NovoRapid FlexPen 100 U/ml solution for injection in a pre-filled pen
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
NovoRapid FlexPen 100 units/ml solution for injection in a pre-filled pen
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 pass it on to others, even if they have the same symptoms as you, because it may 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 analogue) fast-acting insulin. 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 with 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 lower 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.
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 other information).
? If you suspect you are experiencing hypoglycaemia (low blood sugar levels) (see a) Summary of serious and very common adverse effects in section 4).
? If the FlexPen has fallen, been damaged, or broken.
? 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.
? Always use a new needle for each injection to prevent contamination.
? Needles and NovoRapid FlexPen must not be shared.
? NovoRapid FlexPen is intended only for subcutaneous injection. Consult your doctor if you need to inject insulin by another method.
Warnings and precautions
Certain medical conditions and activities may affect your insulin requirements. Consult your doctor:
? If you have kidney, liver, adrenal gland, pituitary, or thyroid gland problems.
? If you are doing more physical exercise than usual or wish to change your diet, as this may affect your blood sugar levels.
? If you are ill, continue your insulin treatment and consult your doctor.
? If you plan to travel abroad, time zone differences between countries may affect your insulin requirements and dosing schedule.
Skin changes at the injection site
You should rotate your injection site 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 in the injection area. 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 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.
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, which 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, which 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 either 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 are taking 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 requirements, as your blood sugar levels may increase or decrease. Careful 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. NovoRapid may be used during pregnancy. Your insulin dose may need to be adjusted during pregnancy and after delivery. Careful diabetes management, especially prevention of hypoglycaemia, is important for your baby's health.
- There are no restrictions on using NovoRapid during breastfeeding.
Consult your doctor, nurse, or pharmacist before using this medicine if you are pregnant or breastfeeding.
Driving and use of machines
? Please ask your doctor whether you may 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 so may your ability to drive or operate machinery. Bear in mind 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 and is therefore considered essentially "sodium-free".
3. How to use NovoRapid
Dosage and when to administer insulin
Follow exactly the insulin administration and dosage 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 your doctor tells you to do so. If your doctor changes you from one type or brand of insulin to another, you may require a dosage adjustment.
Use in children and adolescents
NovoRapid can be used in adolescents and children from 1 year of age onwards as an alternative to human soluble insulin when a more rapid onset of action is preferred. For example, when administration timing in relation to meals is difficult.
Use in special patient populations
If you have impaired kidney or liver function, or if you are over 65 years of age, you should monitor your blood sugar levels more frequently and consult your doctor regarding possible changes in your insulin dosage.
How and where to inject
NovoRapid must be injected under the skin (subcutaneously). It must never be injected directly into a vein (intravenously) or into muscle (intramuscularly). NovoRapid FlexPen is intended only for subcutaneous injection. Consult your doctor if you need to administer insulin by another method.
Each time you inject, 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 your waist. You should always measure your blood sugar level regularly.
How to handle NovoRapid FlexPen
NovoRapid FlexPen is a pre-filled, disposable pen with a colour code containing insulin aspart.
Carefully read the instructions on how to use NovoRapid FlexPen included in this leaflet. You must use the pen exactly as described in the instructions on how to use NovoRapid FlexPen.
Always make sure you are using the correct pen before injecting insulin.
If you use more insulin than you should
If you use 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; he or she will advise you on 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 will experience them.
a) 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.
Low blood sugar levels may occur if:
- too much insulin is injected;
- you eat very little or skip a meal;
- you exercise more than usual;
- you drink alcohol (see Alcohol and use of NovoRapid in section 2).
Warning signs 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 hypoglycaemia 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. Recovery of consciousness may be faster if someone trained in its administration gives you a glucagon injection. If glucagon is administered, you should 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). Check your blood sugar level if possible, 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 about 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. They should not give you anything to eat or drink, as you could choke.
Severe allergic reactions to NovoRapid or any of its components (called systemic allergic reaction) are a very rare but potentially fatal 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 feel dizzy.
? If you experience any of these symptoms, consult your doctor immediately.
Skin changes at the injection site: If you inject insulin in the same place repeatedly, 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 accumulation of a protein called amyloid (cutaneous amyloidosis; frequency unknown). Insulin may not work well if injected into a lumpy, shrunken, or thickened area. Rotate your 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, itching, or hives). These reactions usually disappear after a few weeks of treatment. If symptoms do not resolve, or if they spread throughout your body, contact your doctor immediately. See also Severe allergic reactions above.
Vision problems: when starting insulin treatment, you may experience vision disturbances, but these changes are usually temporary.
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, 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 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 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 level (hyperglycaemia)
High blood sugar levels may occur if:
- you have not injected enough insulin;
- 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 exercise less than usual.
Warning signs of high blood sugar:
warning signs appear gradually. These include: increased need to urinate, thirst, loss of appetite, nausea or vomiting, drowsiness or tiredness, dry and flushed skin, dry mouth, and fruity-smelling breath (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 contact 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 FlexPen label and on the carton, after EXP. The expiry date refers to the last day of the month indicated.
Always keep the cap on the pen when not in use, to protect it from light. NovoRapid must be protected from heat and excessive light.
Before opening: Unused NovoRapid FlexPen must be stored in a refrigerator at 2°C to 8°C, away from the walls or cooling element of the refrigerator. Do not freeze.
