NovoRapid 100 U/ml solution for injection in vial
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
NovoRapid 100 units/ml solution for injection in vial
insulin aspart
Read all of 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, ask your doctor, nurse or pharmacist.
- 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 could harm them.
- If you experience any side effects, talk to your doctor, nurse or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What NovoRapid is and what it is used for
- What you need to know before using NovoRapid
- How to use NovoRapid
- Possible side effects
- How to store NovoRapid
- Contents of the pack and other information
1. What NovoRapid is and what it is used for
NovoRapid is a modern insulin (insulin analogue) with a rapid onset of action. Modern insulins are improved versions of human insulin.
NovoRapid is used to lower high blood glucose levels in adults, adolescents, and children from 1 year of age onwards who have diabetes mellitus (diabetes). Diabetes is a condition in which the body does not produce enough insulin to control blood glucose levels. Treatment with NovoRapid helps prevent complications of diabetes.
NovoRapid begins to reduce blood glucose levels within 10–20 minutes after administration, reaches maximum effect between 1 and 3 hours after injection, and has a duration of action of 3–5 hours. Due to this short duration of action, NovoRapid is usually administered in combination with intermediate- or long-acting insulin preparations. Additionally, NovoRapid may be used for continuous subcutaneous insulin infusion.
2. What you need to know before using NovoRapid
Do not use NovoRapid
? If you are allergic to insulin aspart or to any of the other ingredients of this medicine (see section 6, Contents of the pack and further information).
? If you suspect you are about to experience hypoglycaemia (low blood sugar levels) (see a) Summary of serious and very common adverse effects in section 4).
? If the security seal is missing or broken. Each vial has a plastic security seal. If it is not in perfect condition, return the vial to your supplier.
? If it has not been stored correctly or if it has been frozen (see section 5, Storage of NovoRapid).
? If the insulin does not appear clear and colourless.
If any of these situations apply to you, do not use NovoRapid. Consult your doctor, nurse, or pharmacist.
Before using NovoRapid
? Check the label and make sure the insulin is the type prescribed for you.
? Remove the security seal.
? Always use a new needle for each injection to prevent contamination.
? Needles and syringes must not be shared.
Warnings and precautions
Certain conditions and activities may affect your insulin requirement. Consult your doctor:
? If you have kidney, liver, adrenal gland, pituitary gland, or thyroid gland problems.
? If you are doing more physical exercise than usual or if you wish to change your diet, as this may affect your blood sugar levels.
? If you are unwell, continue your insulin treatment and consult your doctor.
? If you plan to travel abroad, time differences between countries may affect your insulin requirement and administration schedule.
Skin changes at the injection site
Injection sites should be rotated to help prevent changes in fatty tissue, such as thickening of the skin, skin shrinkage, or lumps under the skin. Insulin may not work as well if injected into a lumpy, shrunken, or thickened area (see section 3, How to use NovoRapid). 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.
Children and adolescents
Do not administer this medicine to children under 1 year of age, as clinical studies have not been conducted in children under 1 year of age.
Other medicines and NovoRapid
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Some medicines affect your blood sugar levels and may require adjustment of your insulin dose. The main medicines that may affect your insulin treatment are listed below.
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);
- sulfonamides (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 hormones (used to treat thyroid gland disorders);
- sympathomimetics (such as epinephrine [adrenaline], salbutamol, or terbutaline used to treat asthma);
- growth hormone (a medicine to stimulate somatic and skeletal growth that strongly influences 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 the pituitary gland producing excess growth hormone) may increase or decrease your blood sugar levels.
Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the early warning symptoms that help you recognize when your blood sugar levels are low.
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 mentioned above, inform your doctor, nurse, or pharmacist.
Alcoholic beverages and use of NovoRapid
? If you drink alcohol, it may alter your insulin requirement as your blood sugar levels may increase or decrease. Careful monitoring is recommended.
Pregnancy and breastfeeding
? If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. NovoRapid can be used during pregnancy. Your insulin dose may need to be adjusted during pregnancy and after delivery. Careful control of your diabetes is important for your baby's health, especially prevention of hypoglycaemia.
- There are no restrictions on the use of NovoRapid during breastfeeding.
Consult your doctor, nurse, or pharmacist before using this medicine if you are pregnant or breastfeeding.
Driving and using machines
? Please ask your doctor if you can drive or operate machinery:
- If you frequently experience hypoglycaemia.
- If you have difficulty recognizing hypoglycaemia.
If your blood sugar levels are low or high, your concentration and reaction ability may be impaired, and therefore your ability to drive or operate machinery may also be affected. Be aware that you could endanger your life or the lives of others.
One consequence of the rapid onset of action of NovoRapid is that if hypoglycaemia occurs, it may happen more quickly after injection than with human soluble insulin.
