Ozempic 0.25 mg Pre-Filled Pen

Ozempic Information

• Product Name: Ozempic 0.25 mg solution for injection in a pre-filled pen
• Patient Leaflet Updated: 11-Aug-2023
• Manufacturer: Novo Nordisk Limited

What is Ozempic?

Ozempic is a remarkable medication that contains the active substance semaglutide. It plays a crucial role in helping your body manage blood sugar levels when they become too high and also aids in preventing heart disease.

Who Is Ozempic For?

Ozempic is prescribed for individuals who meet the following criteria:

• When blood sugar levels are not well-controlled through diet and exercise alone, and metformin cannot be used.
• In combination with other diabetes medications when they are insufficient to manage blood sugar levels effectively. These may include oral antidiabetics, such as metformin, thiazolidinediones, sulfonylureas, sodium-glucose cotransporter 2 (SGLT2) inhibitors, or insulin.

Please note that it is crucial to continue following your doctor’s advice regarding diet and exercise while using Ozempic.

Precautions and Warnings

Before using Ozempic, it’s important to consider the following:

Mian Precautions and Warnings

• Allergies: Do not use Ozempic if you are allergic to semaglutide or any of the other ingredients listed in section 6.
• Type 1 Diabetes: Ozempic is not suitable for those with
  type 1 diabetes, a condition where the body does not produce insulin.
• Diabetic Ketoacidosis: If you develop diabetic ketoacidosis, a complication of diabetes characterized by high blood sugar, breathing difficulties, confusion, excessive thirst, or a sweet taste or smell in the mouth, Ozempic is not to be used as it is not an insulin replacement.
• Digestive System Effects: Ozempic may lead to nausea, vomiting, or diarrhea, which can cause dehydration, especially if you have kidney problems. It is essential to stay hydrated during the treatment and consult your doctor with any concerns.
• Pancreatitis: Severe, persistent stomach pain may indicate acute pancreatitis. If you experience such symptoms, seek medical attention promptly.
• Hypoglycemia: Combining Ozempic with sulfonylureas or insulin might increase the risk of low blood sugar levels (hypoglycemia). Your doctor will guide you on monitoring and adjusting your blood sugar levels if needed.
• Diabetic Eye Disease: If you have diabetic eye disease, using Ozempic may worsen your vision, necessitating treatment. Inform your doctor if you have unstable diabetic eye disease.

Other Precautions and Warnings:

• Children and Adolescents: Ozempic is not recommended for individuals under 18 years old due to a lack of established safety and efficacy in this age group.
• Other Medications: Inform your healthcare provider about any other medications, including herbal remedies or over-the-counter drugs, you are currently using, especially warfarin or similar blood-thinning medications.
• Pregnancy and Breastfeeding: Ozempic is not advised during pregnancy, and contraception is recommended while using this medication. If you become pregnant while on Ozempic, consult your doctor for treatment adjustments. Avoid using Ozempic while breastfeeding, as it is unclear if it passes into breast milk.
• Driving and Using Machines: Ozempic is unlikely to affect your ability to drive or use machinery. However, if you combine it with a sulphonylurea or insulin, be cautious of low blood sugar symptoms that may reduce your concentration. Avoid driving or using machinery if you experience these symptoms.
• Sodium Content: Ozempic contains less than 1 mmol sodium per dose, making it essentially ‘sodium-free.’

How to Use Ozempic

Always use Ozempic exactly as prescribed by your healthcare professional. Here’s a general guideline:

Starting Dose:

• Begin with a 0.25 mg injection once a week for four weeks.
• Dose Increase: After four weeks, your doctor may raise your dose to 0.5 mg once a week. Further dose increases may be considered based on your blood sugar control.
• Injection Method: Ozempic is administered as a subcutaneous injection, typically in the front of your thighs, abdomen, or upper arm. Always consult your healthcare provider for specific injection guidance.
• Dosage Timing: Ideally, inject Ozempic once a week on the same day if possible, regardless of meals. To help you remember, label the chosen weekday and the date on the carton after each injection.

Missed Doses:

If you forget to inject a dose, follow these guidelines based on the duration since the missed dose:

• If it’s 5 days or less since the scheduled injection, use it as soon as you remember and continue with your regular schedule.
• If it’s more than 5 days, skip the missed dose and proceed with your normal schedule. Do not take a double dose to compensate for a missed one.

Discontinuation:

Do not stop using Ozempic without consulting your doctor, as this may lead to an increase in blood sugar levels.

Possible Side Effects

Like any medication, Ozempic may cause side effects. Below are some potential side effects to be aware of:

• Common (may affect up to 1 in 10 people): Complications of diabetic eye disease (retinopathy) – inform your doctor if you experience vision changes during Ozempic treatment.
• Rare (may affect up to 1 in 1,000 people): Severe allergic reactions (anaphylactic reactions, angioedema) – contact your healthcare provider and seek immediate medical help if you experience symptoms like difficulty breathing, swelling of the face, lips, tongue, throat, or a rapid heartbeat.
• Very Common (may affect more than 1 in 10 people):
  • Feeling sick (nausea) – this side effect typically improves with time.
  • Diarrhea – this side effect usually improves with time.
  • Vomiting
  • Low blood sugar (hypoglycemia) when Ozempic is used with another antidiabetic medicine
• Uncommon (may affect up to 1 in 100 people):
  • Change in the way food or drink tastes
  • Fast pulse
  • Injection site reactions, such as bruising, pain, irritation, itching, and rash
  • Allergic reactions like rash, itching, or hives
  • A delay in the emptying of the stomach

If you experience any side effects, discuss them with your doctor, pharmacist, or nurse.

