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300 mg

$3.67  -  $3.87

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What is Actigall?

Actigall is a bile acid that decreases the amount of cholesterol produced by the liver and absorbed by the intestines. This medicine helps break down cholesterol that has formed into stones in the gallbladder. This medicine also increases bile flow in patients with primary biliary cirrhosis.

Actigall is used to treat primary biliary cirrhosis.

Actigall capsules are used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. This medicine capsules are not for treating gallstones that are calcified

Actigall may also be used for purposes not listed in this medication guide.

8 Reasons Why Obesity Needs To Be Tackled Now
SLIDESHOW
8 Reasons Why Obesity Needs To Be Tackled Now
Important Information
You should not use Actigall if you have an obstruction in your liver or gallbladder.

Before taking this medicine
You should not use Actigall if you are allergic to it, or if you have an obstruction in your liver or gallbladder.

To make sure Actigall is safe for you, tell your doctor if:

you have been coughing up blood; or

you have gained weight rapidly, especially in your face and midsection.

FDA pregnancy category B. Actigall is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether Actigall passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Actigall?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take the Actigall tablet with food.

You may need to break a tablet in half to get your correct dose. Each tablet is scored in the middle and should break apart easily.

Swallow the tablet piece whole with a glass of water. A broken tablet can have a bitter taste.

Use Actigall regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To treat gallstones, you may have to take Actigall for several months before your gallstones dissolve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Not all gallstones completely dissolve with Actigall treatment, and you may develop new gallstones within 5 years after treatment. Talk to your doctor about your specific risks.

While using Actigall, you may need gallbladder ultrasound exams, or frequent blood tests to check your liver function. Your doctor may also want to check your liver function every 6 months after you stop using this medicine.



Store at room temperature away from moisture and heat. Tablets that are broken in half can be kept at room temperature for up to 28 days.

If you split your tablets, keep them separate from any whole tablets.

What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Actigall?
Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb Actigall.

If you also take cholestyramine or colestipol, avoid taking Actigall at the same time. Ask your doctor how many hours apart you should take your medicines.

Actigall side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

signs of a new infection--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, skin sores, trouble swallowing.

Common side effects may include:

headache, dizziness;

mild stomach pain or discomfort;

nausea, diarrhea, constipation;

cold symptoms such as stuffy nose, sneezing, sore throat;

hair loss; or

mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Actigall?
Other drugs may interact with ursodiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Actigall Side Effects
In Summary
Common side effects of Actigall include: back pain. Other side effects include: arthralgia, alopecia, arthritis, and pharyngitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ursodiol: oral capsule, oral tablet

Along with its needed effects, ursodiol (the active ingredient contained in Actigall) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ursodiol:

More common
Bladder pain
bloody or cloudy urine
difficult, burning, or painful urination
dizziness
fast heartbeat
frequent urge to urinate
indigestion
lower back or side pain
severe nausea
skin rash or itching over the entire body
stomach pain
vomiting
weakness
Less common
Black, tarry stools
chest pain
chills or fever
cough
pinpoint red spots on the skin
severe or continuing stomach pain
sore throat or swollen glands
sores, ulcers, or white spots on the lips or in the mouth
unusual bleeding or bruising
unusual tiredness or weakness
Incidence not known
Clay-colored stools
dark urine
difficulty with swallowing
headache
hives or welts
hoarseness
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
nausea
redness of the skin
slow or irregular breathing
tightness in the chest
unpleasant breath odor
yellow eyes or skin


Some side effects of ursodiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Back pain
body aches or pain
congestion
constipation
general feeling of discomfort or illness
heartburn
loss of voice
muscle aches
muscle or bone pain
pain, swelling, or redness in the joints
runny nose
sweating
trouble sleeping
Less common
Diarrhea
Rare
Worsening psoriasis
Incidence not known
Acid or sour stomach
belching bloating or swelling of face, arms, hands, lower legs, or feet
difficulty with moving
rapid weight gain
stomach discomfort or upset
tingling of the hands or feet
unusual weight gain or loss
For Healthcare Professionals
Applies to ursodiol: oral capsule, oral tablet

Gastrointestinal
Very common (10% or more): Abdominal pain (up to 43.2%), diarrhea (up to 27.1%), constipation (up to 26.4%), nausea (up to 17.4%), dyspepsia (up to 16.8%), vomiting (up to 13.7%)
Common (1% to 10%): Flatulence (up to 7.7%), cholecystitis (5.2%), gastrointestinal disorder (3.9%), esophagitis (1.7%), peptic ulcer (1.3%)
Postmarketing reports: Abdominal discomfort, abdominal pain, diarrhea, constipation, dyspepsia, nausea, vomiting[Ref]

Nervous system
Very common (10% or more): Headache (up to 24.8%), dizziness (16.5%)
Common (1% to 10%): Insomnia (1.9%)
Postmarketing reports: Dizziness, headache[Ref]

Other
Very common (10% or more): Viral infection (up to 19.4%)
Common (1% to 10%): Fatigue (up to 7.8%), influenza-like symptoms (6.5%), chest pain (3.2%), asthenia (1.7%)
Postmarketing reports: Malaise, peripheral edema, pyrexia[Ref]

Respiratory
Very common (10% or more): Upper respiratory tract infection (up to 15.5%), sinusitis (up to 11%)
Common (1% to 10%): Pharyngitis (up to 8.4%), coughing (7.1%), bronchitis (6.5%), rhinitis (5.2%)
Postmarketing reports: Cough[Ref]



Musculoskeletal
Very common (10% or more): Back pain (up to 11.8%)
Common (1% to 10%): Arthralgia (7.7%), musculoskeletal pain (5.9%), arthritis (5.8%), myalgia (5.8%)
Postmarketing reports: Myalgia[Ref]

Genitourinary
Common (1% to 10%): Urinary tract infection (6.5%), dysmenorrhea (5.6%)[Ref]

Dermatologic
Common (1% to 10%): Alopecia (5.3%), skin rash (2.6%)
Postmarketing reports: Alopecia, pruritus, rash[Ref]

Hypersensitivity
Common (1% to 10%): Allergy (5.2%)
Postmarketing reports: Drug hypersensitivity (including facial edema, urticaria, angioedema, laryngeal edema)[Ref]

Hematologic
Common (1% to 10%): Leukopenia (2.6%), thrombocytopenia (1.3%)[Ref]

Metabolic
Common (1% to 10%): Anorexia (1.7%), elevated blood glucose (up to 1.3%)[Ref]

Renal
Common (1% to 10%): Elevated creatinine (1.3%)[Ref]

Hepatic
Postmarketing reports: Jaundice (or aggravation of preexisting jaundice), increased ALT, increased AST, increased blood alkaline phosphatase, increased blood bilirubin, increased gamma-glutamyltransferase, increased hepatic enzymes, abnormal liver function test, increased transaminases[Ref]

References
1. "Product Information. Actigall capsules (ursodiol)." Novartis Pharmaceutical, Research Triangle Pk, NC.

2. "Product Information. Urso (ursodiol)" Scandipharm Inc, Birmingham, AL.

Some side effects of Actigall may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.