WARNING

Taking Actoplus Met XR (a combination of pioglitazone and metformin) comes with several risks that you should be aware of:

• Heart Failure: Pioglitazone can cause or worsen congestive heart failure. Monitor for symptoms like shortness of breath, swelling, or rapid weight gain.
• Lactic Acidosis: Metformin can rarely cause a serious condition called lactic acidosis, especially in people with kidney issues, severe infections, or excessive alcohol use. This requires immediate medical attention.
• Bladder Cancer: Long-term use of pioglitazone may increase the risk of bladder cancer. Report any symptoms like blood in urine or pain during urination to your doctor.
• Hypoglycemia (Low Blood Sugar): The risk of low blood sugar increases when taken with other diabetes medications. Symptoms include dizziness, sweating, and confusion.
• Liver Issues: Both components can affect liver function, so regular monitoring is important.
• Bone Fractures: Pioglitazone may increase the risk of fractures, particularly in women.

These risks highlight the importance of regular monitoring, following your doctor’s guidance, and promptly reporting any unusual symptoms.

Why is this medication prescribed?

Actoplus Met XR is a combination medication used to manage type 2 diabetes. It combines two drugs: pioglitazone (a thiazolidinedione) and metformin (a biguanide). Here’s what each component does:

• Pioglitazone: This helps to increase the body’s sensitivity to insulin, which can help control blood sugar levels.
• Metformin: This reduces the amount of sugar produced by the liver and helps the body use insulin more effectively.

The combination of these two medications helps to improve blood sugar control when diet and exercise alone are not sufficient.

How should this medicine be used?

Actoplus Met XR should be used as prescribed by your healthcare provider. Here’s a general guideline on how it is typically used:

• Dosage: The dosage will be tailored to your individual needs based on your blood sugar levels, other medical conditions, and how you respond to treatment. Typically, it is taken once daily.
• Administration: Take Actoplus Met XR with meals to reduce the risk of gastrointestinal side effects. Swallow the extended-release tablet whole. Do not crush, chew, or break it, as this can release the drug too quickly, increasing the risk of side effects.
• Monitoring: Regular blood sugar monitoring is essential to ensure the medication is working effectively. Your doctor may adjust your dose based on your blood sugar levels and how you tolerate the medication.
• Lifestyle: Continue to follow your prescribed diet and exercise regimen while taking this medication.
• Missed Dose: If you miss a dose, take it as soon as you remember, unless it’s almost time for your next dose. Do not take two doses at the same time.
• Storage: Store at room temperature, away from moisture and heat.

Always follow your healthcare provider’s instructions, and consult them if you have any questions or concerns about your medication.

Other uses for this medicine

• Polycystic Ovary Syndrome (PCOS): Metformin, one of the components, is sometimes used to manage PCOS, particularly in women with insulin resistance.
• Prevention of Type 2 Diabetes: Metformin may be used off-label to help prevent or delay the onset of type 2 diabetes in individuals with prediabetes.

What special precautions should I follow?

Before taking Actoplus Met XR, it’s crucial to consider the following precautions:

• Allergies: Inform your doctor if you have any allergies to pioglitazone, metformin, or any other medications.
• Heart Problems: Pioglitazone may cause or worsen congestive heart failure. Notify your doctor if you have a history of heart disease.
• Liver Disease: Actoplus Met XR should be used with caution if you have liver problems.
• Kidney Problems: Metformin is processed by the kidneys, so its use requires caution in individuals with kidney disease.
• Bladder Cancer: There is a potential risk of bladder cancer with long-term use of pioglitazone. Discuss this risk with your doctor.
• Lactic Acidosis: Metformin can rarely cause a serious condition called lactic acidosis. This risk is higher in people with kidney disease, severe infections, dehydration, or excessive alcohol use.
• Pregnancy and Breastfeeding: Inform your doctor if you are pregnant or plan to become pregnant. They may need to adjust your medication. It’s unclear if Actoplus Met XR passes into breast milk. Discuss the risks and benefits with your healthcare provider.
• Alcohol Use: Limit alcohol consumption while taking Actoplus Met XR, as it can increase the risk of lactic acidosis from metformin.
• Surgery or Procedures: Inform your doctor or dentist that you are taking Actoplus Met XR before any surgery or medical procedures. You may need to stop the medication temporarily.
• Symptoms of Low Blood Sugar (Hypoglycemia): Be aware of signs like dizziness, sweating, and shaking. Carry a source of sugar with you in case of low blood sugar.
• Blood Sugar Levels: Regularly monitor your blood sugar as instructed by your doctor.
• Liver Function Tests: Periodic liver function tests may be needed to check for any adverse effects.
• Kidney Function: Your doctor may monitor your kidney function, especially if you are at risk for kidney problems.
• Medication Interactions: Inform your healthcare provider of all the medications, supplements, and herbal products you are taking, as Actoplus Met XR can interact with other drugs.

