Insulatard 100 IU/ml suspension for injection in vial

Patient Information Leaflet

Introduction

Patient Information Leaflet

Insulatard 100UI/ml (international units/ml) injectable suspension in vial

Human insulin

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

1. What Insulatard is and what it is used for

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

Insulatard is used to lower elevated blood glucose levels in patients with diabetes mellitus (diabetes). Diabetes is a condition in which your body does not produce enough insulin to control blood glucose levels. Treatment with Insulatard helps prevent complications of diabetes.

Insulatard begins to reduce your blood glucose level approximately 1.5 hours after injection, and its effect lasts for approximately 24 hours. Insulatard is usually administered in combination with rapid-acting insulin preparations.

2. What you need to know before using Insulatard

Do not use Insulatard

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

• If you suspect you are beginning to experience hypoglycaemia (low blood sugar), see Summary of serious and very common adverse reactions in section 4.

• In insulin infusion pumps.

• If the protective cap is missing or loose. All vials have a plastic protective cap. If this is not in perfect condition at the time of purchase, return the vial to your 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 cloudy appearance.

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

Before using Insulatard

? Check the label to make sure 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 must not be shared.

Warnings and precautions

Certain conditions and activities may affect your insulin requirements. Consult your doctor:

• If you have problems with your kidneys, liver, adrenal glands, pituitary gland, or thyroid gland.
• If you are doing more physical exercise than usual or wish to change your normal diet, as this may affect your blood sugar levels.
• If you are ill, you must continue using insulin and consult your doctor.
• If you are travelling abroad, travelling across different time zones may affect your insulin requirements and timing of administration.

Skin changes at the injection site

You should rotate your injection sites to help prevent changes in fatty tissue, such as thickening of the skin, skin shrinkage, or lumps under the skin. Insulin may not work well if injected into an area that is lumpy, shrunken, or thickened (see section 3). Inform your doctor if you notice any changes at the injection site. Inform your doctor if you are currently injecting into these affected areas before switching to a different site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin dose or the dose of your other antidiabetic medications.

Other medicines and Insulatard

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

Some medicines affect your blood sugar levels, which may mean that your insulin dose needs to be adjusted. Listed below are the most common medicines that may affect your insulin treatment.

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

• Other medicines for the treatment of diabetes
• Monoamine 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)
• Sympathomimetics (such as epinephrine [adrenaline], salbutamol, or terbutaline, used to treat asthma)
• Growth hormone (a medicine to stimulate bone and somatic growth and with significant influence on the body's metabolic processes)
• Danazol (a medicine that affects ovulation)

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

Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the early warning symptoms that help you 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 prior 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 swelling (edema).

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

Use of Insulatard with alcohol

? If you drink alcohol, your insulin requirements may change, as blood sugar levels may increase or decrease. Close monitoring is recommended.

Pregnancy and breastfeeding

? If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Insulatard can be used during pregnancy. Your insulin dose may need to be adjusted during pregnancy and after delivery. Strict control of diabetes, especially to prevent hypoglycemia, is important for your baby's health.

? There are no restrictions on the use of Insulatard during breastfeeding.

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

Driving and using machines

? Ask your doctor whether you can drive or operate machinery:

• If you experience frequent episodes of hypoglycemia.
• If you have difficulty recognizing the symptoms of hypoglycemia.

If your blood sugar level is too high or too low, it may impair your concentration and reaction ability, and thus also your ability to drive or operate machinery. Remember that you may be putting yourself and others at risk.

Insulatard contains sodium

Insulatard contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to use Insulatard

Dosage and when to use insulin

Follow exactly the instructions for administration and the dose prescribed by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

Do not switch insulin unless instructed by your doctor. If your doctor changes your type or brand of insulin, 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 impairment, or if you are over 65 years of age, you should check your blood sugar levels more frequently and discuss possible insulin dose adjustments with your doctor.

How and where to inject insulin

Insulatard is administered by subcutaneous injection (injected under the skin). It must never be injected directly into a vein (intravenous injection) or into muscle (intramuscular injection).

With each injection, rotate the injection site within the designated skin area you use. This may reduce the risk of developing lumps or dents in the skin; see section 4. The best injection sites are: the front of the waist (abdomen), the buttocks, the front of the thigh, or the upper arm. Insulin will act more quickly if injected into the abdomen. You should measure your blood sugar level regularly.

How to use Insulatard

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

If you use only one type of insulin

1. Roll the vial gently between your hands until the liquid appears uniformly white and cloudy. Resuspension is easier when the insulin has reached room temperature. Draw into the syringe the same amount of air as your insulin dose. Inject this air into the vial.
2. Turn the vial and syringe upside down and withdraw the correct dose of insulin into the syringe. Remove the needle from the vial. Then expel 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, roll the Insulatard vial gently between your hands until the liquid appears 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 Insulatard vial and remove the needle.
3. Draw into the syringe the same amount of air as the dose of rapid-acting insulin. Inject the air into the vial containing the rapid-acting insulin. Then turn the vial and syringe upside down and withdraw 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 Insulatard vial, turn the vial and syringe upside down, and withdraw the prescribed dose. Expel the air from the syringe and check that the dose is correct. Inject the mixture immediately.
5. Always mix Insulatard and rapid-acting insulin in the same order.

