Dolo-denk gel 20g

Composition Active ingredient is etofenamate 1 gram gel contains 100mg etofenamate. Excipients: propylene glycol, carbomer, 2-propanol, macrogol glycerol cocoate, macrogol glycerol hydroxystearate, sodium hydroxide, purified water. Description and packaging: Light yellow, slightly opaque gel. 20g gel in a tube. Pharmacological properties Non-steroidal anti-inflammatory drug / analgesic. ATC code: M02AA06 Etofenamate is a non-steroidal anti-inflammatory drug/analgesic which effectively inhibits prostaglandin synthesis during inflammatory processes in animal studies. Pharmacokinetics In volunteers, after application of 300mg etofenamate patch, maximum plasma concentration of flufenamic acid is observed 12-24 hours after application (21-28 nanog/ml). It binds to proteins by approximately 98-99%. Etofenamate is excreted in the form of numerous metabolites (hydroxylation, cleavage of ethers and esters) and their conjugates, of which 35% is excreted via the kidneys and the rest mainly via bile and feces. Enterohepatic circulation is likely involved. Etofenamate, in the form of flufenamic acid, passes into breast milk in small amounts. Significant inter- and intra-individual variations are observed in the bioavailability of preparations containing etofenamate, which are influenced by the method of administration, skin moisture, and other factors. After external application, the relative bioavailability, specifically the proportion of the systemically available dose, is the same as for other preparations containing etofenamate (up to 20%). Indications Dolo-Denk gel is an external, locally applied preparation. The active ingredient, etofenamate, belongs to the class of non-steroidal (cortisone-free) anti-rheumatic medications and is characterized by anti-inflammatory and analgesic properties. Dolo-Denk gel is used locally to relieve pain and inflammation caused by diseases of the musculoskeletal system, joints, and soft tissues. It is used to relieve pain in the following cases: - In blunt trauma, for example, in acute sprains, strains, or contusions of the limbs caused by sports injuries. - In pain of soft tissues around the joints (e.g., joint capsule, tendon, ligament, or joint capsule). For example, Dolo-Denk gel can be used for muscular rheumatism, muscle strains, painful shoulder stiffness (shoulder-scapular periarthritis), lumbago, sciatica, tendovaginitis, bursitis. Dolo-Denk gel also has a similar effect in painful diseases of soft tissues caused by severe tension and age-related degeneration of the spine and joints (arthrosis, spondylosis). Dosage and administration Dolo-Denk gel should be administered according to the doctor's instructions. If the patient is unsure about anything, they should consult their doctor or pharmacist. Unless otherwise indicated, apply 5-10 cm of gel, depending on the size of the painful area, 3-4 times a day and rub in gently. For external use only! Do not take internally! Before applying bandages, Dolo-Denk gel should be allowed to dry on the skin for a few minutes. The use of occlusive dressings (plastic coverings) is not recommended. The doctor will decide the duration of treatment. In case of blunt trauma (e.g., sports injury), treatment with the preparation for 1 week is usually sufficient. The effectiveness of the preparation for longer use has not been proven. In rheumatic diseases, a treatment period of 3-4 weeks is sufficient in most cases. If pain persists, consult your doctor who will decide how to continue treatment. Inform your doctor or pharmacist if you think that Dolo-Denk gel is too weak or too strong for you. Side effects Like all medicines, Dolo-Denk gel may cause side effects, although not everybody gets them. The table below is used to classify side effects: Very common: more than 1 in 10 patients Common: 1/10 to 1/100 patients Uncommon: 1/100 to 1/1000 patients Rare: 1/1000 to 1/10000 patients Very rare: less than 1/10000, including isolated cases. Reactions on the skin, such as redness, itching, burning sensation, rash, including the development of pustules and blisters, may occur in individual cases. Rarely, Dolo-Denk gel may cause hypersensitivity or local allergic reactions (contact dermatitis). If Dolo-Denk gel is used over a large area of skin for a prolonged period, undesirable effects affecting some organs or the entire body, which develop in specific cases with systemic administration of preparations containing etofenamate, cannot be ruled out. If you notice any side effects not listed in this leaflet, consult your doctor or pharmacist. Contraindications Dolo-Denk gel should not be used in the following cases: - Hypersensitivity to etofenamate, flufenamic acid, other non-steroidal anti-inflammatory drugs, or any other ingredient in Dolo-Denk gel; - On open wounds, inflamed or infected skin, eczematous lesions, or mucous membranes; - In the last trimester of pregnancy; - In children and the elderly; Dolo-Denk gel is not used in children and the elderly due to insufficient clinical data in these age groups. Special precautions when using Dolo-Denk gel - if you suffer from asthma, hay fever, nasal polyps, chronic obstructive pulmonary diseases, or chronic respiratory infections (especially if associated with hay fever-like symptoms). - also if you have hypersensitivity reactions, such as skin reactions, itching or rash, to other substances. Care should be taken to avoid getting Dolo-Denk gel into the eyes. Care should be taken to prevent children from touching areas where the preparation has been applied. Pregnancy and lactation Pregnancy: Dolo-Denk gel should only be used in the first and second trimesters of pregnancy after consulting a doctor. Dolo-Denk gel should not be used in the last trimester of pregnancy as complications for the mother and child cannot be ruled out. Lactation: Since a small amount of etofenamate passes into breast milk, prolonged use of Dolo-Denk gel is not recommended, and the daily dose should not be exceeded (see section 3). To prevent the baby from ingesting the preparation, breastfeeding mothers should not apply it to their breasts. Special information Important information about some ingredients in Dolo-Denk gel Propylene glycol may cause skin irritation. For other ingredients, see section 6 "Further information". Overdose If the recommended dose is exceeded during external use, remove the gel and wash the skin with water. If the patient has used too much Dolo-Denk gel or has accidentally swallowed it, they should inform their doctor. Interactions with other medicines When used correctly, no data on interactions with other medicines are available for Dolo-Denk gel. Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. Storage conditions and expiry dates Store in a cool place. Keep out of reach of children. Do not use after the expiry date indicated on the carton or tube.