Scopolamine Other names: Hyoscine

Teratogenic studies have been performed in pregnant rats and rabbits with hyoscine administered by daily intravenous injection. No adverse effects were noted in rats. In rabbits, the drug had a marginal embryotoxic effect at a high dose (at drug plasma levels approximately 100 times those observed in humans using scopolamine patch).

Scopolamine patch should only be used during pregnancy if the expected benefits to the mother outweigh the potential risks to the foetus.

As scopolamine is excreted in human milk, although only in trace amounts, caution should be exercised when scopolamine patch is administered to a nursing woman.

Scopolamine may cause drowsiness, dizziness, confusion or visual disturbance in certain individuals. Patients using the system must not drive, operate machinery, pilot an aircraft, dive or engage in any other activities in which such symptoms could be dangerous.

Adverse reactions are listed below by system organ class and frequency.

Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), or not known (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Psychiatric disorders

Rare: disorientation, confusion and hallucinations

Nervous system disorders

Very common: somnolence, dizziness

Rare: memory impairment, disturbance in attention, restlessness, disorientation, confusion and visual hallucinations

Eye disorders

Very common: disturbances of visual accommodation (cycloplegia) including blurred vision, myopia and mydriasis (sometimes unilateral)

Common: eyelid irritation

Very rare: pupillary dilatation may precipitate acute glaucoma, particularly narrow angle glaucoma

Gastrointestinal disorders

Very common: dryness of the mouth

Skin and subcutaneous tissue disorders

Common: skin irritation

Very rare: rash generalised

Renal and urinary disorders

Rare: urinary retention

Side-effects after removal of Scopolamine Patch

After discontinuation of treatment, in rare cases – usually after several days of use – symptoms such as dizziness, nausea, vomiting, headache, and disturbances of balance have been reported. In such cases, patients should not drive or engage in other activities requiring concentration.