Skip to Content

ATROPINE SULFATE 3 MG/10 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

xxxxxx MM/17

Package leaflet: Information for the user

Atropine sulfate 3 mg/10 ml
Solution for injection in pre-filled syringe
(Referred to as Atropine sulfate Injection in this leaflet)

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. 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.
In this leaflet:
1. What Atropine sulfate Injection is and what it is used for
2. Before you use Atropine sulfate Injection
3. How to use Atropine sulfate Injection
4. Possible side effects
5. How to store Atropine sulfate Injection
6. Further information
1. WHAT ATROPINE SULFATE INJECTION 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 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 3 mg/10 ml solution for injection in pre-filled syringe is
used to treat adults only.
2. BEFORE YOU USE ATROPINE SULFATE INJECTION
Do not use Atropine sulfate Injection if you:
- are allergic (hypersensitive) to atropine or any of the other ingredients of
this medicine (See section 6. Further information),
- have elevated pressure in your eye (glaucoma),
- have urinary difficulties,
- 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 Injection if you have:
- prostatic disease,
- hyperthyroidism,
- heart failure,
- liver or kidney disease,
- some cardiac diseases,
- stomach disease, such as pyloric narrowing,
- chronic bronchitis,
- heartburn (reflux),
- fever,
- elderly,
- myasthenia gravis (severe muscle weakness).
Using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken or
might take any other medicines:
- tricyclic some antidepressants,
- some antihistamines,
- medicines for Parkinson’s disease,
- phenothiazine, clozapine or neuroleptic drugs (for mental illness),

- quinidine or disopyramide (for heart disease),
- antispasmodics medications (for irritable bowel syndrome).
Pregnancy and breast-feeding
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 Injection contains sodium
This medicinal product contains 3.5 mg (0.154 mmol) of sodium per ml of
injection (a total of 35 mg or 1.540 mmol in 10 ml syringe). This amount
must be taken into consideration by patients on a controlled sodium diet.
3. HOW TO USE ATROPINE SULFATE INJECTION
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
Adults: 0.3-0.6 mg (IV).
To reverse effects of muscle relaxants
Adults: 0.6-1.2 mg intravenously (IV) with neostigmine.
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).
As an antidote to organophosphorus poisoning (insecticides, or nerve gas),
to anticholinesterases and in muscarinic mushroom poisoning:
Adults: 0,5-2 mg depending on the patient’s features and response, can be
repeated after 5 minutes and subsequently as required.
If you have any further questions on the use of this product, 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

The following information is intended for healthcare professionals only
Instructions for use:
Please prepare the syringe carefully as follows
The pre-filled syringe is for single patient only. Discard syringe after use. DO NOT REUSE.
The content of unopened and undamaged blister is sterile, and must not be opened until use.
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.

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.
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.

Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What Atropine sulfate Injection contains:
- The active substance is atropine sulfate:
Each ml of solution for injection contains 0.3 mg atropine sulfate
monohydrate, equivalent to 0.17 mg atropine.
Each 10 ml syringe contains 3 mg atropine sulfate monohydrate, equivalent
to 0.83 mg atropine.
- The other ingredients are: sodium chloride, concentrated hydrochloric acid
(for pH-adjustment), water for injections.
What Atropine sulfate Injection looks like and contents of the pack:
This medicinal product is a clear and colourless solution for injection in a
sterile 10 ml polypropylene pre-filled syringe.
Boxes of 1, 5, 10, 12, 20, 25, 50 or 100 syringes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 LYON - France
Distributed by:
AGUETTANT LTD
N°1, Farleigh House - Flax Bourton
BRISTOL - BS48 1UR - United Kingdom
This leaflet was last revised in 06/2017.
Detailed information on this medicinal product is available on the website of
Medicines and Healthcare Products Regulatory Agency (MHRA).

5. HOW TO STORE ATROPINE SULFATE INJECTION
Keep out of the reach and sight of children.
Do not use Atropine sulfate Injection 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.
This medicinal product does not require any special storage conditions.
Do not use Atropine sulfate Injection if you notice visible signs of
deterioration.

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

5) Expel the air by gently pushing the plunger.

6) Connect syringe to vascular access device or to needle. Push the plunger to inject the required volume.
The needle gauges appropriate for use with the syringe are 23 to 20 gauges for IV administration.
Any unused product or waste material should be disposed of in accordance with local requirements.

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.

Hide