КЕНПЕН 150 МКГ/0,3 МЛ Инъекционный раствор

Содержание инструкции

1. Chenpen 500 micrograms in 0.3 ml of injectable solution in a pre-filled syringe
   1. What is Chenpen 500 micrograms and what is it used for
   2. What you need to know before using Chenpen 5000 micrograms
   3. How to use Chenpen 500 micrograms
   4. How to store Chenpen 500 micrograms
   5. Contents of the pack and other information
2. Chenpen 300 micrograms in 0.3 ml of solution for injections in a pre-filled syringe
   1. What is Chenpen 300 micrograms and what is it used for
   2. What you need to know before using Chenpen 300 micrograms
   3. How to use Chenpen 300 micrograms
   4. How to store Chenpen 300 micrograms
   5. Package contents and other information
3. Chenpen 150 micrograms in 0.3 ml of solution for injections in a pre-filled syringe
   1. What is Chenpen 150 micrograms and what is it used for
   2. What you need to know before using Chenpen 150 micrograms
   3. How to use Chenpen 150 micrograms
   4. How to store Chenpen 150 micrograms
   5. Contents of the pack and other information

Chenpen 500 micrograms in 0.3 ml of injectable solution in a pre-filled syringe

Adrenaline (epinephrine)
Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Chenpen 500 microgramsis and what it is used for
• 2. What you need to know before you use Chenpen 500 micrograms
• 3. How to use Chenpen 500 micrograms
• 4. Possible side effects
• 5. How to store Chenpen 500 micrograms
• 6. Contents of the pack and other information

1. What is Chenpen 500 micrograms and what is it used for

• Chenpen 500 micrograms consists of a pre-filled syringe with adrenaline contained in an automatic injection device (Auto-Injector). This injects a single dose of adrenaline into the muscle.
• This medicine is only for emergenciesand, after using it, must require immediate medical assistance.
• Adrenaline is a hormone that is released naturally in response to stress. In acute allergic reactions it improves blood pressure, heart function and breathing and reduces swelling. Adrenaline is also known as epinephrine.
• Chenpen 500 micrograms is used for the emergency treatment of severe allergic reactions or anaphylaxis caused by peanuts or other foods, medicines, bites or stings of insects and other allergens, as well as by exercise or unknown causes.

2. What you need to know before using Chenpen 5000 micrograms

Do not use Chenpen 500 micrograms
There is no known reason not to use Chenpen 500 micrograms in case of an allergic
emergency

Warnings and precautions
Talk to your doctor or pharmacist before using Chenpen 500 micrograms

• Your doctor should have explained when and how to correctly use the Chenpen Auto-Injector.
• Tell your doctor if you suffer from a heart condition, including angina, hyperthyroidism, high blood pressure, low levels of potassium and increased levels of calcium in the blood, circulatory disorders, pheochromocytoma (a type of tumor in the adrenal gland), increased pressure inside the eye (glaucoma), kidney or prostate diseases, diabetes or any other illness.
• If you suffer from asthma, you may have an increased risk of developing a severe allergic reaction.
• Anyone who has an episode of anaphylaxis should see a doctor to undergo the necessary tests to determine to which substances they are allergic in order to strictly avoid them in the future. It is important to be aware that an allergy to one substance can induce allergy to other substances related to it.
• In case of food allergies, it is important to check the ingredients contained in everything that is ingested (including medicines) as even small quantities can cause severe reactions.
• Repeated injection at the local level can cause damage to the skin at the injection site. Accidental injection into a blood vessel can cause a sudden increase in blood pressure. Accidental injection into the hand or foot can cause loss of blood flow to the affected part. Seek immediate medical attention at the nearest hospital.

If you have a thick layer of subcutaneous fat, there is a risk that the adrenaline will not reach the
muscle tissue and that the effect will not be optimal.

Other medicines and Chenpen 500 micrograms
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine, in particular:

• Medicines for heart diseases, such as digitalis (digoxin), beta-blockers, quinidine.
• Medicines for depression, such as tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), serotonin and norepinephrine reuptake inhibitors (SNRIs).
• Medicines for diabetes, your doctor may change their dosage after using Chenpen 500 micrograms.
• Medicines for Parkinson's disease.
• Medicines for thyroid diseases.
• Other medicines: antihistamines, such as diphenhydramine or chlorpheniramine, theophylline, ipratropium and oxitropium (used for the treatment of respiratory diseases, including asthma), oxytocin (used for labor), inhalational anesthetics, alpha

blockers (used for the treatment of high blood pressure), sympathomimetics (used for the
treatment of asthma, other respiratory diseases and for nasal congestion)

Chenpen 500 micrograms with alcohol
Alcohol consumed in conjunction with this medicine can have negative effects as it
can enhance its effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine

• It is not clear whether taking adrenaline during pregnancy poses a risk to the fetus. This should not prevent you from using Chenpen 500 micrograms in an emergency during pregnancy, given that your life may be in danger. You should discuss this with your doctor before an emergency occurs.
• Adrenaline is not expected to have any effect on the newborn who is breastfed.

Driving and using machines
Do not drive or use machines after injecting this medicine, until the
symptoms related to anaphylactic shock have resolved.