Following these precautions will help you manage your diabetes effectively and reduce the risk of side effects. Always follow your healthcare provider’s guidance and report any unusual symptoms.

What special dietary instructions should I follow?

• Dietary Consistency: Maintain a consistent eating schedule to help manage blood sugar levels effectively. Your doctor may recommend a specific diet plan tailored to your condition.
• Balanced Diet: Focus on a balanced diet rich in whole grains, vegetables, lean proteins, and healthy fats. Limit the intake of refined sugars and high-fat foods.

What should I do if I forget a dose?

• Take It As Soon As You Remember: If you miss a dose, take it as soon as you remember, provided it’s not almost time for your next dose.
• Skip the Missed Dose If Necessary: If it’s nearly time for your next scheduled dose, skip the missed dose. Do not take two doses at the same time to make up for the missed one.
• Set Reminders: Consider setting reminders or using a pill organizer to help ensure you take your medication as prescribed.

What side effects can this medication cause?

Actoplus Met XR is a combination medication containing pioglitazone and metformin, used to manage blood sugar levels in people with type 2 diabetes. Like all medications, it can cause side effects. Common and serious side effects include:

Common Side Effects:

• Gastrointestinal Issues: Nausea, vomiting, diarrhea, stomach pain, and upset stomach.
• Weight Gain: Pioglitazone may cause weight gain.
• Edema: Swelling, particularly in the hands or feet.
• Headache: Mild to moderate headaches.
• Respiratory Infections: Increased risk of colds or respiratory infections.

Serious Side Effects:

• Lactic Acidosis: A rare but serious condition that can occur due to metformin accumulation, particularly in people with kidney problems. Symptoms include muscle pain, difficulty breathing, stomach pain, dizziness, and feeling cold or weak.
• Heart Failure: Pioglitazone can cause or worsen congestive heart failure. Symptoms include shortness of breath, rapid weight gain, and swelling in your ankles or feet.
• Bladder Cancer: Some studies suggest a potential risk of bladder cancer with long-term use of pioglitazone.
• Hypoglycemia: Low blood sugar, particularly when combined with other medications for diabetes.
• Bone Fractures: Pioglitazone may increase the risk of bone fractures in women.
• Liver Problems: Symptoms include yellowing of the skin or eyes (jaundice), dark urine, and severe nausea or vomiting.
• Rash, itching, or swelling: Especially of the face, tongue, or throat.
• Severe dizziness: Difficulty breathing, which can indicate a severe allergic reaction.

If you experience any serious side effects, it’s important to contact your healthcare provider immediately.

What should I know about storage and disposal of this medication?

Storage and Disposal of Actoplus Met XR:

Storage:

• Temperature: Store Actoplus Met XR at room temperature, ideally between 68°F and 77°F (20°C to 25°C).
• Moisture and Heat: Keep the medication in a dry place, away from moisture, heat, and direct sunlight. Do not store it in the bathroom.
• Container: Keep the medication in its original container, tightly closed, and out of reach of children and pets.

Disposal:

• Do Not Flush: Do not flush Actoplus Met XR down the toilet or pour it into a drain unless instructed to do so.
• Disposal Programs: Use a drug take-back program if available. Many pharmacies and community organizations offer these programs.
• Household Trash: If no take-back program is available, mix the medication with an unappealing substance (like dirt, cat litter, or used coffee grounds), place the mixture in a sealed plastic bag, and throw it away in your household trash. Be sure to remove or obscure any personal information on the prescription label before disposing of the container.

In case of emergency/overdose

• Lactic Acidosis Symptoms: Muscle pain, difficulty breathing, stomach pain, dizziness, feeling cold, extreme fatigue, and irregular heartbeat.
• Severe Hypoglycemia: Confusion, seizures, loss of consciousness, and extreme dizziness.
• Immediate Action: If you suspect an overdose, seek emergency medical attention immediately. Contact your local emergency services (911 in the U.S.) or go to the nearest emergency room.
• Poison Control: You can also contact your local poison control center for guidance. In the U.S., the national poison control helpline is 1-800-222-1222.
• Emergency Details: Be prepared to provide information about the amount of medication taken, the time of ingestion, and any symptoms experienced.

What other information should I know?

• Regular Check-Ups: Regular monitoring of blood sugar levels, liver function, and other health indicators is important while taking Actoplus Met XR.
• Medication List: Keep an updated list of all medications and supplements you are taking to share with your healthcare provider to avoid potential interactions.
• Pregnancy and Lactation: If you are pregnant, planning to become pregnant, or breastfeeding, discuss with your healthcare provider whether Actoplus Met XR is appropriate for you.
• Lifestyle Management: Actoplus Met XR is part of a broader diabetes management plan that includes diet, exercise, and possibly other medications.

Always follow your healthcare provider’s instructions for managing your medication and consult them with any questions or concerns about Actoplus Met XR.