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ATROPINE SULFATE INJECTION 600MCG IN 1ML

Active substance(s): ATROPINE SULPHATE

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Package leaflet: Information for the patient

hameln

Atropine Sulfate Injection
atropine sulfate

Important information about your medicine
Your doctor or nurse will give you the injection
► If this injection causes you any problems talk to your doctor, nurse or pharmacist
► Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine
► Please tell your doctor or pharmacist, if you are taking any other medicines


Read all of this leaflet carefully before you start using this medicine because it
contains important information for you. In some circumstances this may not be possible
and this leaflet will be kept in a safe place should you wish to read it.
• Keep this leaflet. You may need to read it again
• If you have any further questions, 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.

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

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

Other medicines and Atropine Sulfate
Injection:

Atropine Sulfate Injection belongs to a group of
medicines known as anticholinergics. It is used:

Tell your doctor, nurse or pharmacist if you are
taking, have recently taken or might take any
other medicines, including medicines obtained
without a prescription. This is especially important
with the following medicines as they may interact
with your Atropine Sulfate Injection:

• 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 Sulfate Injection
You should NOT be given Atropine
Sulfate Injection:
• if you are sensitive or allergic to Atropine
Sulfate or to any of the other ingredients (listed
in section 6) in this injection.
• if you suffer from closed-angle glaucoma (a
condition that affects your eyes).
• if you are a man with an enlarged prostate.
• if you suffer from myasthenia gravis
(weakness of breathing muscles).
• if you suffer from pyloric stenosis (a
narrowing of the opening that takes food away
from your stomach).
• if you suffer from paralytic ileus (your
intestine stops functioning properly).
• if 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 Sulfate Injection:
• if you have urinary difficulties
• if you have heart failure
• if you have had a heart attack
• if you have had a heart transplant
• if you have chronic pulmonary obstructive
disease (a condition where the airflow to your
lungs is restricted and you may cough and feel
breathless)
• if you have an overactive thyroid
• if you have high blood pressure
• if you have fever
• if you have diarrhoea
• if you have reflux oesophagitis (heartburn)

• medicines to treat psychosis or depression.
• amantadine (a medicine for Parkinson’s
Disease)
• antihistamines (medicines used to treat
hayfever and allergies
• medicines to regulate
your
heart
(disopyramide and 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
being given this medicine.

Driving and using machines:
You should not drive or use machinery if you are
affected by the administration of Atropine Sulfate
Injection.

3. How to use Atropine Sulfate Injection
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 are given more Atropine Sulfate
Injection than you should:
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
Like all medicines, Atropine Sulfate Injection
can cause side effects, although not everybody
gets them. The following side effects have been
reported:
• 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
• rashes
• confusion
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. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2
p.m. Mondays to Fridays) or fill in a paper form
available from your local pharmacy. By reporting
side effects you can help provide more information
on the safety of this medicine.

5. How to store Atropine Sulfate Injection
Keep this medicine out of the sight and reach of
children.
Your injection will be stored at less than 25°C and
protected from light.
Do not use this medicine after the expiry date
which is stated on the label and carton after “Exp.
date”. The expiry date refers to the last day of that
month.

6. Contents of the pack and other information
What Atropine Sulfate Injection contains:
The active ingredient is Atropine Sulfate.
Each 1 ml of solution contains 600 micrograms in
a sterile solution for injection.
The other ingredients are sulfuric acid and
water for injections.

What Atropine Sulfate Injection looks like
and contents of the pack:
Atropine Sulfate Injection is a supplied in 1 ml
clear glass ampoules. 10 ampoules are supplied
in each carton.
The marketing authorisation number of this
medicine is: PL 01502/0016R

Marketing Authorisation Holder:
hameln pharmaceuticals ltd
Gloucester
United Kingdom

Manufacturer:
hameln pharmaceuticals gmbh
Langes Feld 13, 31789 Hameln, Germany
hameln rds a.s.
Horná 36, 900 01 Modra, Slovak Republic
HBM Pharma s.r.o.
03680 Martin, Sklabinská, Slovak Republic

For
any
information
about
this
medicine, please contact the Marketing
Authorisation Holder
This leaflet was last revised in December 2014
44171/52/14

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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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