PACKAGE LEAFLET: INFORMATION FOR THE USER

Atropine Injection BP 600 Micrograms in 1 ml (Pre-filled-Syringe)

Atropine Sulphate

(Referred to as Atropine Injection in this leaflet)

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

6.    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 antimuscarinics. 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.

Atropine is also used to reduce fluid in the lungs during general anaesthesia and to reverse paralysis after an operation when used with another medicine called neostigmine.

2.    Before having Atropine Injection

You should not be given Atropine Injection if:

•    you are allergic (hypersensitive) to Atropine Sulphate or to any of the other ingredients of the injection listed in section 6 of this leaflet

•    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)

•    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 mucous in the faeces

•    you have a muscle weakening disease known as myasthenia gravis. Take special care with Atropine Injection

Tell your doctor if:

•    you have a fever or the weather is hot

•    you have diarrhoea

•    you have problems passing urine

•    you have thyroid problems

•    you have a heart disorder or high blood pressure

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

•    you have Down's Syndrome

•    you have lung disease.

Special care should be taken in children and the elderly.

If 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 recently 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) e.g. clomipramine, amitriptyline or amoxapine

•    medicines used to treat severe depression known as monoamine oxidase inhibitors (MAOIs)

•    medicines used to treat schizophrenia and other mental disorders, as well as sickness e.g. haloperidol, chlorpromazine and domperidone

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

•    medicines used to stabilise the heart beat e.g. disopyramide and mexiletine

•    nefopam, a pain killer

•    ketoconazole, a medicine used to treat fungal infections

•    medicines that are designed to be placed under the tongue e.g. sublingual nitrates.

Pregnancy and breast-feeding

This medicine should be avoided if you are pregnant, trying to become pregnant or breast-feeding, unless your doctor has recommended it.

Driving and using machines

Atropine Injection may affect your vision and cause drowsiness. If you feel drowsy or your vision is blurred you should not drive or use machinery.

Continued overleaf

3.    How Atropine Injection is given

This medicine is an injection that 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:

As a treatment to increase a dangerously slow heart beat or to restart the heart:

•    1-2mg into a vein, muscle or under the skin.

As a treatment to increase heart rate due to a heart attack:

•    300 - 600 micrograms into a vein, followed by further doses of 100 micrograms if necessary up to a maximum of 1mg.

For reducing fluid in the lungs during an operation:

•    300 - 600 micrograms under the skin or into a muscle 30 - 60 minutes before the anaesthetic

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

For reversing paralysis after an operation:

•    0.6 - 1.2mg by slow injection into a vein.

Elderly:

•    reduced doses may be given.

Children (age over 1 year):

For drying fluids during an operation:

•    20 micrograms per kilogram of body weight

•    Injected into a muscle 30 - 60 minutes before the anaesthetic

•    You doctor will reduce the dose if you have a fever or if the weather is hot.

If you think you have been given too much Atropine Injection

This medicine is given to you by your doctor so it is unlikely that 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.

Side effects that may occur include:

•    dilated pupils and sensitivity to light

•    fast pulse

•    hot flush

•    dry skin, dry mouth, thirst

•    difficulty swallowing or talking

•    an irregular heart beat (arrhythmias)

•    difficulty passing urine or a need to pass urine more often than usual

•    constipation

•    an allergic reaction causing a red or itchy rash.

Rare side effects include:

•    fever

•    a feeling of confusion

•    feeling or being sick

•    dizziness

•    heartburn

•    raised pressure in the eyes.

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

5.    How to store Atropine Injection

Keep out of the reach and sight of children Do not use Atropine Injection after the expiry date which is stated 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.

Store below 25°C. Keep container in the outer carton.

6.    Further Information

What Atropine Injection contains:

The active ingredient is Atropine Sulphate 0.06% w/v.

The other ingredients are water for injections, sulphuric acid and nitrogen.

What Atropine Injection looks like and contents of the pack:

Atropine Injection is a clear, colourless solution supplied in 1ml pre-filled syringes.

The Marketing Authorisation Holder:

Aurum Pharmaceuticals, Bampton Road, Harold Hill, Romford,

RM3 8UG, United Kingdom.

Manufacturer:

Martindale Pharmaceuticals Ltd, Bampton Road, Romford, RM3 8UG, United Kingdom.

Product Licence Number: PL 12064/0040 Date of revision: September 2009

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

Aurum

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