ANAPEN 0.3 Milligram Solution for Injection

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
EPINEPHRINE
Available from:
Lincoln Medical Ltd
ATC code:
C01CA24
INN (International Name):
EPINEPHRINE
Dosage:
0.3 Milligram
Pharmaceutical form:
Solution for Injection
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Adrenergic and dopaminergic agents
Authorization status:
Authorised
Authorization number:
PA1072/001/002
Authorization date:
2003-02-21

PACKAGE LEAFLET

Common Text - Anapen 300 mcg

PT/H/1189/01-02/IA/040

Change of address of Lincoln Medical Ltd.

Package leaflet: Information for the user

Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe

Adrenaline (Epinephrine)

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 or your pharmacist.

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 or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Anapen is and what it is used for

What you need to know before you use Anapen

How to use Anapen

Possible side effects

How to store Anapen

Contents of the pack and other information

1.

What Anapen is and what it is used for

Anapen consists of a pre-filled syringe of adrenaline contained in an automatic injection device

(Auto-Injector). This injects a single dose of adrenaline into muscle.

This medicine is for emergency only and you should seek immediate medical attention after using

your Auto-Injector.

Adrenaline is a natural hormone released 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.

Anapen is used for the emergency treatment of serious allergic reactions or anaphylaxis caused by

peanuts or other foods, drugs, insect bites or stings and other allergens as well as exercise or an

unknown cause.

2.

What you need to know before you use Anapen

Do not use Anapen

There is no known reason why anyone should not use Anapen during an allergic emergency.

Warnings and precautions

Talk to your doctor or pharmacist before using Anapen.

Common Text - Anapen 300 mcg

PT/H/1189/01-02/IA/040

Change of address of Lincoln Medical Ltd.

Your doctor should have carefully instructed you when to use and the correct way to use your

Anapen Auto-Injector.

You should tell your doctor if you are suffering from heart disease, including angina,

hyperthyroidism, high blood pressure, lowered potassium levels and increased calcium in the

blood, disorders of the blood circulation, phaeochromocytoma (a type of tumour in the adrenal

gland), raised pressure inside the eye (glaucoma), kidney or prostate disease diabetes or any other

medical condition.

If you have asthma you may be at increased risk of a severe allergic reaction.

Anyone who has an episode of anaphylaxis should see their doctor about testing for substances

they may be allergic to, so these can be strictly avoided in future. It is important to be aware that

an allergy to one substance can lead to allergies to a number of related substances.

If you have food allergies it is important to check the ingredients in everything you ingest

(including medicines) as even small amounts can cause severe reactions

Repeated local injection can result in skin damage at sites of injection. Accidental injection into a

blood vessel may result in a sudden rise in blood pressure. Accidental injection into the hand or

foot may result in loss of blood flow to the affected part. You should immediately seek medical

advice at the nearest hospital.

Other medicines and Anapen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including:

Medicines for heart disease, such as digitalis (digoxin), beta-blockers, quinidine,

Medicines for depression, such as tricylic antidepressants, mono amine oxidase inhibitors

(MAOIs), serotonin and noradrenaline reuptake inhibitors (SNRIs),

Medicines for diabetes, your doctor may change the dosage of your medication after using Anapen,

Medicines for Parkinson's disease,

Medicines for thyroid disease,

Other Medicines: antihistamines such as diphenhydramine or chlorpheniramine, theophylline,

ipratropium and oxitropium (used to treat airways disease including asthma), oxytocin (used in

labour in pregnancy), inhaled anaesthetics, alpha adrenergic blockers (used to treat high blood

pressure), sympathomimetics (used to treat asthma, other airways disease and nasal congestion).

Anapen with alcohol

Alcohol may adversely affect this medicine by increasing the effects of this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

It is not clear whether taking adrenaline during pregnancy is of risk to the unborn child. This

should not deter you if you are pregnant from using Anapen in an emergency, as your life might be

in danger. You should discuss this with your doctor before such an emergency occurs.

Adrenaline would not be expected to have any effect on the breastfeeding infant.

