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Adrenaline Injection 1 In 10 000

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Document: leaflet MAH GENERIC_PL 12064-0018 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adrenaline (Epinephrine) Injection 1 in 10,000

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

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

•    If you have further questions, please askyour 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 in 10,000 is and what it is used for

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

3.    Elow Adrenaline (Epinephrine) Injection 1 in 10,000 is given

1. Possible side effects.

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

5. Further information.

1.    What Adrenaline (Epinephrine) Injection 1 in 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 in 10,000 is given

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

•    suffering from high blood pressure.

•    pregnant or breastfeeding.

•    diabetic.

f any of the above apply to you or your child please tell your doctor before you are given this medicine.

Taking other medicines

3lease tell your doctor or nurse if you are taking or have ecently taken any other medicines, including medicines obtained without a prescription.

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

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

•    drugs 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 schizophrenia and other psychiatric disorders).

Pregnancy and breast-feeding

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

Effects on the ability to drive and use machines

Using Adrenaline (Epinephrine) Injection 1 in 10,000 will not affect your ability to drive or operate machinery.

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, which 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 in 10,000 is given

Your doctor, nurse or paramedic will give Adrenaline (Epinephrine) Injection 1 in 10,000 to you 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.

To restart your heart

Adults and Children over 12 years

The usual dose is 10ml by injection into a vein (intravenously).

If your doctor cannot give you an injection into a vein then the medicine can be given into a bone.

Children under 12 years Not recommended.

The elderly

Your doctor will give Adrenaline (Epinephrine) Injection 1 in

10.000    to you with caution.

To treat life threatening allergic reactions (acute anaphylaxis)

Adults and children over 12 years

Slow injection into the vein in a dose of 500 micrograms (5ml of Adrenaline (Epinephrine) Injection 1 in 10,000) given at a rate of 100 micrograms (1ml of Adrenaline (Epinephrine) njection 1 in 10,000) per minute, stopping when there is a response.

Children under 12 years

Children can be given a dose of 10 micrograms per kilogram of body weight (0.1ml of Adrenaline (Epinephrine) Injection 1 in 10,000 per kg) by slow injection into the vein over several minutes.

The elderly

Your doctor will give Adrenaline (Epinephrine) Injection 1 in

10.000    to you with caution. In some circumstances a single dose of Adrenaline may not completely reverse the effects of a serious allergic (hypersensitive) reaction or anaphylaxis. If this is the case you may be given another injection after 10 minutes.

If you are given more of Adrenaline (Epinephrine)

Injection 1 in 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.

Continued overleaf

4.    Possible side effects

_ike all medicines Adrenaline (Epinephrine) Injection 1 in 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. The unwanted effects nclude: 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

subarachnoid 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) n patients with Parkinson's disease Adrenaline (Epinephrine) may increase rigidity (stiffness) and tremors (shaking).

After being given this product, you may experience slight oain, minor bruising/bleeding or some left over liquid where /ou have been injected.

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

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

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

<eep out of the reach and sight of children.

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

Adrenaline (Epinephrine) is sensitive to light; therefore the Adrenaline (Epinephrine) Injection 1 in 10,000 must always oe 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 in 10,000 if you notice it has been used or shows signs of visible damage.


6. Further Information

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

The active ingredient is Adrenaline (Epinephrine) (as acid tartrate) 0.1 mg per ml.

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

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

The Adrenaline (Epinephrine) Injection 1 in 10,000 is a clear, colourless solution supplied in 1 ml, 5ml and 10ml clear glass ampoules. Each pack contains either 1 or 10 ampoules. Marketing Authorisation Holder Aurum Pharmaceuticals Ltd.

Bampton Road, Romford, RM3 8UG, United Kingdom Manufacturer:

Martindale Pharmaceuticals Ltd.

Bampton Road, Romford, RM3 8UG,

United Kingdom

This leaflet was last approved in: March 2011 Product License Number: PL 12064/0018


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

Au R U M