FULTOPAN 

(FULTON ITALY)

 

Hyoscine butylbromide 10 mg suppositories

COMPOSITION:

Each suppository contains: Hyoscine butylbromide 10 mg; excipients: hard fats.

PHARMACOLOGIC CLASSIFICATION:

ATC code: A03BB01

INDICATIONS:

Fultopan is  indicated for the relief of spasm of the genito-urinary tract or gastro- intestinal tract and for the symptomatic relief of Irritable Bowel Syndrome.

CONTROINDICATIONS:

Fultopan should not be administered to patients with myasthenia gravis, megacolon and narrow angle glaucoma. In addition, it should not be given to patients with a known hypersensitivity to hyoscine butylbromide or any other component of the product.

USE IN PREGNANCY:

Pregnancy There are limited data from the use of hyoscine butylbromide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). As a precautionary measure Fultopan is not recommended during pregnancy.

Lactation There is insufficient information on the excretion of hyoscine butylbromide and its metabolites in human milk. A risk to the breastfeeding child cannot be excluded. Use of Fultopan during breastfeeding is not recommended.

Fertility No studies on the effects on human fertility have been conducted.

POSOLOGY:

Adults: 2 suppositories four times daily. For the symptomatic relief of Irritable Bowel Syndrome, the recommended starting dose is 1 suppository  three times daily, this can be increased up to 2 suppositories four times daily if necessary.  Children 6 - 12 years: 1 suppository  three times daily. No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported. Fultopan should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

In case severe, unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting, or blood in stool, medical advice should immediately be sought.

Fultopan should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate. Due to the risk of anticholinergic complications, caution should be used in patients susceptible to intestinal or urinary outlet obstructions. Because of the possibility that anticholinergics may reduce sweating, Fultopan should be administered with caution to patients with pyrexia.

Elevation of intraocular pressure may be produced by the administration of anticholinergic agents such as Fultopan in patients with undiagnosed and therefore untreated narrow angle glaucoma. Therefore, patients should seek urgent ophthalmological advice in case they should develop a painful, red eye with loss of vision whilst or after taking Fultopan

STORAGE INSTRUCTIONS:

Store in a dry place below 30°C, protect from light.