BUSCAPINA 10 mg FILM-COATED TABLETS

1. What is Buscapina and what is it used for

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

Buscapina is used for the treatment of spasms of the gastrointestinal tract, spasms and motility disorders (dyskinesias) of the biliary pathways, and spasms of the genitourinary tract, in adults and children over 6 years of age.

2. What you need to know before taking Buscapina

Do not take Buscapina

• If you are allergic to butylscopolamine bromide or any of the other components 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 hypertrophy.
• If you suffer from 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 or obstructive ileus (intestinal paralysis).
• If you have tachycardia.
• If you have megacolon (abnormally large colon).
• If you have myasthenia gravis (a chronic disease characterized by varying degrees of muscle weakness).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Buscapina.

Be especially careful with Buscapina if you have ever suffered from:

• Increased eye pressure (narrow-angle glaucoma).
• Tachycardias.
• Intestinal or urinary obstructions.
• Prostate hypertrophy with urinary retention.

If you have had the aforementioned diseases at the time of treatment, consult your doctor.

In case of severe abdominal pain of unknown origin that persists or worsens, or presents with symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal pain on palpation, decreased blood pressure, fainting, or presence of blood in stool, you should consult your doctor immediately.

Children

Due to the dosage, this medicine is not indicated in children under 6 years of age.

Other medicines and Buscapina

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

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

• 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 medicines (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 Buscapina is not recommended during pregnancy and breastfeeding.

Driving and using machines

The administration of Buscapina may produce side effects such as confusion, blurred vision, drowsiness, etc., which may affect the ability to drive and use machines. If you notice these effects, do not drive or operate machines.

Buscapina contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Buscapina

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults and children over 6 years of age is 1 to 2 coated tablets, 3 to 5 times a day.

It should be administered orally. Swallow the coated tablets with a little liquid without chewing.

The maximum daily dose should not exceed 100 mg of butylscopolamine bromide (10 coated tablets of Buscapina 10 mg coated tablets).

The optimal duration of symptomatic treatment depends on the indication. No limit has been established for the duration of treatment.

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

No dose adjustment is required in patients with kidney and/or liver function problems.

Use in children

Due to the dosage, this medicine is not indicated in children under 6 years of age.

If you take more Buscapina than you should

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

If you have taken more Buscapina 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 usual 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 necessary.

If you forget to take Buscapina

Do not take 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:

• Uncommon (may affect up to 1 in 100 people): skin reactions, urticaria, itching, tachycardia, dry mouth, abnormal sweating.
• Rare (may affect up to 1 in 1,000 people): difficulty urinating (urinary retention).

Reporting of 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 Buscapina

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. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Buscapina

The active ingredient is butylscopolamine bromide. Each coated tablet contains 10 mg of butylscopolamine bromide.

The other ingredients are calcium hydrogen phosphate, dry corn starch, soluble corn starch, anhydrous colloidal silica, tartaric acid (E 334), stearic-palmitic acid, povidone, sucrose, talc, gum arabic, titanium dioxide (E 171), macrogol 6000, carnauba wax, and white wax.

Appearance of the product and package contents

White, round, and biconvex coated tablets.

It is presented in packages containing 40 and 60 coated tablets.

Marketing authorization holder

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Manufacturer

Delpharm Reims SAS

10 rue Colonel Charbonneaux (Reims)

51100 France

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/publico/detalle.html?nregistro=18221

QR code

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