PACKAGE LEAFLET: INFORMATION FOR THE USER    D00854

Adrenaline (Epinephrine) Injection BP (1:1000) for Anaphylaxis

Adrenaline

Because of your condition it may not be possible for you to read this leaflet before you are given Adrenaline (Epinephrine) Injection BP (1:1000).

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 BP (1:1000) is and what it is used for

2.    Before Adrenaline (Epinephrine) Injection BP (1:1000) is given

3.    How Adrenaline (Epinephrine) Injection BP (1:1000) is given

4.    Possible side effects

5.    Storing Adrenaline (Epinephrine) Injection BP (1:1000)

6.    Further information

1.    What Adrenaline (Epinephrine) Injection BP (1:1000) 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.

2.    Before Adrenaline (Epinephrine) Injection BP (1:1000) is given

You should not be given Adrenaline (Epinephrine) Injection BP (1:1000) 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 BP (1:1000) if you are:

•    suffering from high blood pressure.

•    pregnant or breastfeeding.

•    diabetic.

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

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 BP (1:1000) 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 or 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 & breast-feeding

If you are pregnant or are breast-feeding, your doctor will advise you whether you can be given Adrenaline (Epinephrine) Injection BP (1:1000) as an emergency treatment.

Effects on the ability to drive and use machines

Using Adrenaline (Epinephrine) Injection BP (1:1000) 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 BP (1:1000) is given

Your doctor, nurse or paramedic will administer adrenaline into a muscle (intramuscular)

In emergencies it may be necessary to administer an adrenaline solution slowly into a vein (intravenous). Your doctor will decide the correct dosage for you and when and how the injection should be administered.

Dosage:

Adults: 500 micrograms (0.5 ml) of 1:1000 adrenaline solution given by injection into the muscle (intramuscular)

Elderly: There are no specific dosage regimes for adrenaline injection in elderly patients. However, adrenaline should be given with great caution in these patients who may be more susceptible to cardiovascular side effects of Adrenaline.

Continued overleaf

Children: Volume of 1:1000 adrenaline to administer is shown in brackets.

Children over 12 years:

500 micrograms given by injection into the muscle (intramuscular) (0.5ml i.e. same as adult dose).

300 micrograms (0.3ml if the child is small or prepubertal).

Children 6 to 12 years: 300 micrograms (0.3 ml).

Children 6 months to 6 years: 150 micrograms (0.15ml)

Children under 6 months: 150 micrograms (0.15ml)

Repeat the intramuscular dose if there is no improvement in the patients condition. Further doses can be given at 5 minute intervals according to the patient's response.

If you are given more Adrenaline (Epinephrine) Injection BP (1:1000) 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

Like all medicines Adrenaline (Epinephrine) Injection BP (1:1000) 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 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

•    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)

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

After being given this product, you may experience slight pain, minor bruising/bleeding or some left over liquid 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.

If 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 BP (1:1000)

Keep 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 BP (1:1000) to you. The expiry date refers to the last day of the month.

Adrenaline (Epinephrine) is sensitive to light; therefore the Adrenaline (Epinephrine) Injection BP (1:1000) 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 BP (1:1000) if you notice it has been used or shows signs of visible damage.

6.    Further Information

What Adrenaline (Epinephrine) Injection BP (1:1000) contains

The active ingredient is Adrenaline (Epinephrine) (as acid tartrate) 1mg per ml.

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

What Adrenaline (Epinephrine) Injection BP (1:1000) looks like and contents of the pack

Adrenaline (Epinephrine) Injection BP (1:1000) is a clear, colourless solution supplied in a pre-filled syringe with a needle.

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: June/2009 Product License Number: PL 12064/0058

Aurum

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