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ATROPINE SULPHATE INJECTION BP 1 MG / ML - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - ATROPINE SULPHATE INJECTION BP 1 MG / ML

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

Talkto 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, askyour 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.

Continued overleaf

If you thinkyou 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 thinkyou 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

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 1 ml. 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

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

AA MARTINDALE PHARMA

■ V ■ Bampton Road, Harold Hill, Romford, RM3 8UG, UK

1, RM3 8UG, UK


D04328 ____________

MARTINDALE PHARMA

DEVELOPMENT ARTWORK

Component Code: D04328

Prod: Atropine Sulfate400mcg/ml PIL UK PL 01883/6122R Solution for Injection

Paper Size: 170 × 296m m

Version Control

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Version A:

26/06/18

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Version B:

27/06/18

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Version C:

14/09/18

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Version E:

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Version 1:

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Version 0:

me and you

1 Blighs Road, Sevenoaks, Kent, TNI3 1 DA, UK t:+44 (0) 1732 749 748

e:

Sources: Original (products.mhra.gov.uk)