Driving and using machines

You should not drive or use machinery after injecting this medicine, since you may still be

experiencing the effects of an anaphylactic shock.

Anapen contains sodium metabisulfite (E223)

Sodium metabisulfite can cause allergic type reactions and difficulty in breathing especially in those

with a history of asthma.

You should tell your doctor or pharmacist if you know you are allergic to sodium metabisulfite.

Anapen contains a small amount of sodium chloride (salt)

Common Text - Anapen 300 mcg

PT/H/1189/01-02/IA/040

Change of address of Lincoln Medical Ltd.

This medicinal product contains less than 1mmol sodium (23 mg) per dose. i.e. essentially sodium free.

3.

How to use Anapen

Always carry 2 units of auto-injectors in case the first administration fails or if one dose is not

sufficient.

Always use this medicine exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure.

Only inject into the thigh muscle.

For single use only, please ensure you discard safely immediately after use. Anapen delivers one

single dose of 0.3mL liquid which is equal to 0.3mg (300 micrograms) adrenaline. After use, a

volume of 0.75mL will remain in the auto-injector but this cannot be reused.

The reaction usually starts within minutes of contact with the allergen and the person may experience:

Itching of the skin, a raised urticarial rash (nettle rash), flushing and swelling of eyes, lips or

tongue.

Difficulty in breathing due to swelling of the throat. Wheezing, shortness of breath and coughing

may result from tightening of the muscles in the lungs.

Other symptoms of anaphylaxis including headache, vomiting and diarrhoea.

Collapse and loss of consciousness due to a sudden lowering of blood pressure.

When you experience these signs and symptoms use the Anapen Auto-Injector immediately. You

must only inject this medicine into the muscle on the outer part of your thigh, not the buttock.

Sometimes a single dose of adrenaline may not be sufficient to completely reverse the effects of a

serious allergic reaction. For this reason, your doctor is likely to prescribe more than one Anapen for

you. If your symptoms have not improved or have deteriorated within 5-15 minutes after the first

injection, either you or the person with you should give a second injection. For this reason you should

carry more than one Anapen with you at all times.

Use in adults

The usual dose is 300 micrograms.

Larger adults may require more than one injection to reverse the effect of an allergic reaction.

Use in children and adolescents

The appropriate dose is 150 micrograms or 300 micrograms.

This depends on the body weight of the child and the discretion of the doctor.

An Auto-Injector that delivers 150 micrograms of adrenaline is also available. A dosage below 150

micrograms cannot be administered in sufficient accuracy in children weighing less than 15 kg and

use is therefore not recommended unless in a life-threatening situation and under medical advice.

Instructions for use

It is recommended that your family members, carers or teachers are also instructed in the correct use

of Anapen.

A

Parts of the Anapen Auto-injector:

Before you use your Anapen Auto-Injector, you need to know about the parts of the Auto-Injector.

These are shown in the picture.

Common Text - Anapen 300 mcg

PT/H/1189/01-02/IA/040

Change of address of Lincoln Medical Ltd.

Rotating cover over solution window: You rotate the cover over the solution window to line up

the lenses with the solution window on the Auto-Injector body.

Solution window: You look through the lens into this window before the injection to check 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 Anapen Auto-Injector has not been fired by mistake or tampered with. After

the injection, the injection indicator turns red. This indicates that the Anapen Auto-Injector has

been fired correctly.

Black needle shield (reversible): This protects the needle when you are not using the Anapen

Auto-Injector. You pull the needle shield off before the injection. After the injection, turn the

black needle shield around and put it back onto the same end of Anapen Auto-Injector, to cover the

needle.

Grey safety cap: This covers the red firing button. It stops the button from being pushed by

mistake.

Do not remove the black needle shield or the grey safety cap until you need to use your Anapen

Auto-Injector.

B.

Checking your Anapen Auto-Injector

Before you use your Anapen Auto-Injector, you must check it as follows:

1. Rotate the cover over the solution window fully anticlockwise as indicated by

the arrow to line up the lenses with the solution window on the auto-injector body.

