Insulatard FlexPen 100 IU/ml suspension for injection in a pre-filled pen


What is it and how is it used?

Insulatard is human insulin to treat diabetes. Insulatard is a long-acting insulin. This means that it will start to lower your blood sugar about 1½ hours after you take it, and the effect will last for approximately 24 hours. Insulatard is often given in combination with fast-acting insulin products.

What do you have to consider before using it?

Do not use Insulatard

If you are allergic hypersensitive to this insulin product, metacresol or any of the other ingredients see 7 Further information. Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar. See 4 What to do in an emergency for more about hypos.

Take special care with Insulatard

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill carry on taking your insulin If you are going abroad travelling over time zones may affect your insulin needs and the timing of your injections.

Using other medicines

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed. Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide or lanreotide.

Pioglitazone (oral antidiabetic medicine used for the treatment of type 2 diabetes mellitus) 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).

Pregnancy and breast-feeding

If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.

Driving and using machines

If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

How is it used?

Talk about your insulin needs with your doctor and nurse . Follow their advice carefully. This leaflet is a general guide.
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.
It is recommended that you measure your blood glucose regularly.

Injecting insulin

See overleaf for detailed instructions.

Before using Insulatard

Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination.

Do not use Insulatard

In insulin infusion pumps If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin If it hasnt been stored correctly or been frozen see 6 How to store Insulatard If its not uniformly white and cloudy when its resuspended.

Insulatard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best place to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. Your insulin will work more quickly if you inject it around the waist.

What are possible side effects?

Like all medicines, Insulatard can cause side effects, although not everybody gets them. Insulatard may cause hypoglycaemia (low blood sugar). See the advice in 4 What to do in an emergency.

Side effects reported uncommonly (in less than 1 patient in 100)

Changes at the injection site (Lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse because these reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These reactions usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.
Seek medical advice immediately:

  • if signs of allergy spread to other parts of the body, or
  • if you suddenly feel unwell and you start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy; feel like fainting. You may have a very rare serious allergic reaction to Insulatard or one of its ingredients (called a systemic allergic reaction). See also warning in 2 Before you use Insulatard.

Diabetic retinopathy (eye background changes). If you have diabetic retinopathy and your blood glucose levels improve 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. This soon disappears.

Side effects reported very rarely (in less than 1 patient in 10,000)

Vision problems. When you first start your insulin treatment, it may disturb your vision, but the reaction usually disappears.

Painful neuropathy (nerve related pain). If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Insulatard after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

The FlexPen that is not being used is to be stored in a refrigerator (2°C - 8°C).
Do not store them in or too near the freezer section or cooling element.
Do not freeze.
The FlexPen that is being used, about to be used or carried as a spare is not to be kept in a refrigerator. After removing the FlexPen from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use. See 3 How to use

Insulatard. You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks.
Always keep the pen cap on your FlexPen when you’re not using it in order to protect it from light. Insulatard must be protected from excessive heat and sunlight.

Insulatard should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What is it?

Insulatard is a range of insulin suspensions for injection. Insulatard is supplied in vials, cartridges (Penfill), or pre-filled pens (InnoLet, NovoLet and FlexPen). Insulatard contains the active substance insulin human (rDNA).

What is it used for?

Insulatard is used in patients with diabetes.
The medicine can only be obtained with a prescription.

How is it used?

Insulatard is given subcutaneously (under the skin) by injection, usually in the thigh. If convenient, it may also be given in the abdominal wall (tummy), the gluteal region (buttocks) or the deltoid region (shoulder). The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose. Insulatard is a long-acting insulin. It can be given as a once- or twice-daily injection, with or without a fast-acting insulin (at meal times), according to the doctor’s recommendation.

How does it work?

Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose. Insulatard is a replacement insulin which identical to the insulin made by the pancreas. The active substance in Insulatard, insulin human (rDNA), is produced by a method known as ‘recombinant technology’: the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin. Insulatard contains insulin mixed with another substance, protamine, in an ‘isophane’ form which is absorbed much more slowly during the day. This gives Insulatard a longer duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the blood glucose, the symptoms and complications of diabetes are reduced.

How has it been studied?

Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes,when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients). In most patients, Insulatard was compared with other types of human insulin or insulin analogues. The studies measured the levels of fasting blood glucose or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a pre-filled pen (InnoLet, NovoPen or FlexPen).

What benefits has it shown during the studies?

Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins. Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pens.

What is the risk associated?

As with all insulins, Insulatard may cause hypoglycaemia (low blood glucose). For the full list of all side effects reported with Insulatard, see the Package Leaflet.
Insulatard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients. Insulatard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood glucose. The full list is available in the Package Leaflet.

Why has it been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that Insulatard’s benefits are greater than its risks for the treatment of diabetes. The Committee recommended that Insulatard be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard to Novo Nordisk A/S on 7 October 2002. The marketing authorisation was renewed on 7 October 2007.