This list is not exhaustive, and you should consult your healthcare provider for any concerns.

How to Store Ozempic

Please follow these storage recommendations to ensure the effectiveness and safety of Ozempic:

• Keep Ozempic out of reach of children.
• Do not use Ozempic after the expiry date, which is indicated on the pen label and carton as ‘EXP.’
• Store Ozempic in a refrigerator (2 °C–8 °C) before opening. Do not freeze, and keep it away from direct contact with the cooling element. Protect it from light.
• During use, you can keep the pen for up to 6 weeks if stored at a temperature below 30 °C or in a refrigerator (2 °C–8 °C) away from the cooling element. Do not freeze Ozempic or use it if it has been frozen.
• When not in use, keep the pen cap on to shield it from light.
• Never dispose of medicines via wastewater or household waste. Consult your pharmacist for proper disposal methods to protect the environment.

Contents of the Pack

Each Ozempic 0.25 mg solution for injection pre-filled pen contains 1.5 ml of clear and almost colorless solution, delivering four doses of 0.25 mg. The pack includes one pen and four disposable NovoFine® Plus needles.

Instructions on How to Use Ozempic® 0.25 mg Solution for Injection in a Pre-Filled Pen

For proper administration of Ozempic 0.25 mg, please follow these step-by-step instructions carefully:

• Prepare Your Pen with a New Needle:

  • Verify that your pen contains Ozempic® 0.25 mg.
  • Pull off the pen cap.
  • Check the solution in your pen through the pen window. Do not use if it appears cloudy or discolored.
  • Take a new needle and check for damages on the paper tab and outer needle cap. If damaged, use a new needle.
  • Tear off the paper tab.
  • Push the needle straight onto the pen and secure it.
  • Remove the inner needle cap and discard it.
  • A drop of solution may appear at the needle tip, which is normal, especially if it’s a new pen. Check the flow if it’s your first time using a new pen (see step 2 ‘Check the flow’).

• Check the Flow (For New Pens):

  • Turn the dose selector until the dose counter displays the flow check symbol.
  • Hold the pen with the needle pointing up.
  • Press and hold the dose button until the dose counter returns to 0, ensuring it aligns with the dose pointer.
  • A drop of solution should appear at the needle tip.
  • If no drop appears, repeat the flow check up to 6 times. If there’s still no drop, change the needle and repeat the flow check.
  • If no drop appears even after changing the needle, dispose of the pen and use a new one.

• Select Your Dose:

  • Turn the dose selector to choose 0.25 mg.
  • Continue turning until the dose counter stops at 0.25 mg.
  • Ensure that the dose counter and dose pointer both indicate 0.25 mg.

• Inject Your Dose:

  • Insert the needle into your skin as instructed by your healthcare provider.
  • Keep the dose counter visible without covering it.
  • Press and hold the dose button until the dose counter reaches 0, making sure it lines up with the dose pointer. You may hear or feel a click.
  • Keep the needle in your skin for a count of 6 to ensure you receive the full dose.
  • Remove the needle from your skin. If there’s any blood at the injection site, press gently without rubbing.
  • You may notice a drop of solution at the needle tip after the injection, which is normal and does not affect your dose.

• After Your Injection:

  • Place the needle tip into the outer needle cap, avoiding contact with the needle or cap. Carefully push the outer needle cap over the needle.
  • Unscrew the needle and dispose of it following local disposal guidelines. Consult your healthcare provider or pharmacist for sharps disposal guidance.
  • Always replace the pen cap after each use to protect the solution from light.
  • Remove the needle after each injection for convenience and to prevent blocked needles.

Additional Important Information:

• This information is subject to change, so always refer to the patient leaflet and follow your healthcare provider’s guidance for the most current information and instructions.
• Please remember to report any side effects as they can help provide valuable safety information about this medicine. You can also report side effects directly via the Yellow Card Scheme in Great Britain. Visit MHRA Yellow Card or search for MHRA Yellow Card in the Google Play or Apple App Store to report side effects.
• Always keep your pen and needles out of reach, especially from children.
• Never share your pen or needles with others.
• Caregivers must handle used needles with caution to prevent needle injuries and cross-infection.
• Handle your pen with care to avoid inaccurate dosing due to rough handling or misuse.
• Do not inject Ozempic that has been frozen or exposed to direct sunlight.
• Protect your pen from dust, dirt, and liquid.
• Do not wash, soak, or lubricate your pen. If cleaning is necessary, use a mild detergent on a moist cloth.
• Avoid dropping or knocking your pen against hard surfaces. In case of an accidental drop or suspicion of damage, attach a new needle and check the flow before injection.
• Never attempt to refill or repair your pen.

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We hope these instructions help you use Ozempic effectively and safely. If you have any questions or need further assistance, please reach out to our dedicated team of pharmacists and medical advisors at Ayman Alexan Pharmacy in Hurghada. Your well-being is our priority, and we are here to support your health journey.