2. Look through the lens into the solution window. Check that the solution is clear

and colourless.

If it is cloudy, coloured or contains particles, discard the Anapen Auto-Injector.

3. Make sure that the injection indicator is not red. If it is red, this means that the

Anapen Auto-Injector has already been fired and you must discard it.

4. Rotate the cover over the solution window fully back clockwise as shown by the

arrow, to ensure that the solution window is covered. Put the Anapen Auto-Injector

back in the carton until you need to use it.

Using the Anapen Auto-Injector

If the black needle shield has been removed, do not put your thumb, fingers or hand over the open

end (needle end) of the Anapen Auto-Injector.

Common Text - Anapen 300 mcg

PT/H/1189/01-02/IA/040

Change of address of Lincoln Medical Ltd.

To use the Anapen Auto-Injector, follow the steps below:

1. Remove the black needle shield by pulling hard, in the direction of the arrow.

This also removes a grey protective needle shield.

2. Remove the grey safety cap from the red firing button, by pulling as indicated by

the arrow.

3. Hold the open end (needle end) of Anapen against the outer part of your thigh. If

necessary, you can use Anapen through light clothing, such as denim, cotton or

polyester.

4. Press the red firing button so that it clicks. Keep holding the Anapen Auto-

Injector against your thigh for 10 seconds. Slowly remove Anapen from your

thigh. Then gently massage the injection area.

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

Anapen.

6. After the injection, the needle sticks out. To cover it, click the wide end of the

black needle shield back on the open end (needle end) of Anapen Auto-Injector (as

indicated by the arrow).

Anapen is designed as emergency treatment. You should always get medical help immediately after

using Anapen. Dial 999 or 112; ask for an ambulance and state ‘anaphylaxis’ even if symptoms

appear to be improving. You will need to go to hospital for observation and further treatment as

required. This is because the reaction may happen again at some time later.

While waiting for the ambulance you should lie down with your feet raised unless this makes you

breathless in which case you should sit up. Ask someone to stay with you until the ambulance arrives

in case you feel unwell again.

Unconscious patients should be placed on their side in the recovery position.

Give your used Anapen to the hospital or pharmacist for proper disposal.

If you use more Anapen than you should

If you inject too much adrenaline or inject the medicine accidently into a blood vessel or finger

you should seek immediate medical attention at the nearest hospital.

If you have further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Common Text - Anapen 300 mcg

PT/H/1189/01-02/IA/040

Change of address of Lincoln Medical Ltd.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Anapen contains sodium metabisulfite (E223) which can cause allergic type reactions and

difficulty in breathing especially in those with a history of asthma. You should seek immediate

medical attention if you experience these side effects.

Common side effects of adrenaline include a sensation of heart pounding (palpitations), rapid or

uneven heart beat, sweating, nausea, vomiting, difficulty in breathing, dizziness, weakness, pale

skin (pallor), trembling, headache, apprehension, nervousness, anxiety and coldness of extremities.

Other less frequent side effects include hallucinations, fainting, dilated pupils, difficulty in

urinating, muscle shakes, raised blood pressure and changes to 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 which

may cause bleeding into the brain, irregular heartbeat and heart attack and reduced blood flow to

the skin, mucous tissues and kidneys may occur.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly via HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide

more information on the safety of this medicine.

5.

How to store Anapen

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 and the auto-injector. The

expiry date refers to the last day of that month.

Do not store above 25°C.

Do not use this medicine if you notice that the solution is cloudy, coloured or contains particles. See

'Instruction for use' for guidance on checking this medicine.

Keep the auto-injector in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away any medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Anapen contains

The active substance is adrenaline (epinephrine) 300 micrograms in 0.3ml.

The other ingredients are: sodium metabisulfite (E223), sodium chloride, hydrochloric acid, water

for injections.

What Anapen looks like and contents of the pack

Anapen consists of a pre-filled syringe of adrenaline solution for injection contained in an auto

injection device (Auto-Injector). It is produced in two dosage strengths, Anapen 300 micrograms in

0.3ml solution for injection and Anapen Junior 150 micrograms in 0.3ml solution for injection.

