ATROPINE SULFATE SERRA PAMIES 1 mg/mL INJECTABLE SOLUTION

Introduction

Leaflet: information for the user

Atropine sulfate Serra Pamies 1 mg/ml injectable solution

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any doubts, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Atropine sulfate Serra Pamies is and what it is used for
2. What you need to know before taking Atropine sulfate Serra Pamies
3. How to use Atropine sulfate Serra Pamies
4. Possible side effects
5. Storage of Atropine sulfate Serra Pamies
6. Package contents and additional information

1. What Atropine sulfate Serra Pamies is and what it is used for

The active ingredient is atropine sulfate. It belongs to the group of medications called belladonna alkaloids, tertiary amines.

This medication is used as:

• Preanesthetic: medication used before general anesthesia.
• Spasmolytic: in liver and kidney colic. It is used to help treat irritable bowel syndrome (irritable colon, mucous colitis, and spastic colon).

2. What you need to know before taking Atropine sulfate Serra Pamies

Do not use Atropine sulfate Serra Pamies

• if you are allergic to atropine sulfate or any of the other components of this medication (listed in section 6).
• in patients with narrow-angle glaucoma
• in patients with prostatic hypertrophy, as it may cause urinary retention.
• in patients with pyloric-duodenal obstruction.
• in patients with heart function disorders.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use atropine sulfate:

• if your kidneys do not function properly.
• if your heart beats faster than the normal rhythm.
• if you have heart function disorders.
• if you have ulcerative colitis.
• if you have reflux esophagitis.
• in elderly patients and children.

Children

• Infants and young children are especially sensitive to the toxic effects of this type of medication.
• Strict supervision of medication is recommended in infants and children.
• When this type of medication is administered to children in areas where the ambient temperature is high, there is a risk of rapid increase in body temperature.
• In children who take high doses of this type of medication, an unusual reaction may occur, characterized by hyperexcitability.

Use in elderly patients

• They may respond to the usual doses of this type of medication with excitement, restlessness, agitation, drowsiness, or confusion.
• Additionally, they are especially sensitive to the side effects of this type of medication (constipation, dry mouth, and urinary retention).
• These medications can also precipitate undiagnosed glaucoma and impair memory in geriatric patients.

Other medications and Atropine sulfate Serra Pamies

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The administration of atropine sulfate with the following medications may require modifying the dose of one of them or interrupting treatment.

• Ethyl alcohol:possible potentiation of alcohol toxicity.
• Anticholinergics:medications with anticholinergic effects (amantadine, tricyclic antidepressants, disopyramide, etc.) may potentiate the action and/or toxicity of this medication.
• Phenylephrine:possible potentiation of phenylephrine toxicity, with the appearance of hypertension.
• Metoclopramide:possible inhibition of the prokinetic effect of metoclopramide by antagonism with atropine, as it blocks indirect cholinergic stimulation caused by metoclopramide.
• Verapamil:possible potentiation of atropine-induced tachycardia, as anticholinergics increase the effects of verapamil on heart rate.
• Urinary acidifiers: increase the elimination of atropine by urine and therefore decrease its action, so they are incompatible.
• Urinary alkalizers: decrease the elimination of atropine by urine and therefore potentiate its action, so they are incompatible.
• Antihistamines:potentiate the action of atropine and its toxic effects.
• Phenothiazines:potentiate the action of atropine and its toxic effects.
• Corticosteroids:potentiate the action of atropine and its toxic effects.
• Monoamine oxidase inhibitors:potentiate the action of atropine and its toxic effects.
• Ritodrine:it is believed that there are additive effects between both medications, causing an increase in heart rate.

Use of atropine sulfate with food, beverages, and alcohol

No interactions with food and beverages are known.

The use of atropine with alcohol may potentiate the toxicity of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

Your doctor should weigh the benefits against the risks of this type of medication.

Breastfeeding:

Your doctor should weigh the benefits against the risks of this type of medication, as traces appear in breast milk.

This type of medication can generally inhibit lactation.

Driving and using machines

The administration of atropine may produce side effects such as confusion, blurred vision, drowsiness, etc. that can affect the ability to drive and use machines. If you notice these effects, do not drive or operate machines.

Atropine sulfate Serra Pamies contains:

• Sodium metabisulfite (E-223): this medication may produce severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite (E-223).
• Sodium: this medication contains less than 23 mg (1 mmol) of sodium per ml; i.e., it is essentially "sodium-free".

3. How to use Atropine sulfate Serra Pamies

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

It is administered subcutaneously, intramuscularly, or intravenously.

Intravenous administration should be done by diluting with a minimum volume of 10 ml of physiological serum and administering slowly.

