Baqsimi 3 mg nasal powder in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Baqsimi 3 mg nasal powder in single-dose container

glucagon

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

Contents of this leaflet

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

1. What Baqsimi is and what it is used for

Baqsimi contains the active substance glucagon, which belongs to a group of medicines called glycogenolytic hormones. It is used to treat severe hypoglycaemia (very low blood sugar) in people with diabetes. It can be used in adults, adolescents, and children aged 4 years and older.

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

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

2. What you need to know before Baqsimi is administered to you

Important information

If you are at risk of severe hypoglycemia, Baqsimi must always be readily available:

• Show your family members, friends, or coworkers where you keep this medicine and explain to them when and how it should be used. Delay in treatment can be harmful. It is important that they know how to use Baqsimi before it is needed.

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 of the adrenal gland (a gland located above the kidneys).

Warnings and precautions

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

• if you have a tumor of the pancreas called an insulinoma.
• if you have insufficient liver glycogen. This may occur:
• in states of starvation.
• 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 apply to you, speak with your doctor, pharmacist, or nurse before using Baqsimi.

If you experience an allergic reaction to glucagon such as generalized rash and, in some cases, anaphylactic shock with breathing difficulties and hypotension, seek immediate medical help.

After using Baqsimi, eat as soon as possible to prevent another episode of low blood sugar. Take a fast-acting source of sugar, such as fruit juice or a sugary soft drink.

Children

Use of Baqsimi is not recommended 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 taking, have recently taken, or might need to take any other medicines.

The following medicines may affect how Baqsimi works:

• insulin – used to treat diabetes. Insulin has the opposite effect of glucagon on blood sugar.
• Indomethacin, used to treat joint pain and stiffness. Indomethacin may reduce 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 pulse. This effect will last only for a short period of time.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If your blood sugar drops very low during pregnancy or breastfeeding, you may use Baqsimi.

Driving and using machines

Wait until the symptoms of very low blood sugar have resolved before driving or operating tools or machinery.

3. How Baqsimi is administered

Follow exactly the administration instructions for this medicine provided by your doctor, pharmacist, or nurse. If in 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 it is needed.

Baqsimi is administered as a single 3 mg dose.

Instructions for administering Baqsimi

1. Remove the seal by pulling the red tab.
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, otherwise the single dose in 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 one nostril until your finger touches the outside of the nose.
3. Press the plunger fully 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 assistance.
6. Encourage the person with low blood sugar to eat as soon as possible. A food or drink high in sugar will help prevent another drop in blood sugar levels.

Read the “Instructions for Use” carefully before using Baqsimi.

If you are given more Baqsimi than you should

Excess Baqsimi may cause nausea and vomiting. It may also increase blood pressure and pulse rate. Specific treatment is usually not necessary.

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

4. Possible adverse effects

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

Very common adverse effects, which may affect more than 1 in 10 people taking this medicine, are:

• Headache
• Watery eyes
• Nasal discomfort and other nasal effects such as itching, sneezing, runny nose or blocked nose, and nosebleeds
• Throat irritation and cough
• Changes in sense of smell
• Vomiting
• Nausea

Common adverse effects, which may affect up to 1 in 10 people taking this medicine, are:

• Changes in sense of taste
• Eye redness
• Itchy eyes
• Skin itching
• Increase in blood pressure

Uncommon adverse effects, which may affect up to 1 in 100 people taking this medicine, are:

• Increased heart rate

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton, tube, and single-dose container after EXP. The expiry date refers to the last day of the month indicated.

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 not to work as expected. Periodically check the sealed tube. 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 and containers that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Baqsimi

• The active substance is glucagon. Each single-dose pack delivers a nasal powder containing 3 mg of glucagon.
• The other components 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 supplied in a cardboard box containing 1 or 2 individually sealed single-dose containers in a plastic tube. Only certain pack sizes may be marketed.

Marketing Authorization 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 the most recent revision of this leaflet< {MM/YYYY }><{month YYYY }>.

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

Glucagon

Read these instructions for use carefully before using Baqsimi. Also read the entire patient information leaflet before using the medicine.

• Show your family and friends where you store 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).