Anapen is supplied in packs of 1 or 2 auto-injectors. Not all packs sizes may be marketed.

Exposed needle length: 10 mm ± 1.5 mm.

Common Text - Anapen 300 mcg

PT/H/1189/01-02/IA/040

Change of address of Lincoln Medical Ltd.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Lincoln Medical Ltd

Unit B Stanley Court

Glenmore Business Park

Telford Road

Salisbury SP2 7GH

United Kingdom

Manufacturer:

Owen Mumford Limited,

Primsdown Industrial Estate,

Worcester Road, Chipping Norton,

Oxfordshire OX7 5XP,

This medicinal product is authorised in the Member States of the EEA under the following

names:

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, The Netherlands

Chenpen: Belgium Italy

This leaflet was last revised in 03/2017

Anapen is a registered trade mark.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each millilitre contains 1 mg of adrenaline (epinephrine)

One dose of 0.3 ml contains 300 micrograms of adrenaline (epinephrine)

Excipients with known effect: sodium metabisulfite (E223), sodium chloride

For the full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Solution for injection in a pre-filled syringe

Clear colourless solution practically free from particles.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Emergency treatment for acute allergic reactions (anaphylaxis) caused by peanuts or other foods, drugs, insect bites or

stings, and other allergens as well as exercise-induced or idiopathic anaphylaxis.

4.2 Posology and method of administration

The patient should always carry 2 units of auto injectors in case the first administration fails or if one dose is not

sufficient.

Posology

The effective dose is typically in the range 0.005-0.01 mg/kg but higher doses may be necessary in some cases.

Use in adults: The usual dose is 300 micrograms. Larger adults may require more than one injection to reverse the

effect of an allergic reaction. In the absence of clinical improvement or if deterioration occurs, a second injection with

an additional Anapen may be administered 5–15 minutes after the first injection. It is recommended that patients are

prescribed two Anapen which they should carry at all times.

Use in children: The appropriate dose may be 150 micrograms (Anapen Junior) or 300 micrograms (Anapen) of

adrenaline (epinephrine), depending on the body weight of the child and the discretion of the doctor. Children and

adolescents over 30 kg in weight should be prescribed Anapen 300 micrograms. The auto-injector of Anapen Junior is

designed to deliver a single dose of 150 micrograms adrenaline (epinephrine), a dosage below 150 micrograms cannot

be administered in sufficient accuracy in children weighing less than 15 kg and use is therefore not

recommended

unless in a life-threatening situation and under medical advice.

Method of administration

For intramuscular route only.

Anapen consists of a pre-filled syringe of adrenaline (epinephrine) contained in an auto-injection device. The whole is

referred to as an auto-injector.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

1

/

0

6

/

2

0

1

7

C

R

N

2

1

9

1

1

2

3

p

a

g

e

n

u

m

b

e

r

:

1

One Anapen injection should be administered intramuscularly immediately on the appearance of the signs and

symptoms of anaphylactic shock. These may occur within minutes of exposure to the allergen and are most commonly

manifested by urticaria, flushing or angioedema; more severe reactions involve the circulatory and respiratory systems.

Inject Anapen only into the anterolateral aspect of the thigh, not the buttock. The injected area may be lightly massaged

for 10 seconds following injection to accelerate absorption. The auto-injector is designed to inject through clothing or

directly through the skin.

Anapen auto-injector is intended for immediate self administration by a person with a history of anaphylaxis and is

designed to deliver a single dose of 300 micrograms (0.3 ml) adrenaline (epinephrine). For stability reasons 0.75 ml is

left in the syringe after use but the unit cannot be used again and should be safely discarded.

The patient/carer should be informed that following each use of Anapen:

They should call for immediate medical assistance, ask for an ambulance and state ‘anaphylaxis’ even if symptoms

appear to be improving (see section 4.4).

Conscious patients should preferably lie flat with feet elevated but sit up if they have breathing difficulties.

