BUSCOPRESC 20 mg INJECTABLE SOLUTION

Introduction

Leaflet: information for the user

Buscopresc 20 mg injectable solution

Butylscopolamine bromide

Read the entire 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 or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Buscopresc and what is it used for
2. What you need to know before starting to use Buscopresc
3. How to use Buscopresc
4. Possible side effects
5. Storage of Buscopresc
6. Package contents and additional information

1. What is Buscopresc and what is it used for

The active ingredient of Buscopresc belongs to a group of medicines called semi-synthetic belladonna alkaloids, quaternary ammonium compounds. It has an antispasmodic effect on the smooth muscle of the gastrointestinal, biliary, and genitourinary tracts.

Buscopresc is used in adults and adolescents over 12 years of age 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 procedures where spasm may be a problem, such as gastro-duodenal endoscopy and radiology.

2. What you need to know before starting to use Buscopresc

Do not use Buscopresc

• If you are allergic to butylscopolamine bromide or any of the other ingredients of this medicine (listed in section 6).
• If you have increased eye pressure (narrow-angle glaucoma) and are not being treated.
• If you have prostate enlargement.
• If you have urinary retention due to any urethro-prostatic pathology.
• If you have mechanical stenosis of the gastrointestinal tract (narrowing of the gastrointestinal tract) or pyloric stenosis (narrowing of the pylorus).
• If you have paralytic ileus (intestinal paralysis) or obstructive ileus (intestinal obstruction).
• If you have megacolon (abnormally enlarged colon).
• If you have tachycardia.
• If you have myasthenia gravis (a chronic disease characterized by varying degrees of muscle weakness).
• In patients being treated with anticoagulant medications, as intramuscular hematomas may occur. In these patients, Buscopresc should be administered subcutaneously or intravenously.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Buscopresc.

Be particularly careful with Buscopresc if you are prone to intestinal or urinary obstructions.

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

If severe abdominal pain of unknown origin persists or worsens, or is accompanied by symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal pain on palpation, decreased blood pressure, fainting, or blood in the stool, you should consult your doctor immediately.

Cautious use is required in patients with cardiac conditions undergoing parenteral treatment with Buscopresc. Monitoring of these patients is recommended.

Other medicines and Buscopresc

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

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

• Medicines for the treatment of depression (tricyclic and tetracyclic antidepressants).
• Medicines for the treatment of allergies (antihistamines).
• Medicines for the treatment of certain mental disorders (antipsychotics).
• Medicines for the treatment of cardiac arrhythmias (quinidine, disopyramide).

• Medicines for the treatment of heart failure and/or asthma (digoxin, beta-adrenergics).

• Medicines for the treatment of viral infections and/or Parkinson's disease (amantadine).
• Medicines for the treatment of nausea/vomiting and/or stomach movement paralysis (dopaminergic antagonists, e.g., metoclopramide).
• Other anticholinergic medications (e.g., tiotropium, ipratropium, and atropine-like compounds).

Pregnancy, breastfeeding, and fertility

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

The use of Buscopresc is not recommended during pregnancy and breastfeeding.

Driving and using machines

During treatment with Buscopresc 20 mg injectable solution, you may experience undesirable effects such as changes in visual accommodation and dizziness. Do not drive or use machines after parenteral administration of Buscopresc 20 mg injectable solution if you experience these undesirable effects until your vision returns to normal.

Buscopresc contains sodium

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

3. How to use Buscopresc

Follow the administration instructions for this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose for adults and adolescents over 12 years of age 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 injection, intramuscularly, or subcutaneously.

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

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

Use in children and infants

In severe cases, a dose 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 more Buscopresc than you should

Anticholinergic symptoms (such as urinary retention, dry mouth, skin redness, tachycardia, inhibition of gastrointestinal motility, and transient vision disorders) may occur.

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

Information for the doctor:

If necessary, parasymphathomimetics may be administered. Patients should urgently consult an ophthalmologist 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 will be performed in case of urinary retention.

In addition, adequate supportive measures will be applied as needed.

If you forget to use Buscopresc

Do not administer a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The side effects described are:

• Common (may affect more than 1 in 10 people): visual accommodation disorders, tachycardia, dizziness, dry mouth.
• Frequency not known (cannot be estimated from available data): shock caused by a severe allergic reaction, which can be life-threatening (anaphylactic shock with possible fatal outcome), allergic reaction (anaphylactic reaction), difficulty breathing (dyspnea), skin reactions, urticaria, skin rash (exanthema), skin redness (erythema), itching, hypersensitivity, pupil dilation, increased eye pressure, decreased blood pressure, flushing, abnormal sweating, difficulty urinating (urinary retention).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Buscopresc

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Buscopresc

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

The other ingredients are sodium chloride and water for injectable preparations.

Appearance of the product and package contents

Clear solution, from colorless to almost colorless.

It is presented in 1 ml colorless glass ampoules in packs of 6 ampoules and in a clinical pack of 50 ampoules.

Marketing authorization holder

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer

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

Date of the last revision of this leaflet: March 2023

You can access detailed information about this medicine by scanning the QR code included in the packaging and leaflet with your smartphone. 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 on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.