Chenpen 500 micrograms contains sodium metabisulfite (E223)
Sodium metabisulfite can cause allergic reactions and breathing difficulties,
especially in those with a history of asthma.
Tell your doctor or pharmacist if you know you are allergic to sodium metabisulfite.

Chenpen 500 micrograms contains a small amount of sodium chloride (salt)
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically
‘sodium-free’.
For athletes: the use of the drug without therapeutic necessity constitutes doping
and may still result in positive doping tests.

3. How to use Chenpen 500 micrograms

Always carry 2 auto-injectors with you because the first administration may not go well or may not be sufficient

• Always use this medicine following the doctor's instructions exactly.
• If you have any doubts, consult your doctor or pharmacist.
• Inject it only into the muscles of the thigh.
• For a single administration, please ensure you dispose of the product safely immediately after use. Chenpen 500 micrograms delivers a single dose of 0.3 ml of solution equal to 500 micrograms of adrenaline. After use, a volume of 0.75 ml remains in the auto-injector but cannot be reused.

The anaphylactic reaction generally begins within a few minutes of contact with the allergen
and the symptoms include:

• Itching of the skin, a urticarial skin erythema (hives), flushing and swelling of the eyes, lips or tongue.
• Difficulty breathing due to swelling of the throat. Wheezing, shortness of breath and cough may be due to bronchoconstriction.
• Other symptoms of anaphylaxis include headache, vomiting and diarrhea.
• Collapse and loss of consciousness due to a sudden drop in blood pressure.

If you experience these signs and symptoms, immediately use the Chenpen Auto-Injector. You must inject
this medicine only into the muscles of the outer thigh, not into the buttock.
Sometimes a single dose of adrenaline may not be enough to neutralize the effects
of a severe allergic reaction. For this reason, your doctor is likely to prescribe more than
one Chenpen 500 microgram auto-injector. If within 5-15 minutes of the first injection your
symptoms do not improve or if they worsen, you or the people with you should
administer a second injection. For this reason, you should always carry more than
one Chenpen 500 microgram auto-injector with you.
If a second injection is necessary, it is recommended to administer it to the opposite thigh

Use in adults

• The recommended dose is 300 micrograms in people with a body weight less than 60 kg.
• In adults with a body weight greater than 60 kg, a dose of 300 micrograms may not be sufficient; these patients may need an injection of Chenpen 500 micrograms to counteract the effects of a severe allergic reaction.

Use in children: Chenpen 500 micrograms is not recommended for use in children
Use in children and adolescents

• The appropriate dose is 150 micrograms or 300 micrograms.
• This depends on the child's body weight and is at the doctor's discretion.
• An Auto-Injector that delivers 150 micrograms of adrenaline is also available. A dosage lower than 150 micrograms cannot be administered with sufficient accuracy in children weighing less than 15 kg, therefore use is not recommended unless the child is in life-threatening danger and administration takes place under medical supervision.

Children with a body weight between 15 and 30 kg
The usual dose is 150 micrograms

Children with a body weight greater than 30 kg
The usual dose is 300 micrograms
Chenpen 500 micrograms is designed as an emergency treatment. Immediately
after using Chenpen 500 micrograms, you must always seek medical attention. Call
118, request an ambulance and say "anaphylaxis" even if the symptoms seem to be
improving.You must go to the hospital for a check-up and to ascertain the need for further
treatment because the reaction may occur again at a later time.
While waiting for the ambulance, you must lie down with your legs raised, but if you have
difficulty breathing in this position, sit up. Ask someone to stay with you until
the ambulance arrives, in case you feel unwell again,
The unconscious patient must be placed on their side in the recovery position.

Instructions for use
It is recommended that family members, caregivers or
collaborators also be instructed on the correct use of Chenpen 500 micrograms.

• A.Parts of the Chenpen Auto-Injector

Before using the Chenpen Auto-Injector, the patient needs to know its parts. These
are shown in the figure.

Rotating shutter of the window exposing the solution: rotate the rotating shutter of the
windows exposing the solution to align the lenses with the windows on the Auto-Injector

Window exposing the solution: look through the window, through the lenses, before
the injection to verify that the solution is clear and ready to use.

Injection indicator: before the injection, you can see a white plastic plunger
through the window. This means that the Chenpen Auto-Injector has not been activated
by mistake or tampered with. After the injection, the indicator turns red. This indicates that
the Chenpen Auto-Injector has been activated correctly.

Black needle guard (reversible): this protects the needle when you are not using the Auto-
Injector Chenpen. Remove the guard before injection. After the injection, rotate the
black guard and put it back on the same end of the Chenpen Auto-Injector to cover
the needle.

Gray safety cap: this covers the red activation button. It prevents the
button from being pressed accidentally.

Do not remove the black needle guard or the gray safety cap until you need to use the Chenpen Auto-Injector.

• B.Checking the Chenpen Auto-Injector

Before using the Chenpen Auto-Injector and regularly, you must check it as follows:

• 1. Fully rotate the rotating shutter of the window exposing the solution counterclockwise as shown by the arrow to align the lenses with the windows of the Auto-Injector.

• 2. Look through the lenses into the window exposing the solution.Check that the solution is clear and colorless. If it is cloudy, colored or contains particles, throw away the Chenpen Auto-Injector.

