BAQSIMI 3 mg NASAL POWDER SINGLE-DOSE PACK

Introduction

Package Leaflet: Information for the Patient

Baqsimi 3 mg Nasal Powder in Single-Dose Container

Glucagon

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Baqsimi and what is it used for
2. What you need to know before you are given Baqsimi
3. How Baqsimi is administered
4. Possible side effects
5. Storage of Baqsimi
6. Contents of the pack and further information

1. What is Baqsimi and what is it used for

Baqsimi contains the active substance glucagon, which belongs to a group of medicines called glucogenolytic hormones. It is used to treat severe hypoglycemia (very low blood sugar) in people with diabetes. It can be used in adults, adolescents, and children aged 4 years 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 the sugar stored in the liver, called glycogen, into glucose (a type of sugar that the body uses for energy). The glucose then enters the bloodstream and increases blood sugar levels, reducing the effects of hypoglycemia.

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

2. What you need to know before you are given Baqsimi

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 keep this medicine 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 ingredients of this medicine (listed in section 6).
• If you have a pheochromocytoma, which is a tumor in the adrenal gland (a gland above the kidneys).

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before using Baqsimi:

• If you have an insulinoma, which is a tumor in the pancreas.
• If you have insufficient hepatic glycogen. This can occur:
• In states of starvation.
• If your adrenal gland does not produce enough cortisol or aldosterone.
• If you have chronic hypoglycemia.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist, or nurse before using Baqsimi.

If you experience an allergic reaction to glucagon in the form of a generalized rash and, in some cases, anaphylactic shock with difficulty breathing and hypotension, seek medical help immediately.

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 sugary drink.

Children

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

Other Medicines and Baqsimi

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The following medicines may affect how Baqsimi works:

• Insulin - used to treat diabetes. Insulin has the opposite effect to glucagon on blood sugar levels.
• Indomethacin, used to treat pain and stiffness in the joints. Indomethacin reduces the effect of glucagon or may even cause hypoglycemia.

The following medicines 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 heart rate. This will only last for a short period.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Driving and Using Machines

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

3. How Baqsimi is Administered

Follow the administration instructions for this medicine exactly as told by your doctor, pharmacist, or nurse. If you are unsure, ask 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.

Instructions for Administration of Baqsimi

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

Caution:Do not press the plunger before inserting it into the nose, or the single dose of the single-dose container will be lost.

Dose Administration

1. Hold the single-dose container between your fingers and thumb. Do not test it before use, as it contains only one dose of glucagon and cannot be reused.
2. Gently insert the tip into a 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 on the plunger is no longer visible.
4. If the person with low blood sugar is unconscious, place them on their side to avoid choking.
5. After administering the dose, seek medical help immediately.
6. Encourage the person with low blood sugar to eat as soon as possible. A food or drink with high sugar content 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 may cause nausea and vomiting. It may also increase blood pressure and heart rate. Normally, no specific treatment is needed.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects that may affect more than 1 in 10 people who use this medicine are:

• Headache
• Watery eyes
• Nasal discomfort and other effects in the nose, such as itching, sneezing, runny nose, or stuffy nose and bleeding
• Sore throat and cough
• Altered sense of smell
• Vomiting
• Nausea

Common side effects that may affect up to 1 in 10 people who use this medicine are:

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

Uncommon side effects that may affect up to 1 in 100 people who use this medicine are:

• Increased heart rate

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Baqsimi

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

Do not use this medicine after the expiry date which is stated on the carton, tube, and single-dose container after EXP. The expiry date is the last day of the month stated.

Do not store 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 medicine to not work as expected. Check the sealed tube periodically. If the tube has been opened, replace the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Baqsimi

• The active substance is glucagon. Each single-dose container delivers nasal powder that contains 3 mg of glucagon.
• The other ingredients are betadex (E459) and dodecylphosphocholine.

Appearance of the Product and Contents of the Pack

Baqsimi is a white or almost white nasal powder in a single-dose container (nasal powder).

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

Baqsimi is available in a cardboard box containing 1 or 2 single-dose containers sealed individually in a plastic tube. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Amphastar France Pharmaceuticals

Usine Saint Charles

Eragny Sur Epte

60590

France

Manufacturers

Lilly France S.A.S.

rue du Colonel Lilly

F-67640 Fegersheim,

France

Amphastar France Pharmaceuticals

Usine Saint Charles

Eragny Sur Epte

60590

France

Date of Last Revision 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.eu and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

INSTRUCTIONS FOR USE

Baqsimi 3 mg Nasal Powder in Single-Dose Container

Glucagon

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

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