How to inject Insulatard

? Inject insulin under your skin. Use the injection technique advised by your doctor or nurse.

? Keep the needle under the skin for at least 6 seconds to ensure all the insulin is delivered.

? 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 may drop too low (hypoglycaemia). See Summary of serious and very common adverse reactions in section 4.

If you forget to use insulin

If you forget to use your insulin, your blood sugar level may become too high (hyperglycaemia). See Effects of diabetes in section 4.

If you stop using insulin

Do not stop using insulin without first talking to your doctor, who will advise you on what to do. Stopping insulin may cause excessive increase in blood sugar (severe hyperglycaemia) and ketoacidosis. See Effects of diabetes in section 4.

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

4. Possible adverse effects

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

Summary of serious and very common adverse effects

Decrease in blood sugar level (hypoglycaemia) is a very common adverse effect. It may affect more than 1 in 10 people.

Your blood sugar level may drop if:

• You inject too much insulin.
• You eat very little or skip a meal.
• You do more physical exercise than usual.
• You drink alcohol – see Use of Insulatard with alcohol in section 2.

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

A severe drop in blood sugar may lead to loss of consciousness. If untreated, it may 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 glucagon is administered, you should also take glucose or a sugary product as soon as you regain consciousness. If there is no response to glucagon treatment, you must go immediately to a hospital.

What to do if you experience low blood sugar:

? If you experience low blood sugar, take glucose tablets or another high-sugar product (for example, sweets, biscuits, fruit juice). If possible, check your blood sugar level and rest. Always carry glucose tablets or high-sugar products with you, just in case.

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

? If your blood sugar level was so low that you fainted, if you required a glucagon injection, or if you have had several episodes of low blood sugar, speak to your doctor. You may need to adjust your insulin dose or frequency, eating habits, or exercise routine.

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 onto your side and seek immediate medical help. They should not give you food or drink, as you could choke.

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

Contact your doctor immediately:

• If allergy symptoms spread to other parts of the body.
• If you suddenly feel unwell and have sweating, nausea, difficulty breathing, rapid heartbeat, or dizziness.

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

Skin changes at the injection site: If you inject insulin in the same place repeatedly, fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also occur due to the buildup of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work well if injected into a lumpy, shrunken, or thickened area. Change your injection site regularly to help prevent these skin changes.

List of other adverse effects

Uncommon adverse effects

May affect up to 1 in 100 people.

Allergy symptoms: Local allergic reactions (pain, redness, rash, swelling, bruising, swelling, and itching) may occur at the injection site. These usually disappear within a few weeks of starting insulin treatment. If they do not disappear or spread to the whole body, contact your doctor immediately. See also the information on severe allergic reactions above.

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

Joint swelling: When starting insulin treatment, fluid retention may cause swelling of the ankles and other joints. This effect usually resolves quickly. If it does not, speak to your doctor.

Very rare adverse effects

May affect up to 1 in 10,000 people.

Vision problems: When starting insulin treatment, your vision may be affected, but this is usually temporary.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

Effects related to diabetes

High blood sugar level (hyperglycaemia)

You may experience high blood sugar if:

• You have not injected enough insulin.
• You forget to inject insulin or stop using it.
• You repeatedly 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 symptoms appear gradually and include frequent urination, thirst, loss of appetite, feeling unwell (nausea or vomiting), drowsiness or tiredness, dry and flushed skin, dry mouth, and fruity-smelling breath (acetone).

What to do if blood sugar rises:

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

? These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood due to the body breaking down fat instead of sugar). If untreated, this could lead to diabetic coma and even death.

5. Storage of Insulatard

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

Do not use this medicine after the expiry date stated on the vial label and packaging following EXP. The expiry date refers to the last day of the month indicated.

Before opening: store in the refrigerator (between 2°C and 8°C). Keep away from the refrigerating element. Do not freeze.

During use or when carried as a spare: do not refrigerate or freeze. May be carried on the person and stored at room temperature (below 25°C) for up to 6 weeks.

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

Dispose of the needle and syringe after each injection.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Insulatard

• The active substance is human insulin. Insulatard is an isophane (NPH) suspension of human insulin. Each ml contains 100 IU of human insulin. Each vial contains 1,000 IU of human insulin in 10 ml of injectable suspension.

• The other components are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate, and water for injections.

Appearance of the product and contents of the pack

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

Pack sizes of 1 or 5 vials of 10 ml or multiple pack of 5 packs of 1 vial of 10 ml. Some pack sizes may not be marketed.

The suspension is aqueous, white and cloudy in appearance.

Marketing Authorization Holder

Novo Nordisk A/S,
Novo Allé, DK-2880 Bagsværd, Denmark

Manufacturer

The manufacturer can be identified by the batch number printed on the cap of the carton package 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 most recent revision of this leaflet:

Other sources of information

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