What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 01883/6122.

Atropine Sulfate 400micrograms in 1ml Solution for injection

Package leaflet: Information for the user

Atropine Sulfate 400 micrograms in 1ml Solution for injection

Atropine Sulphate

(Referred to as Atropine Solution for injection in this leaflet)

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 Atropine Solution for injection is and what it is used for
2. What you need to know before you are given Atropine Solution for injection
3. How Atropine Solution for injection is given
4. Possible side effects
5. How to store Atropine Solution for injection
6. Contents of the pack and other information

1. What Atropine Solution for injection is and what it is used for

Atropine Solution for injection belongs to a group of medicines known as anticholinergics.

These medicines are often used:

  • before general anaesthesia to reduce saliva secretions
  • to restore normal heartbeat during a cardiac arrest
  • as an antidote to some insecticides and in mushroom poisoning.
  • In combination with other drugs to reverse the effect of muscle relaxants used during surgery.

2. What you need to know before you are given Atropine Solution for injection

You should NOT be given Atropine Solution for injection if:

  • you are allergic to Atropine sulfate or to any of the other ingredients of this medicine (listed in section 6).
  • you suffer from closed-angle glaucoma (a condition that affects your eyes).
  • you are a man with an enlarged prostate.
  • you suffer from myasthenia gravis (weakness of breathing muscles).
  • you suffer from pyloric stenosis (a narrowing of the opening that takes away food from your stomach).
  • you suffer from paralytic ileus (your intestine stops functioning properly).
  • you suffer from ulcerative colitis – a disease of the colon and rectum.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before being given Atropine Solution for injection if:

  • you have urinary difficulties
  • you have heart failure
  • you have had a heart attack
  • you have had a heart transplant
  • you have chronic obstructive pulmonary disease (a condition where the airflow to your lungs is restricted and you may cough and feel breathless)
  • you have an overactive thyroid
  • you have high blood pressure
  • you have a fever
  • you have diarrhoea
  • you have reflux oesophagitis (heartburn)

Other medicines and Atropine Solution for injection:

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines including medicines obtained without prescription.

Other medicines which may interact with Atropine Solution for injection are:

  • medicines to treat psychosis or depression.
  • amantadine (a medicine for Parkinson’s disease)
  • antihistamines (medicines used to treat hayfever and allergies)
  • medicines to regulate your heart (disopyramide and mexiletine)
  • ketoconazole (a medicine to treat fungal infections).
  • medicines that you take by allowing them to dissolve slowly in your mouth – atropine may cause your mouth to become dry, making it more difficult for these medicines to dissolve.

Pregnancy and breast-feeding

if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

Driving and using machines

You should not drive or use machinery if you are affected by the administration of Atropine Solution for injection.

3. How Atropine Solution for injection is given

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.

If you think you have been given too much Atropine Solution for injection:

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, or you begin to feel your heart beating very fast, you are breathing quickly, have a high temperature, feel restless, confused, have hallucinations, or lose co-ordination you must tell the person giving you the injection immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported.

Contact your doctor or nurse immediately if you get any of the following:

  • Sudden life – threatening allergic reaction such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

Other Side effects include:

  • drowsiness
  • blurred vision
  • dry mouth with difficulty swallowing
  • thirst
  • dilation of the pupils
  • flushing
  • dryness of the skin
  • slow heart beat followed by fast heart beat
  • palpitations (you are aware of your heart beating)
  • difficulty in passing urine or constipation
  • vomiting
  • confusion especially in the elderly or severe confusion
  • coughing and bringing up phlegm ( bronchial plugs)
  • restlessness
  • hallucinations
  • changes in the way the heart beats (arrhythmias)
  • heart condition (atrioventricular block) after heart transplantation
  • fever

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 - website: 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 Atropine Solution for injection

Keep out of the sight and reach of children

You should not be given this medicine if it has passed the expiry date shown on the ampoule label. The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date.

6. Contents of the pack and other information

What Atropine Solution for injection contains:

The active ingredient is Atropine Sulfate 0.04% w/v.

The other ingredients are sodium chloride and water for injections. It may also include sodium hydroxide and sulfuric acid to make a neutral solution.

What Atropine Solution for injection looks like and contents of the pack:

Atropine Solution for injection is a clear, colourless solution supplied in 1ml, Type I clear glass ampoules.

The ampoules are supplied to your pharmacist or doctor in packs of 10.

The Marketing Authorisation Holder and Manufacturer:

Macarthys Laboratories Ltd., T/A Martindale Pharma
Bampton Road
Harold Hill
Romford
RM3 8UG
UK

Product Licence Number: PL 01883/6122R

This leaflet was last revised in: September 2018

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.

Martindale Pharma
Bampton Road
Harold Hill
Romford
RM3 8UG
UK

D0432800000