Precose

PRECOSE is available as 25 mg, 50 mg or 100 mg round, unscored tablets. Each tablet strength is white to yellow-tinged in color. The 25 mg tablet is coded with the word “PRECOSE” on one side and “25” on the other side. The 50 mg tablet is coded with the word “PRECOSE” and “50” on the same side. The 100 mg tablet is coded with the word “PRECOSE” and “100” on the same side. PRECOSE is available in bottles of 100 and 50 mg strength in unit dose packages of 100.

Do not store above 25°C (77°F). Protect from moisture. For bottles, keep container tightly closed.

Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470. Made in Germany. 11/11

Serious side effects have been reported with Precose. See the “Precose Precautions” section.

Common side effects of Precose include the following:

• Abdominal pain
• Diarrhea
• Flatulence

This is not a complete list of Precose side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Precose, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Precose or to any of its ingredients
• have kidney problems
• have liver problems
• have gastrointestinal problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe constipation;

• severe stomach pain, diarrhea that is watery or bloody;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

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

Common side effects may include:

• stomach discomfort, gas, bloating;

• mild diarrhea; or

• mild skin rash or itching.

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.

In the U.S.

• Precose

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Alpha-Glucosidase Inhibitor

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Low blood sugar can happen. The chance of low blood sugar may be raised when this medicine is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
• Very bad and sometimes deadly liver problems have happened with Precose. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Precose is contraindicated in patients with known hypersensitivity to the drug. Precose is contraindicated in patients with diabetic ketoacidosis or cirrhosis. Precose is also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction. In addition, Precose is contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine.

80498595 NDC 50419-863-51

Precose®

(acarbose tablets)

25 mg

100 Tablets

Rx Only

Applies to acarbose: oral tablet

Along with its needed effects, acarbose (the active ingredient contained in Precose) 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 as soon as possible if any of the following side effects occur while taking acarbose:

• Yellow eyes or skin

Some side effects of acarbose 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:

• Abdominal or stomach pain
• bloated feeling or passing of gas
• diarrhea

Applies to acarbose: oral tablet

General

The most frequently reported adverse events include abdominal pain, diarrhea, and flatulence.[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (19%), diarrhea (31%), flatulence (74%)
Uncommon (0.1% to 1%): Nausea,, vomiting, dyspepsia
Postmarketing reports: Ileus/subileus, pneumatosis cystoides intestinalis[Ref]

In large-scale clinical trials, a majority of patients have complained of gastrointestinal (GI) side effects. GI side effects usually developed within the first few weeks of therapy, were usually mild to moderate in severity, and typically decreased over time. The most common GI side effects were due to the fermentation of unabsorbed carbohydrates and resultant gas production. The severity of GI symptoms may be decreased by dosage reduction and by avoidance of gas-producing foods and sucrose.

There have been rare postmarketing reports of pneumatosis cystoides intestinalis associated with alpha-glucosidase inhibitors including this drug. If suspected, discontinue therapy and perform appropriate diagnostic testing.[Ref]

Hepatic

Very common (10% or more): Serum transaminase elevations (14%)
Postmarketing reports: Fulminant hepatitis with fatal outcome, jaundice and/or hepatitis and associated liver damage[Ref]

Treatment-emergent elevations of AST and ALT to greater the upper limit of normal, greater than 1.8 x ULN) and greater than 3 x ULN have been observed in 14%, 6%, and 3% of patients in studies of up to 12 months with doses up to 300 mg 3 times a day. The elevations were more common in women and generally asymptomatic and reversible. Additionally, these elevations appear to be dose-related.

International postmarketing experience: There have been 62 reports of of serum transaminase elevations to greater than 500 international units/liter, 29 were associated with jaundice. Of these 62 cases, 41 were receiving treatment with 100 mg 3 times a day or greater, 33 of 45 patients for whom weight was reported weighed less than 60 kg. In the 59 cases for which follow-up was provided, 55 had improvement or resolution of hepatic abnormalities with drug discontinuation, in 2 cases the hepatic abnormalities remained unchanged. Five cases of fulminant hepatitis with fatal outcome have been reported in Japan.[Ref]

Hematologic

Frequency not reported: Small reductions in hematocrit
Postmarketing reports: Thrombocytopenia[Ref]

Dermatologic

Frequency not reported: Acute generalized exanthematous pustulosis[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity skin reactions (e.g. rash, erythema, exanthema, urticaria)[Ref]

Cardiovascular

Postmarketing reports: Edema[Ref]

Metabolic

This drug when administered as monotherapy should not cause hypoglycemia, but when administered with other agents, it may increase the potential for hypoglycemia. Low serum calcium and low plasma vitamin B6 levels were associated with use of this drug, however, they are thought to be spurious or of no clinical significance.[Ref]

Frequency not reported: Hypoglycemia, low serum calcium, low plasma vitamin B6 levels[Ref]

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