Package leaflet: Information for the user • stomach disease, such as pyloric narrowing,

• chronic bronchitis,
ATROPINE SULFATE • fever,
• myasthenia gravis (severe muscle weakness),
1 mg/5 ml • heartburn (reflux),
Solution for injection in pre-filled syringe • Or if you are elderly.
Read all of this leaflet carefully before you start using this Other medicines and ATROPINE SULFATE
102905 XX/16

medicine because it contains important information for you. Tell your doctor or pharmacist if you are taking, have recently taken or
• Keep this leaflet. You may need to read it again. might take any other medicines:
• If you have any further questions, ask your doctor or pharmacist. • tricyclic antidepressants,
• This medicine has been prescribed for you only. Do not pass it on • some antihistamines,
to others. It may harm them, even if their signs of illness are the • medicines for Parkinson’s disease,
same as yours. • phenothiazine, clozapine or neuroleptic drugs (for mental illness),
• If you get any side effects, talk to your doctor or pharmacist. • quinidine or disopyramide (for heart disease),
This includes any possible side effects not listed in this leaflet. • antispasmodic medications (for irritable bowel syndrome).
See section 4. Pregnancy and breast-feeding
The name of this medicinal product is Atropine sulfate 1 mg/5 ml Pregnancy
solution for injection in pre-filled syringe, but will be referred as Limited data from the use of atropine in pregnant women indicate no
ATROPINE SULFATE throughout the whole leaflet. adverse effects on pregnancy or on the health of the fetus. Atropine
crosses the placenta. Intravenous administration of atropine during
What is in this leaflet: pregnancy or at term may cause a faster heart rate in the fetus
1. What ATROPINE SULFATE is and what it is used for and the mother. This medicine should only be administered during
2. What you need to know before you use ATROPINE SULFATE pregnancy after careful consideration of the benefits and risks of the
3. How to use ATROPINE SULFATE treatment.
4. Possible side effects
5. How to store ATROPINE SULFATE Breast-feeding
6. Contents of the pack and other information Small amounts of atropine may pass into breast milk and may have
effects on the infant. Atropine may inhibit the production of breast
1. What ATROPINE SULFATE is and what it is used for milk. Your doctor will consider the benefit of breast-feeding against
Atropine belongs to a group of medicines known as anticholinergics. the benefit of the treatment. Breast-feeding should be discontinued
An anticholinergic is a substance that blocks the neurotransmitter if the decision to use the treatment is maintained. However, if it is
acetylcholine in the central and peripheral nervous system. decided during treatment to continue breast-feeding, your doctor will
It is used in emergency situations when the heart beats too slowly, perform extra examinations on the infant.
as an antidote to for example organophosphate insecticide or nerve If you are pregnant or breast-feeding, think you may be pregnant or
gas poisoning and in mushroom poisoning. It can be used as part of are planning to have a baby, ask your doctor or pharmacist for advice
the premedication before general anaesthesia. It can also be used before taking this medicine.
to prevent side effects of other drugs which are used to reverse the Driving and using machines
effects of muscle relaxants after surgery. Atropine injection may cause confusion or blurred vision. You should
ATROPINE SULFATE 1 mg/5 ml solution for injection in pre-filled not drive or operate machinery after receiving an injection.
syringe is used to treat adults only.
ATROPINE SULFATE contains sodium
2. What you need to know before you use ATROPINE This medicinal product contains less than 1 mmol sodium (23 mg) per
SULFATE syringe, i.e. essentially «sodium-free.»
Do not use ATROPINE SULFATE if you: 3. How to use ATROPINE SULFATE
• are allergic (hypersensitive) to atropine or any of the other
ingredients of this medicine (listed in section 6) Your doctor will decide the correct dosage for you and how and when
• have urinary difficulties, the injection will be given.
• have elevated pressure in your eye (glaucoma), The usual dosages are:
• have oesophagus disease (achalasia of oesophagus), a blockage As premedication before anaesthesia
in your intestine (paralytic ileus), or acute form of colonic distension Adults: 0.3-0.6 mg IV just before induction of anaesthesia or 0.3-0.6 mg IM,
(toxic megacolon). 30 to 60 minutes before the anaesthesia.
These contraindications do not apply in case of life-threatening To reverse effects of muscle relaxants
emergencies. Adults: 0.6-1.2 mg intravenously (IV) with neostigmine.
Warnings and precautions In low heartbeat, heart block or cardiac arrest
Talk to your doctor before using ATROPINE SULFATE if you have: Adults:
• hyperthyroidism, • Sinus bradycardia (low heartbeat): 0.5 mg IV, every 2-5 minutes
• prostatic disease, until the desired heart rate is achieved.
• heart failure, • AV block (Block the transmission of the contraction between the
• liver or kidney disease, atrium and the ventricle): 0.5 mg IV, every 3-5 minutes (maximum
• some cardiac diseases, 3 mg)

