- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Route of AdministrationTransdermal
AdultsTo achieve the optimum protective effect, Scopoderm Patch should be applied about 5-6 hours before embarking on a journey (or on the evening before the journey). The system should be placed onto a clean, dry, hairless area of skin behind the ear, taking care to avoid any cuts or irritation (see "Instructions for use"). Application of one Scopoderm Patch is quite sufficient to ensure protection for up to 72 hours. Should protection be required for longer periods of time, the scopoderm Patch must be removed after 72 hours and a fresh system applied behind the other. (No more than one system should be used at a time). Conversely, if protection is only required for a shorter period of time, the system should be removed at the end of the journey.To prevent traces of active substance from entering the eyes - which might lead to slight temporary blurring of vision and to dilatation of the pupils (sometimes in one eye only) - patients should wash their hands thoroughly after handling the system. In addition, after removal of the system, the site of application should also be washed. These precautions are necessary to minimise any chance of hyoscine accidentally being transferred to the eyes (see side-effects).Limited contact with water (i.e. during bathing or swimming), should not affect the system, although it should be kept as dry as possible.If the Scopoderm Patch, which normally adheres well to the skin, becomes accidentally detached, it should be replaced by a fresh system.
Use in ElderlyScopoderm Patch may be used in the elderly (see dosage recommendations for adults) although the elderly may be more prone to suffer from the side-effects of hyoscine (see precautions).
Paediatric populationScopoderm Patch can be used in children age 10 years or over (see dosage recommendations for adults). The safety and efficacy of Scopoderm Patch for children younger than 10 years have not been established.
Instructions for useTear open the sachet at the top and take out the flesh-colored system complete with its transparent hexagonal protective foil (Fig. 1).Holding the system only by its edge and taking care if possible not to touch the silvery adhesive side (Fig. 2) - peel off the hexagonal foil.Press the system (silvery adhesive side downwards) firmly on to a clean, dry, hairless area of skin behind the ear (Fig. 3).Once the system has been affixed, it should not be touched again while it is being worn, since pressure exerted on it might possibly cause scopolamine to ooze out at the edge.After the system has been either applied or removed, the hand (and, after its removal, also the site of application) should be thoroughly washed.
Psychiatric disordersRare: disorientation, confusion and hallucinations.
Nervous system disordersVery common: somnolence, dizziness. Rare: memory impairment, disturbance in attention, restlessness, disorientation, confusion and visual hallucinations. (see precautions).
Eye disordersVery common: disturbances of visual accommodation (cycloplegia) including blurred vision, myopia and mydriasis (sometimes unilateral) Common eyelid irritationVery rare: pupillary dilatation may precipitate acute glaucoma, particularly narrow angle glaucoma (see Contra-Indications).
Gastrointestinal disordersVery common: dryness of the mouth.
Skin and subcutaneous tissue disordersCommon: skin irritationVery rare: rash generalised
Renal and urinary disordersRare: urinary retention
Side-effects after removal of Scopoderm PatchAfter 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 reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
SymptomsInitially, restlessness, excitation and confusion may be observed. In response to higher doses, delirium, hallucinations and convulsions set in. At very high doses, coma and respiratory paralysis may occur.
TreatmentIf symptoms of overdosage occur, the system(s) should be removed immediately as some overdose symptoms may persist for up to 24 hours or longer even after patch removal. Physostigmine is the most effective antidote. Depending on the severity of poisoning, physostigmine should be given by slow intravenous injection in doses of 1-4mg (0.5mg in children). Repeated injections may be necessary since physostigmine is rapidly metabolised. Diazepam may be used to counter excitation and convulsions although at higher doses it may cause respiratory depression. In severe cases, artificial respiration may be necessary. If hyperthermia occurs, immediate action should be taken to dissipate heat.
Drug ReservoirLight mineral oilPolyisobutylene (1.200.000)Polyisobutylene (35.000)
Backing FilmPigmented MDPE/AL/PET/HS Film (vapour coated aluminised polyester with outer coating of pigmented medium density polyethylene (MDPE) and a heat sealable inner coating. Thickness 0.0686 mm.
Release Controlling MembranePolypropylene Film. Thickness 0.0254 mm.
Adhesive (to skin)Light mineral oilPolyisobutylene (1.200.000)Polyisobutylene (35.000)
Release Liner (discarded before use)Silicone/Polyester FilmThickness 0.0762 mm
GlaxoSmithKline Consumer Healthcare
980 Great West Road, Brentford, Middlesex, TW8 9GS
0800 783 8881
0800 783 8881