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ATROPINE SULPHATE 600 MICROGRAMS/ ML SOLUTION FOR INJECTION

Active substance(s): ATROPINE SULPHATE

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Product:

Atropine Sulphate Injection BP

Country:

UK

Component:

PIL (Inhouse style mock-up)

Version:

3 (Req by Suresh Babu)

Originated :

14/4/2008

Size:

210 x 148mm

SKU No:

IAT002801/PL/B

Item Code:

N/A

Pharma Code:

N/A

Crease Code:

N/A

Origination by:

Poonam

Revision by:

Kaustubh

Revision date:

13/1/2011

Cols:

Black

Account handler: Freeda Louis

A/Work sign Off:
Final signatures:

Date:

BLACK

PATIENT INFORMATION LEAFLET

Atropine Sulphate Injection BP
500 micrograms in 1ml; 600 micrograms in 1ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Atropine Sulphate Injection is and what it is used for
2. Before you are given Atropine Sulphate Injection
3. How Atropine Sulphate Injection is given to you
4. Possible side effects
5. How to store Atropine Sulphate Injection
6. Further information
1. WHAT IS ATROPINE SULPHATE INJECTION AND WHAT IT IS USED FOR
Atropine Sulphate Injection belongs to a group of medicines called cholinesterase inhibitors. It has the effect
of reversing the action of certain muscle-relaxing drugs. The effects of atropine include an increase in heart
rate, a decrease in production of saliva, sweat, bronchial and intestinal secretions, and a decrease in the
movements of the intestine.
Atropine Sulphate Injection is used in the following conditions:
• During anaesthesia to dry up secretions in the mouth and chest and to keep heart beat normal
• In the treatment of poisoning caused by certain substances like pesticides
• To reverse the effects of certain drugs given during surgery to relax muscles
• To prevent slowing of the heartbeat during CPR (emergency procedure undertaken to revive the heart when
it has suddenly stopped)
• To reverse over activity of certain substances (cholinergic crises) in myasthenia gravis (a condition where
muscles become easily fatigued and weak due to defect in nerve-muscle stimulation).
2. BEFORE YOU ARE GIVEN ATROPINE SULPHATE INJECTION
You should not be given Atropine Sulphate Injection if:
• you know that you are allergic to Atropine Sulphate, other anticholinerigc drugs or any of the other ingredient
present in this injection (listed at the end of this leaflet)
• you have a blockage in your stomach, intestine or urinary passages such as bladder or kidneys
• you suffer from glaucoma (increased pressure in the eye)
• you suffer from enlargement of the prostate.
Make sure your doctor knows if you suffer from any of these.
Before you are given Atropine Sulphate Injection, you should tell your doctor if:
• you suffer from asthma or attacks of wheezing
• you have an abnormally fast heart beat due to an overactive thyroid gland, or to heart failure, or due to some
other cause
• you have a fever
• you are suffering from angina (a type of chest pain) or heart disease
• you are pregnant or breast feeding.
Tell your doctor if any of these apply to you.
Taking other medicines:
Please talk to your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without prescription
• Antihistamines (for allergy)
• Phenothiazine or butyrophenone drugs (for anxiety or for more serious mental illness, or to relieve feeling or
being sick)
• Tricyclic antidepressants (to relieve depression)

• Amantadine used to treat Parkinsonism (a disorder in the brain causing muscle stiffness and shaking), or
viral infections
• Anticholinesterase drugs (for myasthenia gravis)
• You are to receive ether (a general anaesthetic).
If you are taking anticholinesterase drugs such as neostigmine or pyridostigmine, they should be withdrawn,
if necessary for several days, before you are given atropine injection.
Pregnancy and breast-feeding
Atropine Sulphate Injection should only be given during pregnancy and breast feeding if your doctor
considers it essential.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This is unlikely to be applicable as you will not feel well enough to drive or use machinery. Consult your doctor
before considering such action.
3. HOW TO TAKE ATROPINE SULPHATE INJECTION
Atropine Sulphate Injection is administered by injection into a vein, into the muscle or into the tissue just
beneath the skin.
Your doctor will decide the correct dose for you, depending on your circumstances. Your dose may be
calculated according to your weight.
What to do if you have been given more Atropine Sulphate Injection than you should:
This is unlikely because the dose will be administered by a healthcare professional. An overdose may cause
difficulty in breathing, restlessness, hallucinations (seeing things that are not there) and occasionally
convulsions. If you suspect you have been given too much, you should tell the doctor immediately.
If you have any further questions on the use of this product ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines Atropine Sulphate can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden
wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially
affecting your whole body) should be reported to a doctor immediately.
The following side effects have also been reported but their frequency is not known:
• Dry mouth, difficulty in swallowing, dry skin, thirst, dilated pupils and difficulty in adjusting the vision for
various distances, inability to tolerate light, an increase in pressure within the eyes, palpitations, irregular
heartbeats, constipation and difficulty in passing water (urinating).
If any of these become serious, or you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE ATROPINE SULPHATE INJECTION
Keep out of the reach and sight of children.
Do not use after the expiry date printed on the label.
Do not store above 25˚C.
Keep in original container in order to protect from light.
If only part used, discard the remaining solution.
6. FURTHER INFORMATION
The active substance is Atropine Sulphate.
The other ingredients are dilute sulphuric acid and water for injections.
What Atropine Sulphate Injection looks like and contents of pack
Atropine Sulphate Injection is a clear, colourless sterile solution for injection.
Each glass ampoule (a small bottle) contains 1ml of solution which contains either 500 micrograms of Atropine
Sulphate, or 600 micrograms of Atropine Sulphate.
Each carton contains ten 1ml ampoules of Atropine Sulphate Injection.
Marketing Authorisation Holder
Antigen International Ltd., Roscrea, Co. Tipperary, Ireland.
Manufacturer
B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.
This leaflet was last revised in January, 2011.

IAT002801/PL/B

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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