During use or when carried as a spare: Your NovoRapid FlexPen may be carried with you and stored either at a temperature below 30°C or in the refrigerator (between 2°C and 8°C) for up to 4 weeks. If stored in the refrigerator, keep it away from the walls or cooling element of the refrigerator. Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of NovoRapid
- The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre-filled pen contains 300 units of insulin aspart in 3 ml of injectable solution.
- The other ingredients 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.
Packages containing 1 (with or without needles), 5 (without needles) and 10 (without needles) 3-ml pre-filled pens. Only certain pack sizes may be marketed.
The solution is clear and colourless.
Marketing Authorisation Holder and Manufacturer
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 carton cap and on the label:
-
If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.
-
If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.
Now on the reverse, read the information on how to use FlexPen.
Date of latest revision of this leaflet: 03/2023
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Instructions on how to use NovoRapid injectable solution in FlexPen.
Read the following instructions carefully before using your FlexPen. If you do not follow the instructions carefully, you may inject too little or too much insulin, which could result in blood sugar levels that are too high or too low.
FlexPen is a pre-filled insulin dosing pen. Doses from 1 to 60 units can be selected in 1-unit increments. FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length. As a precaution, always keep a spare insulin delivery device in case your FlexPen is lost or damaged.
Care of the pen
You should handle your FlexPen with care.
If it is dropped, damaged or subjected to impact, there is a risk that insulin may leak out. This could lead to inaccurate dosing, which may result in blood sugar levels that are too high or too low.
You may clean the outside of your FlexPen with an alcohol-impregnated cotton swab. Do not immerse, wash or lubricate it, as this may damage the pen.
Do not refill your FlexPen. Once empty, it must be discarded.
Preparing NovoRapid FlexPen
Check the name and colour label of your pen to make sure it contains the correct type of insulin. This is especially important if you use more than one type of insulin. If you use the wrong type of insulin, your blood sugar level may become too high or too low.
A
Remove the pen cap.
B
Remove the paper tab from a new disposable needle.
Screw the needle straight and firmly onto your FlexPen.
C
Remove the large outer needle cap and keep it for later use.
D
Remove the inner needle cap and discard it.
Never try to reinsert the inner needle cap. You could accidentally prick yourself with the needle.
Always use a new needle for each injection. This reduces the risk of contamination, infection, insulin leakage, needle blockage and inaccurate dosing.
Be careful not to bend or damage the needle before use.
Checking insulin flow
Small amounts of air may accumulate in the cartridge during normal use before each injection. To avoid injecting air and to ensure proper dosing:
E
Turn the dose selector to select 2 units.
F
Hold your FlexPen with the needle pointing upwards and gently tap the cartridge a few times with your finger to allow air bubbles to move to the top of the cartridge.
G
With the needle pointing upwards, press the plunger fully. The dose selector returns to 0.
A drop of insulin should appear at the tip of the needle. If not, change the needle and repeat the procedure up to a maximum of 6 times.
If a drop of insulin still does not appear, the pen is defective and you must use a new one.
Always ensure a drop appears at the tip of the needle before injecting. This ensures that insulin is flowing. If no drop appears, no insulin will be injected, even if the dose selector moves. This may indicate that the needle is blocked or damaged.
Always check the flow before injecting. If you do not check the flow, you may receive an insufficient or even no insulin at all. This could result in blood sugar levels that are too high.
Selecting the dose
Check that the dose selector is set to 0.
H
Turn the dose selector to select the number of units you need to inject.
The dose can be adjusted forwards or backwards by turning the dose selector in either direction until the corrected dose is aligned with the dose marker. When turning the dose selector, be careful not to press the plunger, as insulin may leak out.
You cannot select a dose greater than the number of units remaining in the cartridge.
Before injecting insulin, always use the dose selector and dose marker to verify how many units you have selected.
Do not count the clicks of the pen. If you select and inject an incorrect dose, your blood sugar level may become too high or too low. Do not use the remaining insulin scale, as it only shows the approximate amount of insulin left in the pen.
Injection
Insert the needle under the skin. Use the injection technique recommended by your doctor or nurse.
I
Inject the dose by pressing the plunger fully so that the 0 aligns with the dose marker. Be careful to press the plunger only when injecting.
Turning the dose selector will not inject insulin.
J
Keep the plunger fully pressed and keep the needle under the skin for at least 6 seconds. This will ensure the full dose has been delivered.
Remove the needle from the skin and, once done, release the plunger.
Always ensure that the dose selector returns to 0 after injection. If the dose selector stops before reaching 0, the full dose has not been administered, which could result in blood sugar levels that are too high.
K
Cover the needle with the large outer needle cap without touching it. Once the needle is covered, carefully press the large outer needle cap fully on and then unscrew the needle.
Dispose of it carefully and replace the pen cap.
Always remove the needle after each injection and store your FlexPen without a needle attached. This reduces the risk of contamination, infection, insulin leakage, needle blockage and inaccurate dosing.
Other important information
People caring for patients must take great care when handling used needles to reduce the risk of accidental needlestick injuries and infections.
Dispose of your used FlexPen carefully without leaving the needle attached.
Never share the pen or needles with other people. This could cause infections.
Never share the pen with other people. Your medicine could be harmful to their health.
Always keep the pen and needles out of sight and reach of others, especially children.