Package Insert: Information for the User

Escopolamine B. Braun 0.5 mg/mL Injectable Solution

Escopolamine Hydrobromide

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, 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 package insert.

Escopolamina B. Braun is a medication 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.

Do not use Escopolamina B. Braun:

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

If you have:

• glaucoma (high eye pressure)
• urinary retention
• intestinal problems such as intestinal obstruction or slow intestinal movement
• myasthenia gravis (a condition in which muscles tire easily and weaken).

Warnings and precautions

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

Inform your doctor of any type of allergy or medical problem you have or have had, especially if you have:or have had at any time:

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

hyperactive thyroid gland (hyperthyroidism)

Special caution should be taken when administering this medication tochildren,elderly patientsand patients withmuscle weakness.

Some people may react abnormally to normal doses of scopolamine.

Interference with diagnostic tests

If you are to undergo any test in the digestive system, inform the healthcare staff that you have received this medication, as scopolamine may interfere with the results.

Use of Escopolamina B. Braun with other medications:

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

Certain medications may interact with Escopolamina B. Braun and may alter the effects of these. Inform your doctor if you are taking:

• homeopathic medications, herbal medications, and other health-related products. It may be necessary to discontinue treatment or adjust the dose of one of them
• metoclopramide (used to alleviate nausea and vomiting)
• medications that produce depression of the central nervous system
• ketoconazole (used to treat fungal infections)
• antacids containing calcium and/or magnesium, bicarbonate, and carbonic anhydrase inhibitors
• parkinson medications
• monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants, both used for the treatment of depression
• some antihistamines (for treating 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:

Scopolamine should not be administered simultaneously with alcohol, as this may potentiate its sedative action

Pregnancy and lactation:

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

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

Driving and operating machinery

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

This medication will always be administered by healthcare personnel.

Your doctor will decide on the most suitable dose for each patient and situation.

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

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

It is unlikely that this will happen as 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 Toxicological Information Service (phone: 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 auditory and visual hallucinations.

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

Like all medications, Escopolamina B. Braun 0.5 mg/ml may produce adverse effects, although not everyone will experience them.

The adverse effects appear 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 common. In rare cases, abdominal distension has been observed.

Central Nervous System Disorders: drowsiness is the most common. Less frequently, momentary dizziness has been observed. In rare cases, disorientation, memory disturbances, headache, dizziness, restlessness, and mental confusion have been reported.

Skin and Subcutaneous Tissue Disorders: the most common is decreased sweating. Redness or irritation at the injection site has also been observed. The appearance of urticaria or skin eruptions is rare.

Eye Disorders: occasionally, dilated pupils and blurred vision with increased sensitivity to light have been observed. Rarely, eye pain has been reported.

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

Cardiac Disorders: as transient changes in heart rate or palpitations, although they are rare.

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

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

Reporting Adverse Effects

If you experienceany type ofadverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report themdirectly through the Human Medicines Pharmacovigilance System:www.notificaRAM.esBy 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.

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

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

Do not use Scopolamine B. Braun if the solution appears cloudy or if there is sediment (particles at the bottom of the packaging) or if the packaging shows visible signs of deterioration.

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

Medications should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Escopolamina B. Braun 0.5 mg/ml

The active ingredient is escopolamine hydrobromide.

Each ml of the medication contains 0.5 mg of escopolamine.

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

Appearance of the product and contents of the package

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

Package sizes: Boxes of 1 and 100 units.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Name:B. BRAUN MEDICAL, S.A.

Address:Ctra. de Terrassa, 121. (Rubí

(Barcelona)) - 08191 - Spain

Responsible for manufacturing:

Name:B. BRAUN MEDICAL, S.A.

Address:Ronda de los Olivares, Parcela 11

Polígono Industrial Los Olivares

23009-Jaén (Jaén) - Spain

Last review date of this leaflet April 2023

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices. http//www.aemps.gob.es/

----------------------------------------------------------------------------------------------

This information is intended solely for doctors or healthcare professionals:

Dosage:

Adults:

The usual dose is 0.3 to 0.6 mg administered intramuscularly between 30 minutes and 1 hour before anesthesia or at the same time as other preanesthetic medications (e.g. opioids, sedatives).

Children over 2 years:

A dose of 5 μg (0.005 mg) per kg of body weight is recommended. This dose is administered intramuscularly between 30 minutes and 1 hour before anesthesia induction or at the same time as other preanesthetics (e.g. opioids, sedatives).

Overdose:

In case of intoxication, fisostigmine should be administered intravenously at doses 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, to reverse anticholinergic symptoms.

The use of fisostigmine 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 should be initiated and continued until spontaneous effective respiratory movements resume.

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