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

Posology

Adults

5–10 drops, 2–3 times daily.

Individual doses should not exceed 1 ml, and the total daily dose should not exceed 6 ml.

The posology should be individualized taking into account the patient’s general condition, the patient’s age, weight, and medical history (see sections 4.3 and 4.4).

Paediatric population

Dropizol should not be used in children and adolescents aged below 18 years for safety reasons.

Treatment should be initiated and supervised by a specialist.

Particular caution should be exercised when prescribing this drug due to its morphine content. The treatment period should be as short as possible.

Elderly

Caution should be exercised and the dosage initially reduced in treatment of elderly subjects.

Hepatic impairment

Morphine may precipitate coma in hepatic impairment – avoid or reduce dose. See Sections 4.3 and 4.4.

Renal impairment

Elimination is reduced and delayed in renal impairment – avoid or reduce dose. See Sections 4.3 and 4.4.

Method of administration

Oral use.

The product can be used undiluted or mixed in a glass of water. After mixture with water, it should be used immediately. If the product is used undiluted the correct dosage can be administered with a spoon.

Morphine toxicity. Lethal doses are primarily determined by the morphine content.

Symptoms: Depressed level of consciousness increasing to coma. Respiratory depression (apnoea).

30 months.

4 weeks after the bottle has been opened (in-use stability).

This medicinal product does not require any special storage conditions.

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.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.