• 3. Make sure that the injection indicatoris not red. If it is red, this means that the Chenpen Auto-Injector has already been used and must be discarded.

• 4. Fully rotate the mobile cover of the windows exposing the solution clockwise, as shown by the arrow, to ensure that both windows are covered. Put the Chenpen Auto-Injector back in its case until you need it.
• C.Using the Chenpen Auto-Injector

If the black needle guard has been removed, do not put your thumb, fingers or hand over
the unprotected end (the one with the needle) of the Chenpen Auto-Injector
To use the Chenpen Auto-Injector, follow these instructions:

• 1. Remove the black needle guard by pulling it firmly in the direction of the arrow. This also removes the gray needle guard.

• 2. Remove the gray safety cap from the red activation button by pulling as indicated by the arrow

• 3. Hold the open end (the one with the needle) of Chenpen against the outer thigh. If necessary, you can use Chenpen through light clothing, such as denim, cotton or polyester.

• 4. Press the red activation button so that it clicks. Keep the Chenpen Auto-Injector pressed against the outer thigh for 10
  seconds.Slowly remove Chenpen from the thigh. Gently massage the injection site.

• 5. The injection indicator will have turned red.This shows that the injection has been completed. If the injection indicator is not red, you must repeat the injection with a new Chenpen.

• 6. After the injection, the needle comes out. To cover it, snap the wide end of the black needle guard back into place on the open end (the one with the needle) of the Chenpen Auto-Injector (as indicated by the arrow)

Hand over the used Chenpen Auto-Injector to hospital staff or the pharmacist for
appropriate disposal.

If you use more Chenpen 500 micrograms than you should

• If you inject too much adrenaline or inject the medicine accidentally into a blood vessel or a finger, seek immediate medical attention at the nearest hospital.
• If you have any further questions about the use of this product, consult your doctor or pharmacist

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.
The following side effects are based on experience with the use of adrenaline but their
frequency cannot be estimated:

• Changes in the blood, such as high blood sugar levels, low potassium levels and high acid content.
• Anxiety, hallucinations
• Headache, dizziness, tremor, fainting
• Dilated pupils
• Rapid or irregular heartbeat, irregular heartbeat and heart attack, feeling of strong heartbeats (palpitations)
• Increased blood pressure, sudden increase in blood pressure that can cause bleeding in the brain, reduced blood flow to the skin (to the mucous membranes and kidneys), cold extremities.
• Difficulty breathing
• Nausea, vomiting
• Difficulty urinating,
• Sweating, pale skin (pallor), weakness, apprehension, nervousness, muscle tremors

Chenpen 500 micrograms contains metabisulfite (E223),which can cause allergic reactions and breathing difficulties, especially in those with a history of asthma.
Seek immediate medical attention if you experience these side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
contact your doctor or pharmacist. You can also report side effects
directly through the national reporting system
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on
the safety of this medicine

5. How to store Chenpen 500 micrograms

Keep this medicine out of the sight and reach of children.
Do not store it at a temperature above 25°C.
Do not use this medicine after the expiry date (exp:) which is reported on the packaging and
on the auto-injector. The expiry date refers to the last day of that month.
Discard and replace Chenpen 500 micrograms after the expiry date. Check the solution
regularly through the inspection window to ensure that the solution is clear and
colourless.
Discard and replace Chenpen 500 micrograms if the solution appears cloudy, coloured or
contains particles.
Check the auto-injector regularly, as described in Section 3 of this leaflet
in the paragraph “Instructions for use” to ensure that your Chenpen
500 micrograms pack can be used in an emergency situation.
Store the auto-injector in the original packaging to protect it from light.
Keep Chenpen 500 micrograms in a horizontal position.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Chenpen 500 micrograms contains

• The active ingredient is 500 micrograms of adrenaline (epinephrine) in 0.3 ml.
• The other ingredients are: sodium metabisulfite (E223), sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of Chenpen 500 micrograms and contents of the pack
Chenpen consists of a pre-filled syringe with an adrenaline solution for injections
contained in a self-injection device (Auto-Injector). A 0.3 ml dose contains
500 micrograms of adrenaline (epinephrine). Chenpen 500 micrograms is a clear, colorless solution, practically free of particles.
Chenpen is supplied in packs of 1 or 2 auto-injectors. Not all pack sizes may be marketed.
Length of exposed needle part: 10 mm ± 1.5 mm

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
BIOPROJET PHARMA
9, rue rameau
75002 Paris
FRANCE

Manufacturer:
Owen Mumford Limited
Primsdown Industrial Estate,
Worcester Road, Chipping Norton,
Oxfordshire OX7 5XP
UK.

Distributor for sale:
Bioprojet Italia S.r.l.
Via Melchiorre Gioia, 66 – Milano

This medicinal product is authorised in the Member States of the EEA with the following
names:
Anapen: Austria, Cyprus, Czech Republic, France, Germany, Greece, Hungary, Ireland, Poland,
Portugal, Slovenia, Spain.