AGUETTANT SYSTEM®
The following information is intended for healthcare professionals only:
ATROPINE SULFATE 1 mg/5 ml, solution for injection in pre-filled syringe
Safety information:
Atropine must be used solely by or under the supervision of the anaesthetist.
For injection use.
Incompatibilities:
This medicinal product must not be mixed with other medicinal products.
Administration:
Adults
Pre-anaesthetic medication
Intravenous administration immediately before surgery; if necessary an intramuscular administration 30-60 minutes before surgery is possible.
0.3 – 0.6 mg IV (1.5 – 3 ml)
In association with neostigmine to limit its muscarinic effects:
0.6-1.2 mg IV (3 to 6 ml)
Treatment of haemodynamically compromising bradycardia, atrioventricular block, cardiopulmonary resuscitation:
Sinus bradycardia: 0.5 mg IV (2.5 ml), every 2-5 minutes until the desired heart rate is achieved.
AV block: 0.5 mg IV (2.5 ml), every 3-5 minutes (maximum 3 mg)
As an antidote to organophosphates (pesticides, nerve gases), to cholinesterase inhibitors and in muscarinic mushroom poisoning:
Intravenous use.
0.5 - 2 mg atropine sulfate (2.5 - 10 ml), can be repeated after 5 minutes and subsequently every 10-15 minutes as required, until signs and
symptoms disappear (this dose may be exceeded many times).
Dose adjustments
In general, dosage should be adjusted according to patient’s response and tolerance.
Dosage to a total maximum dose of 3 mg in adults is usually increased until adverse effects become intolerable; then a slight reduction in
dosage generally yields the maximum dosage tolerated by the patient.
Caution is advised for patients with renal or hepatic impairment and in elderly.
The pre-filled syringe is not adapted to the administration in paediatric population; the graduation does not permit accurate measurement.
Overdose
Symptoms:
Flushing and dryness of the skin, dilated pupils with photophobia, dry mouth and tongue accompanied by a burning sensation, difficulty in
swallowing, tachycardia, rapid respiration, hyperpyrexia, nausea, vomiting, hypertension, rash and excitement. Symptoms of CNS stimulation
include restlessness, confusion, hallucinations, paranoid and psychotic reactions, incoordination, delirium and occasionally convulsions.
In severe overdose, drowsiness, stupor and CNS depression may occur with coma, circulatory and respiratory failure and death.
Treatment:
Treatment should be supportive. An adequate airway should be maintained. Diazepam may be administered to control excitement and
convulsions but the risk of CNS depression should be considered.

