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: | |
| |
| |
| |
| |
| 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: | |
| |
| with your personal glucose meter as often as your | |
| doctor recommends. | |
| |
| done periodically to determine the average control of | |
| your blood sugar levels. | |
| |
| test to monitor your liver function before you start | |
| ratio-PIOGLITAZONE and may repeat this test | |
| occasionally while you take ratio-PIOGLITAZONE. | |
| |
| 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): | |
| |
| 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. | |
| |
| 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. | |
| |
| 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): | |
| ||||||
| stomach pain, lack of appetite, tiredness, dark urine, or | ||||||
| yellowing of the skin, stop taking ratio-PIOGLITAZONE | ||||||
| and call your doctor right away. | ||||||
| ||||||
| spotting) while using oral contraceptives, or generally, if | ||||||
| you experience any symptoms that persist or become | ||||||
| troublesome, these should be discussed with your doctor. | ||||||
| ||||||
| eye. | ||||||
| ||||||
| been seen with raio-PIOGLITAZONE use in women. | ||||||
| Talk to your doctor about the risk of fracture. | ||||||
| ||||||
| 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): | ||||||
| ||||||
| 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. | ||||||
| ||||||
| feel very weak or tired. | ||||||
| ||||||
| 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 / effect | Talk with your | Stop taking | ||||
| doctor | drug | |||||
| Only if | In all | immediately | ||||
| severe | cases | and seek | ||||
| immediate | ||||||
| emergency | ||||||
| medical | ||||||
| attention | ||||||
| Common | Fluid retention or | √ | ||||
| swelling in | ||||||
| extremities (arms | ||||||
| and legs, hands | ||||||
| and feet) | ||||||
| Common | Low blood sugar | √ | ||||
| (when ratio- | (hypoglycemia): | |||||
| PIOGLITAZONE | Dizziness, lack of | |||||
| is taken with other | energy, | |||||
| antidiabetic | drowsiness, | |||||
| medicines) | headache, | |||||
| trembling | ||||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | ||||
| AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your | Stop taking | ||
| doctor | drug | |||
| Only if | In all | immediately | ||
| severe | cases | and seek | ||
| immediate | ||||
| emergency | ||||
| medical | ||||
| attention | ||||
| sweating, hunger | ||||
| Rare | Liver 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 rare | Heart 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
