DROPIZOL Oral drops, solution Ref.[9176] Active ingredients: Opium

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Pharmanovia A/S, Jægersborg Allé 164, DK-2820 Gentofte, Denmark, Tel: +45 3333 7633, Fax: +45 3332 3107, e-mail: info@pharmanovia.com

Product name and form

Dropizol 10 mg/ml oral drops, solution.

Pharmaceutical Form

Oral drops, solution.

Appearance: dark, reddish brown liquid.

Qualitative and quantitative composition

1 ml of oral liquid contains 1 ml of tincture from Papaver somniferum L., succus siccum (Opium, raw) corresponding to 10 mg of morphine.

1 drop contains 50 mg opium tincture corresponding to 0.5 mg (10 mg/ml) anhydrous morphine

1 ml = 19 drops

Extraction solvent: 33% ethanol (V/V)

Excipients with known effect: 33% ethanol (V/V)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Opium

Opium alkaloids (opioids and isoquinoline derivatives) induce constipation, euphoria, analgesia and sedation dependent on the dose and derivative. The constipating effect is caused by inhibition of the intestines' peristalsis.

List of Excipients

Ethanol 96% v/v
Purified water

Pack sizes and marketing

Brown glass bottle with a white LDPE dropper and white polypropylene (PP) childproof closure.

Pack sizes of 1 × 10 ml, 3 × 10 ml and 10 × 10 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Pharmanovia A/S, Jægersborg Allé 164, DK-2820 Gentofte, Denmark, Tel: +45 3333 7633, Fax: +45 3332 3107, e-mail: info@pharmanovia.com

Marketing authorization dates and numbers

PL 41284/0003

14/09/2017

Drugs

Drug Countries
DROPIZOL Austria, Finland, Ireland, Netherlands, Romania, United Kingdom

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