INSULATARD FLEXPEN 3 ML

How INSULATARD FLEXPEN 3 ML Works

• Insulatard FlexPen 3 ml contains human insulin, which is produced by recombinant DNA technology. Insulin is a hormone naturally produced by the pancreas that helps glucose (sugar) from the blood enter cells to be used for energy. In people with diabetes, the pancreas either doesn't produce enough insulin (Type 1 diabetes) or the body doesn't respond properly to the insulin it produces (Type 2 diabetes). Insulatard is an intermediate-acting insulin. This means it starts working within approximately 1.5 hours after injection, and its effect lasts for up to 24 hours. It provides a background level of insulin to cover the body's needs between meals and overnight.
• When you inject Insulatard, the insulin is absorbed into the bloodstream. It then binds to insulin receptors on cells throughout the body, primarily in the liver, muscle, and fat tissues. This binding triggers a cascade of intracellular events that facilitate glucose uptake. In muscle and fat cells, insulin stimulates the translocation of glucose transporters (GLUT4) to the cell surface, allowing glucose to enter these cells. In the liver, insulin promotes glucose storage as glycogen and inhibits the production of glucose.
• By facilitating glucose uptake and storage, Insulatard helps to lower blood glucose levels. In patients with diabetes, this helps to control hyperglycemia (high blood sugar), which can lead to various complications over time. Regular use of Insulatard, as prescribed by your doctor, helps to maintain stable blood glucose levels, reducing the risk of long-term complications such as nerve damage (neuropathy), kidney damage (nephropathy), eye damage (retinopathy), and cardiovascular problems.
• It's important to use Insulatard FlexPen 3 ml exactly as your healthcare provider instructs. The dosage and timing of injections will depend on your individual needs, blood glucose levels, diet, and activity level. Regular monitoring of blood glucose is crucial to ensure that Insulatard is working effectively and to adjust the dosage as needed. Always consult with your doctor or diabetes educator if you have any questions or concerns about using Insulatard.

Like all medicines, Insulatard FlexPen can cause side effects, although not everybody gets them. **Very Common (may affect more than 1 in 10 people):** * Hypoglycaemia (low blood sugar). Early warning symptoms of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heart beat, feeling sick, feeling very hungry, temporary changes in vision, drowsiness, unusual tiredness and weakness, nervousness or tremor, feeling anxious, feeling confused, difficulty in concentrating. **Uncommon (may affect up to 1 in 100 people):** * Allergic reactions: Local allergic reactions (pain, redness, hives, itching, swelling) may occur at the injection site. These usually disappear within a few weeks of continuing to take your insulin. If the reactions do not disappear, see your doctor immediately. * Lipodystrophy: If you inject insulin too often at the same site, the fatty tissue under the skin may either shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the injection site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or diabetes nurse because these reactions can change the absorption of your insulin. * Oedema (swelling): Swelling may occur around your ankles and other joints at the beginning of your insulin treatment. This is usually temporary. **Rare (may affect up to 1 in 1,000 people):** * Serious allergic reaction: If you have allergic reactions spread to other parts of your body, such as sudden swelling of the face, tongue or throat, difficulty breathing, or sudden drop in blood pressure, this is a potentially serious condition. Seek medical attention immediately. **Very Rare (may affect up to 1 in 10,000 people):** * Vision problems: At the beginning of your insulin treatment, it can cause temporary vision problems, but this usually wears off. * Painful neuropathy (nerve damage): If your blood sugar levels improve very fast, it can cause nerve-related pain – this is usually temporary. **Other possible side effects:** * Skin changes: If you inject insulin too often at the same place, the fatty tissue under the skin may shrink or get thicker (lipodystrophy). If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly.

• If you miss a dose of Insulatard Flexpen, inject the dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.
• Do not inject a double dose to make up for a missed dose.
• Consult your doctor or diabetes educator if you are unsure about what to do after missing a dose. They can provide personalized guidance based on your individual needs and circumstances.
• Monitor your blood sugar levels regularly, even if you miss a dose, to ensure they remain within the target range.

