Baqsimi - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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. 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 signs of illness 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.

What is in 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 given

• 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 is for use 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 raises blood sugar. It does this by converting stored sugar in the liver called glycogen to glucose (a form of sugar that the body uses for energy). The glucose then enters the bloodstream and raises the blood sugar level, so reducing the effects of hypoglycaemia.

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

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

Important information

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

- show your family members, friends, or people you work with where you keep this medicine and explain when and how to use it. Delay in treatment may be harmful. It is important 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 phaeochromocytoma, which is a tumour in the adrenal gland (a gland above your kidneys).

Warnings and precautions

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

• – if you have a tumour in your pancreas called insulinoma.

• – if you have insufficient liver glycogen. This could occur:

• – in states of starvation.

• – if your adrenal gland does not produce enough cortisol or aldosterone.

• – if you suffer from chronic hypoglycaemia.

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 as soon as possible to prevent the recurrence of low blood sugar. Take a fastacting source of sugar, such as fruit juice or a sugar-containing carbonated drink.

Children

Baqsimi is not recommended for children under 4 years of age because 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 can affect the way Baqsimi works:

• – insulin – used to treat diabetes. Insulin has the opposite effect of glucagon on blood sugar.

• – indometacin, used to treat joint pain and stiffness. Indometacin reduces the effect of glucagon.

The following medicines may be affected by Baqsimi:

• – warfarin, used to prevent blood clots. Baqsimi may increase the anticlotting effect of warfarin.

• – beta-blockers, used to treat high blood pressure and irregular heart beat. Baqsimi may increase

blood pressure and pulse. This will only last a short time.

Pregnancy and breast-feeding

If your blood sugar drops very low when you are pregnant or breast-feeding, you can use Baqsimi.

Driving and using machines

Wait until the effects of very low blood sugar have worn off, before driving or using any tools or machines.

• 3. How Baqsimi is given

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Explain how to use Baqsimi to your family, friends, co-workers or care-giver. They will need to know how to use it before you need it.

Baqsimi is given as a single 3 mg dose.

Instructions for giving Baqsimi

• 1. Remove the shrink wrap by pulling on the red stripe.

• 2. Open the lid and remove the single-dose container from the tube.

Caution: Do not press the plunger before insertion into the nose, otherwise the single dose in the single-dose container will be lost.

Giving the dose

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

• 2. Insert the tip gently into a nostril until the finger touches the outside of the nose.

• 3. Push the plunger all the way in with your thumb. The dose is complete when the green line no

longer shows on the plunger.

• 4. If the person with the low blood sugar is unconscious, turn the person to their side to prevent choking.

• 5. After giving the dose, call for medical help right away.

• 6. Encourage the person with the low blood sugar to eat as soon as possible. A high sugar snack will stop another fall in blood sugar level.

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

If you are given more Baqsimi than you should

Too much Baqsimi may cause nausea and vomiting. It may also raise your blood pressure and pulse rate. Specific treatment is not usually necessary.

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 using this medicine are:

• – Nausea (feeling sick) and vomiting (being sick)

• – Headache

• – Discomfort and other effects in the nose, including itchiness, sneezing, runny or blocked nose

and bleeding

• – Altered sense of smell

• – Throat irritation and cough

• – Watery eyes

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

• – Increased blood pressure

• – Itchy and red eyes

• – Itchy skin

• – Altered sense of taste

Uncommon side effects that may affect up to 1 in 100 people using this medicine

• – Increase heart rate

Reporting of side effects

If you get 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. 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, tube and single-dose container after EXP. The expiry date refers to the last day of that month.

Do not store above 30 °C.

Keep the single-dose container in the shrink wrapped tube until ready to use in order to protect from moisture.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Baqsimi contains

• – The active substance is glucagon. Each single-dose container delivers nasal powder with 3 mg of glucagon.

• – The other ingredients are betadex and dodecylphosphocho­line.

What Baqsimi looks like and contents of the pack

Baqsimi is a white to practically white nasal powder in single-dose container (nasal powder).

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

Baqsimi is packed in a carton containing 1 or 2 single-dose containers individually sealed in a plastic tube. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Eli Lilly Nederland B.V.,

Papendorpseweg 83,

3528 BJ Utrecht,

The Netherlands

Eesti Eli Lilly Nederland B.V. Tel: +372 6 817 280	Norge Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00
EZZárta OAPMAEEPB-AIAAY A.E.B.E. Tiy.: +30 210 629 4600	Österreich Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780
España Lilly S.A. Tel: + 34–91 663 50 00	Polska Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 00
France Lilly France Tél: +33-(0) 1 55 49 34 34	Portugal Lilly Portugal Produtos Farmacéuticos, Lda Tel: + 351–21–4126600
Hrvatska Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999	Romania Eli Lilly Romania S.R.L. Tel: + 40 21 4023000
Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377	Slovenija Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10
Ísland Icepharma hf. Sími + 354 540 8000	Slovenská republika Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 111
Italia Eli Lilly Italia S.p.A. Tel: + 39– 055 42571	Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
Kúnpoc Phadisco Ltd Tip.: +357 22 715000	Sverige Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800
Latvija Eli Lilly (Suisse) S.A Pärstävnieciba Latvijä Tel: + 371 67364000	United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377

This leaflet was last revised in {month YYYY }.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

INSTRUCTIONS FOR USE

Baqsimi 3 mg nasal powder in single-dose container glucagon

Read the instructions for use before using Baqsimi. Also read the package leaflet in full before using the medicine.

• Show your family and friends where you keep Baqsimi and explain 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 severe low blood sugar (hypoglycaemia).

IMPORTANT POINTS TO KNOW

• Keep the single-dose container in the shrink wrapped tube until it needs to be used use in order to protect from moisture.
• If the tube has been opened, moisture may have got into the single-dose container and medicine may not work properly.
• Baqsimi contains only 1 dose of glucagon so do not press plunger before inserting into nose
• Baqsimi is for use in the nose and for single use only.

PREPARING THE DOSE

• Remove the shrink wrap by pulling on red stripe.
• Open the lid and remove the single-dose container from the tube.

Caution: Do not press the plunger before insertion into the

nose.

Otherwise the single dose in the single-dose container will be lost

• Hold the single-dose container between fingers. Do not press plunger (A) or test single-dose container.
• Insert the tip (B) gently in a nostril until the finger touches the outside of the nose.
• Push the plunger (A) all the way in with your thumb.
• The dose is complete when the green line on the plunger no longer shows.

AFTER GIVING THE DOSE

• If the person with the low blood sugar is unconscious, turn the person to their side after giving Baqsimi.
• Remove the tip from nose.
• Call for medical help right away.
• Encourage the person with the low blood sugar to eat or drink a high sugar snack like sweets or fruit juice as soon as possible.
• Throw away the used single-dose container and tube.

STORAGE AND HANDLING

• Do not remove the shrink wrapping or open the tube until ready to give the dose.
• Store the single-dose container in the shrink wrapped tube at temperatures up to 30 °C.

Replace Baqsimi before the expiry date printed on the tube or carton.

Expiry Date

OTHER INFORMATION

• Caution: Replace the used Baqsimi right away so you will have a new Baqsimi in case you need it.
• Keep Baqsimi out of the sight and reach of children.

FOR QUESTIONS OR MORE INFORMATION ABOUT BAQSIMI

• Ask your healthcare provider