Label: information for the user

GlucaGen Hypokit 1mg

Powder and solvent for injectable solution

glucagon

Read this label carefully before starting to use this medication,because it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacistor nurse.

- This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you, as it may harm them.

- If you experience any adverse effects,consult yourdoctor,evenifthey are not listed in this label. See section 4.

1.What is GlucaGenHypoKitand how is it used

2.What you need to knowbeforestarting touse GlucaGenHypoKit

3.How to use GlucaGenHypoKit

4.Possible adverse effects

5.Storage of GlucaGenHypoKit

6.Contents of the package and additional information

7.Additional information for healthcare professionals

GlucaGen HypoKit contains the active ingredient “glucagon”.

GlucaGen HypoKit is usedimmediately in emergency cases in children and adults with diabetes who use insulin.It is used when they have fainted (are unconscious) due to very low blood sugar levels. This is called “severe hypoglycemia”. GlucaGenHypoKit is used when they are unable to take sugar orally.

Glucagon is a natural hormone, which has the opposite effect to insulin in the human body. It helps the liver to transform something called “glycogen” into glucose (sugar). The glucose is released into the bloodstream, which causes blood sugar levels to increase.

For healthcare professionals:see section 7.

Important Informationabout GlucaGen HypoKit

•Make sure that your family members, people you work with, or close friends know about GlucaGen HypoKit. Tell them that if you faint (become unconscious), they should use GlucaGen HypoKit right away.

•Show your family members and other people where you keep this kit and how to use it. They should act quickly – if you are unconscious for a period of time, it can be harmful. It is essential that they are trained and know how to use GlucaGen HypoKit before you need it.

•The syringe does not contain GlucaGen. The water in the syringe must be mixed with the compacted powder of GlucaGen in the vial before injection. Tell your family members and other people to follow the instructions in section 3: How to use GlucaGen HypoKit.

•Any mixture of GlucaGen that is not used should be discarded.

•After using GlucaGen HypoKit, you or another person should contact your doctor or a healthcare professional. You need to find out why you had a drop in blood sugar and how to prevent it from happening again.

Do not use GlucaGenHypoKit if

•you are allergic to glucagon or any of the other components of this medication (listed in section 6).

•you have an adrenal gland tumor.

If any of these cases occur to you, do not useGlucaGen HypoKit.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use GlucaGen Hypokit.

GlucaGen will not work properly if:

•you have been fasting for a prolonged period

•you have low adrenaline levels

•you have a low blood sugar level caused by drinking too much alcohol

•you have a tumor that releases glucagon or insulin

If any of these cases occur to you,consult your doctoror nurse.

Using GlucaGen with other medications

The following medications may affect the functioning ofGlucaGen HypoKit:

•insulin – used to treat diabetes

•indometacin – used to treat pain and joint stiffness

The following medications may be affected by GlucaGen HypoKit:

•warfarin – used to prevent blood clots. GlucaGen may increase the anticoagulant effect of warfarin.

•beta-blockers – used to treat high blood pressure and irregular heart rhythm. GlucaGen HypoKit may increase blood pressure and pulse, which will only last for a short time.

If any of these cases occur to you (or you are unsure), consult your doctor or pharmacist before using GlucaGen HypoKit.

Inform your doctor or pharmacistif you are using, have used recentlyor might have to use anyother medication.

Pregnancy and breastfeeding

If you experience a drop in blood sugar when you are pregnant or breastfeeding, you can use GlucaGen HypoKit.

Consult your doctor or pharmacist before using any medicationif you are pregnant.

Driving and operating machinery

Wait until the effects of the drop in blood sugar have disappeared, before driving or using tools or machinery.

GlucaGen contains sodium

GlucaGen contains less than 23mg of sodium (1mmol) per maximum dose (2ml), which is essentially “sodium-free”.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor. In case of doubt, ask your doctor.

Preparation and administration of the injection

1.Remove the plastic cap from the vial. Remove the needle protector from the syringe. Do not remove the syringe safety cap. Insert the needle into the rubber stopper (inside the marked circle) of the vial containing GlucaGen and inject all the liquid from the syringe into the vial.

2.Without removing the needle from the vial, gently shake the vial until GlucaGen is completely dissolved and the solution is transparent.

3.Ensure the plunger is fully seated. While maintaining the needle in the liquid, slowly extract all the solution with the syringe. Make sure the plunger does not come out of the syringe. It is essential to remove any air bubbles from the syringe:

•With the needle pointing upwards, gently tap the syringe with your fingers

•Press the plunger slightly to release any air bubbles that may have remained in the upper part of the syringe.

Continue pressing the plunger until you have the correct dose for the injection. A small amount of liquid will come out of the needle tip when you do this.

See belowDose to be injected

4.Inject the dose under the skin or into the muscle.

5.Place the person unconscious on their side to prevent asphyxiation.

6.Give the person a high-sugar snack such as candy, cookies, or fruit juice as soon as they regain consciousness and are able to swallow. The high-sugar snack will prevent the blood sugar drop from occurring again.

