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Adrenaline Injection Bp 1:1000

PACKAGE LEAFLET: INFORMATION FOR THE USER


Adrenaline (Epinephrine) Injection BP 1:1000


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Adrenaline (Epinephrine)

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 will be 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.

f 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 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 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 (hypersensitivity) are most likely to experience these problems.

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

Your doctor will give Adrenaline (Epinephrine) Injection BP 1:1000 to you into a muscle (Intramuscular - IM), though not usually the buttock, fingers and toes. Your doctor may give you a diluted injection into your vein (intravenous - IV). If repeated injections are required your doctor will change the site of injection.

Your doctor will decide the correct amount for you and when the injection should be given.


Adults

The usual dose is 0.5ml.

Elderly

There are no specific dose regimens for adrenaline injection in elderly patients, however adrenaline should be used with great caution.

Children

Over 12 years 0.5mg IM (0.5ml 1:1000 solution)

0.3mg iM (0.3ml 1:1000 solution if the child is small or prepubertal)

6 - 12 years 0.3mg IM (0.3ml 1:1000 solution)

6 months - 6 years 0.15mg IM (0.15ml 1:1000 solution)

Under 6 months 0.01mg/Kg IM (0.01ml/Kg 1:1000 solution)

If necessary, these doses may be repeated several times at 5 - 15 minutes intervals according to blood pressure, pulse and respiratory function.

A small volume syringe should be used

If you take more of 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).

Continued overleaf


n 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 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 get serious or you notice any other effects not mentioned in this leaflet please tell your doctor or nurse.

Reporting of side effects

f you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this eaflet. You can also report side effects directly via the Yellow Card Scheme Website: http://www.mhra.gov.uk/yellowcard.

3y reporting side effects you can help provide more information on the safety of this medicine.


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 the Adrenaline (Epinephrine) njection 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

The Adrenaline (Epinephrine) Injection BP 1:1000 is a clear, colourless solution supplied in a pack of 10 glass ampoules each containing 0.5, 1, 2, 5 or 10ml.

Marketing Authorisation Holder and Manufacturer:

Martindale Pharmaceuticals Bampton Road Romford, RM3 8UG United Kingdom

This leaflet was last approved in: November 2015 Product License Number: PL 01883/6118R


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MART'NDALE PHARMA

Bampton Road, Harold Hill, Romford, RM3 8UG, UK


D0310100000


3101-C


100mm Measurement Verification Bar