Baqsimi 3 mg polvo nasal en envase unidosis

Patient Information Leaflet

Baqsimi 3 mg nasal powder in single-dose packaging

glucagon

Read this 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Table of Contents

1. What is Baqsimi and how is it used
2. What you need to know before Baqsimi is administered
3. How to administer Baqsimi
4. Possible side effects
5. Storage of Baqsimi
6. Contents of the package and additional information

Baqsimi contains the active ingredient glucagon, which belongs to a group of medications called glucagon-like hormones. It is used to treat severe hypoglycemia (low blood sugar) in people with diabetes. It can be used in adults, adolescents, and children 4 years of age or older.

Glucagon is a natural hormone produced by the pancreas. It works in the opposite way to insulin and increases blood sugar levels. It does this by converting stored sugar in the liver, called glycogen, into glucose (a type of sugar that the body uses for energy). Once the glucose enters the bloodstream, it increases blood sugar levels, thereby reducing the effects of hypoglycemia.

You should always carry Baqsimi with you and tell your friends and family that you have it with you.

Important Information

If you are at risk of severe hypoglycemia, you should always have Baqsimi readily available:

• Show your family, friends, or people you work with where you store this medication and explain to them when and how to use it. Delayed treatment can be harmful. It is essential that they know how to use Baqsimi before you need it.

Do Not Use Baqsimi

• If you are allergic to glucagon or any of the other components of this medication (listed in section 6)
• If you have pheochromocytoma, which is a tumor in the adrenal gland (a gland above the kidneys).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before using Baqsimi:

• If you have a tumor in the pancreas called insulinoma.
• If you have inadequate hepatic glycogen. This may occur:
• In states of malnutrition.
• If your adrenal gland does not produce enough cortisol or aldosterone.
• If you have chronic hypoglycemia.

If you are unsure whether any of the above applies to you, speak with your doctor, pharmacist, or nurse before using Baqsimi.

If you experience an allergic reaction to glucagon in the form ofgeneralized eruption and, in some cases, anaphylactic shock with respiratory difficulty and hypotension, seek immediate medical help.

After using Baqsimi, eat as soon as possible to avoid another low blood sugar level. Take a quick-acting source of sugar, such as fruit juice or a carbonated drink containing sugar.

Children

The use of Baqsimi in children under 4 years of age is not recommended as it has not been studied in this age group.

Other Medications and Baqsimi

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The following medications may affect how Baqsimi works:

• Insulin – used to treat diabetes. Insulin has the opposite effect to glucagon on blood sugar levels.
• Indometacin, used to treat pain and joint stiffness. Indometacin reduces the effect of glucagonor may even cause hypoglycemia.

The following medications may be affected by Baqsimi:

• Warfarin, used to prevent blood clots. Baqsimi may increase the anticoagulant effect of warfarin.
• Beta-blockers, used to treat high blood pressure and irregular heartbeats. Baqsimi may increase blood pressure and pulse. This will only last for a short period of time.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

If your blood sugar level drops too low during pregnancy or breastfeeding, you can use Baqsimi.

Driving and Operating Machines

Wait until the effects of the very low blood sugar level have disappeared before driving or using tools or machines.

Follow exactly the administration instructions for this medication as indicated by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse again.

Explain how to use Baqsimi to your family, friends, coworkers, or caregiver. They will need to know how to use it before you need it.

Baqsimi is administered as a single dose of 3 mg.

Administration Instructions for Baqsimi

1. Remove the seal by pulling the red strip.
2. Open the cap and remove the single-dose vial from the tube.

Precaution:Do not press the plunger before inserting it into the nose, otherwise the single dose in the single-dose vial will be lost.

Administration of the Dose

1. Hold the single-dose vial between your fingers and thumb. Do not taste it before using it, as it contains only one dose of glucagon and cannot be reused.
2. Gently insert the tip into one nostril until your finger touches the outside of the nose.
3. Press the plunger all the way down with your thumb. The dose administration is complete when the green line is no longer visible on the plunger.
4. If the person with low blood sugar is unconscious, place them on their side to prevent choking.
5. After administering the dose, seek immediate medical help.
6. Encourage the person with low blood sugar to eat as soon as possible. A food or drink high in sugar will prevent another drop in blood sugar levels.

Read the "Instructions for Use" carefully before using Baqsimi.

If You Are Given Too Much Baqsimi

Too much Baqsimi can cause nausea and vomiting. It may also raise blood pressure and heart rate. Normally, no specific treatment is needed.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very frequent adverse effects that may affect more than 1 in 10 people who use this medication are:

• Headache
• Watery eyes
• Discomfort and other effects in the nose, such as itching, sneezing, nasal discharge or nasal congestion and bleeding
• Irritation of the throat and cough
• Alteration of the sense of smell
• Vomiting
• Nausea

Frequent adverse effects that may affect up to 1 in 10 people who use this medication are:

• Alteration of the sense of taste
• Redness of the eyes
• Itching of the eyes
• Itching of the skin
• Increased blood pressure

Rare adverse effects that may affect up to 1 in 100 people who use this medication are:

• Increased heart rate

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in the Appendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, the vial, and the single-dose container after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Keep the single-dose container in the sealed tube until the time of use to protect it from moisture.

If the tube has been opened, the single-dose container may have been exposed to moisture. This could cause the medication not to work as expected. Examine the sealed tube periodically. If the tube has been opened, replace the medication.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Baqsimi

• The active ingredient is glucagon. Each single-dose vial administers a nasal powder that contains 3 mg of glucagon.
• The other components are betadex (E459) and dodecylphosphocholine.

Appearance of the product and contents of the package

Baqsimi is a white or almost white nasal powder in a single-dose vial.

Each single-dose vial contains a single dose of glucagon nasal powder.

Baqsimi is presented in a cardboard box that contains 1 or 2 sealed single-dose vials individually in a plastic tube. Some package sizes may be marketed.

Marketing Authorization Holder

Amphastar France Pharmaceuticals

Usine Saint Charles

Eragny Sur Epte

60590

France

Manufacturers Responsible

Lilly France S.A.S.

rue du Colonel Lilly

F-67640 Fegersheim,

France

Amphastar France Pharmaceuticals

Usine Saint Charles

Eragny Sur Epte

60590

France

Last review date of this leaflet<{MM/YYYY}><{month YYYY}>.

Detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.euand on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

INSTRUCTIONS FOR USE

Baqsimi 3 mg nasal powder in single-dose vial

Glucagon

Read the instructions for use carefully before using Baqsimi. Also, read the entire leaflet before using the medicine.

• Show your family and friends where you store Baqsimi and explain how to use it by sharing these instructions.They need to know how to use it before they need it.
• Baqsimi is used to treat very low blood sugar levels (hypoglycemia).