Important information about some of the ingredients of NovoRapid
NovoRapid contains less than 23 mg (1 mmol) of sodium per dose, therefore NovoRapid is considered essentially “sodium-free”.
3. How to use NovoRapid
Dosage and timing of insulin administration
Follow exactly the insulin administration and dose adjustment instructions given by your doctor. If in doubt, consult your doctor, nurse, or pharmacist.
NovoRapid should generally be administered immediately before meals. Eat a meal within 10 minutes after injection to avoid hypoglycaemia. When necessary, NovoRapid may be administered immediately after a meal. For further information, see below under "How and where to inject".
Do not switch insulin unless instructed by your doctor. If your doctor changes you from one type or brand of insulin to another, you may need a dose adjustment.
Use in children and adolescents
NovoRapid can be used in children from 1 year of age and in adolescents instead of soluble human insulin when a faster onset of action is preferred. For example, when administration timing relative to meals is difficult.
Use in special patient groups
If you have impaired kidney or liver function, or if you are over 65 years of age, you should monitor your blood glucose levels more frequently and discuss any required insulin dose adjustments with your doctor.
How and where to inject
NovoRapid must be injected under the skin (subcutaneously) or administered via continuous infusion using an insulin pump. A healthcare professional must train you on how to administer insulin with a pump. Never inject yourself directly into a vein (intravenously) or into muscle (intramuscularly). If intravenous administration is required, NovoRapid may be given directly into a vein, but only by a doctor or other healthcare professional.
With each injection, change the injection site within the specific skin area you usually use. This may reduce the risk of developing lumps or pits in the skin (see section 4, Possible side effects). The best injection sites are: the front of your waist (abdomen), the upper arm, or the front of the thighs. Insulin will act more quickly if injected into the front of the waist. You must always measure your blood sugar level regularly.
NPH insulin (Neutral Protamine Hagedorn) is the only type of insulin that can be mixed with NovoRapid, and the mixture must be injected immediately subcutaneously. NovoRapid must be drawn into the syringe before the NPH insulin.
How to use NovoRapid
If you are using only one type of insulin
- Draw air into the syringe equal to 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. Expel air from the syringe and check that the dose is correct.
If you need to mix two types of insulin
- Just before use, gently roll the NPH insulin vial between your hands until the liquid is uniformly milky.
- Draw air into the syringe equal to the dose of NPH insulin. Inject the air into the NPH insulin vial and remove the needle.
- Draw air into the syringe equal to the dose of NovoRapid. Inject the air into the NovoRapid vial. Turn the vial and syringe upside down and withdraw the prescribed dose of NovoRapid. Expel air from the syringe and check that the dose is correct.
- Insert the needle into the NPH insulin vial, turn the vial and syringe upside down, and withdraw the prescribed dose of NPH insulin. Expel air from the syringe and check the dose. Inject the mixture immediately.
- Always mix NovoRapid and NPH insulin in the same order.
How to inject NovoRapid
? Inject the insulin under the 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 is delivered.
? Dispose of the needle after each injection.
Use in an insulin infusion pump
NovoRapid must not be mixed with other insulins when used in a pump.
Follow your doctor's instructions and recommendations regarding the use of NovoRapid in an insulin pump. Before using NovoRapid in an insulin pump, you must be trained in its use and receive information on what to do if you suddenly become ill, if your blood sugar level becomes too low or too high, or if the pump fails.
- Before inserting the needle, wash your hands and the skin area where the needle will be inserted with soap and water to prevent infection at the infusion site.
- When filling a new reservoir, ensure there are no air bubbles in the syringe or in the catheter.
- The infusion set (catheter and needle) must be changed according to the instructions provided in the product information accompanying the infusion set.
To get the most benefit from insulin infusion and to detect a potential insulin pump failure, it is recommended to measure blood glucose levels regularly.
What to do if the pump fails
You must always have an alternative insulin delivery system available to administer subcutaneous insulin injections in case the pump fails.
If you use more insulin than you should
If you take too much insulin, your blood sugar level may become very low (hypoglycaemia). See a) Summary of serious and very common adverse effects in section 4.
If you forget to use your insulin
If you forget to inject insulin, your blood sugar level may become very high (hyperglycaemia). See c) Effects of diabetes in section 4.
If you stop using your insulin
Do not stop using your insulin without consulting your doctor, who will advise you what to do. This could lead to very high blood sugar levels (severe hyperglycaemia) and ketoacidosis. See c) Effects of diabetes in section 4.
If you have any further questions about the use of this medicine, ask your doctor, nurse, or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
a) Summary of serious and very common adverse effects
Low blood sugar (hypoglycaemia) is a very common adverse effect. It may affect more than 1 in 10 people.
Low blood sugar levels may occur if:
- too much insulin is injected;
- you eat very little or skip a meal;
- you do more physical exercise than usual;
- you drink alcohol (see Alcohol and use of NovoRapid in section 2).