Unconscious patients should be placed on their side in the recovery position.

The patient should if possible remain with another person until medical assistance arrives.

4.3 Contraindications

Hypersensitivity to adrenaline (epinephrine) or to any of the excipients listed in section 6.1 (see section 4.4 for further

information on sodium metabisulfite). There are no absolute contraindications for use in allergic emergency situations.

4.4 Special warnings and precautions for use

Anapen contains sodium metabisulfite which can cause allergic-type reactions including anaphylactic symptoms and

bronchospasm in susceptible people, especially those with a history of asthma. Patients with these conditions must be

carefully instructed in regard to the circumstances under which Anapen should be used.

All patients who are prescribed Anapen should be thoroughly instructed to understand the indications for the use and

the correct method of administration (see section 6.6). It is strongly advised also to educate the patient’s immediate

associates (e.g. parents, caregivers, teachers) for the correct usage of Anapen in case support is needed in the

emergency situation.

Anapen is indicated as emergency supportive therapy only and patients should be advised to seek immediate medical

attention following administration, in order to have close monitoring of the anaphylactic episode and further treatment

as required.

The patient/carer should be informed about the possibility of biphasic anaphylaxis which is characterised by initial

resolution followed by recurrence of symptoms some hours later.

Patients with concomitant asthma may be at increased risk of a severe anaphylactic reaction.

Use with caution in patients with heart disease e.g coronary heart and cardiac muscle diseases (angina may be induced),

cor pulmonale, cardiac arrythmias or tachycardia. There is a risk of adverse reactions following adrenaline

(epinephrine) administration in patients with hyperthyroidism, cardiovascular disease (severe angina pectoris,

obstructive cardiomyopathy and ventricular arrhythmia and hypertension), phaeochromocytoma, high intraocular

pressure, severe renal impairment, prostatic adenoma leading to residual urine, hypercalcemia, hypokalemia, diabetes,

or in elderly or pregnant patients. Repeated local injection can result in necrosis at sites of injection from vascular

constriction. Accidental intravascular injection may result in cerebral haemorrhage due to a sudden rise in blood

pressure. Accidental injection into hands or feet may cause loss of blood flow to adjacent areas due to vasoconstriction.

Anapen contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free.

Patients should be warned regarding related allergens and should be investigated whenever possible so that their

specific allergens can be characterised.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

1

/

0

6

/

2

0

1

7

C

R

N

2

1

9

1

1

2

3

p

a

g

e

n

u

m

b

e

r

:

2

4.5 Interaction with other medicinal products and other forms of interaction

The effects of adrenaline(epinephrine) may be potentiated by tricyclic antidepressants mixed noradrenargic-

serotoninergic antidepressants like venlafaxine, sibutramine or milnacipran and monoamine oxidase inhibitors (sudden

blood pressure increase and possible cardiac arrhythmia),

COMT blocking agent,

thyroid hormones, theophylline, oxytocin, , parasympatholytics, certain antihistamines

(diphenhydramine, chlorpheniramine), levodopa and alcohol.

Severe hypertension and bradykardia may occur when adrenaline(epinephrine) is administered with non-selective beta-

blocking medicinal products.

Concurrent therapy with sympathomimetics may potentiate the effects of adrenaline (epinephrine).

Use Anapen with caution in patients receiving medicinal products which may sensitise the heart to arrhythmias, e.g.

digitalis, quinidine, halogenated anaesthetics.

The pressor effects of adrenaline(epinephrine) may be counteracted by administration of rapidly acting vasodilators or

alpha adrenergic blocking medicinal products.Anti-anaphylactic effects can be antagonised by beta-blocking agents,

especially non-selective beta blockers.

Adrenaline(epinephrine) inhibits insulin secretion and diabetic patients may require upward adjustment of their insulin

or other hypoglycaemic therapy.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate or well controlled studies of adrenaline (epinephrine) in pregnant women.

Adrenaline

(epinephrine) should only be used in pregnancy if the potential benefit justifies the potential risk to the foetus.

