ESCOPOLAMINE B. BRAUN 0.5 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Escopolamina B. Braun 0.5 mg/ml Solution for Injection

Escopolamine Hydrobromide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Escopolamina B. Braun 0.5 mg/ml and what is it used for
2. What you need to know before you use Escopolamina B. Braun 0.5 mg/ml
3. How to use Escopolamina B. Braun 0.5 mg/ml
4. Possible side effects
5. Storage of Escopolamina B. Braun 0.5 mg/ml
6. Contents of the pack and further information

1. What is Escopolamina B. Braun 0.5 mg/ml and what is it used for

Escopolamina B. Braun is a medicine that belongs to the group of anticholinergics (antimuscarinics).

Escopolamina B. Braun is used in surgical interventions. It is administered before anesthesia to reduce:

• excessive salivation and
• respiratory secretions.

2. What you need to know before you use Escopolamina B. Braun 0.5 mg/ml

Do not use Escopolamina B. Braun:

If you are allergic to escopolamine, to other medicines of the same family, or to any of the other components of this medicine (listed in section 6).

If you have:

• glaucoma (high pressure in the eyes)
• urinary retention
• intestinal problems such as intestinal obstruction or slow intestinal movement
• myasthenia gravis (a condition in which muscles become easily fatigued and weakened).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Escopolamina B. Braun:

Tell your doctor about any type of allergy or medical problem you have or have had, especially if you have or have had:

• kidney or liver problems
• fever
• ulcer or any other stomach or intestinal problem.
• cardiac arrhythmias (heart rhythm disorder) or any other heart problem, or

an overactive thyroid gland (hyperthyroidism)

Special caution is required when administering this medicine to children, elderly patients, and patients with muscle weakness.

Some people may react abnormally to normal doses of escopolamine.

Interference with diagnostic tests

If you are to undergo any tests on the digestive system, you should inform the healthcare staff that you have received this medicine, as escopolamine may interfere with the results.

Use of Escopolamina B. Braun with other medicines:

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

Certain medicines may interact with Escopolamina B. Braun and their effects may be altered. Tell your doctor if you are taking:

• homeopathic medicines, herbal medicines, and other health-related products. It may be necessary to discontinue treatment or adjust the dose of one of them
• metoclopramide (used to relieve nausea and vomiting)
• medicines that cause central nervous system depression
• ketoconazole (used to treat fungal infections)
• antacids containing calcium and/or magnesium, bicarbonate, and carbonic anhydrase inhibitors
• medicines for Parkinson's disease
• monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants, both used to treat depression
• certain antihistamines (used to treat allergies)
• narcotic analgesics (such as morphine)
• levomepromazine (antipsychotic treatment).

In case of doubt, consult your doctor or pharmacist.

Escopolamina B. Braun with food, drink, and alcohol:

Escopolamine should not be administered simultaneously with alcohol, as it may enhance its sedative effect

Pregnancy and breastfeeding:

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

In case of pregnancy or breastfeeding, your doctor will decide whether to use this medicine.

Driving and using machines

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

3. How to use Escopolamina B. Braun 0.5 mg/ml

This medicine will always be administered by healthcare personnel.

Your doctor will decide what dose is most suitable for each patient and situation.

Escopolamina B. Braun can be administered subcutaneously (under the skin), intramuscularly (in the muscle), or intravenously (in a vein).

If you use more Escopolamina B. Braun 0.5 mg/ml than you should:

It is unlikely that this will happen since your doctor will determine the most suitable dose for you. If you are given more doses than necessary, your doctor will take the necessary measures to restore your condition.

In case of overdose or accidental ingestion, consult the Toxicology Information Service (telephone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

If your doctor injects more escopolamine than necessary, you may experience: headache, nausea, vomiting, blurred vision, confusion, disorientation, restlessness, memory loss, and hallucinations (auditory and visual).

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Escopolamina B. Braun 0.5 mg/ml can cause side effects, although not everybody gets them.

Side effects seem to be related to the dose and usually disappear when treatment is discontinued.

Gastrointestinal disorders: dry mouth with difficulty swallowing and constipation are the most frequent. Rarely, abdominal distension has been observed.

Central nervous system disorders: drowsiness is the most frequent. Less frequently, a momentary feeling of dizziness has been observed. Rarely, cases of disorientation, memory disorders, headache, dizziness, restlessness, and mental confusion have been reported.

Skin and subcutaneous tissue disorders: the most frequent is decreased sweating. Redness or irritation at the injection site has also been observed. The appearance of urticaria or skin rashes is rare.

Eye disorders: occasionally, pupil dilation and blurred vision with increased sensitivity to light have been observed. Rarely, eye pain occurs.

Renal and urinary disorders: some cases of difficulty urinating and retention, especially in older men, have been reported.

Cardiac disorders: such as transient changes in heart rate or palpitations, although these are infrequent.

Escopolamine may decrease milk secretion, and although it is uncommon, it may cause fatigue, weakness, or a false sense of well-being.

After discontinuing the medication, a rebound phenomenon may occur with anxiety, irritability, nightmares, and sleep problems.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Medicines Monitoring System: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Escopolamina B. Braun 0.5 mg/ml

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

No special storage conditions are required. Store in the outer packaging to protect from light.

The contents of the ampoules should be used immediately after opening. Once the packaging is opened, discard the unused portion of the solution.

Do not use Escopolamina B. Braun if the solution is turbid or sedimented (particles at the bottom of the packaging) or if the packaging shows visible signs of deterioration.

Do not use Escopolamina B. Braun after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Escopolamina B. Braun 0.5 mg/ml

The active ingredient is escopolamine hydrobromide.

Each ml of the medicine contains 0.5 mg of escopolamine.

The other ingredients are hydrochloric acid for pH adjustment and water for injectable preparations.

Appearance of the product and packaging contents

Escopolamina B. Braun is a colorless and transparent aqueous solution presented in 1 ml glass ampoules.

Packaging sizes: Boxes of 1 and 100 units.

Marketing authorization holder and manufacturer

Marketing authorization holder

Name: B. BRAUN MEDICAL, S.A.

Address: Ctra. de Terrassa, 121. (Rubí

(Barcelona)) - 08191 - Spain

Manufacturer:

Name: B. BRAUN MEDICAL, S.A.

Address: Ronda de los Olivares, Parcela 11

Polígono Industrial Los Olivares

23009-Jaén (Jaén) - Spain

Date of the last revision of this leaflet April 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products. http//www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Dosage:

Adults:

The usual dose is 0.3 to 0.6 mg administered intramuscularly between half an hour and one hour before anesthesia or at the same time as other pre-anesthetic medicines (e.g., opioids, sedatives).

Children over 2 years:

It is recommended to administer 5 μg (0.005 mg) per kg of body weight. This dose is administered intramuscularly between half an hour and one hour before the induction of anesthesia or at the same time as other pre-anesthetics (e.g., opioids, sedatives).

Overdose:

In case of intoxication, physostigmine should be administered intravenously at a dose of 1-4 mg (0.5 to 1 mg in children, up to a total dose of 2 mg), at a rate not exceeding 1 mg per minute, in order to reverse the anticholinergic symptoms.

The use of physostigmine should be done with caution and only under cardiac monitoring.

If the patient is very agitated, a short-acting barbiturate, a benzodiazepine (diazepam), or a rectal infusion of 2% chloral hydrate solution may be administered.

To maintain blood pressure, a norepinephrine bitartrate infusion may be administered. If respiratory muscle paralysis occurs, mechanical ventilation will be established and maintained until effective spontaneous respiratory movements resume.

The patient should always be kept well-hydrated and given symptomatic treatment.