Product Description:

Adrenaline Injection

Component:

Leaflet

Manufacturer:

B Braun

Market:

UK

Minimum Font Size & Typeface:

9.5pt Swiss 721BT

Antigen Pharmaceuticals

PATIENT INFORMATION LEAFLET

Adrenaline (Epinephrine) 1:1,000 Solution for Injection

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

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

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

This medicine has been prescribed for you. Do 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.

The name of your medicine is Adrenaline (Epinephrine) 1:1,000 Solution for Injection. It will be referred to as Adrenaline Injection for ease hereafter.

In this leaflet:

1.    What Adrenaline Injection is and what it is used for

2.    Before you are given Adrenaline Injection

3.    How Adrenaline Injection is given to you

4.    Possible side effects

5.    How to store Adrenaline Injection

6.    Further information

1. WHAT ADRENALINE INJECTION IS AND WHAT IT IS USED FOR

Adrenaline belongs to a class of drugs called sympathomimetic agents. Adrenaline Injection may be used to rapidly relieve severe allergic reactions to drugs or other substances causing allergy. It may also be used in the emergency treatment of shock due to a severe allergic reaction.

2. BEFORE YOU ARE GIVEN ADRENALINE INJECTION

You should not be given this medicine:

•    if you know you are allergic to adrenaline, or to any of the other ingredients (see Section 6 of this leaflet)

•    when you are in labour

•    if you have severe heart disease particularly if it is associated with an increased heart rate

•    you are suffering from any infection, disease or tumour of the brain

•    you have atherosclerosis which is a narrowing, and hardening of the body's blood vessels (your doctor will advise you).

Adrenaline injection should not be used in areas such as fingers, toes, ears, nose or penis, as the blood supply to these areas might become inadequate.

Speak to your doctor if one of these applies to you before you are given this medicine.

Take special care and tell your doctor if:

•    you are elderly

•    you suffer from any heart problem, particularly if it affects the heart rate or if you suffer from chest pain

•    you have problems with your brain eg. stroke, brain damage or blood vessel disease

•    you have an overactive thyroid, diabetes or glaucoma (high pressure in the eye)

•    you have phaeochromocytoma (a tumour on the adrenal gland)

•    you have low blood levels of potassium or high blood levels of calcium

•    you have a tumour on your prostate gland or kidney disease

•    you are in shock or have lost a lot of blood

•    you are going to have a surgery under general anaesthesia

•    you are suffering from high blood pressure.

Taking other medicines:

Tell your doctor or midwife before you are given this medicine if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

A large number of drugs can interact with Adrenaline Injection which can significantly alter their effects. These drugs include:

•    monoamine oxidase inhibitors (MAOI) or tricyclic antidepressants both used for depression

•    guanethidine, used for the rapid control of blood pressure

•    diuretics (“water tablets”)

•    inhaled general anaesthetics, such as halothane

•    medicines to raise or lower your blood pressure including betablockers, e.g. propranolol, atenolol, bisoprolol, phentolamine

•    anti -diabetic drugs like insulin or oral hypoglycaemic agents (e.g glipizide)

•    aminophylline and theophylline (medicines to help you breathe)

•    corticosteroids (medicines used to treat inflammatory conditions in your body such as asthma or arthritis)

•    antihistamines (for example: diphenhydramine), used for the treatment of allergies

•    medicines used to treat mental illness like chlorpromazine, pericyazine or fluphenazine

•    medicines used to treat an underactive thyroid gland

•    oxytocin (used to induce labor at term and to control bleeding after delivery)

•    any cough or cold remedies (sympathomimetics).

If you are already taking one of these medicines, speak to your doctor before you receive Adrenaline Injection.

Pregnancy and breastfeeding:

Tell your doctor before you are given this medicine if you are pregnant, think you may be pregnant or are planning to become pregnant. Adrenaline should only be used during pregnancy and breastfeeding if considered essential by your doctor.

Please tell your doctor or nurse before being given this injection if you are breast feeding, this injection should not be used by nursing (breast feeding) mothers.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Adrenaline (epinephrine) 1 in 1000 injection.

Important information about some of the ingredients of Adrenaline Injection:

This medicine contains sodium metabisulphite, a preservative. This may rarely cause severe allergic (hypersensitivity) reactions and wheezing. This medicinal product contains less than 1mmol sodium (23mg) per dose (essentially ‘sodium-free’).

3. HOW ADRENALINE INJECTION IS GIVEN TO YOU

Adrenaline may be injected either into a muscle or into the tissue just beneath the skin. It will be administered by a trained healthcare professional. Your doctor will decide the most suitable dosage for your particular case according to your age and physical circumstances. Depending on the response further doses may be needed, usually at 5 minute intervals. If you have any concerns or questions about how much of this medicine you have received, speak to your doctor immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Adrenaline Injection can sometimes cause side effects, although not everyone gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Other side effects include:

•    headache, dizziness

•    feelings of anxiety or fear or restlessness

•    trembling

•    insomnia, confusion, irritability

•    abnormal mood or behaviour

•    a dry mouth or producing too much saliva

•    weakness or sweating

•    changes in the rhythm and speed of the heart

•    high blood pressure

•    coldness of the arms or legs

•    breathlessness

•    reduced appetite, feeling sick or being sick

•    repeated injections may damage tissues at the site of the injection

•    difficulty of not being able to pass water

•    metabolic acidosis (an imbalance of certain constituents in your blood) may occur

•    there may be some tissue damage at the site of injection after repeated injections of adrenaline

•    increase in tremors and rigidity in patients suffering from a condition called parkinsonian syndrome

•    bleeding in the head

•    paralysis of one half of the body

•    increased sugar levels in the blood

•    breakdown of fat in the body.

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.

5. HOW TO STORE ADRENALINE INJECTION

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and ampoule label after “Exp”. The expiry date refers to the last day of that month.

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

The solution should not be used if it is discoloured in any way.

This medicine should not be mixed with any other drugs.

The solution must not be stored in contact with metals e.g. needles or metal parts of syringes, as dissolved metal ions may cause swelling at the site of the injection.

If only part of an ampoule is used, the remaining solution should be discarded.

6. FURTHER INFORMATION

The active substance is adrenaline. Each 1 ml contains 1 mg adrenaline (epinephrine) as the acid tartrate.

The other ingredients are sodium metabisulphite (E223), sodium chloride, sodium hydroxide or hydrochloric acid in water for injections..

What Adrenaline Injection looks like and contents of pack

Adrenaline Injection is a clear colourless, aqueous, sterile solution for injection, available in 1ml glass ampoules, packed in boxes containing 10 ampoules.

Marketing authorization holder

Antigen International Limited, Roscrea, Co. Tipperary, Ireland.

Manufacturer

B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.

This leaflet was last revised in March 2012    IAD050901/LF/1

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