3 mg nasal powder in a single-dose glucagon container

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Baqsimi is and what it is used for 
2. What you need to know before you use Baqsimi 
3. How to use Baqsimi 
4. Possible side effects 
5. How to store Baqsimi 
6. Contents of the packaging 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 peptide hormone. It is used to treat severe hypoglycemia (very low blood sugar) in people with diabetes. It can be used by adults, adolescents, and children from 4 years of age.

Glucagon is a natural hormone produced in the pancreas. It works in the opposite way to insulin and raises blood sugar. Glucagon converts sugar stored in the liver, called glycogen, into glucose (a type of sugar that the body uses as an energy source). Glucose is then released into the bloodstream, raising blood sugar levels and thus reducing the effects of hypoglycemia.

Always have Baqsimi with you and tell your family and friends that you have it with you.

2. What you need to know before using Baqsimi

Important information

If there is a risk of developing severe hypoglycemia, you should always have Baqsimi readily available.

  • Show your family, friends, and co-workers where you keep the single-dose container and explain when and how to use it. If treatment is started late, it can be dangerous. It is important that they know how to use Baqsimi before you need treatment.

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 pheochromocytoma, a type of tumor in the adrenal glands (a glands above the kidneys).

Warnings and cautions

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

  • if you have a tumor in the pancreas, so-called insulinoma
  • if you do not have enough glycogen in your liver. This can happen:
  • in case of starvation
  • if the adrenal glands do 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.

After using Baqsimi, eat something as soon as possible to prevent you from getting low blood sugar again. Eat something with fast-acting sugar, e.g. fruit juice or a sweetened carbonated beverage.

Children

Baqsimi is not recommended for 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 take any other medicines.

The following medicines may affect the way Baqsimi works:

  • insulin (used to treat diabetes ). Insulin has the opposite effect on blood sugar compared to glucagon.
  • indomethacin (used for stiff and aching joints). Indomethacin reduces the effect of glucagon.

The following medicines may be affected by Baqsimi:

  • warfarin (used to prevent blood clots). Baqsimi may potentiate the blood-thinning effect of warfarin.
  • beta-blockers (used for high blood pressure and irregular heartbeat ). Baqsimi may increase blood pressure and heart rate, but this only lasts a short time.

Pregnancy, breastfeeding, and fertility

If your blood sugar gets very low when you are pregnant or breastfeeding, you can use Baqsimi.

Driving and using machines

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

3. How to use Baqsimi

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

Explain to family, friends, co-workers or relatives how to use Baqsimi. They need to know how to use it before you need the treatment.

Baqsimi is given as a single dose of 3 mg.

How to give Baqsimi

1. Remove the plastic seal by pulling on the red strip.

2. Open the lid and remove the single-dose container from the inner package.

Warning: Do not push the plunger in until the tip of the single-dose container is inserted into the nose.

If you do, the single dose will be lost.

Avge dos en

1. Hold the single-dose container between your fingers and thumb. Do not test it before use, as the single-dose container contains only one dose of glucagon and cannot be reused.

2. Carefully insert the tip into one nostril until the fingers touch the outside of the nose.

3. Push the plunger in completely with your thumb. Dose one has been delivered when the green line is no longer visible on the plunger.

4. If the person with low blood sugar is unconscious, turn sideways to avoid suffocation.

5. Call for medical attention immediately after a dose has been given.

6. Try to get the person with low blood sugar to eat as soon as possible. A snack with high sugar content prevents a new drop in blood sugar.

Read the operating instructions carefully before using Baqsimi.

If you use more Baqsimi than you should  

Too much Baqsimi can cause nausea and vomiting. It can also raise blood pressure and heart rate. No specific treatment is usually needed.

If you have any further questions on the use of this product, 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 (may affect more than 1 user in 10):

  • nausea and vomiting
  • headache
  • feeling uncomfortable and other effects in the nose such as itching, sneezing, runny nose, nasal congestion, and nosebleeds
  • altered sense of smell
  • irritation of the throat and cough
  • watery eyes.

Common side effects (may affect up to 1 in 10 people):

  • high blood pressure
  • itchy and red eyes
  • itchy skin
  • altered sense of taste.

Uncommon side effects (may affect up to 1 in 100 people):

  • elevated heart rate

5. How to store 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, inner carton, and unit dose after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Store the single-dose container in the plastic-sealed inner package until the medicine is to be used, to protect it from moisture.

If the inner container has been opened, the single-dose container may have been exposed to moisture. This may cause Baqsimi to not work as expected. Check the plastic-sealed inner packaging at regular intervals. If the inner container has been opened, another single-dose container should be used.

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

6. Contents of the packaging and other information

Table of Contents

  • The active substance is glucagon. A single-dose container emits nasal powder containing 3 mg of glucagon.
  • The other ingredients are betadex and dodecyl phosphocholine.

Content declaration

Baqsimi is a white to off-white nasal powder in a single-dose container.

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

What the medicine looks like and the contents of the pack

Baqsimi is packed in a carton of 1 or 2 single-dose containers, separately packed in sealed plastic containers. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Eli Lilly Netherlands BV

Papendorpseweg 83

3528 BJ Utrecht

Netherlands

Manufacturer

Lilly France SAS

Rue du Colonel Lilly

F-67640 Fegersheim

France

Muhammad Nadeem

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