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Patient Information Leaflet

Adrenaline (epinephrine) 1 in 1000 Injection

What is in this leaflet

1.    What Adrenaline (epinephrine) 1 in 1000 Injection is and what it is used for

2.    What you need to know before you use Adrenaline (epinephrine) 1 in 1000 Injection

3.    How to use Adrenaline (epinephrine) 1 in 1000 Injection

4.    Possible side effects

5.    How to store Adrenaline (epinephrine) 1 in 1000 Injection

6.    Contents of the pack and other information

1. What Adrenaline (epinephrine) 1 in 1000 Other medicines and Adrenaline Injection is and what it is used for    (epinephrine) 1 in 1000 Injection:

Adrenaline is used in life-threatening emergencies such as acute allergic reactions.

It is an active chemical produced in the body.

Adrenaline acts on receptors in the body and can increase the speed and force of heart muscle contractions, relieve narrowing of the lungs passages helping breathing and relieve some of the symptoms of acute allergic reaction.

2. What you need to know before you use Adrenaline (epinephrine) 1 in 1000 Injection

Do NOT use Adrenaline (epinephrine) 1 in 1000 Injection:

•    if you are allergic to adrenaline or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before using Adrenaline (epinephrine) 1 in 1000 Injection:

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

•    if you have any heart disease or long standing chest disease like asthma or emphysema.

•    if you have Phaeochromocytoma (a tumour on the adrenal gland).

•    if you have low blood levels of Potassium or high blood levels of Calcium.

•    if you are suffering from glaucoma (increased pressure in the eye).

•    if you are going to have an operation under general anaesthetic.

•    if you are a diabetic.

•    if you are suffering from high blood pressure.

•    if 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.

•    if you have an enlarged prostate or have difficulty urinating.

•    if you have any psychological disorders.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Adrenaline (epinephrine) 1 in 1000 Injection:

• Other medicines to treat high blood pressure or a heart condition.

•    Other medicines like adrenaline which increase blood pressure (for example ergot alkaloids or oxytocin).

•    Corticosteroids (medicines used to treat inflammatory conditions in your body such as asthma or arthiritis).

•    Aminophylline and Theophylline (medicines to help you breathe).

•    Any cough or cold remedies.

•    Antihistamines (for the treatment of allergies).

•    Medicines for depression or other mental illness (for example; monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, imipramine).

•    Medicines to treat an underactive thyroid gland.

•    Medicines to treat Parkinson's disease (for example levodopa or entacapone)

Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant. The doctor will then decide if the injection is suitable for you.

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.

3.    How to use Adrenaline (epinephrine) 1 in 1000 Injection

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given. Your doctor or nurse will usually inject Adrenaline (Epinephrine) Injection BP 1:1000 into a muscle (Intramuscular - IM), however, in emergencies your doctor may give you a diluted injection into your vein (intravenous - IV).

If you use more Adrenaline (epinephrine) 1 in 1000 Injection than you should Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you must tell the person giving you ^^^Mthe injection.

Adrenaline must NOT be injected into fingers, toes, ears, nose or genitalia. Intramuscular injection in the buttocks should be avoided.

4.    Possible side effects

Like all medicines, Adrenaline (epinephrine) 1 in 1000 Injection can cause side effects, although not everybody gets them.

•    Allergic reactions to Adrenaline and to Sodium Metabisulfite (contained in this injection) have been reported. The possibility of these should not stop you from using this injection for the treatment of serious allergic reactions or other emergency situations. Tell your doctor immediately if you have any difficulty breathing, a rash or itchy skin.

•    You may experience a feeling of anxiety, fear, confusion or restlessness.

•    You may suffer from headache or tremors.

•    If you suffer from Parkinson's Disease, you may notice that the symptoms or rigidity and tremor get worse.

•    You may feel weak or dizzy.

•    High blood sugar levels may occur.

•    Low blood levels of potassium may occur.

•    Metabolic acidosis (an in-balance of certain constituents in your blood) may occur.

•    You may experience a faster heart beat or high blood pressure.

•    You may experience reduced blood flow to your heart or a heart attack.

•    You may experience stress which causes the symptoms of a heart attack.

•    In rare cases the increase in blood pressure following Adrenaline Injection has caused bleeding around the brain and paralysis.

•    You may experience coldness of the extremities.

•    You may experience difficulty in breathing or sweating.

•    You may experience nausea or vomiting.

•    There may be some tissue damage at the site of injection after repeated injections of adrenaline, and elsewhere in the body (for example; in the fingers and toes, liver and kidney).

•    You may find it difficult to pass urine.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

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 the Yellow Card Scheme at: 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 (epinephrine) 1 in 1000 Injection

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

Your injection will be stored in a cool place and protected from light.

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

6.    Contents of the pack and other information What Adrenaline (epinephrine) 1 in 1000 Injection contains:

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

The other ingredients are sodium metabisulfite, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

What Adrenaline (epinephrine) 1 in 1000 Injection looks like and contents of the pack:

The injection is supplied in 1 ml clear glass ampoules. 10 ampoules supplied in each carton. The marketing authorisation number of this medicine is: PL 01502/0024

Marketing Authorisation Holder:

hameln pharmaceuticals ltd Gloucester, United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh Langes Feld 13, 31789 Hameln, Germany

hameln rds a.s.

Horna 36, 900 01 Modra, Slovak Republic HBM Pharma s.r.o.

03680 Martin, Sklabinska, Slovak Republic

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved in October 2015

43823/43/15