Fiasp 100 units/ml solution for injection in cartridge

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fiasp 100 units/ml Penfill solution for injection in cartridge

insulin aspart

Read the entire 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, 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 side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Fiasp is and what it is used for
2. What you need to know before using Fiasp
3. How to use Fiasp
4. Possible side effects
5. How to store Fiasp
6. Contents of the pack and other information

1. What Fiasp is and what it is used for

Fiasp is an insulin administered at mealtimes that rapidly lowers blood glucose levels. Fiasp is an injectable solution of insulin aspart and is used to treat diabetes mellitus in adults, adolescents, and children from 1 year of age. Diabetes is a disease in which the body does not produce enough insulin to control blood glucose levels. Treatment with Fiasp helps prevent complications of diabetes.

Fiasp should be injected from 2 minutes before starting a meal, with the possibility of administration up to 20 minutes after beginning the meal.

This medicine reaches its maximum effect between 1 and 3 hours after injection, and its effect lasts between 3 and 5 hours.

This medicine should normally be used in combination with intermediate- or long-acting insulins.

2. What you need to know before using Fiasp

Do not use Fiasp

• if you are allergic to insulin aspart or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Fiasp. It is important that you are aware of the following:

• Low blood sugar (hypoglycemia): if your blood sugar level is too low, follow the instructions for low blood sugar provided in section 4 “Possible side effects”. Compared to other insulins taken at mealtimes, Fiasp begins to lower blood sugar more quickly. If you experience hypoglycemia, you may feel it sooner after an injection of Fiasp.
• High blood sugar (hyperglycemia): if your blood sugar level is too high, follow the instructions for high blood sugar provided in section 4 “Possible side effects”.
• Switching from other insulins: your doctor may need to advise you about your insulin dose.
• If you are combining your insulin treatment with pioglitazone (an oral antidiabetic medicine used to treat type 2 diabetes), speak to your doctor as soon as possible if you experience symptoms of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling due to fluid retention (edema).
• Eye disorders: a sudden improvement in blood sugar control may temporarily worsen diabetes-related eye problems such as diabetic retinopathy.
• Nerve damage pain: if your blood sugar level improves very rapidly, you may experience nerve-related pain, which is usually temporary.
• Swelling of joints: when you first start using the medicine, your body may retain more fluid than normal, causing swelling of the ankles and other joints. This effect usually disappears quickly.
• Make sure you are using the correct type of insulin; always check the insulin label before each injection to avoid accidental mix-ups between insulins.
• Treatment with insulin may cause your body to produce antibodies against insulin (substances that act against insulin). However, this very rarely requires a change in your insulin dose.

If you have reduced vision, see section 3 “How to use Fiasp”.

Certain conditions and activities may affect your insulin requirements. 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 wish to change your normal diet, as this may affect your blood sugar level.
• if you are unwell, continue your insulin treatment and consult your doctor.
• if you are travelling abroad, as travelling across different time zones may affect your insulin needs and injection times.

When using Fiasp, it is strongly recommended that you record the name and batch number of each container to maintain a record of the batches used.

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 Fiasp”). 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 medicines.

Children and adolescents

This medicine is not recommended for use in children under 1 year of age.

Other medicines and Fiasp

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines affect your blood sugar level 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 (hypoglycemia) if you take:

• other antidiabetic medicines (oral or injectable)
• sulfonamide antibiotics (used to treat infections)
• anabolic steroids (such as testosterone)
• beta-blockers (used to treat high blood pressure or angina)
• salicylates (used to relieve pain and reduce fever)
• monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat certain heart conditions or high blood pressure).

Your blood sugar level may increase (hyperglycemia) if you take:

• danazol (a medicine that affects ovulation)
• oral contraceptives (birth control pills)
• thyroid hormones (used to treat thyroid gland problems)
• growth hormone (used to treat growth hormone deficiency)
• glucocorticoids (such as “cortisone”, used to treat inflammation)
• sympathomimetics (such as epinephrine (adrenaline), salbutamol, or terbutaline, used to treat asthma)
• thiazides (used to treat high blood pressure or fluid retention (edema)).

Octreotide and lanreotide, used to treat acromegaly, a rare disorder characterized by excessive growth hormone production. These medicines may either increase or decrease your blood sugar level.

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist.

Use of Fiasp with alcohol

If you drink alcohol, it may alter your insulin requirements, as your blood sugar level may increase or decrease. Therefore, you should monitor your blood sugar level more frequently than usual.

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. This medicine can be used during pregnancy; however, your insulin dose may need to be adjusted during pregnancy and after delivery. Your insulin requirement usually decreases during the first 3 months of pregnancy and increases during the remaining 6 months. Careful diabetes control is essential during pregnancy. Preventing low blood sugar (hypoglycemia) is especially important for your baby’s health. After delivery, your insulin requirements will likely return to what they were before pregnancy.

