URSODEOXYCHOLIC ACID 150MG

Introduction

CAPSULES (Ursodeoxycholic Acid) Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Ursodeoxycholic Acid is and what it is used for 2. Before you take Ursodeoxycholic Acid 3. How to take Ursodeoxycholic Acid 4. Possible side effects 5. How to store Ursodeoxycholic Acid 6. Further information 1. What Ursodeoxycholic Acid is and what it is used for Ursodeoxycholic Acid is a bile acid. It is used to treat certain liver diseases, such as primary biliary cirrhosis, primary sclerosing cholangitis and gallstones. It works by reducing the amount of cholesterol in the bile, which helps to dissolve the gallstones. 2. Before you take Ursodeoxycholic Acid Do not take Ursodeoxycholic Acid if you: • are allergic to ursodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6) • have a blockage in the bile ducts • have severe liver disease • are pregnant or breast-feeding. Take special care with Ursodeoxycholic Acid: • Tell your doctor if you have any other medical conditions, especially if you have any problems with your kidneys. • Tell your doctor if you are taking any other medicines, including medicines obtained without a prescription. • If you are pregnant or breast-feeding, tell your doctor before taking this medicine. • If you are taking any other medicines, tell your doctor before taking this medicine. Taking other medicines with Ursodeoxycholic Acid: • Ursodeoxycholic Acid may interact with other medicines, so it is important to tell your doctor or pharmacist if you are taking any other medicines, including medicines obtained without a prescription. • Do not take any other medicines while taking Ursodeoxycholic Acid without first consulting your doctor or pharmacist. 3. How to take Ursodeoxycholic Acid Always take Ursodeoxycholic Acid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one capsule taken twice a day. Swallow the capsule whole with a glass of water. Do not chew or crush the capsule. Do not take more than the recommended dose. If you take more than the recommended dose, contact your doctor or nearest hospital casualty department immediately. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Ursodeoxycholic Acid can cause side effects, although not everybody gets them. The following side effects may occur: • nausea • vomiting • abdominal pain • diarrhoea • constipation • flatulence • headache • rash • itching • dizziness • fatigue • joint pain • muscle pain • fever • increased liver enzymes. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Ursodeoxycholic Acid Keep out of the reach and sight of children. Do not use Ursodeoxycholic Acid after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6. Further information What Ursodeoxycholic Acid contains The active substance is ursodeoxycholic acid. Each capsule contains 150mg of ursodeoxycholic acid. The other ingredients are: lactose monohydrate, maize starch, povidone, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172). What Ursodeoxycholic Acid looks like and contents of the pack Ursodeoxycholic Acid 150mg Capsules are yellow, hard gelatin capsules with a white body and a yellow cap. They are available in packs of 30, 60 and 100 capsules. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is: Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland The Manufacturer is: Actavis Ltd. Blanchardstown Dublin 15 Ireland This leaflet was last revised in: October 2016.

Ursodeoxycholic acid (UDCA) is a medication used to treat certain liver diseases. It is used to treat primary biliary cirrhosis, primary sclerosing cholangitis, and other cholestatic liver diseases. It is taken by mouth. Common side effects include abdominal pain, diarrhea, and nausea. Serious side effects may include gallstones and liver failure. Use during pregnancy is generally safe. It is a bile acid.

UDCA is available as a 150 mg tablet. It is typically taken two to four times a day. The dose may be increased up to 13 to 15 mg/kg/day.

Directions for Use

TABLETS Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Ursodeoxycholic Acid 150mg Tablets are and what they are used for 2. Before you take Ursodeoxycholic Acid 150mg Tablets 3. How to take Ursodeoxycholic Acid 150mg Tablets 4. Possible side effects 5. How to store Ursodeoxycholic Acid 150mg Tablets 6. Further information 1. WHAT URSODEOXYCHOLIC ACID 150MG TABLETS ARE AND WHAT THEY ARE USED FOR Ursodeoxycholic Acid 150mg Tablets are used to treat certain liver diseases. Ursodeoxycholic Acid 150mg Tablets contain ursodeoxycholic acid, which is a naturally occurring bile acid. Ursodeoxycholic acid helps to reduce the amount of cholesterol in the bile, which helps to reduce the risk of gallstones. 2. BEFORE YOU TAKE URSODEOXYCHOLIC ACID 150MG TABLETS Do not take Ursodeoxycholic Acid 150mg Tablets if you: • are allergic to ursodeoxycholic acid or any of the other ingredients of Ursodeoxycholic Acid 150mg Tablets (listed in section 6) • have a blockage in your bile ducts • have a severe liver disease • are pregnant or breast-feeding. Take special care with Ursodeoxycholic Acid 150mg Tablets if you: • have a history of gallstones • have a history of liver disease • have a history of kidney disease • are taking any other medicines. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: • antacids (medicines used to treat indigestion) • cholestyramine (a medicine used to lower cholesterol levels) • colestyramine (a medicine used to treat diarrhoea) • colestipol (a medicine used to treat high cholesterol levels) • ciclosporin (a medicine used to suppress the immune system) • warfarin (a medicine used to thin the blood). Pregnancy and breast-feeding Do not take Ursodeoxycholic Acid 150mg Tablets if you are pregnant or breast-feeding. Driving and using machines Ursodeoxycholic Acid 150mg Tablets are not known to affect your ability to drive or use machines. 3. HOW TO TAKE URSODEOXYCHOLIC ACID 150MG TABLETS Always take Ursodeoxycholic Acid 150mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one tablet taken three times a day. Swallow the tablets whole with a glass of water. Do not chew the tablets. If you take more Ursodeoxycholic Acid 150mg Tablets than you should If you take more Ursodeoxycholic Acid 150mg Tablets than you should, tell your doctor or go to the nearest hospital casualty department straight away. Take the medicine pack with you. If you forget to take Ursodeoxycholic Acid 150mg Tablets If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take the next dose when it is due. Do not take a double dose to make up for a forgotten dose. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ursodeoxycholic Acid 150mg Tablets can cause side effects, although not everybody gets them. Stop taking Ursodeoxycholic Acid 150mg Tablets and tell your doctor immediately if you experience any of the following serious side effects: • an allergic reaction (swelling of the face, lips, tongue or throat, difficulty in breathing, skin rash or itching) • severe abdominal pain • yellowing of the skin or eyes (jaundice). Other side effects include: • diarrhoea • nausea • vomiting • abdominal pain • headache • rash • itching • dizziness • fatigue • joint pain • muscle pain • difficulty sleeping • depression • anxiety • confusion • changes in liver function tests. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE URSODEOXYCHOLIC ACID 150MG TABLETS Keep out of the reach and sight of children. Do not use Ursodeoxycholic Acid 150mg Tablets after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store below 25°C in a dry place. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment. 6. FURTHER INFORMATION What Ursodeoxycholic Acid 150mg Tablets contain The active substance is ursodeoxycholic acid. Each tablet contains 150mg of ursodeoxycholic acid. The other ingredients are lactose monohydrate, maize starch, povidone, magnesium stearate and colloidal anhydrous silica. What Ursodeoxycholic Acid 150mg Tablets look like and contents of the pack Ursodeoxycholic Acid 150mg Tablets are white, round, biconvex tablets, marked with ‘U150’ on one side. Ursodeoxycholic Acid 150mg Tablets are available in packs of 28, 56, 84, 98, 100, 112, 120, 140, 168, 200, 250, 500 and 1000 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK. The Manufacturer is Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland. This leaflet was last revised in April 2017.

