Atropine sulfate Galenica Senese

Package leaflet: Information for the user

ATROPINE SULPHATE GALENICA SENESE 0.5 mg/ml injection solution, 1 mg/ml injection solution

Equivalence medicine
Please read all of this leaflet carefully before you start using this medicine, as 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, as it may 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:

1. What ATROPINE SULPHATE GALENICA SENESE is and what it is used for
2. What you need to know before using ATROPINE SULPHATE GALENICA SENESE
3. How to use ATROPINE SULPHATE GALENICA SENESE
4. Possible side effects
5. How to store ATROPINE SULPHATE GALENICA SENESE
6. Contents of the pack and other information

1. What ATROPINA SOLFATO GALENICA SENESE is and what it is used for

ATROPINA SOLFATO GALENICA SENESE contains the active substance atropine sulfate, which belongs to a group of medicines that work by blocking the action of acetylcholine on the nervous system.
This medicine is used as a premedication before anaesthesia to reduce saliva production and fluid secretions in the bronchi.
It is also used in the treatment of slow heart rate (sinus bradycardia), especially when associated with low blood pressure (hypotension).
Additionally, it is used in emergency situations as an antidote in poisoning by insecticides (organophosphates), to counteract the reduction in heart rate.

2. What you need to know before using ATROPINE SULFATE GALENICA SENESE

Do not use ATROPINE SULFATE GALENICA SENESE

• if you are allergic to atropine sulfate 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 have gastroesophageal reflux problems;
• if you have a narrowing of the stomach or intestine (pyloric stenosis, gastrointestinal obstruction);
• if you have a 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 have muscle weakness caused by a disease called myasthenia gravis (unless administered together with anticholinesterases).

In emergency situations where your life may be at risk (e.g., 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 SULFATE GALENICA SENESE.

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 diarrhea which may indicate intestinal obstruction;
• if your thyroid gland produces high levels of hormones (hyperthyroidism);
• if you suffer from severe kidney or liver problems (renal or hepatic insufficiency);
• if you have circulatory problems affecting the heart (coronary disorders, acute myocardial ischemia, acute myocardial infarction). In cases of ischemia or infarction, this medicine may worsen your condition;
• if you suffer from disturbances in 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 environmental temperatures;
• if you have undergone a heart transplant. This medicine may cause serious heart problems in such cases.

Doses of this medicine higher than 1 mg may cause mental disturbances and adverse effects on the central nervous system, 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 elderly patients. In elderly patients, dosage adjustment may be useful to reduce the risk of adverse effects on the heart and central nervous system.

Other medicines and ATROPINE SULFATE GALENICA SENESE

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

In particular, do not administer ATROPINE SULFATE GALENICA SENESE if you are taking the following medicines:

• other anticholinergic medicines such as belladonna derivatives, as this may increase the medicine's activity;
• halothane, an anaesthetic agent, because it may reduce the medicine's effect on heart rate (depression of cardiac frequency);
• procainamide, used to regulate heartbeats, because it may enhance the medicine's effects on the heart (atrioventricular conduction);
• methacholine, an acetylcholine analogue used in asthma diagnosis, because its effects may be 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 undesirable effects of atropine (urinary retention, constipation, dry mouth):

• other anticholinergic medicines;
• medicines used to treat depression (tricyclic antidepressants);
• medicines used to treat allergies (certain H1 antihistamines);
• certain medicines used to treat Parkinson's disease;
• disopyramide, quinidine, medicines used to treat certain heart rhythm disorders (arrhythmias);
• mequitazine, phenothiazines used to treat allergies;
• medicines used to treat certain mental disorders (neuroleptics, clozapine);
• medicines used to relax the muscles of the intestine and stomach (antispasmodic atropine-like agents).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine. This medicine should not be administered during pregnancy. ATROPINE SULFATE GALENICA SENESE may be used only in cases of absolute necessity during pregnancy.