There are no restrictions on the use of Fiasp during breastfeeding.

Driving and using machines

Low blood sugar can impair your ability to drive or operate tools or machinery. If you have low blood sugar, your concentration and reaction time may be affected. This could endanger your life or the lives of others. Ask your doctor whether you may drive if:

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

Important information about some of the ingredients of Fiasp

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

3. How to use Fiasp

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this medicine without assistance. Ask for help from a person with normal vision who has been trained in the use of the pen.

When to use Fiasp

Fiasp is an insulin that is administered at mealtime.

Adults: Fiasp should be injected just before (0 to 2 minutes before) starting to eat, with the possibility of being administered up to 20 minutes after the start of the meal.

Children: Fiasp should be injected just before (0 to 2 minutes before) starting to eat, with the possibility of being administered up to 20 minutes after the start of the meal in situations where it is uncertain when the child will eat. Consult your doctor about these situations.

This medicine reaches its maximum effect between 1 and 3 hours after injection, and the effect lasts between 3 and 5 hours.

Fiasp dosage

Dosage for type 1 and type 2 diabetes

Your doctor will decide together with you:

• how much Fiasp you need at each meal
• when to check your blood sugar level and whether you need a higher or lower dose.

If you wish to modify your usual diet, consult your doctor, pharmacist, or nurse beforehand, as a change in diet may alter your insulin requirement.

When using other medicines, ask your doctor whether your treatment needs to be adjusted.

Dosage adjustment for type 2 diabetes

The daily dose depends on your blood sugar level at mealtimes the previous day and the previous night.

• Before breakfast: the dose should be adjusted according to the blood sugar level before lunch the previous day.
• Before lunch: the dose should be adjusted according to the blood sugar level before dinner the previous day.
• Before dinner: the dose should be adjusted according to the blood sugar level the previous night.

Use in elderly patients (65 years of age or older)

This medicine can be used in elderly patients. Talk to your doctor about possible dose adjustments.

If you have kidney or liver problems

If you have kidney or liver problems, you may need to monitor your blood sugar level more frequently. Talk to your doctor about possible dose adjustments.

Injecting Fiasp

This medicine is intended only for subcutaneous injection (injection under the skin) using a Novo Nordisk reusable insulin pen.

Before using Fiasp for the first time, your doctor or nurse will show you how to do it. Consult your doctor if you need to inject insulin by another method.

Where to inject

• The best injection sites are the front of the waist (abdomen) or the upper arm.
• Do not inject into a vein or muscle.
• Change the injection site daily within the area where you inject to reduce the risk of developing skin changes (see section 4).

Do not use Fiasp

• if the cartridge or reusable pen you are using is damaged. Return them to your supplier. See the reusable pen user manual for more information.
• if the cartridge has not been stored properly (see section 5 “Storage of Fiasp”).
• if the insulin does not appear clear (e.g., cloudy) and colorless.

How to inject Fiasp

• Read the instructions provided with the reusable pen.
• Check the name and concentration on the cartridge (Penfill) label to ensure it is Fiasp.
• Always use a new needle for each injection to avoid contamination.
• Needles must not be shared.

If you use more Fiasp than you should

If you use too much insulin, your blood sugar level may become very low (hypoglycemia); see section 4 “Low blood sugar level”.

If you forget to use Fiasp

If you forget to inject your insulin, your blood sugar level may become very high (hyperglycemia). See section 4 “High blood sugar level”.

Three simple steps that may help you avoid low or high blood sugar levels:

• Always carry spare Fiasp cartridges.
• Always carry something that indicates you have diabetes.
• Always carry sugary products with you. See section 4 “What to do if your blood sugar level is low”.

If you stop using Fiasp

Do not stop using your insulin without consulting your doctor. Stopping insulin treatment could lead to very high blood sugar (severe hyperglycemia) and ketoacidosis (a condition involving excessive acid in the blood, which can be life-threatening). See symptoms and recommendations in section 4 “High blood sugar level”.

4. Possible adverse effects

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

Low blood sugar (hypoglycaemia) is a very common side effect of insulin treatment (may affect more than 1 in 10 people). It can be very serious. Severe hypoglycaemia can lead to loss of consciousness. A severe episode of hypoglycaemia can cause brain damage and may be life-threatening. If you experience symptoms of low blood sugar, take action to raise your blood sugar level immediately. See the recommendations below under “Low blood sugar”.

If you experience a severe allergic reaction (including anaphylactic shock) to insulin or any of the components of Fiasp (frequency unknown), stop using this medicine immediately and contact emergency medical services without delay.

