Buscapina 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Buscapina 10 mg coated tablets

Butylscopolamine bromide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for use of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days.

Leaflet contents

1. What Buscapina is and what it is used for
2. What you need to know before taking Buscapina
3. How to take Buscapina
4. Possible adverse effects
5. Storage of Buscapina
6. Contents of the pack and additional information

1. What Buscapina is and what it is used for

The active ingredient in Buscapina belongs to a group of medicines known as semisynthetic Belladonna alkaloids, quaternary ammonium compounds. It has an antispasmodic effect on the smooth muscle of the gastrointestinal, biliary, and genitourinary tracts.

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

2. What you need to know before starting to take Buscapina

Do not take Buscapina

• If you are allergic to butylscopolamine bromide or to any of the other ingredients of this medicine (listed in section 6).
• If you have increased pressure in the eye (narrow-angle glaucoma) and are not being treated for it.
• If you have prostate enlargement (benign prostatic hyperplasia).
• If you suffer from urinary retention due to any urethro-prostatic condition.
• If you have mechanical gastrointestinal tract obstruction (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 enlarged 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.

Take special care with Buscapina if you have ever had:

• Increased pressure in the eye (narrow-angle glaucoma).
• Tachycardia.
• Intestinal or urinary obstructions.
• Prostate enlargement with urinary retention.

If you have any of the above-mentioned conditions at the time of treatment, consult your doctor.

If severe abdominal pain of unknown origin persists or worsens, or occurs with symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal pain upon palpation, decreased blood pressure, fainting, or presence of blood in stool, you must consult your doctor immediately.

Children

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

Other medicines and Buscapina

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You must inform your doctor if you are taking any of the following medicines simultaneously:

• Medicines used to treat depression (tricyclic and tetracyclic antidepressants).
• Medicines used to treat allergies (antihistamines).
• Medicines used to treat certain mental disorders (antipsychotics).
• Medicines used to treat cardiac arrhythmias (quinidine, disopyramide).
• Medicines used to treat heart failure and/or asthma (digoxin, beta-adrenergic agents).
• Medicines used to treat viral infections and/or Parkinson's disease (amantadine).
• Medicines used to treat nausea/vomiting and/or gastric motility paralysis (dopaminergic antagonists, e.g., metoclopramide).
• Other anticholinergic medicines (e.g., tiotropium, ipratropio, and atropine-like compounds).

Pregnancy, breastfeeding and fertility

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

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

Driving and operating machinery

Administration of Buscapina may cause adverse effects such as confusion, blurred vision, drowsiness, etc., which may impair your ability to drive or operate machinery. If you experience these effects, do not drive or operate machinery.

Buscapina contains sucrose

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

3. How to take Buscapina

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in 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 daily.

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

The maximum daily dose must 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 for the duration of treatment has been established.

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

Dose adjustment is not required in patients with impaired kidney and/or liver function.

Use in children

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

If you take more Buscapina than you should

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

If you have taken more Buscapina than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.

Information for the physician

If necessary, parasympathomimetic agents may be administered. Patients must seek urgent ophthalmological consultation in case of glaucoma. Cardiovascular complications should be treated according to standard therapeutic measures. In case of respiratory paralysis, intubation and artificial respiration should be performed. Catheterize in case of urinary retention.

In addition, appropriate supportive measures necessary should be applied.

If you forget to take Buscapina

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

The adverse 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 in urinating (urinary retention).

• Frequency not known (cannot be estimated from the available data): shock due to a severe allergic reaction (anaphylactic shock), reaction caused by allergy (anaphylactic reaction), difficulty in breathing (dyspnea), skin rash (exanthema), redness of the skin (erythema), hypersensitivity.

Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Buscapina

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

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

Appearance of the medicinal product and contents of the pack

White, round, biconvex coated tablets.

Available in packs containing 40 and 60 coated tablets.

Marketing Authorization Holder

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 Barcelona, Spain

Manufacturer

Delpharm Reims SAS

10 rue Colonel Charbonneaux (Reims)

51100 France

Date of the most recent revision of this summary: 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/publico/detalle.html?nregistro=18221

QR Code

The detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.