VOLTAROL Medicated Plaster (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Voltarol 140 mg Medicated Plaster.
Qualitative and quantitative composition
Each medicated plaster contains 140 mg diclofenac sodium. For the full list of excipients, see section 6.1.
Pharmaceutical form
Medicated Plaster. Voltarol 140 mg Medicated Plaster is a white 10x14 cm sized self-adhesive plaster made of non-woven fabric on one and paper on other side.
Therapeutic indications
Short term treatment (max. 7 days). Local symptomatic and short term treatment of pain in acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries in adolescents ...
Posology and method of administration
Adults and adolescents from 16 years of age One medicated plaster should be applied to the painful area twice daily, in the morning and in the evening. The maximum daily dose is 2 medicated plasters, even ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; In patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs [NSAIDs]; ...
Special warnings and precautions for use
The medicated plaster must not come into contact with or be applied to the eyes or mucous membranes. It should be applied only to intact non-diseased skin, and not to skin wounds or open injuries. Topical ...
Interaction with other medicinal products and other forms of interaction
Since systemic absorption of diclofenac during labelled use of the medicated plasters is very low, the risk of developing clinically relevant drug-drug interactions is negligible.
Pregnancy and lactation
Pregnancy The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with pharmaceutical forms with systemic ...
Effects on ability to drive and use machines
Voltarol 140 mg Medicated Plaster has no influence on the ability to drive and use machines.
Undesirable effects
The following frequency categories are used for reporting undesirable effects: 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 Not known ...
Overdose
There is no experience with overdose of diclofenac medicated plaster. Should significant systemic undesirable effects occur following incorrect use or accidental overdose (e.g. in children), the precautions ...
Pharmacodynamic properties
Pharmacotherapeutic group: Topical products for joint and muscular pain; Anti-inflammatory preparations, non-steroids for topical use ATC code: M02AA15 Diclofenac is a non-steroidal anti-inflammatory/analgesic ...
Pharmacokinetic properties
Diclofenac is absorbed slowly and incompletely from cutaneous formulations. The plasma concentrations of diclofenac at steady state are characterised by continuous absorption of diclofenac from the plaster, ...
Preclinical safety data
Non-clinical data based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential reveal no special hazards for humans beyond those already outlined in other sections of the ...
List of excipients
Supporting layer: Polyester non-woven fabric Adhesive layer: Basic butylated methacrylate copolymer Copolymer acrylate vinyl acetate PEG 12stearate Sorbitan oleate Liner: Mono silicone coated paper
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store below 30°C. Store in the original package in order to protect from desiccation and light. Keep the sachet tightly closed in order to protect from desiccation and light.
Nature and contents of container
Voltarol 140 mg medicated plasters are individually enclosed in sealed sachets of 145 228 mm made of paper/Alu/PEX laminate, provided with easy open and packed in a cardboard box. Each pack contains 2, ...
Special precautions for disposal and other handling
Used plasters should be folded in half, with the adhesive side inwards. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Marketing authorization number(s)
PL 44673/0158
Date of first authorization / renewal of the authorization
17/03/2018
Date of revision of the text
17/03/2018
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