Chenpen: Belgium, Italy

Chenpen 300 micrograms in 0.3 ml of solution for injections in a pre-filled syringe

Adrenaline (epinephrine)
Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 7. What Chenpen 300 microgramsis and what it is used for
• 8. What you need to know before you use Chenpen 300 micrograms
• 9. How to use Chenpen 300 micrograms
• 10. Possible side effects
• 11. How to store Chenpen 300 micrograms
• 12. Contents of the pack and other information

4. What is Chenpen 300 micrograms and what is it used for

• Chenpen 300 micrograms consists of a pre-filled syringe with adrenaline contained in an automatic injection device (Auto-Injector). This injects a single dose of adrenaline into the muscle.
• This medicine is only for emergenciesand, after using it, you must seek immediate medical assistance.
• Adrenaline is a hormone that is released naturally in response to stress. In acute allergic reactions it improves blood pressure, cardiac function and breathing and reduces swelling. Adrenaline is also known as epinephrine.
• Chenpen 300 micrograms is used for the emergency treatment of severe allergic reactions or anaphylaxis caused by peanuts or other foods, medicines, bites or stings of insects and other allergens, as well as by exercise or unknown causes.

5. What you need to know before using Chenpen 300 micrograms

Do not use Chenpen 300 micrograms
There is no known reason not to use Chenpen 300 micrograms in case of an allergic emergency

Warnings and precautions
Talk to your doctor or pharmacist before using Chenpen 300 micrograms

• Your doctor should have explained when and how to correctly use the Chenpen Auto-Injector.
• Tell your doctor if you suffer from a heart condition, including angina, hyperthyroidism, high blood pressure, low potassium levels and increased calcium levels in the blood, circulatory disorders, pheochromocytoma (a type of tumor in the adrenal gland), increased pressure inside the eye (glaucoma), kidney or prostate diseases, diabetes or any other illness.
• If you suffer from asthma, you may have an increased risk of developing a severe allergic reaction.
• Anyone who has an episode of anaphylaxis should see a doctor to undergo the necessary tests to determine to which substances they are allergic in order to strictly avoid them in the future. It is important to be aware that an allergy to a substance can induce allergy to other substances related to it.
• In case of food allergies, it is important to check the ingredients contained in everything that is ingested (including medicines) as even small quantities can cause serious reactions.
• Repeated injection at the local level can cause damage to the skin at the injection site. Accidental injection into a blood vessel can cause a sudden increase in blood pressure. Accidental injection into the hand or foot can cause loss of blood flow to the affected part. Seek immediate medical attention at the nearest hospital.

Other medicines and Chenpen 300 micrograms
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine, in particular:

• Medicines for heart disease, such as digitalis (digoxin), beta-blockers, quinidine.
• Medicines for depression, such as tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), serotonin and norepinephrine reuptake inhibitors (SNRIs).
• Medicines for diabetes, your doctor may change their dosage after using Chenpen 300 micrograms.
• Medicines for Parkinson's disease.
• Medicines for thyroid diseases.
• Other medicines: antihistamines, such as diphenhydramine or chlorpheniramine, theophylline, ipratropium and oxitropium (used for the treatment of respiratory diseases, including asthma), oxytocin (used for labor), inhalational anesthetics, alpha blockers (used for the treatment of high blood pressure), sympathomimetics (used for the treatment of asthma, other respiratory diseases and nasal congestion)

Chenpen 300 micrograms with alcohol
Alcohol consumed in conjunction with this medicine can have negative effects as it enhances
its effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine

• It is not clear whether taking adrenaline during pregnancy poses a risk to the fetus. This should not prevent you from using Chenpen 300 micrograms in an emergency during pregnancy, given that your life may be in danger. You should discuss this with your doctor before an emergency occurs.
• Adrenaline is not expected to have any effect on the newborn who is breastfed.

Driving and using machines
Do not drive or use machines after injecting this medicine, until the
symptoms related to anaphylactic shock have resolved.

Chenpen 300 micrograms contains sodium metabisulfite (E223)
Sodium metabisulfite can cause allergic-type reactions and breathing difficulties, especially
in those who have a history of asthma.
Tell your doctor or pharmacist if you know you are allergic to sodium metabisulfite.

Chenpen 300 micrograms contains a small amount of sodium chloride (salt)
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically ‘sodium-free’.
For athletes: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

6. How to use Chenpen 300 micrograms

Always carry 2 auto-injectors with you because the first administration may not be successful or
may not be sufficient

• Always use this medicine exactly as your doctor has instructed.
• If you have any doubts, consult your doctor or pharmacist.
• Inject it only into the muscles of the thigh.
• For single use only, please ensure you dispose of the product safely immediately after use. Chenpen 300 micrograms delivers a single dose of 0.3 ml of solution equal to 0.3 mg (300 micrograms) of adrenaline. After use, a volume of 0.75 ml remains in the auto-injector but cannot be reused.

An anaphylactic reaction generally begins within a few minutes of contact with the allergen and the
symptoms include:

• Itching of the skin, a urticarial skin erythema (hives), flushing and swelling of the eyes, lips or tongue.
• Difficulty breathing due to swelling of the throat. Wheezing, shortness of breath and cough may be due to bronchoconstriction.
• Other symptoms of anaphylaxis include headache, vomiting and diarrhea.
• Collapse and loss of consciousness due to a sudden drop in blood pressure.

