Package Insert: Information for the User

Buscopresc 20 mg Injectable Solution

Butylscopolamine bromide

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this package insert. See section 4.

The active ingredient of Buscopresc belongs to a group of medications called Semisynthetic Alkaloids of Belladona, quaternary ammonium compounds. It has antispasmodic action on the smooth muscle of the gastrointestinal, biliary, and genitourinary tracts.

Buscopresc is used in adults and adolescents over 12 years old, and in children and infants, for the treatment of acute spasms of the gastrointestinal, biliary, and genitourinary tracts, including biliary and renal colic. It is also used as an adjunct in diagnostic and therapeutic processes where spasm may be a problem, such as gastro-duodenal endoscopy and radiology.

Do not use Buscopresc

• If you are allergic to butylscopolamine bromide or any of the other components of this medication (listed in section 6).
• If you have narrow-angle glaucoma and are not being treated.
• If you have an enlarged prostate.
• If you suffer from urinary retention due to any urethral or prostatic pathology.
• If you have mechanical intestinal obstruction or pyloric stenosis.
• If you have paralytic ileus or intestinal obstruction.
• If you have megacolon (abnormally enlarged colon).
• If you have tachycardia.
• If you have myasthenia gravis (a chronic disease characterized by variable degrees of muscle weakness).
• In patients being treated with anticoagulant medications, as they may cause intramuscular hematomas. In these patients, Buscopresc should be administered subcutaneously or intravenously.

Inform your ophthalmologist if, after administration of Buscopresc, you experience eye pain and redness with vision loss, as you may have undiagnosed narrow-angle glaucoma (a disease with increased eye pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Buscopresc..

Be especially careful with Buscopresc if you have a predisposition to intestinal or urinary obstructions.

After parenteral administration of Buscopresc, cases of anaphylaxis, including shock episodes, have been observed. As with all medications that cause this type of reaction, if you are administered Buscopresc, you will be under observation.

If severe and unknown abdominal pain persists or worsens, or if you experience symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal pain upon palpation, decreased blood pressure, dizziness, or presence of blood in stool, consult your doctor immediately.

Caution is required in patients with cardiac conditions being treated with parenteral Buscopresc. Monitoring of these patients is recommended.

Other medications and Buscopresc

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

You must inform your doctor in case of simultaneous treatment with the following medications:

• Depression treatment medications (tricyclic and tetracyclic antidepressants).
• Allergy treatment medications (antihistamines).
• Mental disorder treatment medications (antipsychotics).
• Cardiac arrhythmia treatment medications (quinidine, disopyramide).

• Heart failure and/or asthma treatment medications (digoxin, beta-adrenergics).

• Viruses and/or Parkinson's disease treatment medications (amantadine).
• Vomiting/nausea and/or gastric movement paralysis treatment medications (dopamine antagonists, for example metoclopramide).
• Other anticholinergic medications (for example tiotropium, ipratropium, and compounds similar to atropine).

Pregnancy, breastfeeding, and fertility

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

It is recommended to avoid using Buscopresc during pregnancy and breastfeeding.

Driving and operating machines

During treatment with Buscopresc 20 mg injectable solution, you may experience undesirable effects such as visual accommodation disturbances and dizziness. Do not drive or operate machines after parenteral administration of Buscopresc 20 mg injectable solution if you experience these undesirable effects until your vision normalizes.

Buscopresc contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per vial; it is essentially "sodium-free".

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

The recommended dose for adults and adolescents over 12 years old is 1-2 ampoules (20-40 mg), several times a day.

The maximum daily dose should not exceed 100 mg of butylscopolamine bromide (5 ampoules of Buscopresc).

No dose adjustment is required in patients with renal and/or hepatic insufficiency.

It should be administered by slow intravenous, intramuscular, or subcutaneous injection.

The optimal duration of symptomatic treatment depends on the indication, and it is recommended for short-term treatments.

Buscopresc should not be administered continuously or for long periods of time without knowing the cause of abdominal pain.

Use in children and infants

In severe cases, a dosage of 0.3-0.6 mg per kg of body weight is recommended, several times a day.

The maximum daily dose should not exceed 1.5 mg of butylscopolamine bromide per kg of body weight.

If you use moreBuscoprescthan you should

Symptoms of anticholinergic effects (such as urinary retention, dry mouth, skin flushing, tachycardia, inhibition of gastrointestinal motility, and transient visual disturbances) may occur.

If you have used more Buscopresc than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20.

Information for the doctor:

If necessary, parasymptomatics may be administered. Patients should consult an ophthalmologist urgently in case of glaucoma. Cardiovascular complications should be treated according to standard therapeutic measures. If respiratory paralysis occurs, intubation and artificial respiration will be performed. Catheterization should be performed in case of urinary retention.

In addition, the necessary supportive measures will be applied.

If you forgot to useBuscopresc

Do not administer a double dose to compensate for the missed dose.

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

The described adverse effects are:

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 about the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging 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. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofBuscopresc

The active ingredient is butylscopolamine bromide. Each injectable solution of 1 ml contains 20 mg of butylscopolamine bromide.

The other components are sodium chloride and water for injection preparations.

Appearance of the product and contents of the packaging

Clear solution, from colorless to almost colorless.

It is presented in colorless glass vials of 1 ml in packaging of 6 vials and in a clinical packaging of 50 vials.

Holder of the marketing authorization

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

or

Sanofi S.r.l.

VIa Valcanello 4,

03012 Anagni (Frosinone)

Italy

Last review date of this leaflet: March 2023

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging and leaflet. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/18220/P_18220.html

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.