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Atropine Sulphate Injection Bp

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Atropine Sulphate Injection BP 1 mg in 1 ml

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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 askyour 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.    Elow Atropine Injection is given t. 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 askyour 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 nformation from the brain to other parts of the body). This aelps to make the heart beat faster.

Atropine Injection is used to raise the heart rate if it has oecome too slow after a heart attack or as a result of taking oeta-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)

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 suffer from a muscle disorder known as myasthenia gravis

Take special care with Atropine Injection Tell your doctor if:

you have a fever

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)

you suffer from Down's syndrome you are suffering from diarrhoea you have had a heart attack or heart failure you have had heart surgery you are suffering from high blood pressure you are suffering from an overactive thyroid f you are elderly or if this medicine is being given to your child your doctor will take particular care, f any of the above applies to you, please tell your doctor. Taking other medicines

3lease 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 (SSRIs and tricyclic antidepressants) such as paroxetine medicines used to treat severe depression known as monoamine oxidase inhibitors (MAOIs) medicines used to treat schizophrenia and other mental disorders (buterophenones and phenothiazines) such as haloperidol and clozapine

medicines used in the treatment of Parkinson's disease such as amantidine and levodopa


Atropi

(Referred to as Atropin

ffulphate

njection in this leaflet)

•    medicines used to stabilise the heartbeat e.g. disopyramide, mexiletine and digoxin

•    nefopam, a pain killer

•    medicines used to treat fungal infections such as itraconazole and ketoconazole

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

•    medicines used to treat bacterial infections (antibiotics) such as erythromycin and clarithromycin

•    medicines used to treat HIV such as ritonavir and atazanavir

•    medicines used to treat high blood pressure (calcium channel blockers) such as verapamil

•    medicines used to treat feeling or being sick such as domperidone and metoclopramide

•    ciclosporin, a medicine used to prevent rejection after an organ transplant and to treat certain skin conditions

•    memantine, a medicine used to treat Alzheimer's disease

•    medicines used to treat the muscle disorder myasthenia gravis and to reverse the effects of an anaesthetic such as neostigmine, edrophonium chloride and pyridostigmine bromide

•    pilocarpine, a medicine used to treat raised pressure in the eye (glaucoma)

•    medicines used to treat difficulty passing urine such as bethanechol chloride and distigmine bromide

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.

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):

nfants

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 thinkyou 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.

Continued overleaf

4.    Possible side effects

_ike all medicines Atropine Injection can cause side effects, although not everybody gets them, f any of the following symptoms occur tell your doctor or lurse immediately. These are symptoms of a serious allergic eaction.

•    sudden wheeziness and tightness of chest

•    swelling of eyelids, face or lips

•    skin lumps or hives

•    skin rash (red spots), itchiness, fever

•    collapse

Other possible side effects include:

•    excitement or delirium

•    dilated pupils and sensitivity to light

•    blurred vision or difficulty focusing

•    hot flush

•    dry skin, dry mouth, thirst

•    difficulty passing urine

•    constipation

•    an unusually fast, slow or irregular heartbeat

•    a dry cough

•    an increased need to pass urine Rare side effects include:

•    fever

•    a feeling of confusion, particularly if you are elderly

•    a rash

•    feeling or being sick

•    feeling giddy

•    raised pressure in the eye (angle closure glaucoma).

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.    Storing Atropine Injection

<eep out of the reach and sight of children.

Tou should not be given this medicine if it has passed the expiry date shown on the ampoule label.The expiry date efers 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 Sulphate 0.1% w/v.

The other ingredients are sodium chloride and water for njections. 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: PL 1883/6172R

Date of last revision:    March 2009

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 AJL Pharmaceuticals fVi

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