Land: Israel
Språk: engelska
Källa: Ministry of Health
DICLOFENAC SODIUM
GSK CONSUMER HEALTHCARE, ISRAEL LTD
M02AA15
GEL
DICLOFENAC SODIUM 1 %
TOPICAL
Not required
NOVARTIS CONSUMER HEALTH SA, SWITZERLAND
DICLOFENAC
DICLOFENAC
Self medication for the following indications: Local treatment of pain, inflammation and swelling due to: • Pain and inflammation and swelling in trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises and/or backache (e.g. sports injuries). • Localized forms of soft tissue rheumatism such as tendonitis (e.g.tennis elbow), bursitis.By Physicians order :• Pain caused by osteoarthrosis of the peripheral joints, as of the knee or fingers
2013-11-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor’s prescription VOLTAREN EMULGEL 1% ACTIVE INGREDIENT AND ITS QUANTITY IN A DOSE UNIT: Diclofenac Sodium (as Diclofenac Diethylamine) 1% Additional ingredients are listed in section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. You should use the medicine properly. Consult the pharmacist if you have further questions. Refer to the doctor if signs of the ailment (symptoms) worsen or do not improve after 7 days. 1. WHAT IS THE MEDICINE INTENDED FOR? Self-treatment for the following indications: Local treatment of pain, inflammation and swelling due to: • Pain, inflammation and swelling due to injury to: tendons, ligaments, muscles and joints, e.g. due to sprains, strains, bruises and/or back pain (such as: sports injuries). • Localized forms of soft tissue rheumatism, such as tendinitis (e.g. tennis elbow), bursitis. According to a doctor’s order: Pain due to osteoarthritis of the peripheral joints, such as the knee or fingers. THERAPEUTIC CLASS Voltaren emulgel contains the active ingredient diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or any of the additional components the medicine contains (See section 6). • You are in the last trimester of your pregnancy (see also the pregnancy and breastfeeding section). • You have previously had an allergic reaction to diclofenac or to other medicines for treatment of pain, fever or inflammation, such as: aspirin (acetylsalicylic acid) or ibuprofen. Symptoms of an allergic reaction to these medicines may include: asthma, wheezing or shortness of breath; skin rash or urticaria; swelling of the face or tongue; ru Läs hela dokumentet
1. NAME OF THE MEDICINAL PRODUCT Voltaren Emulgel 1 % gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1g of Voltaren Emulgel contains 11.6 mg of the active substance diclofenac diethylamine, which corresponds to 10 mg of diclofenac sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel for topical administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Self medication for the following indications: Local treatment of pain, inflammation and swelling due to: Pain and inflammation and swelling in trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and/or bruises and/or backache (e.g. sports injuries); Localized forms of soft tissue rheumatism such as tendonitis (e.g. tennis elbow), bursitis. By Physicians order: Pain caused by osteoarthritis of the peripheral joints, as of the knee or fingers. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND ADOLESCENTS AGED 12 YEARS AND OVER: Voltaren Emulgel should be applied over the affected area 3 or 4 times daily and rubbed gently into the skin. The amount needed depends on the size of the painful area: 2 g to 4 g Voltaren Emulgel (a quantity ranging in size from a cherry to a walnut) is sufficient to treat an area of about 400-800 cm². After application, the hands should be washed, unless they are the site being treated. The duration of treatment depends on the indication and clinical response. The gel should not to be used for more than 14 days for soft-tissue injuries or soft tissue rheumatism unless recommended by a doctor, or 21 days for arthritis pain When used without medical prescription, patients should consult their doctor if the condition does not improve within 7 days, or if it gets worse. CHILDREN: Voltaren Emulgel is not recommended for use in children below 12 years of age. THE ELDERLY: The usual adult dosage may be used. 4.3. CONTRAINDICATIONS Patients with or without chronic asthma in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicy Läs hela dokumentet