If you experience these signs and symptoms, immediately use the Chenpen Auto-Injector. You should inject this
medicine only into the muscles of the outer thigh, not into the buttock.
Sometimes a single dose of adrenaline may not be enough to neutralize the effects of a
severe allergic reaction. For this reason, your doctor is likely to prescribe more than one auto-
injector of Chenpen 300 micrograms. If your symptoms do not improve or worsen within 5-15 minutes of the first injection, you or those with you should administer a second
injection. For this reason, you should always carry more than one auto-injector of Chenpen 300
micrograms with you.

Use in adults

• The usual dose is 300 micrograms.
• Adults of considerable size may need more than one injection to counteract the effects of an allergic reaction.

Use in children and adolescents

• The appropriate dose is 150 micrograms or 300 micrograms.
• This depends on the child's body weight and is at the doctor's discretion.
• An Auto-Injector that delivers 150 micrograms of adrenaline is also available. A dosage lower than 150 micrograms cannot be administered with sufficient accuracy in children weighing less than 15 kg, therefore use is not recommended unless the child is in life-threatening danger and administration occurs under medical supervision.

Instructions for use
It is recommended that family members, caregivers or teachers
also be instructed on the correct use of Chenpen 300 micrograms.

• D.Parts of the Chenpen Auto-InjectorBefore using the Chenpen Auto-Injector, the patient needs to know its parts. These are shown in the figure.

Rotating shutter of the window exposing the solution: rotate the rotating shutter of the
window exposing the solution to align the lenses with the window on the Auto-Injector

Window exposing the solution: look through the window, through the lenses, before injection
to verify that the solution is clear and ready for use.

Injection indicator: before injection, you can see a white plastic plunger through the
window. This means that the Chenpen Auto-Injector has not been activated accidentally or tampered with.
After injection, the indicator turns red. This indicates that the Chenpen Auto-Injector has been
activated correctly.

Black needle protection (reversible): this protects the needle when you are not using the Auto-Injector
Chenpen. Remove the protection before injection. After injection, rotate the black protection and put it back on the same end of the Chenpen Auto-Injector to cover the needle.

Gray safety cap: this covers the red activation button. It prevents the button from being pressed accidentally.

Do not remove the black needle protection or the gray safety cap until you need to use the Chenpen Auto-Injector.

• E.Checking the Chenpen Auto-InjectorBefore using the Chenpen Auto-Injector, you must check it as follows:

• 1. Fully rotate the rotating shutter of the window exposing the solution counterclockwise as shown by the arrow to align the lenses with the window of the Auto-Injector.

2 . Look through the lenses into the window exposing the solution.Check that the
solution is clear and colorless. If it is cloudy, colored or contains particles, discard
the Chenpen Auto-Injector.

• 3. Make sure that the injection indicatoris not red. If it is red, this means that the Chenpen Auto-Injector has already been used and must be discarded.

• 4. Fully rotate the mobile cover of the window exposing the solution clockwise, as shown by the arrow, to ensure that both windows are covered. Put the Auto-Injector back in its case until you need it.
• F.Using the Chenpen Auto-InjectorIf the black needle protection has been removed, do not place your thumb, fingers or hand overthe unprotected end (the needle end) of the Chenpen Auto-InjectorTo use the Chenpen Auto-Injector, follow these instructions:

• 1. Remove the black needle protection by pulling firmly in the direction indicated by the arrow. This also removes the gray needle protection.

• 2. Remove the gray safety cap from the red activation button by pulling as indicated by the arrow

• 3. Hold the open end (the needle end) of Chenpen against the outer thigh. If necessary, you can use Chenpen through light clothing, such as denim, cotton or polyester.

• 4. Press the red activation button so that it clicks. Keep the Chenpen Auto-Injector pressed against the outer thigh for 10 seconds.Slowly remove Chenpen from the thigh. Gently massage the injection site.

• 5. The injection indicator will have turned red.This shows that the injection has been completed. If the injection indicator is not red, you must repeat the injection with a new Chenpen.

• 6. After the injection, the needle comes out. To cover it, snap the wide end of the black needle protection back into place on the open end (the needle end) of the Chenpen Auto-Injector (as indicated by the arrow)

Chenpen 300 micrograms is designed as emergency treatment. Immediately after using
Chenpen 300 micrograms, you must always seek medical attention. Call 118, ask
for an ambulance and say “anaphylaxis” even if the symptoms appear to be improving.You must go to
hospital for a check-up and to determine the need for further treatment because the reaction
may occur again at a later time.
While waiting for the ambulance, you must lie down with your legs raised, but if you have
difficulty breathing in this position, sit up. Ask someone to stay with you until the
ambulance arrives, in case you feel unwell again,
The unconscious patient must be placed on their side in the recovery position.
Hand the used Chenpen Auto-Injector to the hospital staff or the pharmacist for
appropriate disposal.

If you use more Chenpen 300 micrograms than you should

• If you inject too much adrenaline or accidentally inject the medicine into a blood vessel or a finger, seek immediate medical attention at the nearest hospital.
• If you have any further questions about the use of this product, consult your doctor or pharmacist

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.