Adrenaline (epinephrine) may dramatically reduce placental blood flow, although anaphylactic shock will do this too.

Breast-feeding

Adrenaline (epinephrine) is not orally bioavailable; any adrenaline (epinephrine) excreted in breast milk would not be

expected to have any effect on the nursing infant

4.7 Effects on ability to drive and use machines

It is not recommended that patients should drive or use machines following administration of adrenaline(epinephrine),

since patients will be affected by symptoms of the anaphylactic shock.

4.8 Undesirable effects

The occurrence of undesirable effects depends on the sensitivity of the individual patient and the dose applied.

Common adverse reactions even at low doses due to adrenaline (epinephrine) include palpitations, tachycardia,

sweating, nausea, vomiting, respiratory difficulty, pallor, dizziness, weakness, tremor, headache, apprehension,

nervousness, anxiety, and coldness of extremities.

Less frequently reported effects include hallucinations, syncopes, hyperglycaemia, hypokalaemia, metabolic acidosis,

mydriasis, difficulty in micturition with urinary retention, muscle tremor.

Adverse reactions which occur at higher doses or in susceptible individuals are cardiac arrhythmias (ventricular

fibrillation /cardiac arrest), sudden rise of blood pressure (sometimes leading to cerebral haemorrhage), as well as

vasoconstriction ( e.g in the skin, mucous tissues and kidneys).

Anapen contains sodium metabisulfite which may cause allergic-type reactions including anaphylactic reactions, life-

threatening or less severe asthmatic episodes in certain susceptible patients.

Reporting of suspected adverse reactions

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

1

/

0

6

/

2

0

1

7

C

R

N

2

1

9

1

1

2

3

p

a

g

e

n

u

m

b

e

r

:

3

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Overdose or accidental intravascular injection of adrenaline(epinephrine) may cause cerebral haemorrhage from a

sudden rise of blood pressure.

Death may result from acute pulmonary oedema arising from peripheral vascular

constriction and cardiac stimulation.

The pressor effects of adrenaline(epinephrine) may be counteracted by rapidly acting vasodilators or alpha adrenergic

blocking medicinal products.

Should prolonged hypotension follow such measures, it may be necessary to administer

another pressor medicinal product, such as noradrenaline.

Acute pulmonary oedema with respiratory embarrassment following adrenaline(epinephrine) overdose should be

managed by administration of a rapidly acting alpha adrenergic blocking medicinal product such as phentolamine

and/or with intermittent positive pressure respiration.

Adrenaline(epinephrine) overdose may also result in transient bradycardia followed by tachycardia; these can be

followed by potentially fatal cardiac arrhythmias which may be treated by beta adrenergic blocking medicinal

products.

These must be preceded or accompanied by an alpha-adrenergic blocker to control the alpha-mediated effects

on the peripheral circulation.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: cardiac stimulants excl. cardiac glycosides, adrenergic and dopaminergic agents,

adrenaline (epinephrine).

ATC code: C01CA24

Adrenaline (epinephrine) is a naturally occurring catecholamine secreted by the adrenal medulla in response to exertion

or stress.

It is a sympathomimetic amine which is a potent stimulant of both alpha and beta adrenergic receptors and its

effects on target organs are, therefore, complex.

It is the medicinal product of choice to provide rapid relief of

hypersensitivity reactions to allergies or to idiopathic or exercise induced anaphylaxis.

Adrenaline (epinephrine) has a strong vasoconstrictor action through alpha adrenergic stimulation.

This activity

counteracts the vasodilatation and increased vascular permeability leading to loss of intravascular fluid and subsequent

hypotension, which are the major pharmacotoxicological features in anaphylactic shock.

Through its stimulation of

bronchial beta adrenergic receptors, adrenaline (epinephrine) has a powerful bronchodilator action which alleviates

wheezing and dyspnoea.

Adrenaline (epinephrine) also alleviates pruritus, urticaria and angioedema associated with

anaphylaxis.

5.2 Pharmacokinetic properties

Adrenaline(epinephrine) is rapidly inactivated in the body, mostly in the liver by the enzymes COMT and MAO.