• Keep INSULATARD FLEXPEN 3ML away from the reach of children and pets.
• Store INSULATARD FLEXPEN 3ML in a refrigerator (2 - 8°C). Do not freeze.

• **Understand Your Insulin Needs:** Insulatard is an intermediate-acting insulin. Work closely with your doctor or diabetes educator to determine the correct dosage and timing for your specific needs. Factors like diet, exercise, and stress can influence your insulin requirements, so regular monitoring and adjustments are essential.
• **Proper Injection Technique is Key:** Always inject Insulatard subcutaneously (under the skin) as instructed by your healthcare provider. Rotate injection sites within the same general area (e.g., abdomen, thigh, or upper arm) to prevent lipodystrophy (skin thickening or pitting). Use a new needle for each injection to maintain sterility and minimize discomfort. Make sure the needle length is appropriate for your body type to ensure proper subcutaneous delivery and prevent intramuscular injection.
• **Mixing and Administration:** Insulatard is a suspension, so it's crucial to resuspend the insulin properly before each injection. Gently roll the FlexPen between your hands 10-20 times and invert it 10-20 times until the liquid appears uniformly cloudy or milky. If you see clumps or particles after mixing, do not use the pen. Prime the pen before each injection by dialing 2 units and pressing the injection button until a drop of insulin appears. This ensures accurate dosing.
• **Storage Matters:** Store unopened Insulatard FlexPens in the refrigerator (2°C to 8°C or 36°F to 46°F). Do not freeze. Once in use, the FlexPen can be stored at room temperature (below 30°C or 86°F) for up to 6 weeks, away from direct heat and sunlight. Always keep the pen cap on when not in use to protect the insulin from light. Discard the pen after 6 weeks, even if there is insulin remaining.
• **Be Prepared for Hypoglycemia:** Hypoglycemia (low blood sugar) is a common side effect of insulin therapy. Recognize the symptoms of hypoglycemia, which may include sweating, shakiness, dizziness, hunger, and confusion. Always carry a source of fast-acting carbohydrates, such as glucose tablets or juice, to treat hypoglycemia promptly. Inform your family, friends, and coworkers about your diabetes and how to assist you if you experience a severe hypoglycemic episode. Consider wearing a medical identification bracelet or carrying a card indicating you have diabetes and take insulin.
• **Monitor Blood Glucose Regularly:** Frequent blood glucose monitoring is essential for managing diabetes effectively with Insulatard. Check your blood sugar levels as directed by your doctor or diabetes educator, especially before meals, at bedtime, and when you suspect hypoglycemia. Use a blood glucose meter and test strips that are compatible and properly calibrated. Keep a log of your blood glucose readings to identify patterns and adjust your insulin dosage or other diabetes management strategies as needed.
• **Travel Smart with Insulatard:** When traveling with Insulatard, always carry it in your hand luggage, not in checked baggage, to prevent it from being exposed to extreme temperatures. Bring a copy of your prescription or a letter from your doctor confirming your need for insulin. Pack extra supplies, including insulin, syringes/pen needles, blood glucose meter, test strips, and fast-acting carbohydrates, in case of delays or emergencies. Check the regulations of your destination regarding carrying medications and syringes.

• Insulatard Flexpen 3 ml is an intermediate-acting insulin. It is important to maintain consistency in your diet and meal timings while using this medication. Changes in your food intake, such as skipping meals or altering your carbohydrate intake, can significantly affect your blood sugar levels. It is recommended to monitor your blood glucose levels regularly and adjust your insulin dosage as needed based on your healthcare provider's advice.
• Be cautious about consuming alcohol while using Insulatard Flexpen. Alcohol can lower blood sugar levels and may increase the risk of hypoglycemia. If you consume alcohol, do so in moderation and monitor your blood sugar levels closely.
• If you are experiencing nausea, vomiting, or diarrhea, this can impact your ability to maintain stable blood sugar levels. Consult your doctor for advice on managing your insulin dosage during these times.