducts in your liver are 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. This medicine is used alone or together with another medicine, ursodeoxycholic acid.

Ocafib 10mg Tablet is not recommended for children, adolescents, patients with complete blockage of bile ducts in the gall bladder or liver. You need to tell your doctor if you are pregnant, planning to get pregnant, breastfeeding, taking medicines to lower blood cholesterol levels, or if you experience itching that is difficult to tolerate before taking this medicine.

Uses of Ocafib 10mg Tablet:

• Primary biliary cholangitis

How Ocafib 10mg Tablet works:

Ocafib 10mg Tablet binds to farnesoid X-receptor in the liver and intestinal cells, reduces the production and buildup of bile in the liver and also reduces inflammation.

Interactions with other drugs:

Inform your doctor about any medications you are taking or have taken before the treatment.

More information:

• Keep Ocafib 10mg Tablet out of sight and reach of children.
• Store at room temperature between 20°C to 25°C.

References:

1. Intercept Pharm Ltd, Electronic medicines compendium (emc), [ Revised on March 2018] [ Accessed on 6th July 2021], https://www.medicines.org.uk/emc/files/pil.2561.pdf
2. Intercept Pharmaceuticals, Inc, US Food and Drug Administration, [ Revised on Jan 2018] [ Accessed on 6th July 2021], https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf
3. Vigan Manne et al; Obeticholic acid in primary biliary cholangitis: where we stand; Current Opinion in Gastroenterology; Published on May 2019; Accessed on 06/07/2021; https://pubmed.ncbi.nlm.nih.gov/30844895/

How to use Ocafib 10mg Tablet:

Always take Ocafib 10mg Tablet exactly as your doctor has told you. You can take these tablets with or without food. Do not crush or chew the tablets. Do not stop taking medicine without talking to your physician first.

Safety advice:

Pregnancy:

Tell your doctor if you are pregnant or planning to get pregnant before taking Ocafib 10mg Tablet. It will be given to you if clearly needed.

Breastfeeding:

Inform your doctor if you are breastfeeding before taking Ocafib 10mg Tablet. 

Liver:

You need to tell your physician if you have any other liver disorders before taking Ocafib 10mg Tablet. Your doctor will perform blood tests to monitor the health of your liver. 

Others:

• Inform your doctor if you experience itching that is difficult to tolerate before taking Ocafib 10mg Tablet.
• Inform your doctor if you have a complete blockage of bile ducts in your gall bladder or liver.

Side effects are unwanted symptoms caused by medicines. Even though all medicines cause side effects, not everyone gets them.

Serious:

• Worsening of liver problems (yellowing of skin or white of the eyes, black, tarry or bloody stools, coughing up or vomiting blood, confusion, mood swings, slurred speech)
• Severe itching
• Lower HDL-C (good cholesterol)

Common:

• Tiredness
• Stomach pain, discomfort, constipation
• Joint pain, mouth, and throat pain
• Dizziness
• Fast or irregular heartbeat
• Fever
• Dryness, irritation, or redness of the skin
• Rash
• Swelling of ankles, hands, or feet
• Thyroid hormone irregularity