Instruction for medical use
of Диклофенак-ратиофарм® 1 medicine of % gel
of Диклофенак-ратиофарм® 1% gel
name Diclofenac Dosage Form Gel, 1% 40 g
of 100 g of gel soderzhataktivny substance: diclofenac of sodium of 1.0 g,
excipients: diisopropyl adipate, hydroxypropyl cellulose, lactic acid of 90%, sodium disulphite, isopropyl alcohol, water for injections
Transparent colourless gel with a characteristic smell of isopropanol
Non-steroidal anti-inflammatory drugs for topical administration
the Code of automatic telephone exchange of M 02AA 15
Pharmacokinetics At properties drawing on skin gel is soaked up not completely and slowly gets into the subject fabrics (in hypodermic cellulose, muscle tissue, the articulate capsule and in a joint cavity). In comparison with administration of drug inside only 0.5-6% of active agent reach system blood circulation. The maximum levels in plasma are reached in 1-2 hours. The average period of stay in blood plasma up to 9 h. Linking with proteins of blood plasma makes 99%. After fast metabolism in a liver by hydroxylation and linking with glucuronic acid 2/3 of substance are removed through kidneys and 1/3 – through bile.
of Диклофенак-ратиофарм® 1% gel renders expressed the anti-inflammatory, anesthetizing and moderate febrifugal action. The mechanism of action of Диклофенак-ратиофарм® 1% gel is caused by suppression of activity of enzyme of cyclooxygenase therefore reactions of an arachidonic cascade are blocked and synthesis of PGE2 prostaglandins, PGF2b, A2 thromboxane, prostacyclin, leukotrienes and emission of lizosomalny enzymes which play a major role in pathogenesis of inflammation, pain and fever is broken. Ä¿¬½«õÑ¡á¬-ратиофарм® 1% gel suppresses aggregation of thrombocytes.
– for the local, supporting and symptomatic treatment of a pain syndrome in acute strain of muscle and ligaments, dislocations or bruises tied with injuries (sports, production, household, etc.) without disturbance of integrity of integuments and soft tissues
the Route of administration and doses
of Диклофенак-ратиофарм® 1% gel is applied to skin in a painful part of the body on 9-10 cm of gel (3 g) 3 times a day and easily rubbed. In case of need imposings of a bandage, the bandage is applied in a few minutes after gel to the dried-up surface. Gel cannot be applied under air-tight bandages. The maximum daily dose of gel makes 9 g (or 90 mg of diclofenac of sodium). Duration of therapy is 1-2 weeks.
Often (≥1% – & lt, 10%)
– local skin irritations (reddening, an itching, burning, rash)
Infrequently (≥0.1% – & lt, 1%)
– contact dermatitis
Very seldom (& lt, 0.01%, including isolated cases)
– gastrointestinal disorders
– generalized skin rash
– reactions of hypersensitivity in the form of angionevrotichensky hypostasis and dispnoe
– hypersensitivity to diclofenac, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, isopropyl alcohol, propylene glycol or to other substances of medicine
– open wounds, the inflamed or infected skin, mucous membranes, eczema
– the III trimester of pregnancy (when drawing on big surfaces or for a long time).
– children’s and teenage age up to 18 years
the Medicinal interactions
were not observed
It is necessary to be careful when assigning Диклофенак-ратиофарм® 1% gel the patient having in the anamnesis asthma attacks, skin reactions or acute rhinitis on non-steroidal anti-inflammatory drugs or analgetics.
Patients with asthma, obstructive respiratory diseases, a pollinosis and polyps in a nose more often than others, can react to use of non-steroidal anti-inflammatory drugs in the form of attacks of asthma, local cutaneous dropsies and mucous (including, a Quincke’s edema) or small tortoiseshells.
Диклофенак-ратиофарм® gel is applied only as external means! It is necessary to avoid hit of drug on eyes, mucous membranes, open wounds or damages.
Propylene glycol can cause irritation of skin.
Pregnancy and the period of a lactation
of Диклофенак-ратиофарм® 1% gel can be applied in the I and II trimesters of pregnancy only after thorough examination of a ratio advantage/risk. During the III trimester of pregnancy putting gel on the big site of skin long use is contraindicated. Diclofenac can suppress labor pains, cause premature closing of ductus arteriosus, the increased tendency to bleeding in mother and a fruit, to hypostasis at mother. In the period of a lactation of Диклофенак-ратиофарм® 1% it is preferable not to apply gel as the minimum quantity of diclofenac is distinguished in breast milk.
Features of influence of medicine on ability of driving or potentially dangerous mechanisms
the Overdose does not influence
If the recommended dose is exceeded during skin use, gel has to be removed, and the site of skin is washed with water.
A form of release and packing
On 40 g of gel in aluminum tubas with a cover from polyethylene of high density. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a cardboard box.
To Store storage conditions at a temperature not above 25C.
To store out of children’s reach!
not to apply a period of storage after expiry date!
Merkle GmbH Producer, Germany
the Owner of the registration certificate
‘ratiopharm GmbH’, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of ratiopharm Kazakhstan LLP, 050000, Almaty, Al-Farabi Ave., 13, BC Nurly-Tau, 1B, office 305.
Phone number: +7 (727) 311 10 66/68/73/75, Fax: +7 (727) 311 10 69
E-mail address: email@example.com