Indications 

Actigall is a prescription medicine utilized to dissolve gallstones for individuals who either decline or are not eligible for gallstone surgery. It is also used to prevent gallstone formation in overweight individuals experiencing rapid weight loss.  

Actigall is also indicated for treating primary biliary cholangitis (PBC), an autoimmune disorder characterized by progressive destruction of the liver’s bile ducts. 

Actigall belongs to the class of medications known as gallstone dissolution agents. Its mechanism of action involves reducing cholesterol production, dissolving the cholesterol in bile to prevent stone formation, and lowering toxic levels of accumulated bile acids in primary biliary cholangitis. 

Uses and Dosage 

Before taking Actigall and each time you refill your prescription, carefully read its medication guide and patient information leaflet. Do not hesitate to seek advice from your physician or pharmacist for any questions or concerns. 

Actigall dose may vary per individual based on their medical condition, weight, and response to the treatment.  

Typically, Actigall is taken two to three times a day, with or without food, for treating gallstones and two times a day to prevent gallstones in individuals experiencing rapid weight loss.  

Tablets for primary biliary cholangitis are usually taken two to four times a day with food. To achieve the appropriate dosage, splitting the tablet in half may be necessary. 

To cut the Actigall tablet: 

1. Place the tablet on a flat surface with the scored section on top  
2. Hold the tablet near the score mark with your thumbs and snap it gently into two parts 
3. Swallow the half tablet with water without chewing it 
4. Store the remaining half tablet separately from the whole tablets due to its strong bitter taste 
5. Use the stored half tablet within 28 days 

Take Actigall at the same time every day as prescribed, without increasing or decreasing the dosage or frequency of administration.  

Do not discontinue intake of Actigall without consulting your doctor, even if you feel well. 

Medical examinations, including gallbladder ultrasound scans and blood tests, may be necessary to evaluate liver function. Liver function tests may also be required every six months following the discontinuation of Actigall. 

Side Effects 

Listed below are the possible side effects of Actigall. If any of them last or worsen, tell your doctor right away. 

Common Side Effects 

• Upset stomach 
• Nausea 
• Vomiting 
• Diarrhea 
• Constipation 
• Cough 
• Sore throat 
• Painful urination 
• Hair loss 
• Back pain 

Serious Side Effects 

• Pain or burning during urination 
• Signs of liver problems:  
  • Nausea 
  • Upper stomach pain 
  • Itching 
  • Tiredness 
  • Loss of appetite 
  • Dark urine 
  • Clay-colored stools 
  • Jaundice (yellowing of the skin or eyes) 
• Signs of a new infection:  
  • Sudden weakness or illness 
  • Fever 
  • Chills 
  • Sore throat 
  • Mouth sores 
  • Skin sores 
  • Difficulty swallowing 

Call your doctor immediately if you experience any of the severe symptoms mentioned above. 

Allergic Reactions 

Actigall rarely causes severe allergic reactions; however, seek prompt medical assistance if you observe signs of a serious allergic reaction, such as: 

• Rash 
• Face, tongue, or throat swelling or itching 
• Severe dizziness 
• Breathing difficulties 

The adverse effects of Actigall listed here are not comprehensive. Tell your doctor promptly if you experience any other effects not included above. 

Cautions 

Before starting treatment with Actigall, inform your doctor or pharmacist if you have any known allergies, especially to: 

• Ursodiol 
• Other bile acids 
• Any medications 
• Any ingredients present in Actigall tablets and capsules 

To ensure Actigall is safe for you, disclose to your physician your medical background, specifically regarding any history of: 

• Gallbladder/bile duct issues (e.g., acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, biliary-gastrointestinal fistula) 
• Liver disease (e.g., ascites, variceal bleeding, hepatic encephalopathy). 

Many drugs may interact with Actigall. Tell your healthcare provider about all medications you are currently taking, including prescription and over-the-counter medicines, vitamins, and herbal products, to lower the risk of drug interactions. 

Some of the products that may interact with Actigall include: 

• Aaluminum-containing antacids 
• Birth control pills 
• Cholesterol medications such as: 
  • Cholestyramine 
  • Clofibrate 
  • Colestipol 
• Estrogen 

Actigall may cause dizziness, and consuming alcohol or marijuana can exacerbate it. Avoid driving, operating machinery, or engaging in activities that require alertness until it is safe to do so. Reduce alcohol intake and speak with your doctor if you use marijuana (cannabis). 

Actigall should only be used during pregnancy when necessary. Consult with your doctor to weigh the advantages and disadvantages. 

The excretion of ursodiol in human breast milk is unknown. Consult your doctor before breastfeeding an infant while taking this medication.