Atropine sulfate Bioindustria L.I.M.

Package leaflet: Information for the user

ATROPINE SULPHATE BIOINDUSTRIA L.I.M. 0.5 mg/ml solution for injection, 1 mg/ml solution for injection

Equivalent medicine
Please read all of this leaflet carefully before you use this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms
are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor,
pharmacist or nurse. See section 4.
Contents of this leaflet:
What ATROPINE SULPHATE BIOINDUSTRIA L.I.M. is and what it is used for
What you need to know before using ATROPINE SULPHATE BIOINDUSTRIA L.I.M.
How to use ATROPINE SULPHATE BIOINDUSTRIA L.I.M.
Possible side effects
How to store ATROPINE SULPHATE BIOINDUSTRIA L.I.M.
Contents of the pack and other information
What ATROPINE SULPHATE BIOINDUSTRIA L.I.M. is and what it is used for
ATROPINE SULPHATE BIOINDUSTRIA L.I.M. contains the active substance atropine sulphate, which belongs to
a group of medicines that work by blocking the action of acetylcholine on the nervous system. This
medicine is used as pre-anaesthetic medication to reduce saliva production and bronchial
secretions.
It is also used to treat slow heart rate (sinus bradycardia), especially when associated with low
blood pressure (hypotension). It is further used in emergency situations as an antidote in poisoning by
insecticides (organophosphates), to counteract slowing of the heartbeat.
What you need to know before using ATROPINE SULPHATE BIOINDUSTRIA L.I.M.
Do not use ATROPINE SULPHATE BIOINDUSTRIA L.I.M.
if you are allergic to atropine sulphate or to any of the other ingredients of this medicine (listed in
section 6);
if you have high pressure in the eyes (closed-angle glaucoma);
if you suffer from gastro-oesophageal reflux;
if you have narrowing of the stomach or intestine (pyloric stenosis, gastrointestinal obstruction);
if you suffer from chronic inflammatory bowel disease (ulcerative colitis);
if you have an enlarged prostate (prostatic hypertrophy);
if your intestine is not functioning properly (paralytic ileus, intestinal atony);
if you suffer from a neuromuscular disease characterised by muscle weakness (myasthenia
gravis) (except when you are simultaneously administered a medicine called anticholinesterase).
In emergency situations where your life may be at risk (e.g. in case of severe heart problems such as
bradyarrhythmia or poisoning), healthcare professionals may administer this medicine to you even if
you have one of the conditions listed above.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using ATROPINE SULPHATE BIOINDUSTRIA L.I.M.
Inform your doctor and use this medicine with caution in the following cases:
if you have Down's syndrome;
if you have undergone intestinal surgery such as ileostomy or colostomy, or if you experience episodes of
diarrhoea which may indicate intestinal obstruction;
if your thyroid gland produces high levels of hormones (hyperthyroidism);
if you have severe kidney or liver problems (renal or hepatic insufficiency);
if you have heart circulation problems (coronary disorders, acute myocardial ischaemia, acute
myocardial infarction). In case of ischaemia or infarction, this medicine may worsen your condition;
if you suffer from irregular heart rate (tachycardia, tachyarrhythmia);
if you have urinary tract problems (obstructive uropathies; urinary retention);
if you suffer from a disease affecting the bronchi (chronic obstructive bronchopulmonary disease);
if you have a fever or are exposed to high ambient temperature;
if you have undergone heart transplantation. This medicine may cause serious heart problems in such
cases.
Doses of this medicine higher than 1 mg may cause mental disturbances and central nervous system
side effects, especially in children and elderly patients (see sections “Children” and “Elderly”).
Children
This medicine must be administered with caution in children. A lower dosage than that recommended for
adults is required in children.
Elderly
This medicine must be administered with caution in the elderly. Dose adjustment may be useful in the
elderly to reduce the risk of cardiac and central nervous system side effects.
Other medicines and ATROPINE SULPHATE BIOINDUSTRIA L.I.M.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
medicine.
In particular, ATROPINE SULPHATE BIOINDUSTRIA L.I.M. must not be administered if you are taking the
following medicines:

• other anticholinergic medicines such as belladonna derivatives, because the effect of the medicine may be increased;
• halothane, a medicine used in anaesthesia, because it may reduce the effect of the medicine on heart rate (depression of heart rate);
• procainamide, used to regulate heartbeats, because it may increase the effects of the medicine on the heart (atrioventricular conduction);
• methacholine, an acetylcholine analogue used in asthma diagnosis, because its effects are inhibited. This medicine must not be mixed with alkalis.