Storage

Ursodeoxycholic acid 150mg should be stored at room temperature, between 15-30°C (59-86°F). It should be kept away from light, moisture, and heat.

Treatment

Urso-150 (ursodeoxycholic acid 150mg) is a prescription medication used to treat certain liver and gallbladder conditions. It works by decreasing the amount of cholesterol produced by the liver and increasing the amount of bile acids in the gallbladder. It is usually taken once or twice daily with food. Common side effects include nausea, vomiting, diarrhea, and abdominal pain.

Benefits

Ursodeoxycholic acid (UDCA) is a naturally occurring bile acid that is used to treat a variety of conditions. It is most commonly used to treat gallstones, but it can also be used to treat primary biliary cirrhosis, primary sclerosing cholangitis, and other liver diseases. UDCA works by reducing the amount of cholesterol in bile, which helps to dissolve gallstones and reduce inflammation in the liver. UDCA also helps to reduce the risk of developing gallstones in the future. Additionally, UDCA has been shown to have antioxidant and anti-inflammatory properties, which may help to protect the liver from further damage. UDCA is generally well tolerated and has few side effects.

Side Effects

Common side effects of ursodeoxycholic acid 150mg include:

1. Nausea
2. Diarrhea
3. Abdominal pain
4. Constipation
5. Headache
6. Dizziness
7. Fatigue
8. Rash
9. Itching
10. Joint pain
11. Muscle pain
12. Increased liver enzymes

Precautions and Warnings

• Before taking ursodeoxycholic acid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

• Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, gallstones, bile duct blockage, certain metabolic disorders (e.g., Dubin-Johnson syndrome, Rotor syndrome).

• This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

• It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

• Do not take more than the recommended dose or use for longer than prescribed without checking with your doctor.

• Avoid drinking alcohol while taking ursodeoxycholic acid.

• This medication may cause dizziness. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

• Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

• If you have any questions about the use of this medication, ask your doctor or pharmacist.

How Does It Work?

Ursodeoxycholic acid (UDCA) is a bile acid that is naturally produced by the liver. It is used to treat certain liver and gallbladder disorders, such as primary biliary cirrhosis, primary sclerosing cholangitis, and gallstones. UDCA works by reducing the amount of cholesterol produced by the liver and increasing the amount of bile acids that are released into the intestines. This helps to reduce the risk of gallstones and other complications associated with these conditions. UDCA is available in capsule and tablet form and is usually taken once or twice a day.

Q: Can I take during pregnancy?

It is not recommended to take ursodeoxycholic acid during pregnancy. This medication has not been studied in pregnant women and its safety has not been established. It is best to consult with your doctor before taking any medication during pregnancy.

Can I take while breastfeeding?

It is not recommended to take Ursodeoxycholic Acid while breastfeeding. You should consult your doctor before taking any medication while breastfeeding.

Can I consume alcohol with?

No, you should not consume alcohol while taking URSODEOXYCHOLIC ACID 150MG. Alcohol can increase the risk of side effects such as stomach upset, nausea, vomiting, and headache. It can also increase the risk of liver damage.

Can I drive if I have consumed?

No, you should not drive if you have consumed URSODEOXYCHOLIC ACID 150MG. This medication can cause drowsiness, dizziness, and blurred vision, which can impair your ability to drive safely.

(FAQs)

Q: What is ursodeoxycholic acid 150mg?
A: Ursodeoxycholic acid 150mg is a medication used to treat certain liver and gallbladder disorders. It works by decreasing the production of cholesterol in the body and helps to dissolve gallstones. It is available in tablet form and is taken orally.