Adrenaline (Epinephrine) 1:1,000 Minijet 1mg/ml Solution for Injection

FOR ADMINISTRATION BY HEALTHCARE PROFESSIONALS ONLY

Read all of this leaflet carefully

Please note this medicine is mainly used in emergency situations and the doctor will have decided that you needed it.

It is unlikely therefore, that you will have read this leaflet before the medicine was administered to you.

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

-    If you have any further questions, ask the doctor or nurse.

-    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

-    In this leaflet, Adrenaline 1:1,000 Minijet 1mg/ml Solution for Injection will be called Adrenaline Minijet.

What is in this leaflet:

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

2.    What you need to know before you are given Adrenaline Minijet

3.    How Adrenaline Minijet is used

4.    Possible side effects

5.    How to store Adrenaline Minijet

6.    Further information.

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

Adrenaline is a type of drug that constricts blood vessels, makes the heart pump more strongly and opens airways.

It is used in life-threatening emergencies such as severe allergic reactions or asthma. It will have been used to save your life.

2.    What you need to know before you are given Adrenaline Minijet

In emergencies, it may be impossible for the people looking after you to get all your details before they have to treat you. They will have assessed the situation and decided it was better to give you the injection now and ask questions later.

Please tell your doctor if:

•    You are allergic to any of the ingredients in this medicine (listed in section 6)

•    You suffer from hyperthyroidism (overactive thyroid gland)

•    You suffer from hypertension (high blood pressure)

•    You suffer from heart disease or long standing chest disease like asthma or emphysema

•    You suffer from diabetes

•    You suffer from closed angle

glaucoma (an eye condition that causes sudden blurred vision with pain and redness)

•    You are allergic to sympathomimetic drugs

•    You have a problem with the rate or rhythm of your heartbeat

•    You have had a spinal cord injury and are suffering from over-activity of the involuntary nervous system which causes your blood pressure to be uncontrolled

•    You are allergic to sulfites

•    You suffer from an enlarged prostate or have difficulty urinating

•    You have mental disturbances

•    You are going to have surgery under a general anaesthetic.

Other medicines and

Adrenaline Minijet

Tell your doctor if you are taking

or have recently taken any

medicines.

In particular those:

•    For heart problems or high blood pressure (e.g. propranolol, digoxin, quinidine, guanethidine, alpha blockers or sympathomimetic drugs such as isoproterenol)

•    For migraine (e.g. ergot alkaloids)

•    For depression or other psychiatric illness (e.g.

inhibitors (MAOIs), tricyclic antidepressants, imipramine)

•    For diabetes (e.g. glibenclamide)

•    For post natal bleeding (e.g. oxytocin)

•    For Parkinson’s disease (e.g. levodopa, entacapone)

•    Drugs which cause potassium loss (corticosteroids, potassium-depleting diuretic, aminophylline, theophylline)

•    General anaesthetics (e.g. halothane).

Pregnancy and breast feeding

Tell your doctor if you are pregnant as the heartbeat of the unborn child can be affected. However, it is safe to continue breastfeeding.

Driving and using machines

Not applicable; this medicine is intended for emergency use only.

Adrenaline Minijet contains Sodium

This medicinal product contains less than 1 mmol sodium per ml (3mg/ml), i.e. essentially ‘sodium free’.

Sodium metabisulfite may rarely cause hypersensitivity reactions and bronchospasm (breathing difficulties).

3.    How Adrenaline Minijet is used

This medicine will have been given to you by a healthcare professional. Adrenaline Minijet is given slowly under the skin or into muscle. Repeated injections should be given at a different site on the body.

The following is a guide:

Adults and children over 12 years:

0.5 ml. The dose may be repeated every 5 to 15 minutes as needed.

A lower dose may be used in the elderly.

Children under 12 years old: not recommended.

If you think you have been given too much medicine, please tell your doctor.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4.    Possible Side-effects

Like all medicines this medicine can cause side effects, although not everyone gets them.

•    Your heart may beat an odd rhythm or you could have a heart attack

•    Blood pressure may rise dangerously high leading to stroke or fluid in the lungs

•    Extreme chest pain which does not go away when you rest

•    Stress which causes the symptoms of a heart attack

•    The cells of your bowel may die

•    Cold fingers and toes

•    Pallor, headache, dizziness, breathlessness, shakiness, sweating

•    A feeling of anxiety, fear, restlessness, or weakness

•    Feeling sick or being sick

•    Difficulty urinating

•    Your blood sugar levels may be altered, making you feel ill

•    Repeated injections may damage the skin

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517.

Website: www.hpra.ie;

E-mail: medsafety@hpra.ie.

United Kingdom

Yellow Card Scheme Website:

www.mhra.gov. uk/yellowcard

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

5.    How to store Adrenaline Minijet

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 syringe label. The expiry date refers to the last day of that month.

Store below 25°C. Keep container in outer carton in order to protect from light.

Do not use Adrenaline if you notice that the solution has discoloured. Discard any unused portion. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6.    Contents of the pack and other information

What Adrenaline Minijet contains

The active substance is adrenaline (epinephrine) 1mg per ml.

The other ingredients are citric acid monohydrate, sodium citrate (E331), sodium chloride, sodium metabisulfite (E223), hydrochloric acid (for pH adjustment), water for injection.

What Adrenaline Minijet looks like and contents of the pack

Adrenaline Minijet is a solution for injection. The solution is clear and colourless and is packed in a clear, glass syringe. There is one syringe per carton.

Marketing Authorisation holder:

International Medication Systems (UK) Ltd., 21 St Thomas Street, Bristol, BS1 6JS, UK

Manufacturer:

UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK.

This leaflet was last revised August 2016