Product Information for the User

Insulatard 100UI/ml(International Units per milliliter) injectable suspension in vial

Human Insulin

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

–Keep this product information, as you may need to refer to it again.

–If you have any questions, consult your doctor, pharmacist, or nurse.

–This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

–If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information.See section 4.

Insulatard is a human insulin with a gradual onset of action and long duration.

Insulatard is used to reduce elevated blood sugar levels in patients with diabetes mellitus (diabetes).Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels. Insulatard treatment helps to prevent diabetes complications.

Insulatard begins to reduce blood sugar levels approximately 1and a half hours after injection and the effect lasts approximately 24hours. Insulatard is usually administered in combination with rapid-acting insulin preparations.

No use Insulatard

• If you are allergic to human insulin or any of the other components of this medicine, see section 6.

• If you suspect that you are starting to experience hypoglycemia (low blood sugar), see the Summary of serious and very frequent adverse reactions in section 4.
• In insulin infusion pumps.
• If the protective cap is missing or loose. All vials have a plastic safety cap. If this is not in perfect condition at the time of purchase of the vial, return it to the supplier.
• If it has not been stored correctly or if it has been frozen, see section 5.
• If the resuspended insulin does not have a uniformly white and turbid appearance.

If any of these circumstances occur, do not use Insulatard. Consult your doctor, pharmacist, or nurse.

Before using Insulatard

?Check the label to ensure that it is the correct type of insulin.

?Remove the protective cap.

?Always use a new needle for each injection to avoid contamination.

?Needles and syringes should not be shared.

Warnings and precautions

Some changes and activities may affect your insulin needs. Consult your doctor:

• If you have problems with your kidneys, liver, adrenal glands, pituitary gland, or thyroid gland.
• If you engage in more physical exercise than usual or if you plan to change your usual diet, as this may affect your blood sugar level.
• If you are ill, you should continue using insulin and consult your doctor.
• If you are traveling abroad, traveling to different time zones may affect your insulin requirements and the timing of administration.

Changes in skin at the injection site

Rotate the injection site to help prevent changes in fatty tissue, such as thickening of the skin, shrinking of the skin, or lumps under the skin. Insulin may not work well if injected into an area that is swollen, shrunk, or thickened (see section 3). Inform your doctor if you notice any changes in the injection site. Inform your doctor if you are currently injecting in these affected areas, before starting to inject in a different area. Your doctor may instruct you to check your blood sugar levels more closely, and adjust your insulin or your other antidiabetic medications.

Other medicines and Insulatard

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medicine.

Some medicines affect your blood sugar level, and this may mean that your insulin dose needs to be adjusted. The following medicines are the most common ones that may affect your insulin treatment.

Your blood sugar level may decrease (hypoglycemia) if you take:

•Other medicines for the treatment of diabetes

•Monamine oxidase inhibitors (MAOIs) (used to treat depression)

•Beta-blockers (used to treat high blood pressure)

•Angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat certain heart conditions or high blood pressure)

•Salicylates (used to relieve pain and reduce fever)

•Anabolic steroids (such as testosterone)

•Sulfonamides (used to treat infections)

Your blood sugar level may increase (hyperglycemia) if you take:

•Oral contraceptives (birth control pills)

•Thiazides (used to treat high blood pressure or excessive fluid retention)

•Glucocorticoids (such as cortisone, used to treat inflammation)

•Thyroid hormone (used to treat thyroid gland disorders)

•Adrenergic agonists (such as epinephrine [adrenaline], salbutamol, or terbutaline, used to treat asthma)

•Growth hormone (medicine to stimulate bone and somatic growth and with significant influence on the metabolic processes of the body)

•Danazol (medicine that acts on ovulation)

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by an excess of growth hormone production in the pituitary gland) may increase or decrease blood sugar levels.

Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the early warning signs that help recognize low blood sugar.

Pioglitazone (tablets used to treat type 2 diabetes)

Some patients with long-standing type 2 diabetes and pre-existing heart disease or stroke who were treated with pioglitazone and insulin developed heart failure. Inform your doctor as soon as possible if you have signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized inflammation (edema).

If you have taken any of the medicines listed, inform your doctor, pharmacist, or nurse.

Use of Insulatard with alcohol

?If you drink alcohol, your insulin needs may change, as your blood sugar level may increase or decrease. It is recommended to follow a strict control.

Pregnancy and lactation

?If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Insulatard can be used during pregnancy. You may need to adjust your insulin dose during pregnancy and after delivery. It is essential to maintain a strict control of your diabetes, especially to prevent hypoglycemia, for the health of your baby.

?There are no restrictions on the treatment with Insulatard during lactation.

Consult your doctor, pharmacist, or nurse before using this medicine during pregnancy or lactation.

