Package Insert: Information for the User

Buscapina 10 mg Coated Tablets

Butylescopolamine bromide

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

Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• For advice or more information, consult your pharmacist.
• Consult your doctor or pharmacist if you experience any adverse effects, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days.

The active ingredient of Buscapina belongs to a group of medications called Quaternary Ammonium Alkaloids of Belladona, synthetic compounds. It has antispasmodic action on the smooth muscle of the gastrointestinal, biliary, and genitourinary tracts.

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

Do not take Buscapina

• 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 gastrointestinal tract stenosis (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 experienced:

• Narrow-angle glaucoma.
• Tachycardias.
• Intestinal or urinary obstructions.
• Enlarged prostate with urinary retention.

If you experienced the mentioned diseases during treatment, consult your doctor.

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

Children

Due to the dose, this medication is not indicated for children under 6 years old.

Other medications and Buscapina

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 medications (tricyclic and tetracyclic antidepressants).
• Allergy medications (antihistamines).
• Mental disorder medications (antipsychotics).
• Cardiac arrhythmia medications (quinidine, disopyramide).
• Heart failure and/or asthma medications (digoxin, beta-adrenergics).
• Medications for viral infections and/or Parkinson's disease (amantadine).
• Medications for vomiting/nausea and/or gastric movement paralysis (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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machines

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

Buscapina contains saccharose

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those 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 old 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 of time 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 dose, this medication is not indicated for children under 6 years old.

If you take more Buscapina than you should

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

If you have taken more Buscapina 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, parasymptomaticomimetics 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 in case of urinary retention.

In addition, the necessary supportive measures will be applied.

If you forgot to take Buscapina

Do not take a double dose to compensate for the missed doses.

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

The described adverse effects are:

urinary retention).

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 the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Buscapina

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

The other components are calcium hydrogen phosphate, dried cornstarch, soluble cornstarch, 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 contents of the packaging

White, round, biconvex coated tablets.

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

Holder of the marketing authorization

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing

Delpharm Reims SAS

10 rue Colonel Charbonneaux (Reims)

51100 France

Last review date of this leaflet: March 2023

You can access detailed information about this medicine by scanning the QR code included in the carton 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 Medical Devices (AEMPS) http://www.aemps.gob.es/ .