Actrapid 100 IU/ml solution for injection in a vial
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Actrapid 100IU/ml (international units/ml) solution for injection 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, because it may 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 Actrapid is and what it is used for
Actrapid is a human insulin with rapid-acting effect.
Actrapid is used to lower elevated blood glucose levels in patients with diabetes mellitus (diabetes). Diabetes is a disease in which the body does not produce enough insulin to control blood glucose levels. Treatment with Actrapid helps to prevent complications of diabetes.
Actrapid begins to reduce blood glucose levels about 30 minutes after injection, and its effect lasts for approximately 8 hours. Actrapid is usually administered in combination with intermediate- or long-acting insulin preparations.
2. What you need to know before using Actrapid
Do not use Actrapid
? 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 developing hypoglycaemia (low blood sugar), see Summary of serious and very common adverse effects in section 4.
? In insulin infusion pumps.
? If the protective cap is loose or missing. Each vial has a plastic safety cap. If the cap is not in perfect condition when you receive 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 appear clear and colourless.
If any of these situations apply, do not use Actrapid. Consult your doctor, pharmacist, or nurse.
Before using Actrapid
? 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 level.
? If you are ill, you must continue using insulin and consult your doctor.
? If you are travelling abroad, travelling across time zones may affect your insulin requirements and the timing of administration.
Skin changes at the injection site
Injection sites should be rotated to help prevent changes in fatty tissue, such as skin thickening, skin shrinking, or lumps under the skin. Insulin may not work as well if injected into a lumpy, shrunken, or thickened area (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 Actrapid
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.
Some medicines affect your blood sugar level, which may require adjustment of your insulin dose. Listed below are the more common medicines that may affect your insulin treatment.
Your blood sugar level may decrease (hypoglycaemia) 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 (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)
- Sulphonamides (used to treat infections)
Your blood sugar level may increase (hyperglycaemia) 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 used 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 from 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 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 (oedema).
If you have taken any of the medicines listed above, inform your doctor, pharmacist, or nurse.
Use of Actrapid 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 plan to become pregnant, consult your doctor before using this medicine. Actrapid 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 hypoglycaemia, is important for your baby's health.
? There are no restrictions on the use of Actrapid 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 may drive or operate machinery:
- If you experience frequent episodes of hypoglycaemia.
- If you have difficulty recognizing the symptoms of hypoglycaemia.
If your blood sugar level is high or low, it may affect your concentration and reaction ability, and therefore also your ability to drive or operate machinery. Be aware that you may be putting yourself or others at risk.
Actrapid contains sodium
Actrapid contains less than 1 mmol of sodium (23 mg) per dose; essentially “sodium-free”.
3. How to use Actrapid
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.
Take food containing carbohydrates within 30 minutes after injection to avoid a drop in blood sugar levels.
Do not switch insulin unless instructed by your doctor. If your doctor changes the type or brand of insulin you are using, 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 impairment or 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
Actrapid is administered by subcutaneous injection (under the skin). It must never be injected directly into a vein (intravenous injection) or into muscle (intramuscular injection). However, if necessary, it may be administered directly into a vein, but this must only be done by healthcare professionals.
With each injection, change the injection site within the designated skin area you are using. This may reduce the risk of developing lumps or dents in the skin—see section 4. The best areas for injection are: the front of the waist (abdomen), the buttocks, the front of the thigh, or the upper arm. The effect of insulin will be faster if injected into the abdomen. You should measure your blood sugar level regularly.
How to use Actrapid
Actrapid vials must be used with insulin syringes calibrated to the appropriate unit scale.
If you use only one type of insulin
- Draw into the syringe the same amount of air as the dose of insulin to be injected. Inject this air into the vial.
- Turn the vial and syringe upside down and draw 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
- Just before use, roll the vial of intermediate- or long-acting insulin (cloudy) gently between your hands until the liquid appears uniformly white and cloudy.
- Draw into the syringe the same amount of air as the dose of intermediate- or long-acting insulin. Inject the air into the vial containing the intermediate- or long-acting insulin and remove the needle.
