Package leaflet: information for the user
Package leaflet: information for the user
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Admelog®
insulin lispro 100 units/ml
solution for injection in pre-filled pensubcutaneousGB
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Patient information leaflet
35 sectionsWhat is in this leaflet
What is in this leaflet 1. What Admelog is and what it is used for 2. What you need to know before you use Admelog 3. How to use Admelog 4. Possible side effects 5. How to store Admelog 6. Contents of the pack and other information
1. What Admelog is and what it is used for
Admelog is used to treat diabetes. It works more quickly than normal human insulin because the insulin molecule has been changed slightly. You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Admelog is a substitute for your own insulin and is used to control glucose in the long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally use Admelog within 15 minutes of a meal. Your doctor may tell you to use Admelog as well as a longer-acting insulin. Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change your insulin unless your doctor tells you to. Be very careful if you do change insulin. Admelog is suitable for use in adults and children. Admelog SoloStar is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro. One Admelog pre-filled pen contains multiple doses of insulin. The Admelog pre-filled pen dials 1 unit at a time. The number of units are displayed in the dose window, always check this before your injection. You can give from 1 to 80 units in a single injection. If your dose is more than 80 units, you will need to give yourself more than one injection.
2. What you need to know before you use Admelog
Do not use Admelog
Do not use Admelog – if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to deal with mild hypoglycaemia (see section 3: If you use more Admelog than you need). – if you are allergic to insulin lispro or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Warnings and precautions Admelog in pre-filled pen is only suitable for injecting just under the skin (see also section 3). Speak to your doctor if you need to inject your insulin by another method. Record the brand name (“Admelog”) and Lot number (included on the outer cartons and labels of each pre-filled pen) of the product you are using and provide this information when reporting any side effects.
Skin changes at the injection site
Skin changes at the injection site The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see “How to use Admelog”). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Talk to your doctor, pharmacist or nurse before using Admelog: • If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often. • A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. • If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse – Have you recently become ill? – Do you have trouble with your kidneys or liver? – Are you exercising more than usual? • You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home. • Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema). • This pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the pen.
Talk to your doctor, pharmacist or nurse before using Admelog: • If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this leaflet. You must think carefully about when to have your meals, how often to exercise and how much to do. You must also keep a close watch on your blood sugar levels by testing your blood glucose often. • A few people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. • If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse – Have you recently become ill? – Do you have trouble with your kidneys or liver? – Are you exercising more than usual? • You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. The time difference between countries may mean that you have to have your injections and meals at different times from when you are at home. • Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema). • This pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the pen.
Other medicines and Admelog
Other medicines and Admelog Your insulin needs may change if you are taking • the contraceptive pill, • steroids, • thyroid hormone replacement therapy, • oral hypoglycaemics, • acetyl salicylic acid, • sulpha antibiotics, • octreotide, • “beta 2 stimulants” (for example ritodrine, salbutamol or terbutaline), • beta-blockers, or • some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors), • danazol, • some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and • angiotensin II receptor blockers. Tell your doctor if you are taking, have recently taken or might take any other medicines (see also section “Warnings and precautions”).
Admelog with alcohol
Admelog with alcohol Your blood sugar levels may change if you drink alcohol. Therefore the amount of insulin needed may change.
Pregnancy and breast-feeding
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The amount of insulin you need usually falls during the first three months of pregnancy and increases for the remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet.
Driving and using machines Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines). You should contact your doctor about the advisability of driving if you have: • frequent episodes of hypoglycaemia • reduced or absent warning signs of hypoglycaemia
Driving and using machines Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines). You should contact your doctor about the advisability of driving if you have: • frequent episodes of hypoglycaemia • reduced or absent warning signs of hypoglycaemia
Admelog contains sodium
Admelog contains sodium This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially “sodium-free”.
3. How to use Admelog
Always check the pack and the label of the pre-filled pen for the name and type of the insulin when you get it from your pharmacy. Make sure you get the Admelog that your doctor has told you to use. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used by you only, even if the needle is changed.
Dose
Dose • You should normally inject Admelog within 15 minutes of a meal. If you need to, you can inject soon after a meal. But your doctor will have told you exactly how much to use, when to use it, and how often. These instructions are only for you. Follow them exactly and visit your diabetes clinic regularly. • If you change the type of insulin you use (for example from a human or animal insulin to an Admelog product), you may have to use more or less than before. This might just be for the first injection or it may be a gradual change over several weeks or months. • Inject Admelog under the skin (subcutaneous use or “SC”). You should only inject it into a muscle if your doctor has told you to.
Preparing Admelog
Preparing Admelog • Admelog is already dissolved in water, so you do not need to mix it. But you must use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time you inject yourself.