Warning symptoms of low blood sugar: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, temporary changes in vision, drowsiness, unusual tiredness and weakness, nervousness or trembling, anxiety, confusion, and difficulty concentrating.
Severe low blood sugar may lead to loss of consciousness. If severe and prolonged low blood sugar is not treated, it may cause brain damage (transient or permanent) and even death. Consciousness may be regained more quickly if someone trained administers a glucagon injection. If glucagon is administered, you must take glucose or a sugary product as soon as you regain consciousness. If there is no response to glucagon treatment, you must be treated in a hospital.
What to do if your blood sugar level is low:
? If your blood sugar level is low, take glucose tablets or a sugary product (candies, biscuits, fruit juice). If possible, measure your blood sugar level and then rest. Always carry glucose tablets or sugary foods in case you need them.
? Once the symptoms of hypoglycaemia have disappeared or blood sugar levels have stabilized, continue insulin treatment as usual.
? If your blood sugar level has dropped so low that you became unconscious, if you required a glucagon injection, or if you have had frequent episodes of low blood sugar, speak to your doctor. You may need adjustments to your insulin dose or regimen, diet, or exercise routine.
Inform others that you have diabetes and explain the possible consequences, including the risk of losing consciousness due to low blood sugar. Let them know that if you become unconscious, they should place you in the recovery position and seek immediate medical help. Do not give you anything to eat or drink, as you could choke.
Serious allergic reactions to NovoRapid or any of its components (called systemic allergic reaction) is a very rare but potentially life-threatening adverse effect. It may affect up to 1 in 10,000 people.
Contact your doctor immediately:
- if signs of allergy spread to other parts of your body.
- if you suddenly feel unwell and have sweating, vomiting, difficulty breathing, palpitations, or dizziness.
? If you experience any of these symptoms, consult your doctor immediately.
Skin changes at the injection site: If you inject insulin repeatedly in the same area, fatty tissue may shrink (lipoatrophy) or thicken (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 injection sites to help prevent these skin changes.
b) List of other adverse effects
Uncommon adverse effects
May affect up to 1 in 100 people.
Signs of allergy: local allergic reactions may occur at the injection site (pain, redness, rash, swelling, bruising, swelling, and itching). These reactions usually disappear after a few weeks of treatment. If symptoms do not resolve, or if they spread throughout your body, consult your doctor immediately. See also Serious allergic reactions above.
Vision problems: when starting insulin treatment, you may experience vision disturbances, but these changes are usually temporary.
Swelling of joints: when starting insulin treatment, fluid retention may cause swelling of the ankles and other joints. This effect usually resolves quickly. If it does not, consult your doctor.
Diabetic retinopathy (an eye disease related to diabetes that may lead to vision loss): if you have diabetic retinopathy and your blood sugar level improves very rapidly, the retinopathy may worsen. Consult your doctor.
Rare adverse effects
May affect up to 1 in 1,000 people.
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.
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.
c) Effects of diabetes
High blood sugar (hyperglycaemia)
High blood sugar levels may occur if:
- insufficient insulin has been injected;
- you forget to inject insulin or interrupt insulin treatment;
- you repeatedly inject less insulin than you need;
- you have an infection or fever;
- you eat more than usual;
- you do less physical exercise than usual.
Warning symptoms of high blood sugar:
Warning symptoms develop gradually. These include: increased need to urinate, thirst, loss of appetite, feeling dizzy (nausea or vomiting), drowsiness or tiredness, dry and flushed skin, dry mouth, and fruity breath odour (acetone).
What to do if your blood sugar level is high:
? If you notice any of the symptoms described: check your blood sugar level, check for ketones in your urine if possible, and consult your doctor immediately.
? These may be symptoms of a very serious condition called diabetic ketoacidosis (acid builds up in the blood because the body breaks down fat instead of sugar). If left untreated, it could lead to diabetic coma and death.
5. Storage of NovoRapid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the vial and on the carton, after EXP. The expiry date refers to the last day of the month indicated.
Keep the vial in its outer packaging to protect it from light.
Before opening: store in a refrigerator between 2°C and 8°C, away from the walls or cooling element of the refrigerator. Do not freeze.
During use or when carried as a spare: the product may be stored for up to 4 weeks. Store below 30°C. Do not refrigerate or freeze.
Dispose of the needle after each injection.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any packaging and medicines you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of NovoRapid
- The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each vial contains 1,000 units of insulin aspart in 10 ml of injectable solution.
- The other components are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Appearance of the product and contents of the container
NovoRapid is presented as an injectable solution.
Containers containing 1 or 5 vials of 10 ml or multiple packs of 5 packs of 1 vial x 10 ml. Only certain pack sizes may be commercially available.
The solution is clear and colourless.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
Date of the most recent revision of this leaflet: 03/2023
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.