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ATROPINE SULFATE 0.5 MG/5 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): ATROPINE SULFATE

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102971 09/15

Package leaflet: Information for the user

ATROPINE SULFATE
0.5 mg/5 ml
solution for injection in pre-filled syringe
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, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.

The name of this medicinal product is ATROPINE SULFATE
0.5 mg/5 ml solution for injection in pre-filled syringe, but will be
referred as ATROPINE SULFATE throughout the whole leaflet.
What is in this leaflet:
1. What ATROPINE SULFATE is and what it is used for
2. What you need to know before you use ATROPINE SULFATE
3. How to use ATROPINE SULFATE
4. Possible side effects
5. How to store ATROPINE SULFATE
6. Contents of the pack and other information

1. What ATROPINE SULFATE is and what it is used for

Atropine belongs to a group of medicines known as anticholinergics.
An anticholinergic is a substance that blocks the neurotransmitter
acetylcholine in the central and peripheral nervous system. It is
used in emergency situations when the heart beats too slowly, as an
antidote to for example organophosphate insecticide or nerve gas
poisoning and in mushroom poisoning.
It can be used as part of the premedication before a general
anaesthesia. It can also be used to prevent side effects of other drugs
which are used to reverse the effects of muscle relaxants after surgery.
Atropine sulfate 0.5 mg/5 ml solution for injection in pre-filled
syringe is used to treat adults and children from birth with a body
weight superior to 3 kg.

2. What you need to know before you use ATROPINE
SULFATE
Do not use ATROPINE SULFATE if you:
• are allergic (hypersensitive) to atropine or any of the other
ingredients of this medicine (listed in section 6),
• have urinary difficulties,
• have elevated pressure in your eye (glaucoma),
• have oesophagus disease (achalasia of oesophagus), a blockage in
your intestine (paralytic ileus), or acute form of colonic distension
(toxic megacolon).
These contraindications do not apply in case of life-threatening
emergencies.
Warnings and precautions
Talk to your doctor before using ATROPINE SULFATE if you have:
• hyperthyroidism,
• prostatic disease,
• heart failure,
• liver or kidney disease,
• some cardiac diseases,
• stomach disease, such as pyloric narrowing,
• chronic bronchitis,
• fever,
• if you are a child or elderly,
• myasthenia gravis (severe muscle weakness),
• heartburn (reflux).
Other medicines and ATROPINE SULFATE
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines:
• tricyclic antidepressants,

• some antihistamines,
• medicines for Parkinson’s disease,
• phenothiazine, clozapine or neuroleptic drugs (for mental illness),
• quinidine or disopyramide (for heart disease),
• antispasmodic medications (for irritable bowel syndrome).
Pregnancy and breastfeeding
Pregnancy
Limited data from the use of atropine in pregnant women indicate
no adverse effects on pregnancy or on the health of the fetus.
Atropine crosses the placenta. Intravenous administration of
atropine during pregnancy or at term may cause a faster heart
rate in the fetus and the mother. This medicine should only be
administered during pregnancy after careful consideration of the
benefits and risks of the treatment.
Breast-feeding
Small amounts of atropine may pass into breast milk and may have
effects on the infant. Atropine may inhibit the production of breast
milk. Your doctor will consider the benefit of breast-feeding against
the benefit of the treatment. Breast-feeding should be discontinued
if the decision to use the treatment is maintained. However, if it is
decided during treatment to continue breast-feeding, your doctor will
perform extra examinations on the infant.
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 taking this medicine.
Driving and using machines
Atropine injection may cause confusion or blurred vision. You
should not drive or operate machinery after receiving an injection.
ATROPINE SULFATE contains sodium
This medicinal product contains less than 1 mmol of sodium
(17.7 mg) per syringe, i.e. essentially «sodium-free.»

3. How to use ATROPINE SULFATE

Your doctor will decide the correct dosage for you and how and
when the injection will be given.
The usual dosages are:
As premedication before anaesthesia
Intravenous (IV) administration immediately before surgery; if
necessary an intramuscular administration 30-60 minutes before
surgery is possible.
Adults: 0.3-0.6 mg IV.
Children: 0.01-0.02 mg/kg, dose adjusted according to patient’s
response and tolerance (maximum 0.6 mg per dose).
To reverse effects of muscle relaxants:
Adults: 0.6-1.2 mg IV with neostigmine.
Children: 0.02 mg/kg IV.
In low heartbeat, heart block or cardiac arrest:
Adults:
- Sinus bradycardia (low heartbeat): 0.5 mg IV, every 2-5 minutes
until the desired heart rate is achieved.
- AV block (Block the transmission of the contraction between the
atrium and the ventricle): 0.5 mg IV, every 3-5 minutes (maximum
3 mg).
Children: 0.02 mg/kg IV in a single dose (maximum dose 0.6 mg).
As an antidote to organophosphorus poisoning (insecticides, or
nerve gas), to anticholinesterases and in muscarinic mushroom
poisoning:
Adults: 0.5-2 mg IV, can be repeated after 5 minutes and
subsequently every 10-15 minutes as required.
Children: 0.02 mg/kg possibly repeated several times until signs and
symptoms disappear.
Other forms of this medicine may be more suitable where a dose
above 0.5 mg is required.
Use in children
Atropine is used to treat children from birth with a body weight
superior to 3 kg.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
This injection will be given to you by a doctor or nurse, it is unlikely
that you will be given too much atropine. If you think you have
been given too much atropine, you 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.