Driving and operating machinery

?Ask your doctor if you can drive vehicles or operate machinery:

•If you experience frequent episodes of hypoglycemia.

•If you find it difficult to recognize the symptoms of hypoglycemia.

If your blood sugar level is high or low, it may affect your concentration and reaction time, and therefore also your ability to drive or operate machinery. Be aware that you may put yourself or others at risk.

Insulatard contains sodium

Insulatard contains less than 1 mmol of sodium (23 mg) per dose; that is, it is essentially "sodium-free".

Dosage and when to use insulin

Follow exactly the administration instructions of this medication and the dose indicated by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

Do not change insulin unless your doctor tells you to. If your doctor changes you from one type or brand of insulin to another, you may need to adjust your dose.

Use in children and adolescents

Insulatard can be used in children and adolescents.

Use in special patient groups

If you have renal or hepatic insufficiency or if you are over 65 years old, you must check your blood sugar level more regularly and talk to your doctor about possible changes in insulin dose.

How and where to inject insulin

Insulatard is administered by subcutaneous injection. Never inject directly into a vein (intravenous injection) or muscle (intramuscular injection).

With each injection, change the injection site within the designated area of the skin. This may reduce the risk of developing lumps and skin depressions, see section 4. The best areas for injection are the following: the front of the waist (abdomen), the gluteal region, the front of the thigh, or the upper arm. The effect of insulin will be faster if the injection is made in the waist (abdomen). You must measure your blood sugar level regularly.

How to use Insulatard

Insulatard vials must be used with insulin syringes graduated with the corresponding unit scale.

If you only use one type of insulin

1.Turn the vial between your hands until the liquid has a uniformly white and turbid appearance. Resuspension is easier when the insulin has reached room temperature. Insert into the syringe the same amount of air as the insulin dose to be injected. Inject the air into the vial.

2.Turn the vial and syringe around and extract the correct dose of insulin from the syringe. Remove the needle from 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, turn the vial of Insulatard between your hands until the liquid has a uniformly white and turbid appearance. Resuspension is easier when the insulin has reached room temperature.

2.Insert into the syringe the same amount of air as the dose of Insulatard. Inject the air into the vial containing Insulatard and remove the needle.

3.Insert into the syringe the same amount of air as the dose of rapid-acting insulin. Inject the air into the vial containing rapid-acting insulin. Then, turn the vial and syringe around and extract the prescribed dose of rapid-acting insulin. Expel the air from the syringe and check that the dose is correct.

4.Insert the needle into the vial of Insulatard, turn the vial and syringe around and extract the prescribed dose. Expel the air from the syringe and check that the dose is correct. Inject the mixture immediately.

5.Mix always in the same order Insulatard and rapid-acting insulin.

How to inject Insulatard

?Insulin must be injected under the skin. Use the injection technique advised by your doctor or nurse.

?Keep the needle under the skin for at least 6 seconds to ensure that all the insulin has been injected.

?Dispose of the needle and syringe after each injection.

If you use more insulin than you should

If you use too much insulin, your blood sugar level will drop too low (hypoglycemia). See Severe and very common adverse reactions in section 4.

If you forget to use insulin

If you forget to use insulin, your blood sugar level may rise too high (hyperglycemia). See Diabetes-related effects in section 4.

If you interrupt insulin treatment

Do not stop using insulin without first talking to your doctor, who will explain what you should do. Stopping insulin may cause a severe increase in blood sugar level (severe hyperglycemia) and ketoacidosis. See Diabetes-related effects in section 4.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Summary of severe and very common side effects

Hypoglycemia (low blood sugar)is a very common side effect. It can affect more than 1 in 10people.

The blood sugar level can drop if:

•Too much insulin is injected.

•Very little food is eaten or a meal is skipped.

•More physical exercise than usual is done.

•Alcohol is consumed, see Insulatard with alcohol use in section 2.

Signs of low blood sugar:cold sweat, pale and cold skin, headache, rapid heartbeat, feeling unwell, excessive appetite, temporary visual disturbances, drowsiness, fatigue and weakness, nervousness or tremors, anxiety, confusion, difficulty concentrating.

A severe drop in blood sugar can lead to loss of consciousness. If not treated, it can cause brain damage (temporary or permanent) and even death. You may regain consciousness more quickly if someone who knows how to administer it gives you a glucagon injection. If you are given glucagon, you should also take glucose or a high-sugar product as soon as you regain consciousness. If you do not respond to glucagon treatment, you should go to the hospital immediately.

What to do if you experience low blood sugar:

?Take glucose tablets or another high-sugar product (such as candy, cookies, or fruit juice). If possible, measure your blood sugar level and rest. Always carry glucose tablets or high-sugar products with you, just in case.

