Drug Ingredient Information
PIOGLITAZONE-15MG+METFORMIN-500MG
PIOGLITAZONE
| Information for
patients
|
| Drug Information |
PIOGLITAZONE is a tablet that is used to improve the action of the body?s naturally produced insulin. It is used in the management of type 2 diabetes not controlled by diet. It helps to control the level of glucose in your blood when you have type 2 diabetes. This is the „adult onset? type of diabetes and is controlled by diet, certain oral medications and occasionally insulin.
This medicine is available as pioglitazone hydrochloride and belongs to a group of medicines called glitazones. Glitazones decrease insulin resistance.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
PIOGLITAZONE can be used alone (when diet and exercise is not enough to treat your diabetes) or together with other anti-diabetic medicines.
This medicine is available only with a doctor?s prescription.
The use of PIOGLITAZONE has not been studied in children. |
| Drug Alert |
| Alert |
no data available |
| Before Consuming
the Medicine
|
| Avoid Drug |
Do not take PIOGLITAZONE if you have:
heart failure requiring treatment. Talk to your doctor if you have heart failure
type 1 diabetes or diabetic ketoacidosis (often caused by very high blood glucose levels)
an allergy to any medicine containing pioglitazone hydrochloride or any of the ingredients listed in the contents.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Do not take this medicine after the date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor. |
| Drug Special Care |
Before you start to take it
• Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
• Tell your doctor if you have or have had any of the following medical conditions:
• heart disease with shortness of breath after minimal physical activity
• heart disease with severe symptoms at rest
• swelling of hands, ankles or feet
• problems with your liver
• problems with your kidneys that requires dialysis. PIOGLITAZONE is not recommended for use if you are on dialysis
• some women who do not have monthly periods and have not been through menopause may restart their periods when taking PIOGLITAZONE. These women may be at increased risk of pregnancy
• bone fractures, usually in the hand, upper arm or foot, have been seen in some women when taking PIOGLITAZONE. Talk to your doctor for advice on how to keep your bones healthy.
• Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.Things you must do
It is important that you remember to take PIOGLITAZONE daily and at the dose prescribed by your doctor.
Tell any other doctors, dentists and pharmacists who treat you that you are taking PIOGLITAZONE.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking PIOGLITAZONE.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Tell your doctor if you have gained weight since taking PIOGLITAZONE. Weight gain can be associated with improved blood sugar control however; it may also be a symptom of heart failure.
Things you must not do
Do not take PIOGLITAZONE to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if their symptoms seem similar to yours or they have the same condition as you. |
| Drug Drug Interactions |
Tell your doctor if you are using another medicine for diabetes. PIOGLITAZONE can enhance the action of other medicines. You may be at risk of low blood sugar (hypoglycaemia).
If this happens, your doctor may need to adjust the dose of your other medicines.
Tell your doctor if you suffer from lactose intolerance (because PIOGLITAZONE tablets contain lactose).
If you have not told your doctor about any of the above, tell him/her before you start taking PIOGLITAZONE.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and PIOGLITAZONE may interfere with each other. These include:
chlorpropamide
gemfibrozil
glibenclamide
gliclazide
insulin
metformin
oral contraceptives
rifampicin
tolbutamide
These medicines may be affected by PIOGLITAZONE or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking this medicine. |
| Drug Pregnancy Interaction |
It is not recommended for use during pregnancy. If there is a need to consider PIOGLITAZONE during your pregnancy, your doctor will discuss with you the benefits and risks of taking PIOGLITAZONE. |
| Drug Breast feeding Interaction |
It is recommended that you do not breast-feed while taking PIOGLITAZONE, as it is not known whether this drug passes into breast milk. |
| Drug Machinery Interaction |
PIOGLITAZONE alone is unlikely to affect your ability to drive or operate machinery. However, be careful to avoid hypoglycaemia whilst driving or operating machinery if using PIOGLITAZONE combination with other diabetes medicines. |
| Drug More Information |
no data available |
| How to take the
Medicine
|
| Consumption Info |
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the carton, ask your doctor or pharmacist for help. |
| Drug quanitty |
Your doctor will tell you how many PIOGLITAZONE tablets you should take. The dose your doctor will prescribe for you will usually be in the range of 15 mg to 45 mg per day.
PIOGLITAZONE tablets should be taken once a day as advised by your doctor. Your doctor may increase or decrease your dose in order to find the appropriate dose for your condition. |
| Drug Dose |
PIOGLITAZONE tablets should be swallowed whole with a glass of water.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
It does not matter if you take this medicine before or after food.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well. |
| Excess Drug Consumption |
Immediately telephone your doctor or the Poisons Information Centre or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much PIOGLITAZONE. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention. |
| Forgot Drug Consumption |
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do NOT take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints. |
| Stop Drug Consumption |
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects. |
| Possible Side
Effects
|
| General Information |
Tell your doctor or pharmacist as soon as possible if you experience any undesirable effect or feel unwell while you are taking PIOGLITAZONE.