The recommended dose is:

• As preanesthetic medication: it is administered subcutaneously or intramuscularly approximately one hour before anesthesia, or intravenously immediately before anesthesia.

Adults:0.3 to 0.6 mg of atropine sulfate may be administered. The maximum dose in adults is 3 mg in 24 hours.

Children: the dose is calculated at a rate of 0.02 mg per kg of body weight.

• As spasmolytic medication: adults 0.4 to 0.6 mg at intervals of 4-6 hours.

If you use more Atropine sulfate Serra Pamies than you should

The following may occur:

• dry mouth with difficulty swallowing and speaking
• thirst
• mydriasis (pupil dilation)
• paralysis of visual accommodation (ability to focus vision) and photophobia (sensitivity to light)
• increased intraocular pressure
• dry skin
• decreased heart rate followed by increased heart rate with palpitations and arrhythmias
• constipation
• difficulty urinating
• occasional vomiting.

In case of overdose, peripheral effects may be more pronounced, and other symptoms such as hyperthermia, hypertension, increased respiratory rate, nausea, and vomiting may occur. A rash may appear on the face or upper trunk. Toxic doses also cause central nervous system stimulation, characterized by restlessness, confusion, excitement, difficulty moving, discoordination, paranoia (imagining things that do not exist), and psychotic-manic reactions, hallucinations, and delirium, and occasionally rigidity. However, in severe intoxication, central stimulation may lead to central nervous system depression, coma, circulatory and respiratory failure, and death.

The toxic central and peripheral effects of atropine can be controlled with physostigmine salicylate 1-2 mg, injected subcutaneously, intramuscularly, or intravenously; due to its short duration of action, the injection may be repeated every 1-2 hours if necessary.

The subcutaneous or intramuscular injection of neostigmine methylsulfate only controls peripheral effects. Excitement can be controlled with small doses of short-acting barbiturates such as sodium thiopental (100 mg).

Treatment of atropine poisoning may require assisted respiration and oxygen, ice bags for hyperpyrexia (especially in children), catheterization, and fluid administration.

In case of overdose or accidental administration, consult your doctor or pharmacist immediately or call the toxicology information service, phone: 91 562 04 20, indicating the medication and the amount used. It is recommended to take the packaging and the leaflet of the medication to the healthcare professional.

If you forget to use Atropine sulfate Serra Pamies

Do not use a double dose to make up for forgotten doses.

If you stop treatment with Atropine sulfate Serra Pamies

Your doctor will indicate the duration of your treatment. Do not suspend treatment before, as the expected therapeutic effect may not be achieved.

No withdrawal effects have been described.

4. Possible side effects

Like all medications, this medication can produce side effects, although not all people experience them.

The side effects of atropine are generally frequent but mild and transient. In most cases, the side effects are a prolongation of the pharmacological action and mainly affect the digestive system.

The most characteristic side effects are:

Very common side effects (may affect more than 1 in 10 patients):

• Blurred vision
• Dry mouth

Common side effects (may affect up to 1 in 10 patients):

• Anaphylactic reaction (severe allergic reaction)
• Headache
• Mental confusion
• Excitement (especially in elderly patients)
• Drowsiness
• Accommodation disorders (difficulty focusing)
• Mydriasis (pupil dilation)
• Photophobia (sensitivity to light)
• Glaucoma (increased eye pressure)
• Palpitations
• Bradycardia (decreased heart rate) after low doses
• Tachycardia (increased heart rate) after high doses
• Taste disorders
• Nausea
• Vomiting
• Dysphagia (difficulty swallowing)
• Constipation
• Paralytic ileus (acute intestinal obstruction due to paralysis of intestinal movements)
• Urinary retention

Uncommon side effects (may affect up to 1 in 100 patients):

• Dizziness
• Insomnia
• Nasal congestion
• Impotence

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Atropine sulfate Serra Pamies

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions. Store in the original packaging to protect it from light.

Use immediately once the packaging is opened and discard any remaining solutions.

Do not use this medication after the expiration date shown on the label after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Atropine sulfate Serra Pamies

• The active ingredient is atropine sulfate. Each 1 ml ampoule contains 1 mg of atropine sulfate.
• The other components (excipients) are: sodium chloride, sodium metabisulfite (E-223), and water for injectable preparations.

Appearance of the product and package contents

Atropine sulfate Serra Pamies is a clear, clean, and sterile solution.

It is presented in 1 ml amber glass ampoules containing the injectable solution.

Each package contains 1 or 100 ampoules (clinical package) of 1 ml of solution.

Marketing authorization holder and manufacturer

Laboratorios Serra Pamies, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Date of the last revision of this leaflet:July 2019

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/