PACKAGE LEAFLb I: INFORMATION FOR I Hb USER

Adrenaline (Epinephrine) Injection 1:10,000

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Because of your condition it may not be possible for you to read this leaflet before you are given Adrenaline (Epinephrine) Injection 1:10,000.

The leaflet will be kept for you as you may wish to read it later.

•    If you have further questions, please ask your doctor or nurse.

•    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

1.    What Adrenaline (Epinephrine) Injection 1:10,000 is, and what it is used for

2.    Before Adrenaline (Epinephrine) Injection 1:10,000 is given

3.    How Adrenaline (Epinephrine) Injection 1:10,000 is given

4.    Possible side effects

5.    Storing Adrenaline (Epinephrine) Injection 1:10,000

6.    Further information

1.    What Adrenaline (Epinephrine) Injection 1:10,000 is, and what it is used for

•    Adrenaline (Epinephrine) belongs to a group of medicines used for the treatment of serious shock produced by a severe allergic (hypersensitive) reaction or collapse

•    It may also be used to restart your heart if it has stopped

2.    Before Adrenaline (Epinephrine) Injection 1:10,000 is given

You should not be given Adrenaline (Epinephrine) Injection 1:10,000 if you are:

•    allergic (hypersensitive) to any of the ingredients in this injection

•    suffering from any form of heart disease

•    in shock (other than that caused by a sudden life threatening reaction)

•    suffering from brain damage or hardening of the arteries in the brain

•    suffering from glaucoma (increased pressure in the eye)

•    having or are about to have an operation under general anaesthetic

•    in the second stage of labour

Take special care with Adrenaline (Epinephrine) Injection 1:10,000 if you are:

•    suffering from high blood pressure

•    pregnant or breastfeeding

•    diabetic

If any of the above applies to you or your child, please tell the doctor before this medicine is given.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Medicines that may interact with Adrenaline (Epinephrine) Injection 1:10,000 include:

•    antihistamines (drugs used to treat allergic reactions or allergies)

•    drugs used to treat high blood pressure, heart conditions, depression or thyroid problems

•    ergot alkaloids (drugs used to treat migraine)

•    insulin oral hypoglycaemics (drugs used to treat diabetes)

•    oxytocin (used in childbirth to stimulate contractions of the uterus)

•    doxapram (given as an injection in hospitals to help severe breathing problems)

•    entacapone (for the treatment of Parkinson's disease)

•    antipsychotics (for the treatment of serious mental disorders) Pregnancy & breast-feeding

If you are pregnant or are breast-feeding, your doctor will advise you whether you can have Adrenaline (Epinephrine) Injection 1:10,000 as an emergency treatment.

Effects on the ability to drive and use machines

Having Adrenaline (Epinephrine) Injection 1:10,000 will not affect your ability to drive or use machines.

Important information about some of the ingredients in this medication

The product also contains Sodium Metabisulphite which may cause allergic (hypersensitive) type reactions in some people and can lead to breathing difficulties or collapse. People with a history of asthma or allergies are most likely to experience these problems.

3.    How Adrenaline (Epinephrine) Injection 1:10,000 is given

Your doctor, nurse or paramedic will give Adrenaline (Epinephrine) Injection 1:10,000 to you either into a vein (intravenous) or into a bone (intraosseous). Your doctor will decide the correct amount for you, and when and how this should be given.

Adrenaline must not be injected into the fingers, toes, ears, nose or genital area. Intramuscular injection in the buttocks should be avoided.

Adults and children over 12 years:

When there is either uncontrolled beating of the heart, or if the heart has stopped working:

1mg adrenaline is given either into the vein or into a bone every 3-5 minutes until the heart starts to work. Once the heart is working, further doses may be given but this depends on your blood pressure. Intravenous doses of 50 micrograms are usually sufficient for most patients.

When the heart stops following cardiac surgery:

Following cardiac surgery, your doctor will give adrenaline 1:10,000 into the vein in doses of up to 100 micrograms.

Heart Resuscitation:

In heart resuscitation, the recommended dose is 1mg into the vein. Children under 12 years:

When there is uncoordinated beating of the heart or the heart has stopped:

10 micrograms per kilogram of body weight, repeated every 3-5 minutes.

Continued overleaf

When there is a failure of breathing and blood circulation around the body:

^:irst and further doses: 10 micrograms per kilogram of body weight given into a vein or into a bone.

