BUSCOPAN*6SUPP 10MG

BUSCOPAN 10 mg film-coated tablets
BUSCOPAN 10 mg suppositories
Hyoscine N-butylbromide

What it is and what it is used for
Buscopan contains the active ingredient hyoscine N-butylbromide which belongs to a group of medicines called semi-synthetic belladonna alkaloids used for motility disorders of the stomach, intestine and biliary tract (gastrointestinal tract).
Buscopan is indicated in adults and children over 6 years of age for:
• pain and spasms in the stomach and intestines,
• pain and spasms due to obstructions in the flow of the biliary tract (where bile flows, a substance involved in some digestive processes).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not take Buscopan
• if you are allergic to the active ingredient hyoscine N-butylbromide or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained within it (acute angle-closure glaucoma);
• if you suffer from an enlarged prostate (prostatic hypertrophy);
• if you suffer from the inability of the urinary bladder to empty completely (urinary retention);
• if you suffer from narrowing of the pylorus, the terminal part of the stomach (pyloric stenosis) or narrowing of other areas of the stomach and intestines (stenosis of other parts of the gastrointestinal tract);
• in case of intestinal obstruction or if you suspect you have an intestinal obstruction;
• if you suffer from intestinal disease, associated with intestinal movement disorders (paralytic or obstructive ileus), chronic inflammatory bowel disease (ulcerative colitis) and colon dilation (megacolon);
• if you suffer from a disorder caused by frequent regurgitation of stomach contents into the esophagus, the tube through which food reaches the stomach (reflux esophagitis);
• if you are elderly or if your physical condition is weak and you suffer from a lack of intestinal movements, which cause intestinal obstruction (intestinal atony);
• if you suffer from muscle weakness (myasthenia gravis);
• in children under 6 years of age;
• in case of rare hereditary conditions that may be incompatible with an excipient of the product (see Buscopan film-coated tablets contain sucrose).

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine. Contact your doctor immediately if you experience severe, unexplained abdominal pain that persists or worsens or is accompanied by symptoms such as fever, nausea, vomiting, bowel movement disorders, intestinal tenderness, decreased blood pressure, fainting or blood in the stools.

Use Buscopan with caution:
• if you are elderly,
• if you suffer from a disorder of the nerves that maintain control of the proper functioning of glands and organs (autonomic nervous system),
• if you suffer from or are predisposed to heart rhythm disorders (cardiac tachyarrhythmias),
• if you suffer from high blood pressure (arterial hypertension),
• if your heart does not have enough strength and adequacy to pump blood into circulation (congestive heart failure),
• if you suffer from an alteration in thyroid function that can lead to weight loss, fatigue, weakness (hyperthyroidism),
• if you suffer from liver and/or kidney disease,
• if you are predisposed to a severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained within it (acute angle-closure glaucoma),
• if you are predisposed to obstruction of the intestinal and urinary tracts (intestinal and urinary stasis),
• if you have a fever.

Medicines like Buscopan can prolong gastric emptying time with stagnation of substances.
Do not abruptly stop treatment with high doses. The doctor will evaluate the dose to control mild side effects or the discontinuation of therapy in case of severe side effects.

Children and adolescents
Buscopan should not be given to children under 6 years of age.

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

The possible side effects are listed below according to the following frequency:

Uncommon (may affect up to 1 in 100 people)
• skin reactions (cutaneous reactions),
• appearance of hives accompanied by itching (urticaria),
• itching,
• increased heart rate per minute (tachycardia),
• dry mouth,
• alterations in sweating.

Rare (may affect up to 1 in 1,000 people)
• inability of the urinary bladder to empty completely (urinary retention).

Frequency unknown (frequency cannot be estimated from the available data)
• severe allergic reactions (anaphylactic reactions up to anaphylactic shock),
• difficulty breathing (dyspnea),
• skin rash (skin rash),
• skin irritation (erythema) and other allergic manifestations.

The following side effects have also been observed:
• pupil dilation (mydriasis),
• difficulty focusing images (accommodation disorders),
• increased fluid pressure in the eye (ocular tone),
• drowsiness,
• constipation.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.