Getting the SoloStar pre-filled pen ready to use (Please see user manual)
Getting the SoloStar pre-filled pen ready to use (Please see user manual) • Admelog in pre-filled pen is only suitable for injecting just under the skin. Speak to your doctor if you need to inject your insulin by another method. • First wash your hands. • Read the instructions on how to use your prefilled insulin pen. Please follow the instructions carefully. Here are some reminders. • Use a clean needle (needles are not included). • Always perform a safety test before each injection.
Injecting Admelog
Injecting Admelog • Before you make an injection, clean your skin as you have been instructed. Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle in the skin for ten seconds to make sure you have injected the whole dose. Do not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Admelog injection will still work quicker than soluble human insulin. • You must not administer Admelog by the intravenous route (IV). Inject Admelog as your physician or nurse has taught you. Only your physician can administer Admelog by the intravenous route. He will only do this under special circumstances such as surgery or if you are ill and your glucose levels are too high.
After injecting
After injecting • As soon as you have done the injection, unscrew the needle from the pre-filled pen using the outer needle cap. Do not share your needles. Do not share your pen. Replace the cap on your pen.
Further injections
Further injections • Every time you use a pre-filled pen you must use a new needle. Always perform a safety test before each injection. You can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale. • Do not mix any other insulin in your pre-filled pen. Once the pre-filled pen is empty, do not use it again. Please get rid of it carefully – your pharmacist or diabetes nurse will tell you how to do this.
If you use more Admelog than you should
If you use more Admelog than you should If you use more Admelog than you need or are unsure how much you have injected, a low blood sugar may occur. Check your blood sugar. If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon.
If you forget to use Admelog
If you forget to use Admelog If you use less Admelog than you need or are unsure how much you have injected, a high blood sugar may occur. Check your blood sugar.
If you stop using Admelog
If you stop using Admelog If you use less Admelog than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Systemic allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows: • rash over the whole • blood pressure body dropping • difficulty in breathing • heart beating fast • wheezing • sweating If you think you are having this sort of insulin allergy with Admelog, tell your doctor at once.
Systemic allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows: • rash over the whole • blood pressure body dropping • difficulty in breathing • heart beating fast • wheezing • sweating If you think you are having this sort of insulin allergy with Admelog, tell your doctor at once.
Local allergy is common (may affect up to 1 in 10 people).
Local allergy is common (may affect up to 1 in 10 people). Some people get redness, swelling or itching around the area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this happens to you, tell your doctor.
Skin changes at the injection site
Skin changes at the injection site Lipodystrophy is uncommon (it may affect up to 1 in 100 people). If you inject insulin too often at the same place, the fatty tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes.
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve control of your blood glucose.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Admelog
Keep out of the sight and reach of children. Do not use Admelog in pre-filled pen after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month. Before the first use store your pre-filled pen in a refrigerator (2 °C – 8 °C). Do not freeze. Keep the pre-filled pen in the outer carton in order to protect from light. Keep your Admelog pre-filled pen in use at room temperature (below 30 °C) and dispose of after 4 weeks. Do not keep the pre-filled pen that you are using in the fridge. The pre-filled pen should not be stored with the needle attached. Always keep the cap on the pre-filled pen when you are not using it in order to protect from light. Do not use Admelog pre-filled pen if the solution is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Admelog contains
What Admelog contains • The active substance is insulin lispro. Each ml of the solution contains 100 units (equivalent to 3.5 mg) of insulin lispro. Each pre-filled pen contains 3 ml of solution for injection, equivalent to 300 units. • The other ingredients are: metacresol, glycerol, disodium hydrogen phosphate heptahydrate, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity (see section 2 “Admelog contains sodium”).
What Admelog looks like and contents of the pack Admelog, solution for injection is a clear, colourless, aqueous solution. Each pre-filled pen contains 3 ml. The Admelog in pre-filled pen (SoloStar) comes in a pack of 1, 3, 5 or 10 pre-filled pens. Not all pack sizes may be marketed. The Admelog in your pre-filled pen is the same as the Admelog, which comes in separate Admelog cartridges. The pre-filled pen simply has a built-in cartridge. When the pre-filled pen is empty you cannot use it again.
What Admelog looks like and contents of the pack Admelog, solution for injection is a clear, colourless, aqueous solution. Each pre-filled pen contains 3 ml. The Admelog in pre-filled pen (SoloStar) comes in a pack of 1, 3, 5 or 10 pre-filled pens. Not all pack sizes may be marketed. The Admelog in your pre-filled pen is the same as the Admelog, which comes in separate Admelog cartridges. The pre-filled pen simply has a built-in cartridge. When the pre-filled pen is empty you cannot use it again.
Marketing Authorisation Holder Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Tel: 0800 035 2525 Email: uk-medicalinformation@sanofi.com Manufacturer Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
Marketing Authorisation Holder Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Tel: 0800 035 2525 Email: uk-medicalinformation@sanofi.com Manufacturer Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
This leaflet was last revised in February 2022
This leaflet was last revised in February 2022