If you are breastfeeding, your doctor may advise you to discontinue either breastfeeding or treatment with this medicine. If you decide to continue breastfeeding during atropine treatment, your doctor must monitor your baby.

Driving and using machines

This medicine may impair your ability to drive or operate machinery.

ATROPINE SULFATE GALENICA SENESE contains sodium metabisulfite

This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use ATROPINE SULFATE GALENICA SENESE

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

ATROPINE SULFATE GALENICA SENESE will be administered by a doctor or other healthcare professional either into a vein (intravenous route), into the muscle (intramuscular route), or under the skin (subcutaneous route), depending on your needs.

Pre-anesthetic 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 0.3–1.0 mg administered intravenously.

Antidote in organophosphorus poisoning:
The recommended dose is 2 mg administered intramuscularly or intravenously, repeated every 5–10 minutes according to the severity of poisoning, until the skin becomes flushed and dry, the pupils dilate, and an increase in heart rate (tachycardia) develops.

Use in children and adolescents:
The recommended dose for pre-anesthetic medication is 0.02 mg per kg of body weight (maximum dose 0.6 mg).
The recommended dose for treatment of organophosphorus poisoning is 0.02 mg per kg of body weight.

If you use more ATROPINE SULFATE GALENICA SENESE than you should
This medicine will be administered by a doctor or nurse; therefore, it is unlikely that you will receive an excessive dose. However, if you think you have been given too much atropine and experience symptoms such as dryness of mucous membranes, pupil dilation, increased heart rate, fever, and skin irritations, or if you feel restless, confused, disoriented, or have hallucinations, inform your doctor or nurse immediately. They 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, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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;
• increased or decreased body temperature (hyperthermia or hypothermia);
• drowsiness (sedation), disorientation, and dizziness;
• hallucinations (especially at higher doses);
• seizures;
• headache;
• disturbances in short-term memory;
• mental disorders (psychosis);
• 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);
• decreased heart rate (bradycardia) followed by increased heart rate (tachycardia, palpitations, and arrhythmias);
• increased blood pressure (hypertension);
• hot flushes;
• reduced bronchial secretions;
• esophageal reflux;
• dry mouth with difficulty swallowing and speaking;
• nausea;
• vomiting;
• sensation of bloating;
• inhibition of gastric secretion;
• skin redness and dryness;
• urticaria;
• skin rash;
• reduced sweating;
• incontinence;
• 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, please consult your doctor or pharmacist.
You may also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at the following website: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store ATROPINE SULFATE GALENICA SENESE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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.
The medicine should 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.

6. Package contents and other information

What ATROPINA SOLFATO GALENICA SENESE contains
ATROPINA SOLFATO GALENICA SENESE 0.5 mg/ml injectable solution

• The active substance is atropine sulfate monohydrate. 1 ml of solution contains 0.5 mg of atropine sulfate monohydrate, equivalent to 0.21 mg of atropine base.
• The other components (excipients) are: sodium metabisulfite, water for injectable preparations.

ATROPINA SOLFATO GALENICA SENESE 1 mg/ml injectable solution

• The active substance is atropine sulfate monohydrate. 1 ml of solution contains 1 mg of atropine sulfate monohydrate, equivalent to 0.42 mg of atropine base.
• The other components (excipients) are: sodium metabisulfite, water for injectable preparations.

Description of the appearance of ATROPINA SOLFATO GALENICA SENESE and package contents
Pack sizes: 1, 5 or 10 vials of 1 ml.
Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351
53014 Monteroni d'Arbia (SI)
Italy

The following information is intended exclusively for physicians and healthcare professionals:
OVERDOSE
At the first signs, in case of respiratory depression, administration of oxygen 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 performed.
Since atropine is eliminated via the kidneys, intravenous fluid administration is recommended. In cases of delirium and coma, physostigmine should be administered by slow intravenous infusion at a dose between 1 and 4 mg (0.5 – 1 mg in children).