• Chenpen 300 micrograms contains metabisulfite (E223),which can cause allergic reactions and breathing difficulties, especially in those with a history of asthma. Seek immediate medical attention if you experience these side effects.
• Common side effects of adrenaline include a feeling of strong heartbeats (palpitations), rapid or irregular heartbeat, sweating, nausea, vomiting, difficulty breathing, dizziness, weakness, pale skin (pallor), tremor, headache, apprehension, nervousness, anxiety and cold extremities.
• Other less common side effects are hallucinations, fainting, dilated pupils, difficulty urinating, muscle spasms, increased blood pressure and changes in the blood, such as high sugar levels, low potassium levels and high acid content.
• Occasionally, at high doses or in susceptible patients, a sudden increase in blood pressure may occur, which can cause bleeding in the brain, irregular heartbeat, a heart attack and reduced blood flow to the skin, mucous membranes and kidneys.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell
your doctor or pharmacist. You can also report side effects directly through the national reporting system www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine

7. How to store Chenpen 300 micrograms

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 packaging and on the auto-injector after expiry. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Do not use this medicine if the solution appears cloudy, discolored or contains particles. See “Instructions for Use” for guidance on checks to be performed on this medicine.
• Store the auto-injector in the original packaging to protect it from light. Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

8. Package contents and other information

What Chenpen 300 micrograms contains

• The active ingredient is 300 micrograms of adrenaline (epinephrine) in 0.3 ml.
• The other ingredients are: sodium metabisulfite (E223), sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of Chenpen 300 micrograms and package contents
Chenpen consists of a pre-filled syringe with an adrenaline solution for injection contained in
an auto-injector device. It is produced in two dosages, Chenpen 300
micrograms in 0.3 ml of injection solution and Chenpen 150 micrograms in 0.3 ml of injection
solution. Chenpen is supplied in packs of 1 or 2 auto-injectors. Not all pack sizes may be
marketed.
Length of exposed needle: 10 mm ± 1.5 mm

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
BIOPROJET PHARMA
9, RUE RAMEAU
Paris, France

Manufacturer:
Owen Mumford Limited
Primsdown Industrial Estate, Worcester Road, Chipping Norton, Oxfordshire OX7 5XP, UK.

Distributor for sales:
Bioprojet Italia S.r.l.
Via Melchiorre Gioia, 66 – Milan

This medicinal product is authorised in EEA member states with the following denominations:
Anapen: Austria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania,
Slovenia, Spain, Sweden, Netherlands.

Chenpen: Belgium, Italy
Anapen is a registered trademark

Chenpen 150 micrograms in 0.3 ml of solution for injections in a pre-filled syringe

Adrenaline (epinephrine)
Read this leaflet carefully before you use this medicineas it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Chenpen 150 microgramsis and what it is used for
• 2. What you need to know before you use Chenpen 150 micrograms
• 3. How to use Chenpen 150 micrograms
• 4. Possible side effects
• 5.How to store Chenpen 150 micrograms
• 6. Contents of the pack and other information

1. What is Chenpen 150 micrograms and what is it used for

• Chenpen 150 micrograms consists of a pre-filled syringe with adrenaline contained in an automatic injection device (Auto-Injector). This injects a single dose of adrenaline into the muscle.
• This medicine is only for emergenciesand, after using it, you must seek immediate medical assistance.
• Adrenaline is a hormone that is released naturally in response to stress. In acute allergic reactions it improves blood pressure, heart function and breathing, and reduces swelling. Adrenaline is also known as epinephrine.
• Chenpen 150 micrograms is used for the emergency treatment of severe allergic reactions or anaphylaxis caused by peanuts or other foods, medicines, insect bites or stings and by other allergens, as well as by exercise or of unknown causes.

2. What you need to know before using Chenpen 150 micrograms

Do not use Chenpen 150 micrograms
There is no known reason not to use Chenpen 150 micrograms in case of an allergic emergency

Warnings and precautions
Consult your doctor or pharmacist before using Chenpen 150 micrograms.

• Your doctor should have explained when and how to correctly use the Chenpen Auto-Injector.
• Tell your doctor if you suffer from a heart condition, including angina, hyperthyroidism, high blood pressure, low potassium levels and increased calcium levels in the blood, circulatory disorders, pheochromocytoma (a type of tumor in the adrenal gland), increased pressure inside the eye (glaucoma), kidney or prostate diseases, diabetes or any other illness.
• If you suffer from asthma, you may have an increased risk of developing a severe allergic reaction.
• Anyone who has an episode of anaphylaxis should consult a doctor to undergo the necessary tests to determine to which substances they are allergic in order to strictly avoid them in the future. It is important to be aware that an allergy to a substance may induce allergy to other substances related to it.
• If you have food allergies, it is important to check the ingredients contained in everything you ingest (including medicines) as even small quantities can cause serious reactions.
• Repeated injection at the local level can cause damage to the skin at the injection site. Accidental injection into a blood vessel can cause a sudden increase in blood pressure. Accidental injection into the hand or foot can cause loss of blood flow to the affected part.
• Seek immediate medical attention at the nearest hospital.