AGUETTANT SYSTEM®
As an antidote to organophosphorus poisoning (insecticides, or nerve • chest pain,
gas), to anticholinesterases and in muscarinic mushroom poisoning: • spike in blood pressure.
Adults: 0.5-2 mg depending on the patient’s features and response, Not known (frequency cannot be estimated from the available data)
can be repeated after 5 minutes and subsequently as required. • headache,
If you have any further questions on the use of this medicine, ask • restlessness,
your doctor or pharmacist. • unsteady walking and balance problems,
This injection will be given to you by a doctor or nurse, it is unlikely • sleeplessness.
that you will be given too much atropine. If you think you have been Reporting of side effects
given too much atropine, you feel your heart beating very fast, If you get any side effects, talk to your doctor or pharmacist. This
you are breathing quickly, have a high temperature, feel restless, includes any possible side effects not listed in this leaflet. You can
confused, have hallucinations, or lose co-ordination you must tell the also report side effects directly via the national reporting system:
person giving you the injection.
United Kingdom
4. Possible side effects Yellow Card Scheme
Like all medicines, this medicine can cause side effects, although not Website: www.mhra.gov.uk/yellowcard
everybody gets them. By reporting side effects, you can help provide more information on
The side effects depend on the dose you are given and usually the safety of this medicine.
disappear when the treatment is discontinued. 5. How to store ATROPINE SULFATE
Rarely an allergic reaction may develop. This may cause skin rashes,
severe itching, peeling of the skin, swelling of the face (especially Keep this medicine out of the sight and reach of children.
around the lips and eyes), tightening of the throat and difficulty Do not use this medicine after the expiry date which is stated on the
breathing or swallowing, fever, dehydration, shock and fainting. These carton, the syringe and blister. The expiry date refers to the last day
are all very serious side effects. Tell your doctor immediately if you of that month.
experience any of these side effects. You may need urgent medical This medicinal product does not require any special storage
attention. conditions.
Do not use this medicine if you notice visible signs of deterioration.
Very common side effects (may affect more than 1 in 10 people) Do not throw away any medicines via wastewater or household
• v isual disturbances (widening of the pupils, difficulty focussing, waste. Ask your pharmacist how to throw away medicines you no
blurred vision, inability to tolerate light), longer use. These measures will help protect the environment.
• reduced bronchial secretion,
• dry mouth (difficulty in swallowing and talking, feeling thirsty), 6. Contents of the pack and other information
• constipation and heartburn (reflux), What ATROPINE SULFATE contains
• reduced secretion of gastric acid, - The active substance is atropine sulfate:
• loss of taste, Each ml of solution for injection contains 0.2 mg atropine sulfate
• nausea, monohydrate, equivalent to 0.17 mg atropine
• vomiting, Each 5 ml syringe contains 1 mg atropine sulfate monohydrate,
• bloated feeling, equivalent to 0.83 mg atropine.,
• lack of sweating,
• skin dryness, - The other ingredients are: sodium chloride, concentrated
• hives, hydrochloric acid (for pH adjustment), water for injections.
• rash. What ATROPINE SULFATE looks like and contents of the
Common side effects (may affect up to 1 in 10 people) pack.
• excitement (especially with higher dosages), This medicinal product is a clear and colourless solution for injection
• loss of coordination (especially with higher dosages), in a sterile 5 ml polypropylene pre-filled syringe.
• confusion (especially with higher dosages), Boxes of 1, 5, 10, 12 and 20 syringes.
• hallucinations (especially with higher dosages), Not all pack sizes may be marketed.
• overheated body, Marketing Authorisation Holder and Manufacturer
• c ertain heart conditions (rapid heart beat, irregular heart beat,
temporary further slowing down of heart beat), Laboratoire AGUETTANT
• flushing, 1, rue Alexander Fleming
• difficulty in passing urine. 69007 LYON
Uncommon side effects (may affect up to 1 in 100 people) France
• psychotic reactions. DISTRIBUTOR
Rare side effects (may affect up to 1 in 1,000 people) AGUETTANT LTD. N°1, Farleigh House
• allergic reactions, Flax Bourton - Bristol BS48 1UR UNITED KINGDOM
• fits (seizures), This leaflet was last revised in 05/2016.
• drowsiness.
Detailed information on this medicinal product is available on the
Very rare side effects (may affect up to 1 in 10,000 people) web site of Medicines and Healthcare Products Regulatory Agency
• severe hypersensitivity reaction, (MHRA).
• irregular heart beat, including ventricular fibrillation,

AGUETTANT SYSTEM®
Instructions for use:

Be careful to strictly respect the protocol for the use of the syringe.

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 use.
The product should be inspected visually for particles and discolouration 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.

‚ „ 4) Check the syringe seal (plastic cover to

the end cap and seal under end cap) has
been completely removed. If not, replace
2) Push on the plunger to free the bung. the cap and twist again.

ƒ …

3) Twist off the end cap to break the seals. 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.
Any unused product or waste material should be disposed of in accordance with local requirements.

Storage and Shelf life:

This medicinal product does not require any special storage conditions
Unopened blister pack: 3 years

AGUETTANT SYSTEM®