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CHEMICAL NAME
Pioglitazone Hydrochloride and Metformin Hydrochloride.
INDICATIONS
ACTOPLUS MET is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and metformin or whose diabetes is not adequately controlled with metformin alone, or for those patients who have initially responded to pioglitazone alone and require additional glycemic control. Management of type 2 diabetes should also include nutritional counseling,weight reduction as needed, and exercise. These efforts are important not only in the primary treatment of type 2 diabetes, but also to maintain the efficacy of drug therapy.
DIRECTIONS
Take Actoplus Met exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain the instructions to you.
Take each dose with a full glass of water.
Take Actoplus Met with meals to reduce nausea, diarrhea, and upset stomach that may occur with Actoplus Met therapy. These symptoms may be more likely to occur during the first few weeks of therapy.
It is important to take Actoplus Met regularly to get the most benefit.
A decrease in vitamin B12 may also occur during Actoplus Met therapy. Your doctor may want to monitor blood levels of vitamin B12 and you may need to take a B12 supplement. A vitamin B12 deficiency may rarely cause anemia.
Your doctor may want to monitor your blood sugar control and other factors with blood tests during treatment.
Usually, liver function is monitored with blood tests at the start of treatment, every two months for the first year of treatment, and periodically thereafter during treatment with pioglitazone. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, or dark urine. These symptoms may be early signs of liver problems.
Store Actoplus Met at room temperature away from moisture and heat.
MISSED DOSE:Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose.
SIDE EFFECTS
Stop taking Actoplus Met and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, or dark urine. These symptoms may be early signs of liver problems.
Notify your doctor immediately if you experience an unusually rapid increase in weight or edema (water retention), shortness of breath, or chest pain during treatment with metformin pioglitazone. These may be early symptoms of heart problems.
A small number of people who have taken metformin (with and without pioglitazone), have developed a serious condition called lactic acidosis that has been fatal in up to 50% of cases. Lactic acidosis has occurred most often in people whose kidneys were not working properly. Liver problems may also increase the risk of developing lactic acidosis. Stop taking Actoplus Met and call your doctor immediately if you experience a feeling of general discomfort or sickness; weakness; sore or aching muscles; trouble breathing, unusual drowsiness, dizziness or lightheadedness; unusual or unexplained stomach upset (after the initial stomach upset that may occur at the start of therapy with Actoplus Met); or the sudden development of a slow or irregular heartbeat. These may be signs of lactic acidosis.
Actoplus Met does not usually cause hypoglycemia (low blood sugar). Nevertheless, hypoglycemia may occur, as a result of skipped meals, excessive exercise, or alcohol consumption. Know the signs and symptoms of low blood sugar, which include hunger, headache, drowsiness, weakness, dizziness, a fast heartbeat, sweating, tremor, and nausea. Carry a non-dietetic candy or glucose tablets to treat episodes of low blood sugar.
- Other, less serious side effects may be more likely to occur. Continue to take Actoplus Met and talk to your doctor if you experience
- nausea, vomiting, abdominal pain, or diarrhea at the start of therapy;
- abdominal bloating or increased gas production;
- decreased appetite or changes in taste (metallic taste in the mouth);
- cold-like symptoms (may indicate an upper respiratory tract infection);
- weight gain;
- fatigue; or
- headache.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
PRECAUTIONS
Some conditions may increase the risk of developing lactic acidosis while taking Actoplus Met. Tell your doctor that you are taking Actoplus Met if you become ill; if you have a heart attack; have a stroke; develop congestive heart failure; experience diarrhea, vomiting, fever, or dehydration from any cause; decrease the amount of food or liquid in your normal diet, or develop other health conditions. You may need to stop treatment with Actoplus Met for a short amount of time until you are feeling better. Avoid excessive alcohol intake while taking Actoplus Met. Together, alcohol and Actoplus Met may increase the risk of lactic acidosis and hypoglycemia. Follow diet, medication, and exercise routines very closely. Changing any of these things can affect blood sugar levels. Tell your doctor or other health care provider that you are taking this medication if you need to have surgery or x-ray procedures that require injection of contrast agents. Treatment with Actoplus Met may need to be stopped for a short period of time.
OVERDOSAGE
Seek emergency medical attention if an overdose is suspected. An overdose of Actoplus Met is likely to cause lactic acidosis. Symptoms of lactic acidosis include a feeling of general discomfort or sickness; weakness; sore or aching muscles; trouble breathing; unusual drowsiness, dizziness or lightheadedness; unusual or unexplained stomach upset (after the initial stomach upset that may occur at the start of therapy with Actoplus Met); and the sudden development of a slow or irregular heartbeat.
INFORMATION
Do not share this medicine with others. Store at 25 degree C (77 degree F); excursions permitted to 15-30 degree C (59-86 degree F). Keep container tightly closed, and protect from moisture and humidity.
NOTES
The above information is intended to supplement, not substitute for, the expertise and judgment of your physician,pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.
DRUG INTERACTIONS
Do not take any over-the-counter cough, cold, allergy, pain, or weight loss medications without first talking to your doctor. Many drugs may interact with Actoplus Met or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
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