?When the symptoms of low blood sugar have disappeared or your blood sugar level has stabilized, continue with insulin treatment as usual.

?If your blood sugar level is so low that you faint, if you have needed a glucagon injection, or if you have had many episodes of low blood sugar, talk to your doctor. You may need to adjust the dose or frequency of insulin, your eating habits, or exercise.

Inform relevant people that you have diabetes and what the consequences may be, such as the risk of fainting (loss of consciousness) due to low blood sugar. Let them know that if you faint, they should turn you on your side and seek medical help immediately. Do not give you food or drinks, as you may choke.

A severe allergic reactionto Insulatard or one of its components (called a systemic allergic reaction) is a very rare but potentially life-threatening side effect. It can affect up to 1 in 10,000people.

Consult your doctor immediately:

•If allergy symptoms spread to other parts of the body.

•If you suddenly feel unwell and have sweating, feeling unwell (vomiting), difficulty breathing, rapid heartbeat, or dizziness.

?If you notice any of these symptoms, seek medical help immediately.

Changes in skin at the injection site: If insulin is injected in the same place, the fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (this can affect up to 1 in 100 people). Bumps under the skin can also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency of this is unknown). Insulin may not work well if injected in a thickened, shrunk, or swollen area. Change the injection site to help prevent these skin changes.

List of other side effects

Less common side effects

They can affect up to 1 in 100people.

Allergic reactions:local allergic reactions (pain, redness, rashes, inflammation, bruises, swelling, and itching) can occur at the injection site. They usually disappear a few weeks after starting insulin use. If they do not disappear or spread to the entire body, you should consult your doctor immediately. Also see the severe allergic reactions mentioned earlier.

Diabetic retinopathy(eye disease related to diabetes that can cause vision loss): if you have diabetic retinopathy and your blood sugar level improves rapidly, the retinopathy may worsen. In this case, you should consult with your doctor.

Joint inflammation:when starting insulin treatment, fluid accumulation can cause joint inflammation. This effect usually disappears quickly. If it does not, talk to your doctor.

Rare side effects

They can affect up to 1 in 10,000people.

Visual problems:starting insulin treatment can affect your vision, but it is usually temporary.

Painful neuropathy(pain due to nerve damage): if your blood sugar level improves rapidly, you may experience pain related to nerves. This is known as acute painful neuropathy and is usually transient.

Reporting side effects

If you experienceany type of side effect,consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Effects related to diabetes

High blood sugar (hyperglycemia)

You may experience high blood sugar if:

•Not enough insulin is injected.

•You forget to inject insulin or stop using it.

•You inject less insulin than you need.

•You have an infection and/or fever.

•You eat more than usual.

•You do less physical exercise than usual.

Warning signs of high blood sugar:

Warning signs appear gradually and include frequent urination, thirst, loss of appetite, feeling unwell (nausea or vomiting), drowsiness or fatigue, dry and red skin, dry mouth, and breath with a fruity odor (acetone).

What to do in case of high blood sugar:

?If you experience any of the symptoms described above: check your blood sugar level and the presence of ketones in your urine if possible, and then consult your doctor immediately.

?They may be symptoms of a severe condition called diabetic ketoacidosis (formation of acid in the blood due to the body breaking down fat instead of sugar). If not treated, it could cause diabetic coma and even death.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial label and packaging after CAD. The expiration date is the last day of the month indicated.

Before opening:store in the refrigerator (between2°Cand 8°C). Keep away from the refrigerator element. Do not freeze.

During use or if taking as a spare:do not refrigerate or freeze. It canbe carried on the person andstoredat room temperature (below 25ºC)for up to 6weeks.

Always store the vial in the outer packaging,when not in use,to protect it from light.

Dispose of the needle and syringe after each injection.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Composition of Insulatard

–The active principle ishuman insulin.Insulatard is a suspension of human insulin isophane (NPH). Eachml contains 100UI of human insulin. Each vial contains 1,000UI of human insulin in 10ml of injectable suspension.

–The other components arezinc chloride, glycerol, metacresol, phenol,disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate, and water for injectable preparations.

Appearance of the product and contents of the container

Insulatard is presented as an injectable suspension. After resuspension, the liquid must have a uniformly white and turbid appearance.

Container sizes of 1 or 5vials of 10ml or multiple container of 5containers of 1vial of 10ml. Some container sizes may only be marketed.

The suspension is aqueous, white, and turbid in appearance.

Holder of the marketing authorization

Novo Nordisk A/S,

Novo Allé, DK-2880 Bagsværd, Denmark

Responsible for manufacturing

The manufacturer can be identified by the batch number printed on the cardboard container lid and on the label:

–If the second and third characters are S6 or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.

–If the second and third characters areT6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.

Date of the last review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.