Package leaflet: INFORMATION FORTHE USER

Atropine Sulfate injection BP 400micrograms in 1ml

(Referred to as Atropir

Read all of this leaflet carefully before you are given Atropine injection

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

•    If you have any further questions, please ask your doctor or nurse

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

in this leaflet:

1.    What Atropine Injection is and what it is used for

2.    Before Atropine Injection is given

3.    How Atropine Injection is given

4.    Possible side effects

5.    How to store Atropine Injection 5. Further information

This leaflet contains a summary of the information available for this medicine. You should ask your doctor or nurse if you are unsure about any aspect of this medicine.

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

Atropine belongs to a group of medicines called antimuscarinic. These medicines are often used in anaesthesia to reduce the flow of saliva and other body fluids. Atropine may also act on the vagus nerve (a nerve that sends information from the brain to other parts of the body). This helps to make the heart beat faster.

Atropine Injection is used to raise the heart rate if it has become too slow after a heart attack or as a result of taking beta-blocker drugs.

Atropine Injection is also given to reduce fluid in the lungs during general anaesthesia.

2.    Before Atropine injection is given

You should not be given Atropine injection if:

•    you have problems with your prostate, often indicated by a difficulty passing urine, particularly in elderly men

•    you have glaucoma (increased pressure in the eye)

•    you have difficulty having bowel movements because you have paralysis of the bowel (paralytic ileus).

Take special care with Atropine injection Tell your doctor or nurse if:

•    you have a fever

•    you have a condition called pyloric stenosis which means that it is difficult for food to move from your stomach into the small intestine and which causes pain or vomiting

•    you have an inflamed gut with symptoms of blood and mucus in the faeces

•    you have a heart disorder

•    you have acid reflux with heartburn (gastro-oesophageal reflux).

f any of the above applies to you, please tell your doctor.

Taking other medicines

Please tell your doctor or nurse if you are taking, or have ecently taken, any other medicines including medicines obtained without prescription.

Other medicines which may interact with Atropine Injection are:

•    medicines used to treat allergies (antihistamines)

•    medicines used to treat depression (tricyclic antidepressants)

•    medicines used to treat schizophrenia and other mental disorders (buterophenones and phenothiazines)

•    amantidine (a medicine used in the treatment of Parkinson's disease)

•    metoclopramide (a medicine used to stop you being sick). Pregnancy and breast-feeding

Tell your doctor if you are pregnant or trying to become pregnant before you are given this medicine. You should not be given this medicine if you are breast-feeding.

Driving and using machines

Atropine Injection may affect your vision or your mood (you might become excited or delirious or become confused). If you feel at all unwell you should not drive or use machinery.

Sulfate e Injection in this leaflet)

3.    How Atropine injection is given

This medicine is an injection which will be given to you by a doctor. Your doctor will determine the dose you require. It will be given under the skin, into a vein or into a muscle.

Adults (including the elderly):

As treatment to increase heart rate:

•    100 micrograms into the vein or under the skin.

For reducing fluid in the lungs during an operation:

•    300 - 600 micrograms under the skin or into a muscle 30 minutes before the anaesthetic

•    Alternatively, 300-600 micrograms may be given into a vein immediately before the anaesthetic.

Children:

For drying fluids during an operation (given 30 minutes before the anaesthetic):

Infants

•    Premature Up to 60 micrograms given under the skin

•    Full term Up to 100 micrograms given under the skin

•    6-12 months Up to 200 micrograms given under the skin.

Older Children

•    Up to 20 micrograms per kg of body weight given into a muscle.

if you think you have been given too much Atropine injection

This medicine is given to you by your doctor so it is unlikely you will receive too much. Your doctor has information on how to recognise and treat an overdose. If you are concerned about your treatment, please talk to your doctor.

4.    Possible side effects

Like all medicines Atropine Injection can cause side effects, although not everybody gets them.

Possible side effects include:

•    excitement or delirium

•    dilated pupils

•    fast pulse

•    hot flush

•    dry skin, dry mouth, thirst

•    an irregular heart beat (arrhythmias)

•    difficulty passing urine

•    constipation.

Rare side effects include:

•    fever

•    a feeling of confusion

•    a rash.

If any of these side effects gets serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or nurse.

5.    Storing Atropine injection

Keep out of the reach and sight 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.    Further information

What Atropine 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 sulphuric acid to make a neutral solution.

What Atropine injection looks like and contents of the pack:

Atropine Injection is a clear, colourless solution supplied in glass ampoules each containing 1ml. The ampoules are supplied to your pharmacist or doctor in packs of 10.

The Marketing Authorisation Holder and Manufacturer:

Martindale Pharmaceuticals, Bampton Road, Harold Hill, Romford, RM3 8UG, UK

Product Licence Number:    01883/6122R

Date of last revision:    August 2013

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 AJU Pharmaceuticals fVi

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom

D02557

100mm Measurement Verification Bar