Scopolamine B. Braun 0.5 mg/ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Escopolamine B. Braun 0.5 mg/ml Injection Solution

Hydrobromide Scopolamine

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet.

Leaflet contents:

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

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

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

Escopolamine B. Braun is used during surgical procedures. It is administered before anesthesia to reduce:

• excessive salivation and
• respiratory secretions.

2. What you need to know before using Escopolamine B. Braun 0.5 mg/ml

Do not use Escopolamine B. Braun:

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

If you have:

• glaucoma (increased 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 weak).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Escopolamine B. Braun:

Inform your doctor of any allergies or medical conditions you currently have or have had in the past, especially if you have or have previously had:

• kidney or liver problems
• fever
• stomach or intestinal ulcers or any other gastrointestinal problems
• cardiac arrhythmias (abnormal heart rhythm) or any other heart problems, or
• overactive thyroid gland (hyperthyroidism)

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

Some individuals may have an unusual reaction to normal doses of scopolamine.

Interference with diagnostic tests

If you are scheduled for any gastrointestinal diagnostic tests, inform healthcare personnel that you have received this medicine, as scopolamine may interfere with test results.

Use of Escopolamine B. Braun with other medicines:

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

Certain medicines may interact with Escopolamine B. Braun, altering their effects. Inform your doctor if you are taking:

• homeopathic medicines, herbal medicinal products, and other health-related products. Treatment may need to be discontinued or the dose adjusted
• 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 (an antipsychotic treatment).

If in doubt, consult your doctor or pharmacist.

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

Scopolamine should not be administered simultaneously with alcohol, as alcohol may enhance its sedative effect.

Pregnancy and breastfeeding:

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

During pregnancy or breastfeeding, your doctor will decide whether it is appropriate to use this medicine.

Driving and use of machines

The administration of Escopolamine B. Braun may cause adverse effects such as confusion, blurred vision, drowsiness, etc., which may impair your ability to drive or operate machinery. If you experience these effects, do not drive or operate machinery.

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

This medicine will always be administered by healthcare personnel.

Your doctor will decide the most appropriate dose for each patient and type of situation.

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

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

This is unlikely to happen, as your doctor will determine the most appropriate dose for you. If you are given a higher dose than recommended, your doctor will take the necessary measures to restore your condition.

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

If your doctor administers more scopolamine than recommended, the following may occur: headache, nausea, vomiting, blurred vision, confusion, disorientation, restlessness, memory loss, and hallucinations (auditory and visual).

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

4. Possible adverse effects

Like all medicines, Escopolamine B. Braun 0.5 mg/ml may cause adverse effects, although not everyone experiences them.

Adverse effects appear to be dose-related and usually disappear when treatment is discontinued.

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

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

Skin and subcutaneous tissue disorders: decreased sweating is the most common. Redness or irritation at the injection site has also been observed. Urticaria or skin rashes are rare.

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

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

Cardiac disorders: transient changes in heart rate or palpitations, although uncommon.

Scopolamine may reduce milk secretion and, although infrequent, may cause fatigue, weakness, or a false sense of well-being.

After discontinuation of the medication, a rebound phenomenon may occur, with anxiety, irritability, nightmares, and sleep disturbances.

Reporting of 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 leaflet. You may also report them directly via the Medicines Pharmacovigilance System for Human Use: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Scopolamine 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 must be used immediately after opening. After opening, discard any unused portion of the solution.

Do not use Scopolamine B. Braun if the solution is cloudy or shows sedimentation (particles at the bottom of the container), or if the container shows visible signs of deterioration.

Do not use Scopolamine B. Braun after the expiry date stated on the packaging. The expiry date refers to 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 medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Scopolamine B. Braun 0.5 mg/ml

The active substance is scopolamine hydrobromide.

Each ml of medicinal product contains 0.5 mg of scopolamine.

The other components are hydrochloric acid for pH adjustment and water for injections.

Appearance of the product and contents of the container

Scopolamine B. Braun is a colorless, clear aqueous solution supplied in 1 ml glass ampoules.

Pack 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 most recent revision of this leaflet: April 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios): http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Dosage:

Adults:

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

Children over 2 years of age:

A dose of 5 μg (0.005 mg) per kg of body weight is recommended. This dose should be administered intramuscularly half an hour to one hour before anesthesia induction or concomitantly with other pre-anesthetic agents (e.g., opioids, sedatives).

Overdose:

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

The use of physostigmine must be carried out with caution and only under cardiac monitoring.

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

To maintain blood pressure, an infusion of norepinephrine bitartrate may be given. If respiratory muscle paralysis occurs, mechanical ventilation should be initiated and maintained until effective spontaneous respiratory movements resume.

The patient must always be kept well hydrated, and symptomatic treatment should be administered.