DIVIDOL Coated tablet Ref.[28246] Active ingredients: Butylscopolamine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Dividol 10 mg coated tablets.

Pharmaceutical Form

Coated tablet.

White, round, sugar-coated tablets.

Qualitative and quantitative composition

Each coated tablet contains 10 mg hyoscine butylbromide.

Excipient(s) with known effect: This product contains 32.5 mg lactose and 47.718 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Butylscopolamine

Butylscopolamine is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs.

List of Excipients

Core:

Cellulose, microcrystalline
Lactose monohydrate
Maize starch
Povidone
Starch, pregelatinised
Magnesium stearate
Talc

Coating:

Gelatin
Macrogol 6000
Povidone
Sucrose
Talc
Calcium carbonate
Titanium dioxide
Hypromellose
Macrogol 400

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 20 and 100 coated tablets.

PP containers with PE closure. Pack size of 1000 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

19675

Date of first authorization: 07 June 2005
Date of latest renewal: 11 April 2011

Drugs

Drug Countries
DIVIDOL Albania, Cyprus, Hong Kong, Malta

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