This medicine helps most people with type 2 diabetes not controlled by diet, but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Some side effects may be related to the dose of PIOGLITAZONE. Accordingly, it is important that you tell your doctor as soon as possible about any unwanted effects. Your doctor may then decide to adjust the dose of PIOGLITAZONE you are taking.
Do not be alarmed by the following list of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have. |
| Common Drug Side Effects |
A few patients have experienced the following side effects whilst taking PIOGLITAZONE:
a small increase in weight
low blood sugar levels (hypoglycaemia). This occurs more often when PIOGLITAZONE is taken with a sulfonylurea or insulin
heart failure which may show as localised swelling of the ankles, feet and hands (oedema) and/or fluid in the lungs (pulmonary oedema). This has been reported in clinical trials mainly in patients who are taking PIOGLITAZONE in combination with insulin
increased risk of fracture in women
macular oedema (an eye disorder that can affect vision)
altered or impaired liver function. |
| Rare Drug Side Effects |
dark urine or pale stools, yellowing of the skin or eyes, severe cramps of the stomach, nausea or vomiting, loss of weight, tiredness
shortness of breath when at rest or after minimal physical activity with swelling of legs, feet and hands, rapid increase in weight
The above list includes serious side effects, which may require medical attention. Serious side effects are rare. |
| Very Rare Drug Side Effects |
no data available |
| Drug Side Effects Symptoms |
weight gain
signs of hypoglycaemia which may include weakness, trembling or shaking, sweating, light-headedness, headache, dizziness, lack of concentration, tearfulness or crying, irritability, hunger, numbness around the lips and fingers
eye problems including blurred or double vision. |
| How to Store the
Medicine
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| How to Store the Medicine |
Storage
Keep your tablets in the aluminium blister pack until it is time to take them.
Keep your tablets in a cool, dry place where the temperature stays below 30 degree celcius.
Do not store PIOGLITAZONE or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking PIOGLITAZONE or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over. |
METFORMIN
| Information for
patients
|
| Drug Information |
Metformin is used alone or with other medications, including insulin, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Metformin helps to control the amount of glucose (sugar) in your blood. It decreases the amount of glucose you absorb from your food and the amount of glucose made by your liver. Metformin also increases your body's response to insulin, a natural substance that controls the amount of glucose in the blood. Metformin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). |
| Drug Alert |
| Alert |
no data available |
| Before Consuming
the Medicine
|
| Avoid Drug |
Tell your doctor if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time (binge drinking). Drinking alcohol increases your risk of developing lactic acidosis or may cause a decrease in blood sugar. Ask your doctor how much alcohol is safe to drink while you are taking metformin. |
| Drug Special Care |
Before taking metformin,
tell your doctor and pharmacist if you are allergic to metformin or any other medications.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiloride (Midamor, Moduretic); antihistamines; beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Lexxel, Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan); cimetidine (Tagamet); digoxin (Lanoxin, Lanoxicaps); furosemide (Lasix); hormone replacement therapy; insulin or other medications for diabetes; isoniazid (INH, Nydrazid); medications for asthma and colds; medications for mental illness and nausea such as fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon), prochlorperazine (Compazine), promethazine (Phenergan), thioridazine (Mellaril), thiothixene (Navane), trifluoperazine (Stelazine), and triflupromazine (Vesprin); medications for thyroid disease; morphine (MS Contin, Roxanol, others); nicotinic acid; oral contraceptives ('birth control pills'); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); phenytoin (Dilantin, Phenytek); procainamide (Procanbid); quinidine (Quinidex); quinine; ranitidine (Zantac); triamterene (Dyazide, Maxzide, others); or trimethoprim (Proloprim, Trimpex). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had any medical condition, especially those mentioned in the IMPORTANT WARNING section.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking metformin, call your doctor.
if you are using the extended-release tablets, you should know that sometimes the tablet shell may appear in your stool. If this occurs, it is not harmful and will not affect the way the medication works.