The following information is intended for healthcare professionals only:
The pre-filled syringe is for single patient only. Discard syringe after use. Do not reuse.
The content of un-opened and un-damaged blister is sterile, and must not be opened until used.
The product should be inspected visually for particles and discoloration prior to administration. Only clear colourless solution free from
particles or precipitates should be used.
The product should not be used if the tamper evident seal on syringe (plastic cover to the end cap) is broken.
The external surface of syringe is sterile until blister is opened.
1) Withdraw the pre-filled syringe from the sterile blister.
2) Push on the plunger to free
the bung.

3) Twist off the end cap to break
the seal.

N° projet : 15_042_09

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The side effects depend on the dose you are given and usually
disappear when the treatment is discontinued.
Rarely an allergic reaction may develop. This may cause skin rashes,
severe itching, peeling of the skin, swelling of the face (especially
around the lips and eyes), tightening of the throat and difficulty
breathing or swallowing, fever, dehydration, shock and fainting.
These are all very serious side effects. Tell your doctor immediately
if you experience any of these side effects. You may need urgent
medical attention.
Very common side effects (may affect more than 1 in 10 people)
• visual disturbances (widening of the pupils, difficulty focussing,
blurred vision, inability to tolerate light),
• reduced bronchial secretion,
• dry mouth (difficulty in swallowing and talking, feeling thirsty),
• constipation and heartburn (reflux),
• reduced secretion of gastric acid,
• loss of taste,
• nausea,
• vomiting,
• bloated feeling,
• lack of sweating,
• skin dryness,
• hives,
• rash.
Common side effects (may affect up to 1 in 10 people)
• excitement (especially with higher dosages),
• loss of coordination (especially with higher dosages),
• confusion (especially with higher dosages),
• hallucinations (especially with higher dosages),
• overheated body,
• certain heart conditions (rapid heart beat, irregular heart beat,
temporary further slowing down of heart beat),
• flushing,
• difficulty in passing urine.
Uncommon side effects (may affect up to 1 in 100 people)
• psychotic reactions.
Rare side effects (may affect up to 1 in 1,000 people)
• allergic reactions,
• fits (seizures),
• drowsiness.
Very rare side effects (may affect up to 1 in 10,000 people)
• severe hypersensitivity reaction,
• irregular heart beat, including ventricular fibrillation,
• chest pain,
• spike in blood pressure.
Not known (frequency cannot be estimated from the available data)
• headache,
• restlessness,
• unsteady walking and balance problems,
• sleeplessness.

This medicinal product does not require any special storage
conditions.
Do not use this medicine if you notice visible signs of deterioration.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What ATROPINE SULFATE contains
- The active substance is atropine sulfate:
Each ml of solution for injection contains 0.1 mg atropine sulfate
monohydrate, equivalent to 0.085 mg atropine.
Each 5 ml syringe contains 0.5 mg atropine sulfate monohydrate,
equivalent to 0.415 mg atropine.
- The other ingredients are:
Sodium chloride, concentrated hydrochloric acid (for pH
adjustment), water for injections.
What ATROPINE SULFATE looks like and contents of the pack.
This medicinal product is a clear and colourless solution for injection
in a sterile 5 ml polypropylene pre-filled syringe.
Boxes of 1, 5, 10, 12 and 20 syringes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Laboratoire AGUETTANT
1, rue Alexander Fleming
69007 LYON
France
Distributor
AGUETTANT LTD.
N°1 Farleigh House - Flax Bourton
BRISTOL BS48 1UR United Kingdom
This leaflet was last revised in 06/2015.
Detailed information on this medicinal product is available on the
web site of the Medicines and Healthcare Products Regulatory
Agency (MHRA).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the national reporting system:
United Kingdom
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 SULFATE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton, the syringe and blister. The expiry date refers to the last day
of that month.

4) Check the syringe seal (plastic
tip) has been completely
removed. If not, replace the cap
and twist again.

5) Expel the air by gently pushing
the plunger.

6) Connect the syringe to vascular access device or needle. Push the plunger to inject the required volume.
The needle gauge appropriate for use with the syringe are 23 to 20 gauge for IV administration and 23 to 21 gauge for IM administration.

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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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