NovoRapid PenFill 100 U/ml solution for injection in cartridge

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NovoRapid Penfill 100 units/ml solution for injection in cartridge

insulin aspart

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

• Keep this leaflet. 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. Do 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 this leaflet

1. What NovoRapid is and what it is used for
2. What you need to know before you use NovoRapid
3. How to use NovoRapid
4. Possible side effects
5. How to store NovoRapid
6. 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 rapid action. Modern insulins are improved versions of human insulin.

NovoRapid is used to lower high blood sugar 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 sugar levels. Treatment with NovoRapid helps prevent complications of diabetes.

NovoRapid begins to reduce blood sugar 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. Because of this short action, NovoRapid is usually administered in combination with intermediate-acting 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 further information).

? If you suspect you are going to have hypoglycaemia (low blood sugar levels) (see a) Summary of serious and very common adverse effects in section 4).

? If the cartridge or the device containing the cartridge has been dropped, 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 check the cartridge, including the rubber stopper at the end of the cartridge. Do not use it if it is damaged or if the rubber stopper has moved beyond the white band at the end of the cartridge. This could indicate that insulin has leaked out. If you suspect the cartridge is damaged, return it to your supplier. For more information, refer to the instructions for your pen.

? Always use a new needle for each injection to prevent contamination.

? Needles and NovoRapid Penfill must not be shared.

? NovoRapid Penfill is intended only for subcutaneous injection using a reusable pen. Consult your doctor if you need to administer insulin by another method.

Warnings and precautions

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

? If you have kidney, liver, adrenal, pituitary, 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 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 administration schedule.

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 effectively if injected into an area that is lumpy, shrunken, or thickened (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 affected areas before switching to a different injection 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, 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] or salbutamol or terbutaline used to treat asthma);
• growth hormone (a medicine used 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 (edema).

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

Alcohol 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 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 control of your diabetes is important for your baby’s health, especially the prevention of hypoglycaemia.

• There are no restrictions on treatment with 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. 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 essentially considered “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 the 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 adolescents and children from 1 year of age onwards instead of soluble human insulin, when a more rapid 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 consult your doctor regarding possible changes in your insulin dose.

How and where to inject

NovoRapid must be injected under the skin (subcutaneously). You must never inject it directly into a vein (intravenously) or into a muscle (intramuscularly). NovoRapid Penfill is intended only for subcutaneous injection using a reusable insulin pen. 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 hollows in the skin (see section 4, Possible side effects). The best areas for injection 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 glucose level regularly.

? Do not refill the cartridge. Once empty, it must be discarded.

? NovoRapid Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and with NovoFine or NovoTwist needles.

? If you are being treated with both NovoRapid Penfill and another insulin in a Penfill cartridge, you must use two insulin delivery devices, one for each type of insulin.

? Always keep a spare Penfill cartridge in case your cartridge is lost or broken.

How to inject NovoRapid

? Insulin must be injected under the skin. Use the injection technique recommended by your doctor or nurse and described in the instructions for use of your delivery device.

? Keep the needle under the skin for at least 6 seconds. Keep the plunger fully pressed until the needle is withdrawn from the skin. This ensures proper delivery and minimizes the potential for blood backflow into the needle or remaining insulin.

? After each injection, remove and dispose of the needle, and store NovoRapid without the needle attached. Otherwise, liquid may leak out, leading to incorrect dosing.

If you use more insulin than you should

If you use too much insulin, your blood glucose 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 glucose 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 glucose 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 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 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. Recovery of consciousness may be faster if someone trained administers 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, hospital treatment is required.

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, check your blood sugar level and then rest. Always carry glucose tablets or sugary foods with you 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) are a very rare but potentially life-threatening adverse effect. It may affect up to 1 in 10,000 people.

Contact your doctor immediately:

• if allergy symptoms 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 become thicker (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 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.

Allergic reactions: local allergic reactions may occur at the injection site (pain, redness, rash, swelling, bruising, oedema, and itching). These reactions usually resolve after a few weeks of treatment. If symptoms do not disappear, 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 (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. 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 (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 exercise less than usual.

Warning signs of high blood sugar:

warning symptoms appear gradually. These include: increased need to urinate, 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 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 cartridge label and packaging, after EXP. The expiry date is the last day of the month indicated.

Always store the cartridge in its outer packaging when not in use, to protect it from light. NovoRapid must be protected from excessive heat and light.

Before opening: unused NovoRapid Penfill must be stored in the 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: NovoRapid Penfill in use or carried as a spare must not be stored in the refrigerator. It may be carried with you and stored at room temperature (below 30°C) for up to 4 weeks.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers 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 cartridge contains 300 units of insulin aspart in 3 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 a solution for injection.

Pack sizes containing 5 and 10 cartridges of 3 ml. 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.

Date of the most recent revision of this leaflet: 03/2023

Other sources of information

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