Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac diethylammonium
Haleon UK Ltd
M02AA15
Diclofenac diethylammonium
11.6mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 10030200; GTIN: 5012131743003 5051562005908 5051562032102 5051562032805 5051562032904
Pharma code XXX READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Voltarol Back and Muscle Pain Relief 1.16% Gel carefully to get the best results from it. • Keep this leaflet, you may need to read it again. • Ask your pharmacist if you need more information or advice. • YOU MUST CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE WITHIN 7 DAYS. • If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What Voltarol Back and Muscle Pain Relief 1.16% Gel is and what it is used for 2. Before you use Voltarol Back and Muscle Pain Relief 1.16% Gel 3. How to use Voltarol Back and Muscle Pain Relief 1.16% Gel 4. Possible side effects 5. How to store Voltarol Back and Muscle Pain Relief 1.16% Gel 6. Further information 1. WHAT VOLTAROL BACK AND MUSCLE PAIN RELIEF 1.16% GEL IS AND WHAT IT IS USED FOR Voltarol Back and Muscle Pain Relief 1.16% Gel contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs). It is specially formulated for rubbing into the skin and is used to relieve pain and reduce inflammation and swelling in painful conditions affecting the joints and muscles. Voltarol Back and Muscle Pain Relief 1.16% Gel can be used to treat: • muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries) • tendonitis (e.g. tennis elbow) 2. BEFORE YOU USE VOLTAROL BACK AND MUSCLE PAIN RELIEF 1.16% GEL DO NOT USE VOLTAROL BACK AND MUSCLE PAIN RELIEF 1.16% GEL IF YOU: • have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 ‘What Voltarol Back and Muscle Pain Relief 1.16% Gel contains’). • have ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin (acetylsalicyclic acid) or ibupro Aqra d-dokument sħiħ
1 NAME OF THE MEDICINAL PRODUCT Voltarol Pain-eze Emulgel Voltarol Back and Muscle Pain Relief 1.16% Gel 2 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, see section 6.1. 3 PHARMACEUTICAL FORM Gel for topical administration. 4.1 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 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use only _ _ _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 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. A period of at least 4 hours should be left between applications. The dose should not be applied more than 4 times in a 24 hour period. If symptoms persist after 7 days or get worse at any time, medical advice should be sought. Not to be used for more than 7 days unless recommended by a doctor. _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. 4.3 CONTRAINDICATIONS • Patients with or without chronic asthma in whom attacks of asthma, angioedema, urticaria or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other non-steroidal anti- infla Aqra d-dokument sħiħ