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Ratio-Pioglitazone: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Post Market
Strength:
15 mg, 30 mg, 45 mg

Patient Medication Information: uses, side effects, how to take - Ratio-Pioglitazone

ABOUT THIS MEDICATION

What ratio-PIOGLITAZONE is used for:

Your doctor has prescribed ratio-PIOGLITAZONE to treat type 2 diabetes, as an addition to diet and exercise, in order to improve your blood sugar control. ratio-PIOGLITAZONE may be used alone or in combination with a sulfonylurea or metformin.

What Is Type 2 Diabetes?

Insulin is a hormone that the body makes to help use food for energy. There are two types of diabetes: in type 1 diabetes, the body stops producing insulin. In type 2 diabetes, the body does not respond to insulin as well as it should, and/or cannot make enough insulin on its own. When this happens, glucose (sugar) builds up in the blood. This can lead to serious medical problems, including kidney damage, eye damage, nerve damage, heart disease, or stroke. The main goal of diabetes treatment is to lower blood sugar to a normal level.

How Is Type 2 Diabetes Usually Controlled?

Treatment of type 2 diabetes must always include proper diet, exercise and weight control under the guidance of your physician.

What ratio-PIOGLITAZONE does:

ratio-PIOGLITAZONE is a member of a class of drugs that are insulin-sensitizing agents. ratio-PIOGLITAZONE helps your body respond better to its own insulin, thereby reducing blood sugar levels in the body. Because ratio-

PIOGLITAZONE does not cause your body to produce more insulin, it rarely causes hypoglycemia (low blood sugar) when used alone. Even if you are taking ratio-PIOGLITAZONE, you should still exercise and follow the recommended nutritional plan for your diabetes.

When ratio-PIOGLITAZONE should not be used:

ratio-PIOGLITAZONE should not be used by patients who:
  • have or have had heart problems or heart failure
  • have serious liver damage
  • are pregnant
  • are allergic to pioglitazone hydrochloride or any
other ingredients of ratio-PIOGLITAZONE
  • have or have had bladder cancer
  • have blood or a red colour in their urine

What the medicinal ingredient is:

Pioglitazone Hydrochloride

What the nonmedicinal ingredients are:

Lactose monohydrate, hydroxypropylcellulose, carboxymethylcellulose calcium and magnesium stearate.

What dosage forms it comes in:

ratio-PIOGLITAZONE is available as tablets, 15 mg, 30 mg and 45 mg

WARNINGS AND PRECAUTIONS

Because ratio-PIOGLITAZONE works only in the
presence of insulin, it should not be used if you have type
1 diabetes (when the pancreas does not produce insulin).

Serious side effects with ratio-PIOGLITAZONE include:

  • heart failure. Symptoms of heart failure include shortness of breath, weakness, tiredness, swelling (edema), or unusual weight gain
  • liver problems. Symptoms of liver problems include tiredness, lack of appetite, dark urine, yellowing of the skin or the white part of the eye
  • bladder cancer. Symptoms of bladder cancer include blood or a red colour in your urine, an increased need to urinate, or pain while you urinate ratio-PIOGLITAZONE is not approved for use with metformin and a sulfonylurea, therefore ratio-

PIOGLITAZONE should not be taken with metformin and a sulfonylurea.

ratio-PIOGLITAZONE is not approved for use with insulin therapy, therefore ratio-PIOGLITAZONE should not be taken with insulin.

If you are taking ratio-PIOGLITAZONE with a sulfonylurea,
you may develop low blood sugar. Make sure to ask your
doctor, pharmacist, or diabetes educator what to do if your
blood sugar is low. Teach your friends, coworkers, and
family members what they can do to help you if you have low
blood sugar.
Consult your doctor promptly during periods of stress, such as
fever, trauma, infection or surgery, since your medication
requirements may change during these times.
Fractures, usually in the hand, upper arm or foot, have been
seen with ratio-PIOGLITAZONE use in women. Talk to
your doctor about the risk of fracture.

IMPORTANT: PLEASE READ

Before or while taking ratio-PIOGLITAZONE, talk to your

doctor or pharmacist if you:

  • have liver disease. ratio-PIOGLITAZONE is not

    recommended in patients with liver disease.

  • are planning to become pregnant. Only insulin should be

    used during pregnancy to maintain blood glucose levels as

    close to normal as possible.