Much

of a dose of adrenaline(epinephrine) is excreted as metabolites in urine.

The plasma half life is about 2-3 minutes.

However, when given by subcutaneous or intramuscular injection, local vasoconstriction may delay absorption so that

the effects may last longer than the half life suggests.

5.3 Preclinical safety data

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

1

/

0

6

/

2

0

1

7

C

R

N

2

1

9

1

1

2

3

p

a

g

e

n

u

m

b

e

r

:

4

Adrenaline(epinephrine) has been widely used in the clinical management of allergic emergencies for many years.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other

sections of the SPC .

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride

Sodium metabisulfite (E223)

Hydrochloric acid

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal product.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25

Keep the auto-injector in the outer carton in order to protect from light

6.5 Nature and contents of container

Anapen consists of a pre-filled syringe contained in a single use auto-injection device.

The syringe contains adrenaline(epinephrine) solution.

The auto-injection device delivers 0.3ml of this solution. The

immediate container is a glass syringe sealed by a rubber plunger at one end, and at the other end by a rubber needle

shield.

Syringe

BD (Becton Dickinson) borosilicate glass type 1, 27G 1/2”

Exposed needle length: 10 mm ± 1.5 mm.

Plunger

BD (Becton Dickinson) black chlorobutyl rubber PH 701/50

In pack sizes of 1 or 2.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

See Section 4.2 for instructions to be conveyed to the patient/carer regarding actions to be taken following each use of

Anapen.

Instructions for Use

A. Parts of the Anapen Auto-injector:

Before using the Anapen Auto-Injector, the patient needs to know about the parts of the auto-injector. These are

shown in the picture.

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

1

/

0

6

/

2

0

1

7

C

R

N

2

1

9

1

1

2

3

p

a

g

e

n

u

m

b

e

r

:

5

Rotating cover over solution window:

The patient rotates the cover over the solution window to line up the lenses with the solution window on the auto-

injector body.

Solution window: The patient looks through the lens into this window before the injection to check that the solution

is clear and ready to use.

Injection indicator: Before the injection, the patient can see a white plastic plunger through the window. This means

that the Anapen Auto-Injector has not been fired by mistake or tampered with. After the injection, the injection

indicator turns red. This indicates that the Anapen Auto-Injector has been fired correctly.

Black needle shield (reversible): This protects the needle when the patient is not using the Anapen Auto-Injector.

The patient pulls the needle shield off before the injection. After the injection, the patient turns the black needle shield

around and puts it back onto the same end of Anapen Auto-Injector, to cover the needle.

Grey safety cap: This covers the red firing button. It stops the button from being pushed by mistake.

The patient must not remove the black needle shield or the grey safety cap until they need to use the Anapen

Auto-Injector.

B. Checking the Anapen Auto-Injector

Before using the Anapen Auto-Injector, the patient must check it as follows:

C. Using the Anapen Auto-Injector

If the black needle shield has been removed, the patient must not put their thumb, fingers or hand over the open

end (needle end) of the Anapen Auto-Injector.

To use the Anapen Auto-Injector, the patient must follow the steps below:

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

1

/

0

6

/

2

0

1

7

C

R

N

2

1

9

1

1

2

3

p

a

g

e

n

u

m

b

e

r

:

6

Immediately after using Anapen the patient should call the emergency services, ask for an ambulance and say

"anaphylaxis". The patient should explain to the paramedic that he/she has received an injection of adrenaline

into his/her thigh muscle and show them them box and these instructions.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Lincoln Medical Ltd

Unit B Stanley Court

Glenmore Business Park,

Telford Road,

Salisbury SP2 7GH

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA1072/001/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 21 March 2003

Date of last renewal: 11 July 2006

10 DATE OF REVISION OF THE TEXT

May 2017

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

1

/

0

6

/

2

0

1

7

C

R

N

2

1

9

1

1

2

3

p

a

g

e

n

u

m

b

e

r

:

7

Similar products

Search alerts related to this product

View documents history

Share this information