This medicine should be administered with caution if you are taking any of the following
medicines, as they may increase the side effects of atropine (urinary retention, constipation, dry mouth):
tricyclic antidepressants, medicines used for depression;
H1 antihistamines and mequitazine, medicines used for allergies;
medicines for the treatment of Parkinson's disease;
disopyramide and quinidine, medicines used for heart problems;
phenothiazines, neuroleptic medicines and clozapine, medicines used for mental disorders;
antispasmodic anticholinergics, medicines that relax smooth muscle.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine. This medicine should not be administered
to you if you are pregnant. ATROPINE SULPHATE BIOINDUSTRIA L.I.M. may be used only in cases of absolute
necessity during pregnancy.
If you are breastfeeding, your doctor may advise you to stop breastfeeding or stop treatment with this
medicine. If you decide to continue breastfeeding during treatment with atropine, your doctor must monitor
your baby.
Driving and using machines
This medicine may affect your ability to drive or use machinery.
ATROPINE SULPHATE BIOINDUSTRIA L.I.M. contains sodium metabisulphite
Rarely, it may cause severe hypersensitivity reactions and bronchospasm.
How to use ATROPINE SULPHATE BIOINDUSTRIA L.I.M.
Use this medicine exactly as your doctor or pharmacist has told you. If you are in doubt, consult your
doctor or pharmacist.
ATROPINE SULPHATE BIOINDUSTRIA L.I.M. will be administered by a doctor or other healthcare professional
intravenously (into a vein), intramuscularly (into a muscle) or subcutaneously (under the skin), depending
on your needs.
Pre-anaesthetic medication:
The recommended dose is 0.3–0.6 mg by intravenous injection immediately before induction of anaesthesia
or by subcutaneous or intramuscular injection 30–60 minutes before anaesthesia.
Treatment of sinus bradycardia:
The recommended dose is between 0.3 and 1.0 mg intravenously.
Antidote in organophosphate poisoning:
The recommended dose is 2 mg by intramuscular or intravenous route depending on the severity of
poisoning, repeated every 5–10 minutes until the skin becomes flushed and dry, pupils dilate and an
increase in heart rate (tachycardia) occurs.
Use in children and adolescents
The recommended dose for pre-anaesthetic medication is 0.02 mg per kg of body weight (maximum dose 0.6 mg).
The recommended dose for treatment of organophosphate poisoning is 0.02 mg per kg of body weight.
If you use more ATROPINE SULPHATE BIOINDUSTRIA L.I.M. than you should
This medicine will be administered by a doctor or nurse; it is unlikely that an overdose will be given.
However, if you think you have been given an excessive dose of atropine and experience symptoms such as:
dryness of mucous membranes, pupil dilation, increased heart rate, fever and skin irritation, or if you feel
restless, confused, disoriented or have hallucinations, inform your doctor or nurse immediately, who will
take appropriate measures.
These symptoms may last for more than 48 hours. In some cases, severe effects such as respiratory
arrest, coma, severe drop in blood pressure (circulatory collapse) and death may occur.
If you have any doubts about the use of this medicine, contact your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Not known (frequency cannot be estimated from available data)
changes in growth hormone levels;
porphyria, a rare blood disorder;
increase or decrease in body temperature (hyperthermia or hypothermia);
drowsiness (sedation), disorientation and dizziness;
short-term memory disturbances;
mental disorders (psychosis);
hallucinations;
seizures;
headache;
double vision (diplopia) and visual disturbances (accommodation disorders);
pupil dilation (mydriasis);
changes in intraocular pressure;
heart circulation problems (angina, atrioventricular block);
changes in heart rate (arrhythmias);
decrease in heart rate (transient bradycardia) followed by an increase in heart rate (tachycardia, palpitations and arrhythmias);
hot flushes;
increase in blood pressure (hypertension);
reduction of bronchial secretions;
gastro-oesophageal reflux, dry mouth, difficulty swallowing and speaking, nausea, vomiting, bloating sensation, stomach problems (inhibition of gastric secretion);
skin redness and dryness, skin reactions such as urticaria and rashes;
reduced sweating;
bladder problems (inhibition of parasympathetic control of the urinary bladder) and urinary retention;
allergic reactions, even severe (anaphylactic) ones.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the Italian Medicines Agency - Website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.
How to store ATROPINE SULPHATE BIOINDUSTRIA L.I.M.
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 packaging after “Expiry”.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
No special storage conditions related to temperature are required.
The medicine must be used immediately after opening; any remaining solution must be discarded. The solution must be clear, colourless and free from visible particles. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Contents of the pack and other information What ATROPINE SULPHATE BIOINDUSTRIA L.I.M. contains
ATROPINE SULPHATE BIOINDUSTRIA L.I.M. 0.5 mg/ml solution for injection
The active substance is atropine sulphate. 1 ml of solution contains 0.5 mg of atropine sulphate monohydrate,
equivalent to 0.21 mg of atropine base.
The other components (excipients) are: Sulphuric acid, water for injections.
ATROPINE SULPHATE BIOINDUSTRIA L.I.M. 1 mg/ml solution for injection
The active substance is atropine sulphate. 1 ml of solution contains 1 mg of atropine sulphate monohydrate,
equivalent to 0.42 mg of atropine base.
The other components (excipients) are: Sulphuric acid, water for injections.
Description of the appearance of ATROPINE SULPHATE BIOINDUSTRIA L.I.M. and contents of the pack
Solution for injection
Pack of 5 or 10 vials of 1 ml of atropine sulphate 0.5 mg/ml
Pack of 5 or 10 vials of 1 ml of atropine sulphate 1 mg/ml
Marketing Authorisation Holder and Manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL) - Italy

The following information is intended exclusively for doctors and healthcare professionals:
OVERDOSE
At the first signs, in case of respiratory depression, oxygen administration is recommended. If seizures persist and circulatory conditions allow, intravenous administration of short-acting barbiturates (e.g. thiopental) or benzodiazepines (e.g. diazepam) should be considered.
Since atropine is eliminated via the kidneys, intravenous fluid administration is recommended. In cases of delirium and coma, intravenous infusion of physostigmine is recommended, slowly administered at a dose of 1 to 4 mg (0.5–1 mg in children).