Actos (Page 7 of 7)

16 HOW SUPPLIED/ STORAGE AND HANDLING

ACTOS is available in 15 mg, 30 mg, and 45 mg tablets as follows:

15 mg tablet: White to off-white, round, convex, non-scored tablet with “ACTOS” on one side, and “15” on the other, available in:

bottles of 30 NDC 54868-4343-0

30 mg tablet: White to off-white, round, flat, non-scored tablet with “ACTOS” on one side, and “30” on the other, available in:

bottles of 30 NDC 54868-4354-0
bottles of 90 NDC 54868-4354-1

45 mg tablet: White to off-white, round, flat, non-scored tablet with “ACTOS” on one side, and “45” on the other, available in:

bottles of 30 NDC 54868-4391-0
bottles of 90 NDC 54868-4391-1

Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Medication Guide (17.2).

17.1 Instructions

  • It is important to instruct patients to adhere to dietary instructions and to have blood glucose and glycosylated hemoglobin tested regularly. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be reminded to seek medical advice promptly.
  • Patients who experience an unusually rapid increase in weight or edema or who develop shortness of breath or other symptoms of heart failure while on ACTOS should immediately report these symptoms to a physician.
  • Tell patients to promptly stop taking ACTOS and seek immediate medical advice if there is unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine as these symptoms may be due to hepatotoxicity.
  • Tell patients to promptly report any sign of macroscopic hematuria or other symptoms such as dysuria or urinary urgency that develop or increase during treatment as these may be due to bladder cancer.
  • Tell patients to take ACTOS once daily. ACTOS can be taken with or without meals. If a dose is missed on one day, the dose should not be doubled the following day.
  • When using combination therapy with insulin or other antidiabetic medications, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and their family members.
  • Therapy with ACTOS, like other thiazolidinediones, may result in ovulation in some premenopausal anovulatory women. As a result, these patients may be at an increased risk for pregnancy while taking ACTOS. Therefore, adequate contraception should be recommended for all pre-menopausal women who are prescribed ACTOS.

17.2 FDA-Approved Medication Guide

See attached leaflet.

Distributed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

©1999, 2006, 2010-2011 Takeda Pharmaceuticals America, Inc.

July 2011
ACT003 R16

Distributed and Repackaged by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

MEDICATION GUIDE

ACTOS® (ak-TŌS)
(pioglitazone hydrochloride) tablets

Read this Medication Guide carefully before you start taking ACTOS and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about ACTOS, ask your doctor or pharmacist.

What is the most important information I should know about ACTOS?

ACTOS can cause serious side effects, including new or worse heart failure.

  • ACTOS can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough
  • Do not take ACTOS if you have severe heart failure
  • If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, ACTOS may not be right for you

Call your doctor right away if you have any of the following:

  • swelling or fluid retention, especially in the ankles or legs
  • shortness of breath or trouble breathing, especially when you lie down
  • an unusually fast increase in weight
  • unusual tiredness

ACTOS can have other serious side effects. See “What are the possible side effects of ACTOS?”

What is ACTOS?

ACTOS is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is a diabetes medicine called pioglitazone hydrochloride that may be taken alone or with other diabetes medicines.

It is not known if ACTOS is safe and effective in children.

Who should not take ACTOS?

See “What is the most important information I should know about ACTOS?”

Do not take ACTOS if you:

  • have severe heart failure
  • are allergic to any of the ingredients in ACTOS. See the end of this Medication Guide for a complete list of ingredients in ACTOS

Talk to your doctor before taking ACTOS if you have either of these conditions.

What should I tell my doctor before taking ACTOS?

Before you start taking ACTOS, tell your doctor if you:

  • have heart failure
  • have type 1 (“juvenile”) diabetes or had diabetic ketoacidosis
  • have a type of diabetic eye disease that causes swelling in the back of the eye (macular edema)
  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if ACTOS will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant about the best way to control your blood glucose levels while pregnant
  • are a premenopausal woman (before the “change of life”) who does not have periods regularly or at all. ACTOS may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking ACTOS. Tell your doctor right away if you become pregnant while taking ACTOS
  • are breast-feeding or plan to breast-feed. It is not known if ACTOS passes into your milk and if it can harm your baby. You should not take ACTOS if you breastfeed your baby. Talk to your doctor about the best way to control your blood glucose levels while breastfeeding

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

ACTOS and some of your other medicines can affect each other. You may need to have your dose of ACTOS or certain other medicines changed.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is okay to take ACTOS with other medicines.

How should I take ACTOS?

  • Take ACTOS exactly as your doctor tells you to take it
  • Your doctor may change your dose of ACTOS. Do not change your ACTOS dose unless your doctor tells you to
  • ACTOS may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled
  • Take ACTOS 1 time each day, with or without food
  • If you miss a dose of ACTOS, take your next dose as prescribed unless your doctor tells you differently. Do not take two doses at one time the next day
  • If you take too much ACTOS, call your doctor or go to the nearest hospital emergency room right away
  • If your body is under stress such as from a fever, infection, accident, or surgery the dose of your diabetes medicines may need to be changed. Call your doctor right away
  • Stay on your diet and exercise programs and test your blood sugar regularly while taking ACTOS
  • Your doctor should do certain blood tests before you start and while you take ACTOS
  • Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with ACTOS
  • Your doctor should check your eyes regularly while you take ACTOS
  • It may take 2 to 3 months to see the full effect of ACTOS on your blood sugar level.

