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SPC, UK: BUSCOPAN Coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Buscopan 10 mg Tablets.

Qualitative and quantitative composition

Each tablet contains hyoscine butylbromide 10 mg.

Pharmaceutical form

Coated tablets.

Therapeutic indications

Buscopan 10 mg Tablets are indicated for the relief of spasm of the genito-urinary tract or gastro- intestinal tract and for the symptomatic relief of Irritable Bowel Syndrome.

Posology and method of administration

Buscopan 10 mg Tablets are for oral administration only. Buscopan 10 mg Tablets should be swallowed whole with adequate water. Adults: 2 tablets four times daily. For the symptomatic relief of Irritable ...

Contraindications

Buscopan 10 mg Tablets are contraindicated in: Patients who have demonstrated prior hypersensitivity to hyoscine butylbromide or any other component of the product. Myasthenia gravis. Mechanical stenosis ...

Special warnings and precautions for use

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, ...

Interaction with other medicinal products and other forms of interaction

The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, quinidine, amantadine, antipsychotics (e.g. butyrophenones, phenothiazines), disopyramide and other anticholinergics ...

Fertility, pregnancy and lactation

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 ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Because of possible visual accommodation disturbances patients should not drive or operate machinery if affected. ...

Undesirable effects

Many of the listed undesirable effects can be assigned to the anticholinergic properties of BUSCOPAN. Adverse events have been ranked under headings of frequency using the following convention: Very common ...

Overdose

Symptoms Serious signs of poisoning following acute overdosage have not been observed in man. In the case of overdosage, anticholinergic effects such as urinary retention, dry mouth, reddening of the skin, ...

Pharmacodynamic properties

ATC code: A03BB01 Buscopan exerts a spasmolytic action on the smooth muscle of the gastrointestinal, biliary and genito-urinary tracts. As a quaternary ammonium derivative, hyoscine butylbromide does not ...

Pharmacokinetic properties

Absorption As a quaternary ammonium compound, hyoscine butylbromide is highly polar and hence only partially absorbed following oral (8%) or rectal (3%) administration. After oral administration of single ...

Preclinical safety data

In limited reproductive toxicity studies hyoscine butylbromide showed no evidence of teratogenicity in rats at 200 mg/kg in the diet or in rabbits at 200 mg/kg by oral gavage or 50 mg/kg by subcutaneous ...

List of excipients

Tablet core: Calcium hydrogen phosphate Maize starch, dried Starch, soluble Colloidal silica Tartaric acid Stearic acid Tablet coating: Sucrose Talc Acacia Titanium dioxide Macrogol 6000 Carnauba wax ...

Incompatibilities

None stated.

Shelf life

Shelf life: Five years.

Special precautions for storage

Buscopan 10 mg Tablets should be protected from light and stored in a dry place below 25°C.

Nature and contents of container

Blister packs of 56, 100, 500 and 560. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

None stated.

Marketing authorization holder

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom

Marketing authorization number(s)

PL 04425/0708

Date of first authorization / renewal of the authorization

10.10.2014

Date of revision of the text

January 2018

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