Prospect: information for the user

Atropine sulfate Serra Pamies 1 mg/ml injectable solution

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, 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 only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this prospect. See section 4.

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

This medication is used as:

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

Irritable bowel syndrome (irritable colon, mucous colitis, and spastic colon).

No 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, in which 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 gastroesophageal 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 medication supervision is recommended for infants and children.
• When administering this type of medication to children in warm environments, there is a risk of rapid body temperature increase.
• In children taking high doses of this type of medication, an unusual reaction characterized by hyperexcitability may occur.

Use in Elderly Patients

• They may respond to usual doses of this type of medication with excitement, restlessness, agitation, drowsiness, or confusion.
• They are also 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

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

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

• Alcohol Ethyl: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.
• Fenilefrina:possible potentiation of fenilefrina toxicity, with appearance of hypertension.
• Metoclopramida:possible inhibition of the prokinetic effect of metoclopramide by antagonism with atropine, blocking this the cholinergic stimulation indirectly caused by metoclopramide.
• Verapamilo:possible potentiation of the tachycardia induced by atropine, by increasing the anticholinergic effects of verapamil on heart rhythm.
• 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.
• Fenotiazinas:potentiate the action of atropine and its toxic effects.
• Corticoesteroides:potentiate the action of atropine and its toxic effects.
• Inhibidores de la monoamino-oxidasa:potentiate the action of atropine and its toxic effects.
• Ritodrina:it is believed that there are additive effects between both medications, causing an increase in heart rate.

Use of Atropine Sulfate with Foods, Beverages, and Alcohol

No interactions with foods and beverages are known.

The use of atropine with alcohol may potentiate alcohol toxicity.

Pregnancy and Lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy:

Your doctor must evaluate the benefits against the risks of this type of medication.

Lactation:

Your doctor must evaluate the benefits against the risks of this type of medication, as it appears in breast milk.

This type of medication, in general, may inhibit lactation.

Driving and Operating Machines

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

Atropine Sulfate Serra Pamies contains:

- Sodium Metabisulfite (E-223):This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) because it contains sodium metabisulfite (E-223).

- Sodium: this medication contains less than 23 mg (1 mmol) of sodium per ml; this is, essentially "sodium-free".

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

This medication is administered subcutaneously, intramuscularly, or intravenously.

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

The recommended dose is:

• As pre-anesthetic 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 doses will be calculated at a ratio of 0.02 mg per kilogram of body weight.

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

If you use more Atropine sulfate Serra Pamiesthan you should

You may experience:

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

In case of overdose, peripheral effects may become 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 torso. Toxic doses also cause central nervous system stimulation, characterized by restlessness, confusion, excitement, difficulty moving, discoordination, paranoia (imagining things that do not exist), and psychomotor reactions, hallucinations, and delirium, and occasionally rigidity. However, in severe poisoning, central nervous system stimulation can lead to depression of the central nervous system, coma, circulatory and respiratory failure, and death.

The central and peripheral toxic 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.

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

The treatment of atropine poisoning may require assisted respiration and oxygen, ice bags for hyperpyrexia (especially in children), catheterization, and the administration of fluids.

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 bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to use Atropine sulfate Serra Pamies

Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment with Atropine sulfate Serra Pamies

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

No withdrawal effects have been described.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The adverse effects of atropine are generally frequent, although mild and transient. In most cases, adverse effects are a prolongation of the pharmacological action and primarily affect the digestive system.

The most characteristic adverse effects are:

Very frequent adverse effects (may affect more than 1 in 10 patients):

• Blurred vision
• Dry mouth

Frequent adverse 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)
• Midriasis (pupil dilation)
• Photophobia (sensitivity to light)
• Glaucoma (increased eye pressure)
• Palpitations
• Bradyarrhythmia (decreased heart rate) after low doses
• Tachyarrhythmia (increased heart rate) after high doses
• Taste alterations
• Nausea
• Vomiting
• Dysphagia (difficulty swallowing)
• Constipation
• Paralytic ileus (acute intestinal obstruction due to paralysis of intestinal movements)
• Urinary retention

Rare adverse effects (may affect up to 1 in 100 patients):

• Dizziness
• Insomnia
• Nasal congestion
• Impotence

Reporting Adverse Effects

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

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 container is opened and discard any remaining solutions.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Atropine sulfate Serra Pamies

• The active ingredient is atropine sulfate. Each ampoule of 1 ml 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 contents of the packaging

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

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

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

Holder of the marketing authorization and responsible manufacturer

Laboratorios Serra Pamies, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Date of the last review of this leaflet:July 2019

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/