What are the possible side effects of ACTOS?

ACTOS may cause serious side effects including:

  • See “What is the most important information about ACTOS.”
  • liver problems. Call your doctor right away if you have:
    • nausea or vomiting
    • stomach pain
    • unusual or unexplained tiredness
    • loss of appetite
    • dark urine
    • yellowing of your skin or the whites of your eyes
  • broken bones (fractures). Usually in the hand, upper arm, or foot in women. Talk to your doctor for advice on how to keep your bones healthy.
  • bladder cancer. There may be an increased chance of having bladder cancer when you take ACTOS. You should not take ACTOS if you are receiving treatment for bladder cancer. Tell your doctor right away if you have any of the following symptoms of bladder cancer:
    • blood or a red color in your urine
    • an increased need to urinate
    • pain while you urinate
  • low blood sugar (hypoglycemia). This can happen if you skip meals, if you also use another medicine that lowers blood sugar, or if you have certain medical problems. Lightheadedness, dizziness, shakiness, or hunger may happen if your blood sugar is too low. Call your doctor if low blood sugar levels are a problem for you
  • diabetic eye disease with swelling in the back of the eye (macular edema). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly
  • release of an egg from an ovary in a woman (ovulation) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take ACTOS. This can increase your chance of getting pregnant

The most common side effects of ACTOS include:

  • cold-like symptoms (respiratory tract infection)
  • headache
  • sinus infection
  • muscle pain
  • sore throat

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the side effects of ACTOS. For more information, ask your doctor or pharmacist.

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

How should I store ACTOS?

  • Store ACTOS at 59°F to 86°F (15°C to 30°C). Keep ACTOS in the original container and protect from light
  • Keep the ACTOS bottle tightly closed and protect from getting wet (away from moisture and humidity)
  • Keep ACTOS and all medicines out of the reach of children

General information about the safe and effective use of ACTOS

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACTOS for a condition for which it was not prescribed. Do not give ACTOS to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about ACTOS. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ACTOS that is written for healthcare professionals. For more information, go to www.actos.com or call 1-877-825-3327.

What are the ingredients in ACTOS?

Active Ingredient: pioglitazone hydrochloride

Inactive Ingredients: lactose monohydrate, hydroxypropylcellulose, carboxymethylcellulose calcium, and magnesium stearate.

ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015
© 2009-2011 Takeda Pharmaceuticals America, Inc.

July 2011
ACT003 R16

PRINCIPAL DISPLAY PANEL — 15 mg Bottle Label

actos®
(pioglitazone HCl)
Tablets

15 mg

Each tablet contains pioglitazone
hydrochloride equivalent to 15 mg
pioglitazone.

Dispense with Medication Guide
available in package insert or at
www.actos.com


Rx Only

PRINCIPAL DISPLAY PANEL -- 15 mg Bottle LabelPRINCIPAL DISPLAY PANEL — 15 mg Bottle Label

PRINCIPAL DISPLAY PANEL — 30 mg Bottle Label

actos®
(pioglitazone HCl)
Tablets

30 mg

Each tablet contains pioglitazone
hydrochloride equivalent to 30 mg
pioglitazone.

Dispense with Medication Guide
available in package insert or at
www.actos.com


Rx Only

PRINCIPAL DISPLAY PANEL -- 30 mg Bottle LabelPRINCIPAL DISPLAY PANEL — 30 mg Bottle Label

PRINCIPAL DISPLAY PANEL — 45 mg Bottle Label

actos®
(pioglitazone HCl)
Tablets

45 mg

Each tablet contains pioglitazone
hydrochloride equivalent to 45 mg
pioglitazone.

Dispense with Medication Guide
available in package insert or at
www.actos.com

Rx Only

PRINCIPAL DISPLAY PANEL -- 45 mg Bottle LabelPRINCIPAL DISPLAY PANEL — 45 mg Bottle Label
ACTOS pioglitazone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4343(NDC:64764-151)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
pioglitazone hydrochloride (pioglitazone) pioglitazone hydrochloride 15 mg
Inactive Ingredients
Ingredient Name Strength
carboxymethylcellulose calcium
hydroxypropyl cellulose
lactose monohydrate
magnesium stearate
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (round, convex) Size 7mm
Flavor Imprint Code ACTOS;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4343-0 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021073 11/20/2007
ACTOS pioglitazone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4354(NDC:64764-301)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
pioglitazone hydrochloride (pioglitazone) pioglitazone hydrochloride 30 mg
Inactive Ingredients
Ingredient Name Strength
carboxymethylcellulose calcium
hydroxypropyl cellulose
lactose monohydrate
magnesium stearate
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (round, flat) Size 7mm
Flavor Imprint Code ACTOS;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4354-0 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:54868-4354-1 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021073 03/04/2005
ACTOS pioglitazone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4391(NDC:64764-451)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
pioglitazone hydrochloride (pioglitazone) pioglitazone hydrochloride 45 mg
Inactive Ingredients
Ingredient Name Strength
carboxymethylcellulose calcium
hydroxypropyl cellulose
lactose monohydrate
magnesium stearate
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (round, flat) Size 8mm
Flavor Imprint Code ACTOS;45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4391-0 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:54868-4391-1 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021073 10/22/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-4343), relabel (54868-4354), relabel (54868-4391), repack (54868-4343), repack (54868-4354), repack (54868-4391)

Revised: 09/2012 Physicians Total Care, Inc.

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