- insulin glulisine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: EU/1/04/285/032.
Apidra Solostar 100 Units/ml solution for injection in a pre-filled pen
Package leaflet: Information for the user
100 Units/ml solution for injection in a pre-filled pen
Read carefully all of this leaflet including the Instructions for Use of Apidra SoloStar, pre-filled pen, before using this medicine because it contains important information for you.
What is in this leaflet
1. What Apidra is and what it is used for
2. What you need to know before you use Apidra
3. How to use Apidra
4. Possible side effects
5. How to store Apidra
6. Contents of the pack and other information
1. What Apidra is and what it it used for
Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
It is made by biotechnology. It has a rapid onset within 10-20 minutes and a short duration, about 4 hours.
2. What you need to know before you use Apidra
Do not use Apidra
Warnings and precautions
Apidra in a 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.
Talk to your doctor, pharmacist or nurse before using Apidra.
Follow closely the instructions for dose, monitoring (blood tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
Special patient groups
If you have liver or kidney problems, speak to your doctor as you may need a lower dose.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Before travelling consult your doctor. You may need to talk about
Illnesses and injuries
In the following situations, the management of your diabetes may require extra care:
In most cases you will need a doctor. Make sure that you contact a doctor early.
If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. Always tell people who are caring for you or treating you that you require insulin.
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).
Other medicines and Apidra
Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high. Be careful when you start or stop taking another medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.
Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
Your blood sugar level may either rise or fall if you take:
Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Apidra with alcohol
Your blood sugar levels may either rise or fall if you drink alcohol.
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 or pharmacist for advice before taking this medicine.
Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your insulin dose may need to be changed during pregnancy and after giving birth. Careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
There are no or limited data on the use of Apidra in pregnant women.
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Driving and using machines
Your ability to concentrate or react may be reduced if:
Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines).
You should contact your doctor for advice on driving if:
Important information about some of the ingredients of Apidra
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.
Apidra contains metacresol
Apidra contains metacresol, which may cause allergic reactions.
3. How to use Apidra
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will determine how much Apidra you will need.
Apidra is a short-acting insulin. Your doctor may tell you to use it in combination with an intermediate, long acting insulin, a basal insulin or with tablets used to treat high blood sugar levels. If you switch from another insulin to insulin glulisine, your dosage may have to be adjusted by your doctor.
Many factors may influence your blood sugar level. You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low. See the box at the end of this leaflet for further information.
Method of administration
Apidra is injected under the skin (subcutaneously). Your doctor will show you in which area of the skin you should inject Apidra. Apidra can be injected in the abdominal wall, the thigh or upper arm or by continuous infusion in the abdominal wall.
The effect will be slightly quicker if the insulin is injected into your abdomen. As for all insulins, injection sites and infusion sites within an-injection area (abdomen, thigh or upper arm) must be rotated from one injection to the next.
Frequency of administration
Apidra should be taken shortly (0-15 minutes) before or soon after meals.
Instructions for proper use
How to handle SoloStar
SoloStar is a pre-filled disposable pen containing insulin glulisine. Apidra in a 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.
Read carefully the “SoloStar Instructions for use” included in this package leaflet. You must use the pen as described in these Instructions for use.
To prevent the possible transmission of disease, each pen must be used by one patient only. Before use always attach a new needle, and perform a safety test. Only use needles that are compatible for use with SoloStar (see “SoloStar Instructions for use”).
Look at the cartridge sealed in the disposable pen injector before you use it. Only use it if the solution is clear, colourless and has no visible particles in it. Do not shake or mix it before use. Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with SoloStar, please consult your Health Care Professional.
If you use more Apidra than you should
If you forget to use Apidra
If you stop using Apidra
This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop Apidra without speaking to a doctor, who will tell you what needs to be done.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
You must always check the insulin label before each injection to avoid mix-ups between Apidra and other insulins.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Hypoglycaemia (low blood sugar) can be very serious. Hypoglycaemia is a very commonly reported side effect (may affect more than 1 in 10 people).
Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood.
If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening.
If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately. See the box at the end of this leaflet for important further information about hypoglycaemia and its treatment.
If you experience the following symptoms, contact your doctor immediately:
Systemic allergic reactions are side effects reported uncommonly (may affect up to 1 in 100 people).
Generalised allergy to insulin: Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. These could be symptoms of severe cases of generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening.
Hyperglycaemia (high blood sugar) means that there is too much sugar in the blood.
The frequency of hyperglycaemia cannot be estimated. If your blood sugar level is too high, this tells you that you may need more insulin than you have injected. This can be serious if your blood glucose level becomes very high.
For more information on signs and symptoms of hyperglycaemia refer to the box at the end of this leaflet.
Other side effects
Common reported side effects (may affect up to 1 in 10 people)
Rare reported side effect (may affect up to 1 in 1,000 people)
If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken. Insulin that you inject in such a site may not work very well. Changing the injection site with each injection may help to prevent such skin changes.
Side effects where the frequency cannot be estimated from the available data
A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
Reporting of side effects
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 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.
You can also report side effects directly via
You can also report side effects directly via
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Apidra
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 carton and on the label of the pen after “EXP”. The expiry date refers to the last day of that month.
Not in-use pens
Store in a refrigerator (2 °C-8 °C).
Do not freeze.
Do not put SoloStar next to the freezer compartment or a freezer pack.
Keep the pre-filled pen in the outer carton in order to protect from light.
Pre-filled pens in use (or carried as a spare) may be stored for a maximum of 4 weeks below 25 °C and away from direct heat or direct light. The pen in use must not be stored in a refrigerator.
Do not use it after this time period.
Do not use this medicine if it does not appear clear and colourless.
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 protect the environment.
6. Contents of the pack and other information
What Apidra contains
What Apidra looks like and contents of the pack
Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen. It is a clear, colourless, aqueous solution with no particles visible.
Each pen contains 3 ml solution, equivalent to 300 Units. Packs of 1, 3, 4, 5, 6, 8, 9 and 10 prefilled pens are available. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This leaflet was last revised in April 2018
Other source of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Always carry some sugar (at least 20 grams) with you.
Carry some information with you to show you are a person with diabetes.
HYPERGLYCAEMIA (high blood sugar levels)
If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Why does hyperglycaemia occur?
Warning symptoms of hyperglycaemia
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat and glucose and ketone bodies in urine. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
What should you do if you experience hyperglycaemia?
Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
HYPOGLYCAEMIA (low blood sugar levels)
If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Why does hypoglycaemia occur?
Hypoglycaemia is also more likely to occur if:
Warning symptoms of hypoglycaemia
The first symptoms which alert you to hypoglycaemia (“warning symptoms”) may change, be weaker or may be missing altogether if:
In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
What should you do if you experience hypoglycaemia?
1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
2. Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta). Your doctor or nurse should have discussed this with you previously.
3. If the hypoglycaemia comes back again take another 10 to 20 g sugar.
4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Tell your relatives, friends and close colleagues the following:
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar). These injections are justified even if it is not certain that you have hypoglycaemia.
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
Apidra® SoloStar® solution for injection in a pre filled-pen INSTRUCTIONS FOR USE
SoloStar is a pre-filled pen for the injection of insulin. Your doctor has decided that SoloStar is appropriate for you based on your ability to handle SoloStar. Talk with your doctor, pharmacist or nurse about proper injection technique before using SoloStar.
Read these instructions carefully before using your SoloStar. If you are not able to use SoloStar or follow all the instructions completely on your own, you must use SoloStar only if you have help from a person who is able to follow the instructions completely. Hold the pen as shown in this leaflet. To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
You can set doses from 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.
Keep this leaflet for future reference.
If you have any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurse or call the local Sanofi number on the front of this leaflet.
Important information for use of SoloStar:
Step 1. Check the insulin
A. Check the label on your SoloStar to make sure you have the correct insulin. The Apidra SoloStar is blue. It has a dark blue injection button with a raised ring on the top.
B. Take off the pen cap.
C. Check the appearance of your insulin. Apidra is a clear insulin. Do not use this SoloStar if the insulin is cloudy, coloured or has particles.
Step 2. Attach the needle
Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.
A. Remove the protective seal from a new needle.
B. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).
Step 3. Perform a safety test
Always perform the safety test before each injection. This ensures that you get an accurate dose by:
A. Select a dose of 2 units by turning the dosage selector.
B. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it.
C. Hold the pen with the needle pointing upwards.
D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.
E. Press the injection button all the way in. Check if insulin comes out of the needle tip.
You may have to perform the safety test several times before insulin is seen.
Step 4. Select the dose
You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.
A. Check that the dose window shows “0” following the safety test.
B. Select your required dose (in the example below, the selected dose is 30 units). If you turn past your dose, you can turn back down.
Step 5. Inject the dose
A. Use the injection method as instructed by your doctor, pharmacist or nurse.
B. Insert the needle into the skin.
C. Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to “0” as you inject.
D. Keep the injection button pressed all the way in. Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.
The pen plunger moves with each dose. The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.
Step 6. Remove and discard the needle
Always remove the needle after each injection and store SoloStar without a needle attached.
This helps prevent:
A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.
B. Dispose of the needle safely, as instructed by your doctor, pharmacist or nurse.
C. Always put the pen cap back on the pen, then store the pen until your next injection.
Please check the reverse (insulin) side of this leaflet for instructions on how to store SoloStar.
If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up to room temperature. Cold insulin is more painful to inject.
Discard your used SoloStar as required by your local authorities.
Protect your SoloStar from dust and dirt.
You can clean the outside of your SoloStar by wiping it with a damp cloth.
Do not soak, wash or lubricate the pen as this may damage it.
Your SoloStar is designed to work accurately and safely. It should be handled with care. Avoid situations where SoloStar might be damaged. If you are concerned that your SoloStar may be damaged, use a new one.
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