  • are breastfeeding
  • are a woman who has not reached menopause but have no

    menstrual periods. You may become pregnant unless you

    use an effective method of birth control. ratio-

    PIOGLITAZONE, like other drugs in this class, may

    cause women with insulin resistance to ovulate again.

  • have edema (water retention)

ratio-PIOGLITAZONE should not be used in children under

18 years of age.

INTERACTIONS WITH THIS MEDICATION

Drugs that interact with ratio-PIOGLITAZONE include:

Oral Contraception. Women using oral birth control pills

should check with their doctor about the possible need to

adjust the dose or use alternative methods of contraception

when taking ratio-PIOGLITAZONE. Women should also

inform their doctors of any changes in their monthly cycle.

ratio-PIOGLITAZONE may also interact with some other

drugs such as gemfibrozil, rifampicin, nifedipine and

atorvastatin calcium. Tell your doctor if you are taking these

medicines.

PROPER USE OF THIS MEDICATION

Usual dose:

ratio-PIOGLITAZONE should be taken once daily without

regard to meals. The initial dose is 15 or 30 mg once daily. Do

not exceed 45 mg once daily.

Take your ratio-PIOGLITAZONE each day, as instructed by

your doctor or pharmacist. ratio-PIOGLITAZONE can help

you control your blood glucose levels only if you take it

regularly. ratio-PIOGLITAZONE should generally be taken

at the same time each day at whatever time you find most

convenient to remember.

Your doctor has prescribed ratio-PIOGLITAZONE

specifically for you. Do not give your medicine to anyone

else, even if they have a similar condition.

Overdose:

In the event of overdosage, consult your doctor, pharmacist,

or contact a poison control centre immediately.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of ratio-PIOGLITAZONE, do not take a
double dose to make up for the missed dose. Take your dose
at the regular time on the following day.
Monitoring:
  • Fasting blood glucose: Test your blood sugar levels
with your personal glucose meter as often as your
doctor recommends.
  • Glycosylated hemoglobin (HbA1c): This blood test is
done periodically to determine the average control of
your blood sugar levels.
  • Liver Enzymes: Your doctor may recommend a blood
test to monitor your liver function before you start
ratio-PIOGLITAZONE and may repeat this test
occasionally while you take ratio-PIOGLITAZONE.
  • Eye: should be checked regularly. Rarely, some
patients have experienced vision changes due to
swelling in the back of the eye while taking ratio-
PIOGLITAZONE.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The following side effects have been commonly reported with
ratio-PIOGLITAZONE (could affect up to 1 in 10 patients):
  • Edema (fluid retention or swelling) which could lead to
heart failure. If you notice swelling in extremities (arms
and legs, hands and feet), unusually rapid increase in
weight, tiredness, trouble breathing or shortness of breath,
call your doctor. These symptoms, although not specific,
may signal heart problems or heart failure.
  • Low blood sugar (hypoglycemia) if you are taking ratio-
PIOGLITAZONE in combination with another diabetes
medicine (e.g., metformin or a sulfonylurea). Dizziness,
lack of energy, drowsiness, headache, trembling, sweating,
or hunger may mean that your blood sugar is too low. This
can happen if you skip meals, drink alcohol, use another
medicine that lowers blood sugar, exercise (particularly
hard or long), or if you have certain medical problems.
Call your doctor if you feel that your symptoms of low
blood sugar are uncomfortable. If you are using ratio-
PIOGLITAZONE by itself, there is less risk of having
low blood sugar.
  • Increased weight. Tell your doctor if you gain a lot of
weight in a short period of time.
The following side effects have been reported rarely with
ratio-PIOGLITAZONE (could affect up to 1 in 1000
patients):
  • Liver problems. If you experience nausea, vomiting,
stomach pain, lack of appetite, tiredness, dark urine, or
yellowing of the skin, stop taking ratio-PIOGLITAZONE
and call your doctor right away.
  • Breakthrough bleeding (unexpected vaginal bleeding or
spotting) while using oral contraceptives, or generally, if
you experience any symptoms that persist or become
troublesome, these should be discussed with your doctor.
  • Blurred vision due to swelling (or fluid) in the back of the
eye.
  • Fractures, usually in the hand, upper arm or foot, have
been seen with raio-PIOGLITAZONE use in women.
Talk to your doctor about the risk of fracture.
  • Bladder cancer. If you experience blood or a red colour in
your urine, an increased need to urinate, or pain while you
urinate, stop taking ACTOS and call your doctor right
away.
The following side effects have been reported very rarely
with ratio-PIOGLITAZONE (could affect up to 1 in
10,000 patients):
  • Heart failure or pulmonary edema (fluid accumulation in
the lungs). Symptoms of heart failure include shortness of
breath, getting tired easily after light physical activity such
as walking, waking up short of breath at night and swollen
ankles or feet. Symptoms of fluid in the lungs are
breathlessness, which may be very severe and usually
worsens on lying down. Stop taking ratio-
PIOGLITAZONE and call your doctor right away if you
experience these symptoms.
  • Anemia (low red blood cell count) which may make you
feel very weak or tired.
  • Swelling of the face, lips, mouth, tongue or throat (which
may cause difficulty in swallowing or breathing); hives or
rash (which may be itchy). Stop taking ratio-
PIOGLITAZONE and call your doctor right away if you
experience these symptoms.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN
AND WHAT TO DO ABOUT THEM
Symptom / effectTalk with yourStop taking
doctordrug
Only ifIn allimmediately
severecasesand seek
immediate
emergency
medical
attention
CommonFluid retention or√
swelling in
extremities (arms
and legs, hands
and feet)
CommonLow blood sugar√
(when ratio-(hypoglycemia):
PIOGLITAZONEDizziness, lack of
is taken with otherenergy,
antidiabeticdrowsiness,
medicines)headache,
trembling
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN
AND WHAT TO DO ABOUT THEM
Symptom / effectTalk with yourStop taking
doctordrug
Only ifIn allimmediately
severecasesand seek
immediate
emergency
medical
attention
sweating, hunger
RareLiver problems:√
nausea,
vomiting,
stomach pain,
lack of appetite,
tiredness, dark
urine, or
yellowing of the
skin
Blurred vision√
or decreased
vision [which
may be due to
swelling (or
fluid) in the back
of the eye].
Fractures,√
usually in the hand, upper arm
or foot, in
women.
Bladder cancer:√

blood or

red colour in

urine,
increased need
to
urinate, pain
while you
urinate
Very rareHeart failure or√
fluid in the lungs (pulmonary
edema): trouble
breathing or
shortness of
breath, getting
tired easily after
light physical
activity, unusual
tiredness,
waking up short
of breath at
night, swollen
ankles or feet,
unusually rapid
increase in
weight
Allergic√
reactions:
swelling of the
face, lips, mouth,
tongue or throat
(may cause
difficulty in
swallowing or
breathing), hives
or rash

This is not a complete list of side effects. For any unexpected effects while taking ratio-PIOGLITAZONE, contact your

doctor or pharmacist.

HOW TO STORE IT

Store your ratio-PIOGLITAZONE in its bottle with cap
tightly closed at room temperature (15°C - 30°C). Protect from
moisture.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:

    • Fax toll-free to 1-866-678-6789, or
    • Mail to:

      Canada Vigilance

      Program Health

      Canada

      Postal Locator 0701E

      Ottawa, Ontario

      K1A 0K9

      Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at:

1-800-268-4127 ext. 5005 (English)

1-877-777-9117 (French)

or druginfo@tevacanada.com ratiopharm inc.

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: February 01, 2013

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02301423

Revision date stated in the text: February 1, 2013

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Ratio-Pioglitazone

Rx or OTC
Prescription (Rx)?
DIN 02301423, 02301431, 02301458
Schedule(s) PRESCRIPTION
Active ingredient(s) Pioglitazone (pioglitazone hydrochloride)
Dosage form(s) Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. A Alimentary tract and metabolism drugs
    1. A10 Drugs used in diabetes
      1. A10B Blood glucose lowering drugs, excl. insulins
        1. A10BG Thiazolidinediones, blood glucose lowering drugs
          1. A10BG03 Pioglitazone
Company RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
Current status Cancelled Post Market
Current status date October 26, 2015
Strengths and forms
DIN Strength Dosage form(s) Current status
02301423 15 MG Tablet Cancelled Post Market October 26, 2015
02301431 30 MG Tablet Cancelled Post Market October 26, 2015
02301458 45 MG Tablet Cancelled Post Market October 26, 2015

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.