VOLTAROL PAIN-EZE EMULGEL Gel for topical administration (2018)
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Περιεχόμενα
Name of the medicinal product
Voltarol Pain-eze Emulgel. Voltarol Back and Muscle Pain Relief 1.16% Gel.
Qualitative and quantitative composition
Diethylammonium-{o[2,6-dichlorophenyl)-amino]-phenyl}-acetate. 100g of this medicine contains 1.16g of the active substance diclofenac diethylammonium, which corresponds to 1g diclofenac sodium. For excipients, ...
Pharmaceutical form
Gel for topical administration.
Therapeutic indications
For the local symptomatic relief of pain and inflammation in: Trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises. Localised forms of soft tissue rheumatism. ...
Posology and method of administration
Adults and children aged 14 years and over this medicine should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm ...
Contraindications
Patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory agents (NSAIDs). ...
Special warnings and precautions for use
The possibility of systemic adverse events from application of this medicine cannot be excluded if the preparation is used on large areas of skin and over a prolonged period (see the product information ...
Interaction with other medicinal products and other forms of interaction
Since systemic absorption of diclofenac from a topical application of this medicine is very low such interactions are very unlikely. There are no known interactions with this medicine but for a list of ...
Pregnancy and lactation
The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following ...
Effects on ability to drive and use machines
Cuetaneous application of topical diclofenac has no influence on the ability to drive and use machines.
Undesirable effects
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare ...
Overdose
Signs and symptoms The low systemic absorption of topical diclofenac renders overdose very unlikely. However, undesirable effects similar to those observed following an overdose of Diclofenac tablets can ...
Pharmacodynamic properties
This medicine is an anti-inflammatory and analgesic preparation designed for external application. Due to an aqueous-alcoholic base the gel exerts a soothing and cooling effect.
Pharmacokinetic properties
When this medicine is applied locally, the active substance is absorbed through the skin. In healthy volunteers approximately 6% of the dose applied is absorbed when determined by urinary excretion of ...
Preclinical safety data
None known.
List of excipients
Diethylamine Carbomers Cetomacrogol Cocoyl caprylocaprate Isopropyl alcohol Liquid paraffin Perfume creme 45 (containing benzyl benzoate) Propylene glycol Purified water
Incompatibilities
None stated.
Shelf life
Shelf life: Three years.
Special precautions for storage
Do not store above 30°C. This medicine should be kept out of the sight and reach of children.
Nature and contents of container
Sealed aluminium tubes with protective inner coating, closed with a polypropylene screw cap. Packaging available in packs of 10g, 30g, 40g and 50g. Aluminium laminated tube (low density polyethylene/aluminium/high ...
Special precautions for disposal and other handling
None.
Marketing authorization holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Marketing authorization number(s)
PL 44673/0156
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 November 2004. Date of latest renewal: 24 February 2011.
Date of revision of the text
08<sup>th</sup> August 2018
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