Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac diethylammonium
Waymade Healthcare Plc
M02AA15
Diclofenac diethylammonium
11.6mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 10030200
1500 24.04.20[13] VOLTAROL ® 1.16 % EMULGEL ® DICLOFENAC DIETHYLAMMONIUM 1.16% W/W GEL (diclofenac diethylammonium) PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Your medicine is available using the above name but will be referred to as Voltarol Emulgel throughout this leaflet. IN THIS LEAFLET 1. What Voltarol Emulgel is and what it is used for 2. What you need to know before you use Voltarol Emulgel 3. How to use Voltarol Emulgel 4. Possible side effects 5. How to store Voltarol Emulgel 6. Contents of the pack and other information 1. WHAT VOLTAROL EMULGEL IS AND WHAT IT IS USED FOR Voltarol Emulgel contains the active substance diclofenac which belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). It is specially formulated for rubbing into the skin and used to relieve pain and reduce inflammation and swelling in painful conditions affecting the joints and muscles. Voltarol Emulgel can be used to treat: - muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries) - tendonitis (e.g. tennis elbow) - osteoarthritis. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VOLTAROL EMULGEL DO NOT USE VOLTAROL EMULGEL IF YOU: - are in the last 3 months of your pregnancy (see also pregnancy and lactation section) - have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 ‘What Voltarol Emulgel contains’). - have ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin (acetylsalicylic acid) o Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Voltarol 1.16% Emulgel, gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate. 1g of Voltarol Emulgel contains 11.6mg of the active substance diclofenac diethylammonium, which corresponds to 10mg diclofenac sodium. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gel for topical administration Oil emulsion in an aqueous gel. White to off white, soft, homogeneous, cream like 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the local symptomatic relief of pain and inflammation in: - trauma of the tendons, ligaments, muscles and joints, eg due to sprains, strains and bruises - localised forms of soft tissue rheumatism It is recommended that the treatment be reviewed after 14 days in these indications. For the treatment of osteoarthritis of superficial joints such as the knee. In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use only _Adults and children 14 years and over_: Voltarol Emulgel 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 in diameter) of gel should be applied 3 - 4 times a day. After application, the hands should be washed unless they are the site being treated. _ _ _Use in the elderly_: The usual adult dosage may be used. _Children _ _and _ _adolescents: _ There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also contraindications section 4.3). In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor. Voltarol Emulgel is suitable for the transmission of ultrasound and may be used as a couplant in combination with ultrasound therapy. If large areas of the body are co Lees het volledige document