Other medicines and Chenpen 150 micrograms
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicine, especially:

• Medicines for heart diseases, such as digitalis (digoxin), beta-blockers, quinidine.
• Medicines for depression, such as tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), serotonin and norepinephrine reuptake inhibitors (SNRIs).
• Medicines for diabetes, your doctor may change their dosage after using Chenpen 150 micrograms.
• Medicines for Parkinson's disease.
• Medicines for thyroid diseases.
• Other medicines: antihistamines, such as diphenhydramine or chlorpheniramine, theophylline, ipratropium and oxitropium (used for the treatment of respiratory diseases, including asthma), oxytocin (used for labor), inhalational anesthetics, alpha blockers (used for the treatment of high blood pressure), sympathomimetics (used for the treatment of asthma, other respiratory diseases and nasal congestion)

Chenpen 150 micrograms with alcohol
Alcohol consumed in conjunction with this medicine can have negative effects as it enhances
its effects.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine

• It is not clear whether taking adrenaline during pregnancy poses a risk to the fetus. This should not prevent you from using Chenpen 150 micrograms in an emergency during pregnancy, given that your life may be in danger. You should discuss this with your doctor before an emergency occurs.
• Adrenaline is not expected to have any effect on the newborn who is breastfed.

Driving and operating machinery
Do not drive or operate machinery after injecting this medicine, until the
symptoms related to anaphylactic shock have resolved.

Chenpen 150 micrograms contains sodium metabisulfite (E223)
Sodium metabisulfite can cause allergic-type reactions and breathing difficulties, especially
in those who have a history of asthma.
Tell your doctor or pharmacist if you know you are allergic to sodium metabisulfite.

Chenpen 150 micrograms contains a small amount of sodium chloride (salt)
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically ‘sodium-free’.
For those who engage in sports: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

3. How to use Chenpen 150 micrograms

Always carry 2 auto-injectors with you because the first administration may not be successful or may not be sufficient.

• Always use this medicine following exactly the doctor's instructions.
• If you have any doubts, consult your doctor or pharmacist.
• Inject it only into the muscles of the thigh.
• For single use only, please ensure you dispose of the product safely immediately after use. Chenpen 150 micrograms delivers a single dose of 0.3 ml of solution equal to 0.15 mg (150 micrograms) of adrenaline. After use, a volume of 0.75 ml remains in the auto-injector but cannot be reused. Anaphylactic reaction generally begins within a few minutes of contact with the allergen and symptoms include:
• Itching of the skin, a urticarial skin erythema (hives), flushing and swelling of the eyes, lips or tongue.
• Difficulty breathing due to swelling of the throat. Wheezing, shortness of breath and cough may be due to bronchoconstriction.
• Other symptoms of anaphylaxis include headache, vomiting and diarrhea.
• Collapse and loss of consciousness due to a sudden drop in blood pressure.

If you experience these signs and symptoms, use the Chenpen Auto-Injector immediately. You must inject this medicine only into the muscles of the outer thigh, not into the buttock. Sometimes a single dose of adrenaline may not be enough to neutralize the effects of a severe allergic reaction. For this reason, your doctor is likely to prescribe more than one Chenpen 150 microgram auto-injector. If your symptoms do not improve or worsen within 5-15 minutes of the first injection, you or those with you should administer a second injection. For this reason, you should always carry more than one Chenpen 150 microgram auto-injector with you.

Use in adults

• The usual dose is 300 micrograms.
• Adults of considerable size may need more than one injection to counteract the effects of an allergic reaction.

Use in children and adolescents

• The appropriate dose is 150 micrograms or 300 micrograms.
• This depends on the child's body weight and is at the doctor's discretion.
• In children and adolescents weighing more than 30 kg, Chenpen 300 micrograms should be prescribed.
• An Auto-Injector that delivers 300 micrograms of adrenaline is also available. A dose lower than 150 micrograms cannot be administered with sufficient accuracy in children weighing less than 15 kg, therefore use is not recommended unless the child is in life-threatening danger and administration occurs under medical supervision.

Instructions for use
It is recommended that family members, caregivers, or teachers also be instructed on the correct use of Chenpen 150 micrograms.

• A.Parts of the Chenpen Auto-InjectorBefore using the Chenpen Auto-Injector, the patient needs to know its parts. These are shown in the figure.

Rotating shutter of the window exposing the solution: rotate the rotating shutter of the window exposing the solution to align the lenses with the window on the Auto-Injector

Window exposing the solution: look through the window, through the lenses, before injection to verify that the solution is clear and ready to use.

Injection indicator: before injection, you can see a white plastic plunger through the window. This means that the Chenpen Auto-Injector has not been activated accidentally or tampered with. After injection, the indicator turns red. This indicates that the Chenpen Auto-Injector has been activated correctly.

Black needle protection (reversible): this protects the needle when you are not using the Chenpen Auto-Injector. Remove the protection before injection. After injection, rotate the black protection and put it back on the same end of the Chenpen Auto-Injector to cover the needle.

Gray safety cap: this covers the red activation button. It prevents the button from being pressed accidentally.

Do not remove the black needle protection or the gray safety cap until you need to use the Chenpen Auto-Injector.

• B.Checking the Chenpen Auto-InjectorBefore using the Chenpen Auto-Injector, you must check it as follows:

• 1. Fully rotate the rotating shutter of the window exposing the solution counterclockwise as shown by the arrow to align the lenses with the Auto-Injector window.

