Soliqua SoloStar 10-40 DS 100U+50MCG 3 Pens (Refrigerator) What Insulin glargine + lixisenatide is used for: Insulin glargine + lixisenatide is used to improve blood sugar levels in adult patients with type 2 diabetes mellitus. It contains two active substances that help your body control your blood sugar: insulin glargine – a long-acting basal insulin which lowers your blood sugar levels. lixisenatide – a ‘GLP-1 analogue’ that helps your body make more insulin during meals and lowers the amount of sugar made by your body. Insulin glargine + lixisenatide is used with oral medicines for diabetes (such as metformin, pioglitazone and sulfonylurea medicines). It is prescribed when these medicines (used alone or with GLP-1 treatment or with basal insulin) are not enough to control your blood sugar levels. Do not use Insulin glargine + lixisenatide: if you are allergic to insulin glargine or lixisenatide or any of the other ingredients of this medicine. Warnings and Precautions: Talk to your doctor, before using Insulin glargine + lixisenatide: If you are also taking other medicines to treat diabetes Do not use Insulin glargine + lixisenatide if you have type 1 diabetes mellitus or if you have ‘ketoacidosis’ (a condition with a build-up of acid in the blood). Do not use insulin glargine + lixisenatide before the age of 18 years. The use of Insulin glargine + lixisenatide is not recommended in patients with inflammatory bowel disease or delayed gastric emptying. If you have eye problems. If you have or have had a thyroid disease. If you have a severe stomach ache which does not go away, this could be a sign of inflamed pancreas. If you have dehydration (loss of fluids from the body) which can happen if you are feeling or being sick (nausea or vomiting) or have diarrhea – it is important to drink plenty of fluids to stop dehydration. Possible side effects of Insulin glargine + lixisenatide: Insulin glargine + lixisenatide is given as an injection under the skin (subcutaneously). Do not inject it into a vein or muscle. The best places to inject are the front of your thighs, upper arms or the front of your waist (abdomen). Change the place within the area where you inject each day to reduce the risk of developing lumps and skin pitting. Always use a new needle for each injection. Re-use of needles may increase the risk of blocked needles leading to inaccurate dosing. Dispose of the needle safely after each use. Other medicines and Insulin glargine + lixisenatide: Please tell your doctor, if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially if you take medicines for: birth control, pain, hormonal replacement, diabetes, hypertension, asthma, depression, auto-immune diseases and infection. How to take Insulin glargine + lixisenatide: Your dose of Insulin glargine + lixisenatide is administered as ‘dose steps’. The dose counter on the pen shows the number of dose steps. Use Insulin glargine + lixisenatide once each day, preferably at the same time every day. Choose a time of the day that works best for you. Insulin glargine + lixisenatide is given as an injection under the skin (subcutaneously). Do not inject it into a vein or muscle. The best places to inject are the front of your thighs, upper arms or the front of your waist (abdomen). Change the place within the area where you inject each day to reduce the risk of developing lumps and skin pitting. Always use a new needle for each injection. Re-use of needles may increase the risk of blocked needles leading to inaccurate dosing. Dispose of the needle safely after each use. How to store Insulin glargine + lixisenatide: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP’. Before opening: Store in a refrigerator (2°C to 8°C). Keep away from the freezing element. Do not freeze. During use: You can carry Insulin glargine + lixisenatide with you and keep it at room temperature (no more than 30°C) or in a refrigerator (2°C to 8°C) for up to 21 days. The product should be thrown away 21 days after first opening. Always keep the cap on the pre-filled pen when you are not using it in order to protect it from light. Do not throw away any medicines via wastewater or household waste.