After using GlucaGen HypoKit, you or someone else should contact your doctor or a healthcare professional. You need to find out why you had a blood sugar drop and how to prevent it from happening again.

Dose to be injected

The recommended dose is:

•Adults:Inject the entire medication (1ml) – this is marked as “1” on the syringe.

•Children under 8years or children over 8years with a weight of less than 25kg:Inject half the medication (0.5ml) – this is marked as “0.5” on the syringe.

•Children over 8years or children under 8years with a weight of more than 25kg:Inject the entire medication (1ml) – this is marked as “1” on the syringe.

If more GlucaGen is administered than it should be

An excess of GlucaGen may cause nausea and vomiting. Generally, no specific treatment is required.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone (91) 562.04.20 indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may occur with this medication:

Consult your doctor immediately if you experience any of the following severe adverse effects:

Very rare:may affect up to 1 in 10,000 people

•Allergic reaction – symptoms may include difficulty breathing, sweating, rapid heart rate (tachycardia), skin rash, facial inflammation, and collapse.

?Consult your doctor immediatelyif you experience any of the adverse effects mentioned above.

Other Adverse Effects

Frequent:may affect up to 1 in 10 people

•Dizziness (nausea)

Infrequent:may affect up to 1 in 100 people

•Vomiting

Rare:may affect up to 1 in 1,000 people

•Abdominal pain (stomach pain)

Unknown frequency:frequency cannot be estimated from available data

•Reactions at the injection site.

?If you experience any type of adverse effect mentioned above, consult your doctor, even if it is a possible adverse effect not listed in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

•Keep this medication out of the sight and reach of children

•Store, properly:

• in the refrigerator (between 2°C and 8°C),or
• outside the refrigerator,below 25°C for up to 18 months, within the expiration period.

•Store in the original packaging to protect it from light

•Do not freeze to prevent damage to the product

•Use immediately after mixing. Do not save it for later use

•Do not use this medication after the expiration date shown on the label. The expiration date is the last day of the month indicated.

•Do not use if the mixed solution has a gel-like appearance or if part of the powder has not dissolved properly.

•Do not use if the plastic cap is missing or loose when you receive the product. In this case, return the product to your pharmacy.

•Medications should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of GlucaGen

–The active principle is glucagon 1mg as hydrochloride, produced in yeast using recombinant DNA technology.

–The other components are: lactose monohydrate, water for injection, hydrochloric acid and/or sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the package

GlucaGen is presented in a vial with glucagon, white and sterile powder, witha disposable syringe containing the solvent.The powder is compacted. Once mixed, the reconstituted solution contains glucagon 1mg/ml.

Holder of the marketing authorization and responsible for manufacturing

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd, Denmark

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany, Austria, Belgium, Bulgaria, Cyprus, Croatia, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, United Kingdom (Northern Ireland), Czech Republic: GlucaGen

Norway and Sweden: Glucagon Novo Nordisk

7.Additional information for healthcare professionals

Healthcare professionals must consult all previous sections before reading this additional information.

Due to the instability of GlucaGen in solution, the product must be administered immediately after reconstitution and should not be administered as an intravenous infusion.

Do not attempt to replace the cap on the used needle. Place the used syringe in the orange case and dispose of the used needle in a sharp object container when possible.

Treatment of severe hypoglycemia

Administer as subcutaneous or intramuscular injection. If the patient does not respond within 10minutes, glucosa should be administered intravenously. When the patient has responded to treatment, administer carbohydrates orally to restore hepatic glycogen and prevent recurrence of hypoglycemia.

Diagnostic procedures

Carbohydrates should be administered orally when the procedure has finished, if this is compatible with the diagnostic procedure used. Remember that GlucaGen has the opposite effect to insulin. In endoscopic or radiographic procedures, caution should be exercised when administering GlucaGen to diabetic patients or individuals with heart problems.

In diagnostic procedures, it may be more suitable to use a syringe with a finer needle and more precise graduation.

Gastrointestinal tract examination:

Doses vary from 0.2–2mg depending on the diagnostic technique used and the route of administration. The diagnostic dose to produce relaxation of the stomach, duodenal bulb, duodenum and small intestine is 0.2–0.5mg administered intravenously or 1mg intramuscularly. The dose to relax the colon is 0.5– 0.75mgintravenously or 1– 2mg intramuscularly. The onset of effect after intravenous injection of 0.2–0.5mg occurs in one minute and the duration of effect is 5–20minutes. The onset of effect after an intramuscular injection of 1–2mg occurs after 5–15minutes and lasts approximately 10–40minutes.

Additional adverse effects after use in diagnostic procedures

Changes in blood pressure, rapid heart rate, hypoglycemia, and hypoglycemic coma.

Last review date of this leaflet: 12/2022

Other sources of information

Thedetailedandupdatedinformationon this medicine is available on thewebsite of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/