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: PLGB 04668/0366.
100 IU/ml (international units/ml) suspension for injection in pre-filled pen
1. What Insulatard® is and what it is used for
2. What you need to know before you use Insulatard®
3. How to use Insulatard®
4. Possible side effects
5. How to store Insulatard®
6. Contents of the pack and other information
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.
If any of these apply, do not use Insulatard®. Talk to your doctor, pharmacist or nurse for advice.
Some conditions and activities can affect your need for insulin. Consult your doctor:
The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas 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.
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.
Ask your doctor, pharmacist or nurse for advice before taking this medicine while pregnant or breast-feeding.
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 less than 1 mmol sodium (23 mg) per dose, i.e. Insulatard® is essentially ‘sodium-free’.
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.
Insulatard® can be used in children and adolescents.
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.
Insulatard® is administered by injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). Insulatard® InnoLet® is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.
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.
Insulatard® InnoLet® is a pre-filled disposable pen containing human insulin as isophane (NPH).
Read carefully the Instructions on how to use Insulatard® InnoLet® included in this package leaflet. You must use the pen as described in the Instructions on how to use Insulatard® InnoLet®.
Always ensure you use the correct pen before you inject your insulin.
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 your blood sugar may get too high (hyperglycaemia). See Effects from diabetes in section 4.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
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:
Skin changes at the injection site: If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect less than 1 in 100 people). 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, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.
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.
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.
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.
High blood sugar (hyperglycaemia)
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.
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 InnoLet® 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 30°C) for up to 6 weeks.
Always keep the pen cap on your InnoLet® when you are not using it, in order to protect from light.
Discard the needle 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.
Insulatard® is presented as a suspension for injection. After resuspension, the liquid should appear uniformly white and cloudy.
Pack sizes of 1, 5 and 10 pre-filled pens of 3 ml. Not all pack sizes may be marketed.
The suspension is cloudy, white and aqueous.
This leaflet was last revised in 09/2022
Now turn over for information on how to use your InnoLet®.
Insulatard®, InnoLet®, NovoFine® and NovoTwist®
are trademarks owned by
Novo Nordisk A/S, Denmark
Novo Nordisk A/S
Read the instructions carefully before using your InnoLet®. If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level.
Your InnoLet® is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
InnoLet® is designed to be used with NovoFine® or NovoTwist® disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet® is lost or damaged.
Check the name and coloured label of your InnoLet® to make sure that it contains the correct type of insulin. This is especially important if you take more than one type of insulin. If you take the wrong type of insulin, your blood sugar level may get too high or too low. Take off the pen cap.
Resuspending is easier when the insulin has reached room temperature.
Before every injection:
Small amounts of air may collect in the needle and cartridge during normal use.
To avoid injection of air and ensure proper dosing:
If a drop of insulin still does not appear, the device is defective and must not be used.
You cannot set a dose larger than the number of units remaining in the cartridge.
Always use a new needle for each injection.
Always remove and discard the needle after each injection and store your InnoLet® without the needle attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Caregivers must be very careful when handling used needles – to reduce the risk of needle sticks and cross-infection.
Dispose of your used InnoLet® carefully without the needle attached.
Never share your pen or your needles with other people. It might lead to cross-infection.
Never share your pen with other people. Your medicine might be harmful to their health.
Always keep your InnoLet® and needles out of sight and reach of others, especially children.
Your InnoLet® is designed to work accurately and safely. It must be handled with care. If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
You can clean your InnoLet® by wiping it with a medicinal swab. Do not soak, wash or lubricate it.
This may damage the mechanism and may cause inaccurate dosing, which can lead to too high or too low blood sugar level.
Do not refill your InnoLet®. Once empty, it must be disposed of.