Leaflet: information for the user

Actrapid 100UI/ml(international units/ml) injectable solution in vial

human insulin

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

–Keep this leaflet, as you may need to read it again.

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

–This medicine has been prescribed for you only, 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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Actrapid is a rapid-acting human insulin.

Actrapid is used to reduce high levels of sugar in the blood in patients with diabetes mellitus (diabetes). Diabetes is a disease in which the body does not produce enough insulin to control the level of sugar in the blood. Treatment with Actrapid helps to prevent complications of diabetes.

Actrapid starts to reduce blood sugar levels about 30 minutes after injection and the effect lasts approximately 8 hours. Actrapid is usually administered in combination with intermediate- or long-acting insulin preparations.

No use Actrapid

?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 side effects in section 4.

?In insulin infusion pumps.

?If the protective cap is loose or missing. Each vial comes with a plastic safety cap. If the cap is not in perfect condition when you acquire the vial, return the vial to your supplier.

?If it has not been stored correctly or has been frozen, see section 5.

?If the insulin does not have a transparent and colorless appearance.

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

Before using Actrapid

?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.

?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 the 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 diabetes medications.

Other medicines and Actrapid

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 diabetes medications

•MAOIs (used to treat depression)

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

•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 body's metabolic processes)

•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 excessive production of growth hormone 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 levels.

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 experience 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 Actrapid 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 breastfeeding

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

?There are no restrictions on using Actrapid during breastfeeding.

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

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.

Actrapid contains sodium

Actrapid 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.In case of doubt, consult your doctor, pharmacist, or nurse again.

Take foods containing carbohydrates within 30 minutes after injection to prevent a decrease in blood sugar levels.

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

Actrapid 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 frequently and talk to your doctor about possible changes in insulin dose.

How and where to inject insulin

Actrapid is administered by subcutaneous injection under the skin. Never inject directly into a vein (intravenous injection) or muscle (intramuscular injection). If necessary, it can be administered directly into a vein, but only healthcare professionals should do this.

With each injection, change the injection site within the designated area of the skin that you use. This may reduce the risk of developing lumps and depressions in the skin, 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 should measure your blood sugar level regularly.

How to use Actrapid

Actrapid vials should be used with insulin syringes graduated with the corresponding unit scale.

If you only use one type of insulin

1.Extract the same amount of air from the syringe 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, extract the air from the syringe and check that the dose is correct.

If you need to mix two types of insulin

1.Just before use, shake the vial of intermediate or prolonged-acting insulin (clear) between your hands until the liquid has a uniform white and turbid appearance.

2.Extract the same amount of air from the syringe as the dose of intermediate or prolonged-acting insulin. Inject the air into the vial containing the intermediate or prolonged-acting insulin and remove the needle.

3.Extract the same amount of air from the syringe as the dose of Actrapid. Inject the air into the vial containing Actrapid. Then, turn the vial and syringe around and extract the prescribed dose of Actrapid.Extract the air from the syringe and check that the dose is correct.

4.Insert the needle into the vial of intermediate or prolonged-acting insulin, turn the vial and syringe around, and extract the dose prescribed.Extract the air from the syringe and check that the dose is correct.Inject the mixture immediately.

5.Mix Actrapid and intermediate or prolonged-acting insulin in the same order.

How to inject Actrapid

?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 decrease excessively (hypoglycemia). See Severe and very common adverse reactions in section 4.

If you forget to use the insulin

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

If you interrupt insulin treatment

Do not stop using insulin without talking to your doctor first, who will tell you what to do. Stopping insulin may cause a severe increase in blood sugar levels (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 serious and very common side effects

Hypoglycemia (low blood sugar level)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 Use of Actrapid with alcohol in section 2.

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

A severe drop in blood sugar level can lead to loss of consciousness. If prolonged low blood sugar level is 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 an injection of glucagon. If glucagon is administered, 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 a low blood sugar level:

?If you experience a low blood sugar level, take glucose tablets or another high-sugar product (such as candies, cookies, or fruit juice). Measure your blood sugar level, if possible, and rest. Always carry glucose tablets or high-sugar products with you, just in case.

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

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

Inform relevant people that you have diabetes and what the consequences may be, such as the risk of fainting (losing consciousness) due to low blood sugar level. 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.

Severe allergic reactionto Actrapid or one of its components (called 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, and the feeling of losing consciousness.

?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) (it 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; it is not known how often this occurs). 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

Uncommon side effects

They can affect up to 1 in 100people.

Allergic reactions:allergic reactions can cause local reactions (pain, redness, rashes, inflammation, hematoma, swelling, and itching) 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, talk to your doctor immediately. Also see the severe allergic reactions mentioned earlier.

Visual problems:starting insulin treatment can affect your vision, but usually only temporarily.

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

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 temporary.

Rare side effects

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: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 level (hyperglycemia)

You may experience high blood sugar level if:

•Not enough insulin is injected.

•You forget to inject insulin or stop using it.

•You inject less insulin than you need repeatedly.

•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 level:

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

What to do if you experience high blood sugar level:

?If you experience any of the symptoms mentioned earlier: check your blood sugar level and ketone levels in urine, if possible, and seek medical help 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 produce 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 label and packaging of the vial after CAD. The expiration date is the last day of the month indicated.

Before opening:store in the refrigerator (between 2°C and 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 can be carried and stored at room temperature (below 25°C) 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 thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Actrapid

–The active ingredient is human insulin. Each ml contains 100 UI of human insulin. Each vial contains 1,000 UI of human insulin in 10 ml of injectable solution.

–The other components are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid, and water for injectable preparations.

Appearance of the product and contents of the packaging

Actrapid is presented as an injectable solution.

Packaging sizes of 1 or 5 vials of 10 ml or a multiple pack of 5 packs of 1 vial of 10 ml. Only some packaging sizes may be marketed.

The solution is transparent and colorless.

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 carton packaging 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 are T6, 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.