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ATROPINE SULFATE INJECTION 600MCG IN 1 ML

Active substance(s): ATROPINE SULFATE / ATROPINE SULFATE / ATROPINE SULFATE

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D03310

Atropine Sulfate 600 micrograms in 1ml Solution
for Injection Pre-filled Syringe
Atropine Sulfate
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor,
pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

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.
If you think you have been given too much Atropine Solution
for injection than you should be given:
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 think you 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

What is in this leaflet
1. What Atropine Solution for injection is and what it is used for
2. What you need to know before you are given Atropine Solution
for injection
3. How Atropine Solution for injection is given
4. Possible side effects
5. How to store Atropine Solution for injection
6. Contents of the pack and other information

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 sensitive or 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
Talk to 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 pulmonary obstructive 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, or have recently
taken, 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 allergies)
• medicines used to regulate your heart (disopyramide or
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, ask your 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.
Continued overleaf

Like all medicines Atropine Solution for injection 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
If you think this injection is causing you any problems, or you are at
all worried, talk to your doctor, nurse or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse:
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme - website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Atropine Solution for injection
Keep out of the sight and reach of children
Do not use Atropine Solution for 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 packaging.

6. Contents of the pack and other Information
What Atropine Solution for injection contains:
The active ingredient is Atropine Sulfate 0.06% w/v.
The other ingredients are water for injections, sulfuric acid and
nitrogen.
What Atropine Solution for injection looks like and contents of
the pack:
Atropine Solution for injection is a clear, colourless solution supplied in
1ml pre-filled syringes.
The Marketing Authorisation Holder:
Aurum Pharmaceuticals Ltd., T/A Martindale Pharma, 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
This leaflet last revised in: December 2016
If you would like more information, or would like the leaflet in a
different format, please contact Medical Information at the above
address.

D03310

Package leaflet: Information for the User

3310-F

100mm Measurement Verification Bar

DEVELOPMENT ARTWORK
D03310
PIL ATROPINE SULFATE INJ 600
MCG/ML 1ML PFS
100 x 310 mm

18/04/16

BM

25/04/16

BM

28/07/16

ME

29/07/16

ME

16/08/16

BM

13/12/16

BM

Expand Transcript

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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