Metformin ER 1000mg Osmotic Tabs

Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. It does not stimulate insulin secretion and therefore does not cause hypoglycemia when used alone.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Stomach problems that occur later during treatment, as these may be a sign of lactic acidosis (an acid health problem in the blood)
Low blood sugar symptoms, which may include:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating

If you experience low blood sugar, follow your doctor's instructions for treatment, which may include taking glucose tablets, liquid glucose, or some fruit juices.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only have minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:

Stomach pain or heartburn
Gas
Diarrhea, upset stomach, or vomiting
Feeling tired or weak
Headache

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Acidic blood problems
+ Kidney disease
+ Liver disease
Recent medical events, such as a heart attack or stroke
Any difficulties with eating or drinking, including situations where you may be required to fast before a procedure or surgery

Additionally, if you are scheduled to undergo an exam or test that involves contrast agents, or have had one within the past 48 hours, discuss this with your doctor.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you are experiencing

This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before consuming alcohol, discuss the potential risks with your doctor.

If you experience low blood sugar, do not operate a vehicle, as this can increase your risk of being involved in an accident. Monitor your blood sugar levels as instructed by your doctor, and undergo blood tests as recommended by your healthcare provider.

Be aware that stress, such as fever, infection, injury, or surgery, can affect your blood sugar control. Additionally, changes in physical activity, exercise, or diet may also impact your blood sugar levels. Adhere to the diet and exercise plan prescribed by your doctor to maintain optimal blood sugar control.

If you experience diarrhea or vomiting, contact your doctor promptly, as you may need to increase your fluid intake to prevent excessive fluid loss. In hot weather or during physical activity, be cautious and drink plenty of fluids to avoid dehydration.

Long-term treatment with metformin may lead to a decrease in vitamin B-12 levels. If you have a history of low vitamin B-12 levels, consult your doctor. You may notice the appearance of the tablet in your stool, but this is a normal occurrence and not a cause for concern. If you have any questions or concerns, discuss them with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age who have not been ovulating may experience a return of fertility while taking this medication. To avoid pregnancy, use birth control measures while taking this drug.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to you and your baby.

• Iodinated contrast media (temporarily discontinue at time of or prior to procedure)
• Severe renal impairment (eGFR <30 mL/min/1.73m2)

• Alcohol (increased risk of lactic acidosis)
• Cimetidine (increases metformin exposure)
• Ranolazine (increases metformin exposure)
• Dolutegravir (increases metformin exposure)
• Dofetilide (increases dofetilide exposure, potential for QT prolongation)
• Verapamil (increases metformin exposure)
• Rifampin (decreases metformin exposure)

• Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide - increased risk of lactic acidosis)
• Drugs that reduce metformin excretion (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, triamterene, trimethoprim, vancomycin - may increase metformin levels)
• Drugs that may cause hyperglycemia (e.g., thiazide and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid - may require dose adjustment of metformin)

• Symptoms of lactic acidosis (e.g., malaise, myalgia, respiratory distress, somnolence, abdominal distress, unusual muscle pain, feeling cold, irregular heartbeat, lightheadedness)
• Symptoms of hypoglycemia (if used in combination with insulin or sulfonylureas: e.g., sweating, tremor, dizziness, confusion, hunger)
• Symptoms of vitamin B12 deficiency (e.g., anemia, peripheral neuropathy, fatigue, weakness)

Metformin crosses the placenta. While insulin is generally preferred for glycemic control in pregnancy, metformin may be considered in some cases, particularly for gestational diabetes or polycystic ovary syndrome (PCOS), based on emerging data and individual risk-benefit assessment. Discuss with your healthcare provider.

Metformin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding, but infants should be monitored for potential adverse effects (e.g., hypoglycemia, gastrointestinal upset).

Metformin ER is not recommended for children under 10 years of age. For children 10-16 years, use with caution and careful dose titration due to limited data and potential for increased risk of adverse effects compared to IR formulation.

Use with caution due to the higher likelihood of decreased renal function in older adults. Renal function should be assessed more frequently. Start with lower doses and titrate slowly to minimize adverse effects and lactic acidosis risk.

• Metformin ER tablets should be swallowed whole and not crushed, chewed, or broken, as this can affect the extended-release mechanism and lead to rapid release of the drug.
• Patients may notice a 'ghost tablet' (the empty shell of the osmotic tablet) in their stool, which is a normal occurrence and does not mean the medication was not absorbed.
• Temporarily discontinue metformin before or at the time of iodinated contrast imaging procedures and for any surgical procedures or other procedures requiring restricted food or fluid intake. Re-evaluate renal function 48 hours later before restarting metformin.
• Long-term use of metformin has been associated with vitamin B12 deficiency. Consider periodic monitoring of vitamin B12 levels, especially in patients with risk factors or symptoms of deficiency.
• Educate patients on the symptoms of lactic acidosis and the importance of seeking immediate medical attention if they occur.

• Sulfonylureas (e.g., glipizide, glyburide)
• DPP-4 inhibitors (e.g., sitagliptin, saxagliptin)
• SGLT2 inhibitors (e.g., empagliflozin, canagliflozin)
• GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
• Thiazolidinediones (e.g., pioglitazone, rosiglitazone)
• Insulin therapy

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure your safety and the effectiveness of your treatment, never share your medication with others or take medication prescribed to someone else.

It's possible that some medications come with additional patient information leaflets. If you have any questions or concerns, consult with your pharmacist for more information.

If you have any questions or concerns about your medication, it's crucial to discuss them with your healthcare provider, which may include your doctor, nurse, pharmacist, or other healthcare professionals.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.