SCOPODERM Transdermal patch Ref.[11092] Active ingredients: Scopolamine

Scopoderm Patch should be used with caution in patients with pyloric stenosis or those who have difficulty in passing water owing to an impeded flow of urine (e.g. in diseases of the prostate), as well as in patients with intestinal obstruction.

Patients should not consume alcohol whilst using Scopoderm Patch.

Scopoderm Patch should also be used with caution in elderly patients, and in patients with impaired hepatic or renal function.

In patients whose case history indicates that there might be raised intra-ocular pressure (pressure pain, blurred vision, glaucomatous halo), Scopoderm Patch should only be employed after an ophthalmological examination.

In rare cases, confusional states and visual hallucinations may occur. In such cases, Scopoderm Patch should be removed immediately. If severe symptoms persist in a severe form, appropriate therapeutic measures should be taken e.g. administration of physostigmine, 1-4 mg (in children 0.5 mg), slowly IV (intravenous) to be repeated if necessary (see overdose section).

Idiosyncratic reactions may occur with ordinary therapeutic doses of hyoscine.

In isolated cases an increase in seizure frequency in epileptic patients has been reported.

Care should be taken after removal of the system as side-effects may persist for up to 24 hours or longer.

Due the presence of aluminium in one of the layers of the system, the patch should be removed before medical scans.

Scopoderm Patch should be used with caution in patients being treated with drugs that act on the central nervous system or drugs with anticholinergic properties e.g. other belladonna alkaloids, antihistamines, tricyclic antidepressants (such as amitriptyline and imipramine), amantadine, quinidine.

Patients should refrain from consuming alcohol during use of Scopoderm Patch.

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 Scopoderm Patch).

Scopoderm 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 Scopoderm Patch is administered to a nursing woman.

Scopoderm 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 (see side-effects).

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 (see precautions)

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 (see Contra-Indications)

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 Scopoderm 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 (see warnings).

Reporting of suspected adverse reactions

Reporting of suspect adverse reactions is an important way to continuously monitor the benefit/risk balance of the medicinal product in the real conditions of use. Healthcare professionals are asked to report any suspected adverse reaction via the Yellow Card Scheme, www.mhra.gov.uk/yellowcard.

Not applicable.