tell your doctor if you eat less or exercise more than usual. This can affect your blood sugar. Your doctor will give you instructions if this happens. |
| Drug Drug Interactions |
acyclovir (Zovirax); acetaminophen (Tylenol); aminoglycoside antibiotics such as amikacin (Amikin), gentamicin (Garamycin), Kanamycin (Kantrex), Neomycin (Neo-Fradin, Neo-Rx), netilmicin (Netromycin), paromomycin (Humatin), streptomycin and tobramycin (Nebcin, Tobi); amphotericin B (Abelcet, Amphocin, others); angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinvil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); cancer chemotherapy medications; cyclosporine (Sandimmune, Neoral); dapsone (Avlosulfon); diuretics (water pills); foscarnet (Foscavir); gold compounds such as auranofin (Ridaura), aurothioglucose (Aurolate, Solganol), and gold sodium thiomalate (Myochrysine); hydralazine (Hydra-Zide); lithium (Eskalith, Lithobid); medications to treat human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); methicillin (Staphcillin); nitrates; penicillin and sulfa antibiotics; penicillamine (Cuprimine, Depen); primaquine; propranolol (Inderal); rifampin (Rifadin, Rimactane); tacrolimus (Prograf); vancomycin (Vancocin); or if you have ever taken the Chinese weight-loss herb Aristolochia. |
| Drug Pregnancy Interaction |
no data available |
| Drug Breast feeding Interaction |
no data available |
| Drug Machinery Interaction |
no data available |
| Drug More Information |
In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
In patients already being treated with these medicines
In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines |
| How to take the
Medicine
|
| Consumption Info |
If you are having surgery, including dental surgery, any x-ray procedure in which dye is injected, or any major medical procedure, tell the doctor that you are taking metformin. You may need to stop taking metformin before the procedure and wait 48 hours to restart treatment. Your doctor will tell you exactly when you should stop taking metformin and when you should start taking it again. |
| Drug quanitty |
no data available |
| Drug Dose |
Metformin comes as a liquid, a tablet and an extended-release (long-acting) tablet to take by mouth. The liquid is usually taken with meals one or two times a day. The regular tablet is usually taken with meals two or three times a day. The extended-release tablet is usually taken once daily with the evening meal. To help you remember to take metformin, take it around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take metformin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow metformin extended-release tablets whole; do not split, chew, or crush them.
Your doctor may start you on a low dose of metformin and gradually increase your dose not more often than once every 1 to 2 weeks. You will need to monitor your blood sugar carefully so your doctor will be able to tell how well metformin is working.
Metformin controls diabetes but does not cure it. Continue to take metformin even if you feel well. Do not stop taking metformin without talking to your doctor. |
| Excess Drug Consumption |
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
extreme tiredness
weakness
discomfort
vomiting
nausea
stomach pain
decreased appetite
deep, rapid breathing
shortness of breath
dizziness
lightheadedness
abnormally fast or slow heartbeat
flushing of the skin
muscle pain
feeling cold |
| Forgot Drug Consumption |
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. |
| Stop Drug Consumption |
Do not stop the drug untill your doctor says you to do so. |
| Possible Side
Effects
|
| General Information |
extreme tiredness, weakness, or discomfort; nausea; vomiting; stomach pain; decreased appetite; deep and rapid breathing or shortness of breath; dizziness; lightheadedness; fast or slow heartbeat; flushing of the skin; muscle pain; or feeling cold. |
| Common Drug Side Effects |
Metformin may rarely cause a serious, life-threatening condition called lactic acidosis. Tell your doctor if you have or have ever had a heart attack; stroke; high blood pressure; diabetic ketoacidosis (blood sugar that is high enough to cause severe symptoms and requires emergency medical treatment) or coma; surgery to remove part of your small intestine; anemia (not enough red blood cells), or heart, kidney, lung, or liver disease. |
| Rare Drug Side Effects |
no data available |
| Very Rare Drug Side Effects |
no data available |
| Drug Side Effects Symptoms |
This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.
You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:
shakiness
dizziness or lightheadedness
sweating
nervousness or irritability
sudden changes in behavior or mood
headache
numbness or tingling around the mouth
weakness
pale skin
hunger
clumsy or jerky movements
If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately:
confusion
seizures
loss of consciousness
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):
extreme thirst
frequent urination
extreme hunger
weakness
blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms:
dry mouth
nausea and vomiting
shortness of breath
breath that smells fruity
decreased consciousness
Metformin may cause side effects. Tell your doctor if any of these symptoms are severe, do not go away, go away and come back, or do not begin for some time after you begin taking metformin:
diarrhea
bloating
stomach pain
gas
constipation
unpleasant metallic taste in mouth
heartburn
headache
sneezing
cough
runny nose
flushing of the skin
nail changes
muscle pain
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:
chest pain
rash
Some female laboratory animals given high doses of metformin developed non-cancerous polyps (abnormal growths of tissue) in the uterus (womb). It is not known if metformin increases the risk of polyps in humans. Talk to your doctor about the risks of taking this medication.
Metformin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. |
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. |
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