Symptoms of a severe allergic reaction may include:

• local reactions (e.g., rash, redness, itching) spreading to other parts of the body
• sudden feeling of being unwell with sweating
• vomiting
• difficulty breathing
• palpitations or dizziness.

Allergic reactions such as widespread skin rash and facial swelling may occur. These are uncommon and may affect up to 1 in 100 people. Consult a doctor if symptoms worsen or if you do not see improvement within a few weeks.

Skin changes at the injection site: If you inject insulin in the same place repeatedly, fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (these are uncommon and may affect up to 1 in 100 people). Lumps under the skin may also develop due to the accumulation 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.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

Reaction at administration site: Local reactions at the injection site may occur. Symptoms may include rash, redness, swelling, bruising, irritation, pain, and itching. These reactions usually resolve after a few days.

Skin reactions: Skin allergy signs such as eczema, rash, itching, hives, and dermatitis may occur.

General effects of insulin treatment including Fiasp

• Low blood sugar (hypoglycaemia) (very common)

Low blood sugar may occur if you:

Drink alcohol, inject too much insulin, exercise more than usual, eat too little, or skip a meal.

Warning signs of low blood sugar, which may appear suddenly:

Headache,
difficulty speaking,
palpitations,
cold sweating,
cold and pale skin,
nausea,
feeling of excessive hunger,
tremor, nervousness, or anxiety,
feeling of unusual tiredness, weakness, or drowsiness,
confusion,
difficulty concentrating,
temporary changes in vision.

What to do if your blood sugar level is low

• If you are conscious, treat your low blood sugar immediately with 15–20 g of fast-acting carbohydrates: take glucose tablets or a sugary product such as fruit juice, sweets, or biscuits (always carry glucose tablets or sugary products with you in case you need them).
• It is recommended to recheck your blood glucose levels after 15–20 minutes and repeat treatment if your blood glucose levels are still below 4 mmol/l.
• Wait until symptoms of hypoglycaemia have disappeared or your blood sugar level has stabilized. Continue insulin treatment as usual.

What people close to you should do if you lose consciousness

Inform people you spend time with that you have diabetes. Let them know about the possible consequences of low blood sugar, including the risk of losing consciousness.

Tell them that if you become unconscious, they should:

• lay you on your side to prevent choking
• seek immediate medical assistance
• not give you anything to eat or drink, as you could choke.

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 take glucose or a sugary product as soon as you regain consciousness.
• If you do not respond to glucagon treatment, you must be treated in a hospital.

If severe hypoglycaemia is not treated, it may over time cause brain damage. This damage may be transient or permanent. It can ultimately lead to death.

Talk to your doctor if:

• you have had such low blood sugar levels that you lost consciousness
• you have received a glucagon injection
• you have recently experienced several episodes of low blood sugar.

You may need adjustments to your insulin dose or injection frequency, diet, or exercise routine.

• High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Eat more or exercise less than usual, drink alcohol, have an infection or fever, do not inject enough insulin, repeatedly inject less insulin than you need, forget to inject insulin, or stop insulin treatment.

Warning signs of high blood sugar, which usually appear gradually:

Skin redness,
dry skin,
feeling drowsy or tired,
dry mouth,
fruity breath odour (acetone),
increased need to urinate,
thirst,
loss of appetite,
nausea or vomiting.

These may be symptoms of a very serious condition called ketoacidosis. This is an accumulation of acid in the blood due to the body metabolizing fat instead of sugar. If untreated, it could lead to diabetic coma and even death.

What to do if your blood sugar level is high

• Monitor your blood sugar level.
• Administer a correction dose of insulin if you have been trained to do so.
• Check your urine for ketones.
• If you have ketones, seek immediate medical assistance.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fiasp

Keep this medicine out of sight and reach of children.

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

Before first use

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the freezer compartment. Store the cartridge in its outer packaging to protect it from light.

After opening or when carried as a spare

Do not refrigerate. The cartridge (Penfill) may be carried with you and stored at room temperature (not exceeding 30°C) for up to 4 weeks. Always keep the cartridge in its outer packaging to protect it from light.

Dispose of the needle after each injection.

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 helps protect the environment.

6. Contents of the pack and other information

Composition of Fiasp

• The active substance is insulin aspart. 1 ml of solution contains 100 units of insulin aspart. Each cartridge contains 300 units of insulin aspart in 3 ml of solution.
• The other components are phenol, metacresol, glycerol, zinc acetate, disodium phosphate dihydrate, arginine hydrochloride, nicotinamide (vitamin B3), hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) (see end of section 2 “Important information about some of the components of Fiasp”), and water for injections.

Appearance of Fiasp and contents of the pack

Fiasp is presented as a clear, colourless, aqueous, injectable solution in a cartridge.

Pack sizes of 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Date of the most recent revision of this summary:

Other sources of information

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