Baqsimi – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Baqsimi, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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.
ℹ️ 1. What Ba qsimi 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 1 year 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 g lucose 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 carry ing 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, pharmacis t or nurse before using Baqsimi :
- if you have a tumour in your pancreas called insulinoma.
- if you have insufficient liver glycogen. This could occur:
26 – in states of starvation .
- if your adrenal gland does not produce enough cortisol or aldosterone .
- in case of chronic alcohol abuse.
- 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.
If you have an allergic reaction to glucagon with generalised rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension , call for immediate medical assistance .
After using Baqsimi, eat as soon as possible to prevent the recurrence of low blood sugar. Take a fast-acting source of sugar, such as fruit juice or a sugar -containing carbonated drink.
Potential issues, such as a stuffy nose, or inability to clear nasal passages, are expected to have a limited impact on the glucose response after nasal administration of Baqsimi .
Children
Baqsimi is not recommended for children under 1 year 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.
- indomet hacin, used to treat joint pain and stiffness . Indomet hacin reduces the effect of glucagon or may even produce hypoglycaemia .
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 you r 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 ha s 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 caregiver. 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 inse rtion 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 in to a nostril until the finger touch es 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 show s 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 vomit ing. It may also raise your blood pres sure 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:
- Headache
- Watery eyes
- Discomfort and other effects in the nose, including itchiness, sneezing, runny or blocked nose and bleeding
- Throat irritation and cough
- Altered sense of smell
- Vomiting (being sick)
- Nausea (feeling sick) Common side effects that may affect up to 1 in 10 people using this medicine are:
- Altered sense of taste
- Red eyes
- Itchy eyes
- Itchy skin
- Increased blood pressure Uncommon side effects that may affect up to 1 in 100 people using this medicine are:
- Increase d 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 beta dex (E459) 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
Amphastar France Pharmaceuticals Usine Saint Charles Eragny Sur Epte 60590 France
Manufacturer
Amphastar France Pharmaceuticals Usine Saint Charles Eragny Sur Epte 60590 France This leaflet was last revised in .
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu 29 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 B aqsimi 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 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 .
Tube Single -dose container 30 GIVING THE DOSE
- 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 touch es 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 show s.
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 -wrap ping 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 ºC.
- Replace B aqsimi before the expir y date printed on the tube or carton.
Tip (B) Plunger (A) Green line Expiry Date OTHER INFORMATION
- Caution: Replace the used B aqsimi right away so you will have a new B aqsimi in case you need it.
- Keep Baqsimi out of the sight and reach of children.
FOR QUESTIONS OR MORE INFORMATION ABOUT B AQSIMI
- Ask your doctor, pharmacist or nurse .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Baqsimi (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/19/1406).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.