Maximum dose is 1mg. If needed, further doses should be given every 3-5 minutes. If your doctor is unable to give adrenaline in any other way, the doctor can inject the adrenaline into the airway (called the trachea), in a dose of 100 micrograms per kilogram of body weight.

Newborn:

When ventilation and chest compression have not increased the heart above 60 beats per minute, adrenaline may be given into the vein in a dose of 10-30 micrograms per kilogram of body weight. The doctor can give this using a thin tube through the umbilical cord.

Although not recommended, if necessary, the doctor may inject the adrenaline into the airway in a dose of 50-100 microgram per kilogram of body weight.

Treating life threatening allergic reactions (acute anaphylaxis):

Jsually, adrenaline is given into a muscle using a different strength of injection. Adrenaline 1:10,000 can also be given into the vein by experienced doctors. For adults, if given into the vein, a dose of 50 micrograms of Adrenaline 1:10,000 will be used.

If you are given more Adrenaline (Epinephrine) Injection 1:10,000 than you should

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much; however, tell your doctor or nurse if you have any concerns.

4.    Possible side effects

_ike all medicines, Adrenaline (Epinephrine) Injection 1:10,000 can cause side effects, although not everybody gets them.

Adrenaline (Epinephrine) solutions may be associated with some unwanted effects although these are normally related to higher strengths of the drug. These unwanted effects include:

•    anxiety

•    difficulty in breathing

•    high blood sugar levels

•    high blood pressure

•    restlessness

•    palpitations (irregular or faster heart beat)

•    tremors (shaking)

•    weakness

•    dizziness

•    headache

•    coldness of the fingers and toes

•    feeling sick (nausea)

•    being sick (vomiting)

•    sweating

•    cerebral haemorrhage (bleeding in the brain which can cause very severe headaches, stiff neck, fits and loss of consciousness)

•    hemiplegia (paralysis of one side of the body)

•    pulmonary oedema (fluid in the lungs)

•    ECG changes

n patients with Parkinson's disease, adrenaline may increase rigidity (stiffness) and tremors (shaking).

After being given this product, you may experience slight pain, minor aruising/bleeding or some left over liquid in the place where you have been injected.

Repeated injection may cause tissue damage in the place where you have been injected. Tissue damage may also occur in the extremities (fingers and toes), kidneys and liver.

f any of the side effects gets serious or you notice any other effects not mentioned in this leaflet, please tell your doctor or nurse.

5.    Storing Adrenaline (Epinephrine) Injection 1:10,000

Keep out of the sight and reach of children.

Your doctor, nurse or paramedic will check that the expiry date on the label has not passed before giving Adrenaline (Epinephrine) njection 1:10,000 to you. The expiry date refers to the last day of that month.

Adrenaline (Epinephrine) is sensitive to light, therefore Adrenaline (Epinephrine) 1:10,000 must always be kept in the original outer carton.

Do not store above 25°C and do not freeze.

You should not be given Adrenaline (Epinephrine) Injection 1:10,000 f it has been used or shows signs of visible damage.

6.    Further Information

What Adrenaline (Epinephrine) Injection 1:10,000 contains

The active ingredient is Adrenaline (Epinephrine) as acid tartrate.

Each 10ml solution for injection contains 1mg of adrenaline (epinephrine) as the acid tartrate.

The other ingredients are Sodium Chloride, Citric Acid Monohydrate, Sodium Citrate Dihydrate, Sodium Metabisulphite and Water for njections. Dilute Hydrochloric acid may be added to adjust the acidity.

What Adrenaline (Epinephrine) Injection 1:10,000 looks like and contents of the pack

Adrenaline (Epinephrine) Injection 1:10,000 is a clear colourless solution supplied in a pre-filled syringe. Each pre-filled syringe contains 10ml of the solution.

Marketing Authorisation Holder: Manufacturers:

Aurum Pharmaceuticals Ltd.    Martindale Pharmaceuticals Ltd.

3ampton Road    Bampton Road

Romford, RM3 8UG    Romford, RM3 8UG

Jnited Kingdom    United Kingdom

Agila Specialties Polska Sp.z.oo 10 Daniszewska Str.

03-230 Warsaw, Poland

This leaflet was last revised in April 2013 Product License Number: PL 12064/0006

Bampton Road, Harold Hill, Romford RM3 8UG, United Kingdom

Aurum

D02483 l|

100mm Measurement Verification Bar

2483-B