SCOPODERM Transdermal patch (2021)

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Περιεχόμενα

1. Name of the medicinal product

Scopoderm 1.5mg Patch.

2. Qualitative and quantitative composition

Each patch contains 1.5mg hyoscine U.S.P. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Transdermal Patch. It is a flat, round reservoir patch approximately 1.8 cm in diameter. One side of the patch is tan; the other side is silver and is placed on an oversized clear hexagonal film. The unit ...

4.1. Therapeutic indications

For the prevention of travel sickness symptoms e.g. nausea, vomiting and vertigo.

4.2. Posology and method of administration

Route of Administration Transdermal. Posology Adults To achieve the optimum protective effect, Scopoderm Patch should be applied about 5-6 hours before embarking on a journey (or on the evening before ...

4.3. Contraindications

Scopoderm Patch is contra-indicated in patients with glaucoma or with a history of the condition, and in patients with known hypersensitivity to hyoscine or to any of the excipients listed in section 6.1. ...

4.4. Special warnings and precautions for use

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 ...

4.5. Interaction with other medicinal products and other forms of interaction

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, ...

4.6. Pregnancy and lactation

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 ...

4.7. Effects on ability to drive and use machines

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 ...

4.8. Undesirable 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); ...

4.9. Overdose

Symptoms Initially, 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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antiemetics and antinauseants ATC code: A04AD01 The transdermal therapeutic system (TTS) is a novel form of drug delivery designed to achieve a continuous release ...

5.2. Pharmacokinetic properties

Following Scopoderm Patch administration, measurement of the urinary excretion has shown the equilibrium between absorption and elimination to be reached within about 6 hours. Steady plasma concentrations ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, skin irritation, genotoxicity, carcinogenic potential and toxicity to reproduction. A marginal ...

6.1. List of excipients

Drug Reservoir: Light mineral oil Polyisobutylene Backing Film: Pigmented MDPE/AL/PET/HS Film (vapour coated aluminised polyester with outer coating of pigmented medium density polyethylene ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

48 months.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Scopoderm Individually packed into sealed paper laminated aluminium foil pouches. Outer cardboard carton containing two patches.

6.6. Special precautions for disposal and other handling

The transdermal patch should be folded in half (sticky side inwards) before being discarded. Patients should wash their hands thoroughly after handling the system. In addition, after removal of the system, ...

7. Marketing authorization holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

8. Marketing authorization number(s)

PL 44673/0170

9. Date of first authorization / renewal of the authorization

16 March 2004 / 02 March 2009

10. Date of revision of the text

15 March 2021

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