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Adrenaline (Epinephrine) 1 In 1000 Solution For Injection Bp

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Document: leaflet MAH GENERIC 2_PL 12064-0122 change

Package leaflet : information for the user

Adrenaline (Epinephrine) 1 in 1000

Solution for Injection BP Auto-injector For anaphylaxis

Read all of this leaflet carefully before you use Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector.

-    Keep this leaflet. You may need to read it again.

-    If you have further questions, please ask your doctor or pharmacist.

-    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    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 pharmacist.

-    You should seek immediate medical attention following the administration of this product.

In this Leaflet

1.    What is Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector and what is it used for

2.    Before you use Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector

3.    How to use Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector

4.    Possible side effects

5.    Storing Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector

6.    Further information

1. What is Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector and what is it used for

Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Autoinjector is a pre-filled syringe of Adrenaline in an auto injection device referred to as an Auto-injector. The Auto-injector is for single use only.

Adrenaline belongs to a group of medicines used for the treatment of serious shock produced by a severe allergic reaction or collapse. The Auto-injector is used for the emergency self treatment of serious allergic reactions or anaphylaxis caused by foods, drugs and insects or by an unknown cause.

2. Before you use Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector

Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector is not suitable for children under 12 years of age.

Do not use Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector if:

-    You are allergic to any of the ingredients in this injection.

-    You are suffering from any form of heart disease.

You are in shock (other than that caused by an acute life threatening reaction).

You are suffering from brain damage or hardening of the arteries in the brain.

You are suffering from glaucoma (increased pressure in the eye).

You are undergoing or are about to undergo an operation under general anaesthetic. You are in the second stage of labour.

Take special care with Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector if:

-    You are suffering from high blood pressure.

-    You are pregnant or breastfeeding.

-    You are diabetic.

Do not inject adrenaline into fingers, toes, ears, nose or genitalia.

Do not inject adrenaline into the buttocks because this may cause tissue damage.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken:

-    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 and oral hypoglycaemics (drugs used to control 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). or any other medicines, including medicines obtained without prescription.

Pregnancy & breast-feeding

If you are pregnant or are breast-feeding, your doctor will advise you whether you can use Adrenaline Auto-injector as an emergency treatment.

Effects on the ability to drive and use machines

Using the Adrenaline Auto-injector will not affect your ability to drive or operate machines.

Important information about some of the ingredients in this medication

The product also contains Sodium Metabisulphite which may cause allergic 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.

Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector contains less than 1mmol sodium (23mg) per pre-filled syringe, i.e. essentially ‘sodium-free’.

3. How to use the Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector You should seek immediate medical attention following the administration of this product.

For Intramuscular use only

Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector is designed to deliver a single dose of 0.5ml of a clear colourless solution, containing 0.5mg Adrenaline (Epinephrine) (as acid tartrate).

Please follow the instructions for the use of this device carefully to avoid accidental injection

Always use Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector exactly as your doctor has told you. Your doctor should have carefully explained the circumstances under which you would need to use this medication.

You must make sure that you are clear on when and how to use the Auto-injector in case of an emergency allergic reaction. You should check with your doctor if you are not sure, before attempting to use the Auto-injector.

The product has been designed so that it can be used by people who do not have any medical training.

If you experience the symptoms of a life threatening allergy that the doctor has described to you, you must use the Auto-injector immediately. These symptoms include:

-    Itching of the skin.

-    Flushing and swelling of the    eyes, lips or tongue.

-    Breathing difficulties.

-    Coughing and wheezing.

-    Headaches, vomiting and diarrhoea.

Adults and Children over 12 years

Inject the contents of the Auto-injector into the outer part of the thigh as shown in Diagram 2. The Autoinjector should not be injected into the buttocks.

Directions for use

The instructions below should be followed carefully only when you are ready to use the Auto-injector.

Remove the red safety cap only when you are ready to use the Auto-injector (Diagram 1).

Hold the Auto-injector to the outer thigh at a 90° angle (Diagram 2).

Push against the thigh firmly until an audible click is heard. You can inject through light clothing if necessary.

-    Hold the Auto-injector in position for 10 seconds as this allows the required dose of adrenaline to be administered.

-    Once the Auto-injector is removed, the needle from the prefilled syringe retracts back. The red indicator comes on (Diagram 1).

-    Gently massage the area injected.

-    Replace the red cap on the Auto-injector and return the Autoinjector to your pharmacy or doctor for safe disposal.

In some circumstances a single dose of Adrenaline may not completely reverse the effects of a serious allergic reaction or anaphylaxis, for such patients a repeat injection may be administered to the other thigh after 10 minutes.

If you take more of Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector than you should

Please seek immediate medical attention in a situation where an overdose is given or the Autoinjector is accidentally administered into a blood vessel or finger.

4. Possible side effects

Like all medicines Adrenaline Auto-injector can cause side effects, although not everybody gets them.

Adrenaline solutions may be associated with some undesirable effects although these are normally related to higher strengths of the drug.

The undesirable effects include:

-    Anxiety.

-    Difficulty in breathing.

-    High blood sugar levels.

-    High blood pressure.

-    Restlessness.

-    Palpitations.

-    Irregular or faster heart beat.

-    Tremors.

-    Weakness.

-    Dizziness.

-    Headache and coldness of the extremities.

-    Nausea.

-    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 may increase rigidity and tremors.

Following administration of this product, you may experience slight pain, minor bruising/bleeding or some residual liquid at the site of the injection.

Repeated injection may cause tissue damage at the site of the injection. Tissue damage may also occur in the extremities, kidneys and liver.

If any of the side effects are troublesome, get serious or you notice any other effects not mentioned in this leaflet please tell your doctor or pharmacist.

5. Storing Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector

Keep out of the reach and sight of children

Do not use this product after the expiry date on the carton has passed. The expiry date refers to the last day of that month.

Adrenaline is sensitive to light; therefore the Auto-injector must always be kept in the original outer carton. Do not store above 25°C and do not freeze.

Do not use the Auto-injector if you notice it has been used or shows signs of visible damage.

Use once and return the Auto-injector to your pharmacy or doctor for safe disposal.

6. Further Information

Adrenaline (Epinephrine) 1 in 1000 Solution for Injection BP Auto-injector contains the active substance Adrenaline (Epinephrine) (as acid tartrate) 1mg per ml. The Auto-injector is designed to deliver a dose of 0.5ml of a clear colourless solution, containing 0.5mg Adrenaline (Epinephrine) (as acid tartrate).

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

The Auto-injector consists of a white applicator pen with a red cap.

The applicator has one indicator bar showing the internal pre-filled syringe of Adrenaline (Epinephrine). After the Auto-injector is used, the indicator bar becomes red.

Marketing Authorisation Holder:    Manufacturer:

Aurum Pharmaceuticals Ltd.    Federa SC

Bampton Road,    Avenue Jean Jaureslaan 71,

Romford, RM3 8UG.    Brussels B-1030.

United Kingdom.    Belgium.

This leaflet was last approved in: August 2006 Product Licence Number: PL 12064/0122 © Martindale Pharmaceuticals Aurum Pharmaceuticals Ltd.

Bampton Road, Harold Hill, Romford, Essex, RM3 8UG.

United Kingdom.