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Adrenaline (Epinephrine) Injection BP 1 in 1000

Active Ingredient:
adrenaline acid tartrate
Company:  
hameln pharma ltd See contact details
ATC code: 
C01CA24
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 14 Jun 2024
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL01502/0024.

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Adrenaline (Epinephrine) Injection BP 1 in 1000

Package Leaflet: Information for the patient

Adrenaline (epinephrine) BP 1 in 1000 Injection

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again
  • If you have any further questions, please ask your doctor, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Adrenaline (epinephrine) BP 1 in 1000 Injection is and what it is used for
2. What you need to know before you are given Adrenaline (epinephrine) BP 1 in 1000 Injection
3. How Adrenaline (epinephrine) BP 1 in 1000 Injection is given
4. Possible side effects
5. How to store Adrenaline (epinephrine) BP 1 in 1000 Injection
6. Contents of the pack and other information

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

Adrenaline is used in life-threatening emergencies such as sudden 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 a sudden allergic reaction.

2. What you need to know before you are given Adrenaline (epinephrine) BP 1 in 1000 Injection
You should not be given Adrenaline (epinephrine) BP 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 you are given Adrenaline (epinephrine) BP 1 in 1000 Injection if you:

  • are in shock or have lost a lot of blood.
  • have any heart disease, as it may impact the medications you are currently taking and may bring on an attack of chest pain called angina.
  • have a long standing chest disease like asthma or emphysema.
  • have Phaeochromocytoma (a tumour on the adrenal gland).
  • have low blood levels of Potassium or high blood levels of Calcium.
  • are suffering from glaucoma (increased pressure in the eye).
  • are going to have an operation under general anaesthetic.
  • are a diabetic.
  • have high blood pressure.
  • 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.
  • have an enlarged prostate or have difficulty urinating.
  • have any psychological disorders.

Other medicines and Adrenaline (epinephrine) BP 1 in 1000 Injection

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) BP 1 in 1000 Injection:

  • Medicines to treat high blood pressure or a heart condition.
  • 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 arthritis).
  • 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 catechol-O-methyl transferase inhibitors (COMT inhibitors) such as entacapone)

Pregnancy or breast feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given the injection.

If you are breast feeding, tell your doctor or pharmacist – Adrenaline (epinephrine) BP 1 in 1000 Injection will only be used during breast-feeding if considered essential by your doctor.

Driving and using machines

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

3. How Adrenaline (epinephrine) BP 1 in 1000 Injection is given

Your doctor or nurse will usually give Adrenaline (epinephrine) BP Injection 1:1000 into a muscle (Intramuscular - IM), however, in emergencies your doctor may give you a diluted injection into your vein (intravenous - IV).

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

If you are given more Adrenaline (epinephrine) BP 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 the injection.

4. Possible side effects

Like all medicines, Adrenaline (epinephrine) BP 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 being given 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 also experience the following:

  • a feeling of anxiety, fear, confusion or restlessness.
  • headache or tremors.
  • notice that the symptoms or rigidity and tremor get worse if you suffer from Parkinson’s Disease.
  • feel weak or dizzy.
  • high blood sugar levels.
  • low blood levels of potassium.
  • metabolic acidosis (an imbalance of certain constituents in your blood).
  • a faster heartbeat or high blood pressure.
  • experience reduced blood flow to your heart or a heart attack.
  • stress which causes the symptoms of a heart attack.
  • severe chest pains.
  • In rare cases the increase in blood pressure following Adrenaline Injection has caused bleeding around the brain and paralysis.
  • coldness of the extremities.
  • difficulty in breathing.
  • sweating.
  • nausea or vomiting.
  • 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).
  • difficulty passing 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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

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

Your injection will be stored at less than 25 °C and protected from light.

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

6. Contents of the pack and other information
What Adrenaline (epinephrine) BP 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) BP 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.

Marketing Authorisation Holder
hameln pharma ltd
Nexus
Gloucester Business Park
Gloucester
GL3 4AG
United Kingdom

Manufacturer
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany

hameln rds s.r.o.
Horná 36
900 01 Modra
Slovak Republic

HBM Pharma s.r.o.
03680 Martin
Sklabinská
Slovak Republic

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

This leaflet was last approved in May 2024

xxxxxx/21/24

hameln pharma ltd
Company image
Address
Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
WWW
https://www.hameln-pharma.com
Telephone
+44 (0)1452 621 661
Fax
+44 (0)1452 632 732
Medical Information e-mail
[email protected]