- Draw into the syringe the same amount of air as the dose of Actrapid. Inject the air into the vial containing Actrapid. Then turn the vial and syringe upside down and draw the prescribed dose of Actrapid into the syringe. Expel the air from the syringe and check that the dose is correct.
- Insert the needle into the vial of intermediate- or long-acting insulin, turn the vial and syringe upside down, and draw the prescribed dose. Expel the air from the syringe and check that the dose is correct. Inject the mixture immediately.
- Always mix Actrapid and intermediate- or long-acting insulin in the same order.
How to inject Actrapid
? Insulin should be injected under your skin. Use the injection technique recommended by your doctor or nurse.
? Keep the needle under the skin for at least 6 seconds to ensure 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 much (hypoglycaemia). See Summary of serious and very common adverse effects in section 4.
If you forget to use insulin
If you forget to use insulin, your blood sugar level may rise too much (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 levels (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
Low 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 Actrapid 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, and difficulty concentrating.
A severe drop in blood sugar may lead to loss of consciousness. If prolonged low blood sugar is not treated, it may cause brain damage (temporary or permanent) and even death. You may regain consciousness more quickly if glucagon is injected by someone who knows how to do it. 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, immediate hospitalization is required.
What to do if you experience low blood sugar:
? If you experience low blood sugar, consume glucose tablets or another high-sugar product (for example, sweets, biscuits, fruit juice). Check your blood sugar level if possible, and rest. Always carry glucose tablets or high-sugar products with you, just in case.
? Once the 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 drops so low that you faint, if you required a glucagon injection, or if you have experienced multiple 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 explain the possible consequences, such as the risk of fainting (losing 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. Do not give you food or drink, as you could choke.
Severe allergic reaction to Actrapid or one of its components (called systemic allergic reaction) is a very rare adverse effect, but it can be fatal. 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, and feel like you might lose consciousness.
? 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 accumulation of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work effectively if injected into a lumpy, shrunken, or thickened area. Rotate your injection sites 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 if they spread throughout the body, speak to your doctor immediately. See also the serious allergic reactions described above.
Vision problems: When starting insulin treatment, your vision may be affected, but this is usually temporary.
Joint swelling: When starting insulin treatment, fluid retention may cause swelling of the ankles and other joints. This effect usually disappears quickly. If it does not, speak to your doctor.
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very rapidly, you may experience nerve-related pain. This is known as acute painful neuropathy and is usually temporary.
Very rare adverse effects
May affect up to 1 in 10,000 people.
Diabetic retinopathy (a diabetes-related eye disease that may 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 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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
Effects arising from 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:
Symptoms develop gradually and include frequent urination, thirst, loss of appetite, feeling unwell (nausea and vomiting), drowsiness or tiredness, dry and flushed skin, dry mouth, and fruity breath odour (acetone).
What to do if you experience high blood sugar:
? If you experience any of the symptoms listed above: check your blood sugar level and, if possible, test for ketones in your urine, then seek immediate medical help.
? 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 left untreated, it could lead to diabetic coma and even death.
5. Storage of Actrapid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging of the vial after EXP. The expiry date refers to the last day of the month indicated.
Before opening: store in a refrigerator (between 2°C and 8°C). Keep away from the cooling 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 no longer required. This helps protect the environment.
6. Contents of the pack and other information
Composition of Actrapid
- The active substance is human insulin. Each ml contains 100 IU of human insulin. Each vial contains 1,000 IU of human insulin in 10 ml of injectable solution.
- The other components are zinc chloride, glycerol, metacresol, sodium hydroxide, hydrochloric acid and water for injections.
Nature of the product and contents of the pack
Actrapid is presented as an injectable solution.
Pack sizes of 1 or 5 vials of 10 ml or multiple pack of 5 packs of 1 vial of 10 ml. Only some pack sizes may be marketed.
The solution is clear and colourless.
Marketing Authorisation Holder
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Manufacturer
The manufacturer can be identified by the batch number printed on the lid of the carton pack and on the label:
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If the second and third characters are S6 or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
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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 review of this summary:
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.