2. Look through the lenses into the window exposing the solution.Check that the solution is clear and colorless. If it is cloudy, colored, or contains particles, throw away the Chenpen Auto-Injector.

• 3. Make sure that the injection indicatoris not red. If it is red, this means that the Chenpen Auto-Injector has already been used and must be discarded.

• 4. Fully rotate the mobile cover of the window exposing the solution clockwise, as shown by the arrow, to ensure that both windows are covered. Put the Chenpen Auto-Injector back in the case until you need it.
• C.Using the Chenpen Auto-Injector

If the black needle protection has been removed, do not put your thumb, fingers or hand over the unprotected end (the needle end) of the Chenpen Auto-Injector
To use the Chenpen Auto-Injector, follow these instructions:

• 1. Remove the black needle protection by pulling firmly in the direction indicated by the arrow. This also removes the gray needle protection.

• 2. Remove the gray safety cap from the red activation button by pulling as indicated by the arrow

• 3. Hold the open end (the needle end) of Chenpen against the outer thigh. If necessary, you can use Chenpen through light clothing, such as denim, cotton or polyester.

• 4. Press the red activation button so that it clicks. Keep the Chenpen Auto-Injector pressed against the outer thigh for 10 seconds.Slowly remove Chenpen from the thigh. Gently massage the injection site.

• 5. The injection indicator will have turned red.This shows that the injection is complete. If the injection indicator is not red, you must repeat the injection with a new Chenpen.

• 6. After injection, the needle comes out. To cover it, snap the wide end of the black needle protection back into place on the open end (the needle end) of the Chenpen Auto-Injector (as indicated by the arrow)

Chenpen 150 micrograms is designed as emergency treatment. Immediately after using Chenpen 150 micrograms, you must always seek medical attention. Call 118, ask for an ambulance and say “anaphylaxis” even if the symptoms seem to be improving.You must go to the hospital for a check-up and to determine the need for further treatment because the reaction may occur again at a later time. While waiting for the ambulance, you must lie down with your legs raised, but if you have difficulty breathing in this position, sit up. Ask someone to stay with you until the ambulance arrives, in case you feel unwell again. The unconscious patient must be placed on their side in the recovery position. Hand the used Chenpen Auto-Injector to the hospital staff or the pharmacist for proper disposal.

If you use more Chenpen 150 micrograms than you should

• If you inject too much adrenaline or accidentally inject the medicine into a blood vessel or a finger, seek immediate medical attention at the nearest hospital.
• If you have any further questions about the use of this product, consult your doctor or pharmacist

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

• Chenpen 150 micrograms contains metabisulfite (E223),which can cause allergic reactions and breathing difficulties, especially in those with a history of asthma. Seek immediate medical attention if you experience these side effects.
• Common side effects of adrenaline include a sensation of strong heartbeat (palpitations), rapid or irregular heartbeat, sweating, nausea, vomiting, difficulty breathing, dizziness, weakness, pale skin (pallor), tremor, headache, apprehension, nervousness, anxiety and cold extremities.
• Other less common side effects are hallucinations, fainting, dilated pupils, difficulty urinating, muscle spasms, increased blood pressure and changes in the blood, such as high sugar levels, low potassium levels and high acid content.
• Occasionally, at high doses or in susceptible patients, a sudden increase in blood pressure can occur, which can cause bleeding in the brain, irregular heartbeat, a heart attack and reduced blood flow to the skin, mucous membranes and kidneys.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine

5. How to store Chenpen 150 micrograms

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 packaging and on the auto-injector after expiry. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Do not use this medicine if the solution appears cloudy, discoloured or contains particles. See “Instructions for Use” for information on checks to be performed on this medicine.
• Store the auto-injector in the original packaging to protect it from light.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Chenpen 150 micrograms contains

• The active ingredient is 150 micrograms of adrenaline (epinephrine) in 0.3 ml.
• The other ingredients are: sodium metabisulfite (E223), sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of Chenpen 150 micrograms and contents of the pack
Chenpen consists of a pre-filled syringe with an adrenaline solution for injection contained in
an auto-injector device. It is produced in two dosages Chenpen 300 micrograms
in 0.3 ml of solution for injection and Chenpen 150 micrograms in 0.3 ml of solution for injection.
Chenpen is supplied in packs of 1 or 2 auto-injectors.
Not all pack sizes may be marketed.
Length of exposed part of the needle: 10 mm ± 1.5 mm.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
BIOPROJET PHARMA
9, RUE RAMEAU
Paris, France

Manufacturer:
Owen Mumford Limited
Primsdown Industrial Estate, Worcester Road, Chipping Norton, Oxfordshire OX7 5XP, UK.

Distributor for sale:
Bioprojet Italia S.r.l.
Via Melchiorre Gioia, 66 – Milan

This medicinal product is authorised in EEA member states with the following denominations:
Anapen Junior: Austria, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Hungary,
Iceland, Ireland, Luxembourg, Malta, Poland, Portugal, Romania, Sweden, Netherlands.

Anapen(junior):Norway

Anapen:Estonia, Finland, Latvia, Lithuania, Luxembourg, Spain

Chenpen: Belgium, Italy
Anapen is a registered trademark