Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ketoprofen
Pinewood Healthcare
M02AA10
Ketoprofen
25mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 10030200; GTIN: 5099186003764 5099186003887
148 148 210 210 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. What Ketoprofen Gel is and what it is used for 2. Before you use Ketoprofen Gel 3. How to use Ketoprofen Gel 4. Possible side effects 5. How to store Ketoprofen Gel 6. Contents of the pack and other information 1. WHAT KETOPROFEN GEL IS AND WHAT IT IS USED FOR Ketoprofen Gel is a homogeneous and colourless gel for application to the surface of the skin only. It contains ketoprofen which belongs to a non-steroidal group of anti-inflammatory drugs (NSAIDs), like aspirin, which help to reduce pain and inflammation. Ketoprofen Gel is used for pain relief in: • soft tissue injuries including sports injuries and sprains and strains • musculo-tendonitis • swelling • backache • conditions affecting the joints and/or connective tissues e.g. arthritis (inflammation of the joints). 2. BEFORE YOU USE KETOPROFEN GEL DO NOT USE KETOPROFEN GEL • If you have a history of allergy or hypersensitivity to Ketoprofen or to any of the other ingredients of Ketoprofen Gel (see section 6), tiaprofenic acid, fenofibrate, UV blockers or perfumes. Symptoms of this would include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • If you have ever had asthma, urticaria (skin rash), or runny nose and sneezing after taking aspirin or other NSAIDs • On an area where you have any skin conditions, eczema or acne, open wounds or infections • In your eyes, mouth, nose, or on the anal or genital areas; if this happens, WASH WITH PLENTY OF CLEAN WATER. Baca dokumen lengkap
OBJECT 1 KETOPROFEN 2.5% W/W GEL Summary of Product Characteristics Updated 05-Jun-2018 | Pinewood Healthcare 1. Name of the medicinal product Ketoprofen 2.5% w/w Gel 2. Qualitative and quantitative composition Ketoprofen 25 mg/g For excipients, see 6.1 3. Pharmaceutical form Gel Homogenous transparent gel with an odour of lavender and alcohol 4. Clinical particulars 4.1 Therapeutic indications Symptomatic relief of pain in such conditions as soft tissue injuries, including sport injuries, sprains, strains, musculo-tendonitis, swelling, backache and rheumatic pain. 4.2 Posology and method of administration For cutaneous use. Penetration of the gel by gentle and prolonged massage on the painful or inflamed surface for up to seven days. Two to four daily applications of approximately 2 to 4g gel, representing approximately 5 to 10cm. The usual maximum dose is 15g per day. Children (under 15 years): Not recommended, as safety in children has not been established. 4.3 Contraindications • Known allergy to Ketoprofen, to substances of similar activity to aspirin. • History of hypersensitivity to any of the excipients. • History of any photosensitivity reactions. • Known hypersensitivity reactions, such as symptoms of asthma, allergic rhinitis to ketoprofen, fenofibrate, tiaprofenic acid, acetylsalicylic acid, or to other NSAIDs (including when taken by mouth). • History of skin allergy to ketoprofen, tiaprofenic acid, fenobrate or UV blocker or perfumes. • Sun exposure, even in the case of hazy sun, including UV light from solarium, during the treatment and 2 weeks after its discontinuation (see Section 4.4. Special warnings and precautions for use). • Third trimester of pregnancy (see section 4.6). • Patholgical skin changes such as dermatosis, eczema or acne, infected skin lesions, or open wounds. • Not to be applied neither to mucous membranes, anal or genital areas, nor on the eyes . • Not to be used with occlusive dressings. • Treatment should be discontinued immediately upon development of a Baca dokumen lengkap