Package Insert: Information for the User

Buscopresc 10 mg Suppositories

Butylscopolamine bromide

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

Follow exactly the medication administration instructions 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.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist,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 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 for the treatment of gastrointestinal spasms, spasms, and motility disorders (dyskinesias) of the biliary ducts and genitourinary tract spasms, in adults and children over 6 years old.

Do not use Buscopresc

• If you are allergic to butylscopolamine bromideor to any of the other ingredients 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 (intestinal tract narrowing) or pyloric stenosis (pyloric narrowing).
• 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 variable degrees of muscle weakness).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Buscopresc.

Be especially careful with Buscopresc if you have ever had:

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

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

If severe and unknown abdominal pain persists or worsens, or if symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal pain with palpation, decreased blood pressure, dizziness, or presence of blood in stool occur, 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 Buscopresc

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

You must inform the 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, 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 medication.

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

Driving and operating machines

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

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 suppositories, 3 to 5 times a day.

It must be administered rectally.

The maximum daily dose should not exceed 100 mg of butylscopolamine bromide(10 Buscopresc 10 mg suppositories).

The optimal duration of symptomatic treatment depends on the indication. There is no established limit for the duration of treatment.

Buscopresc 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 use more Buscoprescthan 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 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 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 in case of urinary retention.

Appropriate supportive measures will also be applied, as necessary.

If you forgot to use Buscopresc

Do not use 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:

-Infrequent (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).

-Unknown frequency (cannot be estimated from available data): shock caused by a severe allergic reaction (anaphylactic shock), reaction caused by an allergy (anaphylactic reaction), difficulty breathing (dyspnea), skin eruption (exanthema), skin redness (erythema), hypersensitivity.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition ofBuscopresc

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

The other components are demineralized water and solid semisynthetic glycerides.

Appearance of the product and content of the container

Torpedo-shaped suppositories, smooth, white to ivory in color.

Presented in containers containing 6 suppositories.

Holder of the marketing authorization

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing

Istituto de Angeli S.R.L

Località i Prulli

50066 Reggello (Florence)

Italy

Last review date 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/18218/P_18218.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/.