Admelog 100 units/ml solution for injection in cartridge

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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).

Admelog in cartridges is only suitable for injecting just under the skin using a reusable pen (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 cartridge) of the product you are using and provide this information when reporting any side effects.

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).

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,
• “beta₂ 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”).

Your blood sugar levels may change if you drink alcohol. Therefore the amount of insulin needed may change.

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.

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

This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially “sodium-free”.

• 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.

• 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.

• First wash your hands. Disinfect the rubber membrane of the cartridge.
• The 3 ml cartridge only fits the 3 ml pen. Admelog in cartridges is only suitable for injecting just under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method. To ensure you get the accurate dose, the Admelog cartridges are to be used only with the following pens:
  
  • JuniorSTAR which delivers doses in steps of 0.5 units
  • Tactipen, AllStar and AllStar PRO which deliver doses in steps of 1 unit.
  Not all of these pens may be marketed in your country.
• Follow the instructions that come with the pen. The manufacturer’s instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
• Always perform a safety test before each injection.

• 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.

• As soon as you have done the injection, take the needle off the pen using the outer needle cap. Do not share your needles. Do not share your pen.
  Replace the cap on your pen. Leave the cartridge in the pen.

Always use a new sterile needle for each injection. Always perform a safety test before each injection.

Do not mix any other insulin in an Admelog cartridge. Once the cartridge is empty, do not use it again.

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 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 hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids (dehydration), unconsciousness, coma or even death (see “Hypoglycaemia” and “Hyperglycaemia and diabetic ketoacidosis” in section 4 “Possible Side Effects”).

Three simple steps to avoid hypoglycaemia or hyperglycaemia are:

• Always keep spare syringes and a spare vial of Admelog, or a spare pen and cartridges, in case you lose your pen or cartridges or they get damaged.
• Always carry something to show you are diabetic.
• Always carry sugar with you.

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.

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.

A. Hypoglycaemia

Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood.

This can be caused if:

• you inject too much Admelog or other insulin;
• you miss or delay meals or change your diet;
• you exercise or work too hard just before or after a meal;
• you have an infection or illness (especially diarrhoea or vomiting);
• there is a change in your need for insulin; or
• you have trouble with your kidneys or liver which gets worse.

Alcohol and some medicines can affect your blood sugar levels (see section 2).

The first symptoms of low blood sugar usually come on quickly and include the following:

• tiredness
• nervousness or shakiness
• headache
• rapid heartbeat
• feeling sick
• cold sweat

While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a car, in which you or others would be put at risk by hypoglycaemia.

B. Hyperglycaemia and diabetic ketoacidosis

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. Hyperglycaemia can be brought about by:

• not using your Admelog or other insulin;
• using less insulin than your doctor tells you to;
• eating a lot more than your diet allows; or
• fever, infection or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many hours or days. The symptoms include the following:

• feeling sleepy
• flushed face
• thirst
• no appetite
• fruity smell on the breath
• feeling or being sick

Severe symptoms are heavy breathing and a rapid pulse.

Get medical help immediately.

C. Illness

If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even when you are not eating normally, you still need insulin.

Test your urine or blood, follow your ‘sick rules’, and tell your doctor.

• The active substance is insulin lispro.
  One ml of the solution contains 100 units (equivalent to 3.5 mg) of insulin lispro. Each cartridge 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”).

Admelog solution for injection is a clear, colourless, aqueous solution.

Each cartridge contains 3 ml.

The Admelog cartridges come in a pack of 5 or 10 cartridges. Not all pack sizes may be marketed.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist