- human insulin
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 leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/02/233/003.
Insulatard Vial 10 ml
Package leaflet: Information for the user
100 IU/ml (international units/ml) suspension for injection in vial
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
1. What Insulatard® is and what it is used for
Insulatard® is human insulin with a gradual onset and long duration of action.
Insulatard® is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with Insulatard® helps to prevent complications from your diabetes.
Insulatard® will start to lower your blood sugar about 1½ hours after you inject it, and the effect will last for approximately 24 hours. Insulatard® is often given in combination with fast-acting insulin preparations.
2. What you need to know before you use Insulatard®
Do not use Insulatard®
If any of these apply, do not use Insulatard®. Talk to your doctor, pharmacist or nurse for advice.
Before using Insulatard®
Warnings and precautions
Some conditions and activities can affect your need for insulin. Consult your doctor:
Other medicines and Insulatard®
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.
Your blood sugar level may fall (hypoglycaemia) if you take:
Your blood sugar level may rise (hyperglycaemia) if you take:
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.
Pioglitazone (tablets used for the treatment of type 2 diabetes)
Some patients with long-standing type 2 diabetes 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).
If you have taken any of the medicines listed here, tell your doctor, pharmacist or nurse.
Insulatard® with alcohol
Pregnancy and breast-feeding
Ask your doctor, pharmacist or nurse for advice before taking this medicine while pregnant or breast-feeding.
Driving and using machines
If your blood sugar is low or high, it might affect your concentration and ability to react and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others.
Insulatard® contains sodium
Insulatard® contains less than 1 mmol sodium (23 mg) per dose, i.e. Insulatard® is essentially ‘sodium-free’.
3. How to use Insulatard®
Dose and when to take your insulin
Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
Use in children and adolescents
Insulatard® can be used in children and adolescents.
Use in special patient groups
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
How and where to inject
Insulatard® is administered by injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly).
With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting, see section 4. The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
The insulin will work more quickly if you inject into the waist (abdomen). You should always measure your blood sugar regularly.
How to take Insulatard®
Insulatard® vials are for use with insulin syringes with the corresponding unit scale.
If you only use one type of insulin
1. Roll the vial between your hands until the liquid is uniformly white and cloudy. Resuspension is easier when the insulin has reached room temperature.
Draw into the syringe the same amount of air as the dose of insulin you are going to inject. Inject the air into the vial.
2. Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull the needle out of the vial. Then expel the air from the syringe and check that the dose is correct.
If you have to mix two types of insulin
1. Just before use, roll the vial of Insulatard® between your hands until the liquid is uniformly white and cloudy. Resuspension is easier when the insulin has reached room temperature.
2. Draw into the syringe the same amount of air as the dose of Insulatard®. Inject the air into the vial containing Insulatard® and pull out the needle.
3. Draw into the syringe the same amount of air as the dose of fast-acting insulin. Inject the air into the vial containing fast-acting insulin. Then turn the vial and syringe upside down and draw up the prescribed dose of fast-acting insulin. Expel any air from the syringe and check that the dose is correct.
4. Push the needle into the vial of Insulatard®, turn the vial and syringe upside down and draw out the dose you have been prescribed. Expel any air from the syringe and check that the dose is correct. Inject the mixture immediately.
5. Always mix Insulatard® and fast-acting insulin in the same sequence.
How to inject Insulatard®
If you take more insulin than you should
If you take too much insulin your blood sugar gets too low (hypoglycaemia). See Summary of serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See Effects from diabetes in section 4.
If you stop taking your insulin
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See Effects from diabetes in section 4.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Summary of serious and very common side effects
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.
Low blood sugar may occur if you:
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.
What to do if you experience low blood sugar:
Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink, because you may choke.
Serious allergic reaction to Insulatard® or one of its ingredients (called a systemic allergic reaction) is a very rare side effect, but it can potentially be life threatening. It may affect less than 1 in 10,000 people.
Seek medical advice immediately:
List of other side effects
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Serious allergic reactions above.
Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.
Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.
Very rare side effects
May affect less than 1 in 10,000 people.
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.
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 via
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.
Effects from diabetes
High blood sugar (hyperglycaemia)
High blood sugar may occur if you:
Warning signs of high blood sugar:
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
What to do if you experience high blood sugar:
5. How to store Insulatard®
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 vial label and carton after ‘EXP’. The expiry date refers to the last day of that month.
Before opening: Store in a refrigerator at 2°C - 8°C. Keep away from the cooling element. Do not freeze.
During use or when carried as a spare: Do not refrigerate or freeze. You can carry it with you and keep it at room temperature (below 25°C) for up to 6 weeks.
Always keep the vial in the outer carton when you are not using it, in order to protect from light.
Discard the needle and syringe after each injection.
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 Insulatard® contains
What Insulatard® looks like and contents of the pack
Insulatard® is presented as a suspension for injection. After resuspension, the liquid should appear uniformly white and cloudy.
Pack sizes of 1 or 5 vials of 10 ml or a multipack of 5 packs of 1 x 10 ml vial. Not all pack sizes may be marketed.
The suspension is cloudy, white and aqueous.
Marketing Authorisation Holder
The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:
This leaflet was last revised in 04/2018
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Insulatard® is a trademark
owned by Novo Nordisk A/S, Denmark
Novo Nordisk A/S