The instruction on medical primeneniyulekarstvenny means
Диклофенак-ратиофарм® 50 suppositories
the Trade name
Диклофенак-ратиофарм® 50 suppositories
the International unlicensed
name Diclofenac Dosage Form
Suppositories on 50 mg
One suppository soderzhitaktivny substance – diclofenac of sodium of 50.0 mg,
excipients: – microcrystalline cellulose,
silicon colloidal anhydrous, fat firm (Vitepsol H15).
Suppositories from white till yellowish color, a torpedo-shaped form with a smooth surface.
Non-steroidal anti-inflammatory drugs. Derivatives of acetic acid.
The code of automatic telephone exchange of M 01AB 05
Pharmacokinetics Later properties of rectal administration the maximum concentration of diclofenac in blood is reached on average in 1 hour. Diclofenac contacts blood albumine for 99%. Gets into synovial fluid. It is metabolized in a liver. 60% of drug are removed by kidneys in the form of metabolites, less than 1% – in not changed look, the rest is removed in the form of metabolites with bile.
Diclofenac belongs to non-steroidal anti-inflammatory drugs. Renders expressed the anti-inflammatory, anesthetizing and moderate febrifugal action.
The mechanism of effect of diclofenac is caused by suppression of activity of enzyme of cyclooxygenase therefore reactions of an arachidonic cascade are blocked and synthesis of PGE2, PGF2α prostaglandins, A2 thromboxane, prostacyclin, leukotrienes and emission of lizosomalny enzymes which play a major role in pathogenesis of inflammation, pain and fever is broken. Diclofenac suppresses aggregation of thrombocytes. In rheumatic diseases diclofenac reduces a joint pain at rest and at the movement, morning constraint, a swelling of joints, improves their functional capacity. At the inflammatory processes arising after operations and injuries quickly facilitates both spontaneous pain, and an oxycinesia, reduces inflammatory hypostasis on the place of a wound.
– acute arthritises of various genesis (including, gout)
– chronic arthritises, rheumatic arthritises (chronic polyarthritises)
– an ankylosing spondylitis (Bekhterev’s disease) and other spondylarthrites
– arthroses and spondylarthroses (degenerative diseases of joints and a backbone)
– rheumatism of soft tissues
– painful hypostasis and inflammations after injuries and surgeries.
The route of administration and doses
of the Dosage and duration of treatment are established by the attending physician depending on features of a course of the disease and weight of a state. In rheumatic diseases the drug treatment can be long.
To adults and teenagers 15 years are more senior appoint on 1 suppository 2-3 times a day. The daily dose should not exceed 150 mg. Ä¿¬½«õÑ¡á¬-ратиофарм® 50 suppositories enter after release of intestines, on – opportunities, deeply into an anus.
– headaches, sleep disorders, feeling of fatigue, irritability, excitability, dizziness, dysmnesias, a disorientation, feeling of fear, a spasm, a tremor, depressions
– disturbances of taste, a visual disturbance (doubling in eyes or illegibility of perception), sonitus with a hearing disorder
– symptomatology of aseptic meningitis with tension of occipital muscles, headaches, nausea, vomiting, fervescence and disturbance of consciousness. Patients with autoimmune diseases (system lupus erythematosus, the mixed collagenoses)
– a pneumonitis
– nausea, vomiting, a diarrhea, including, with blood impurity which in exceptional cases can lead to anemia
– lack of appetite, spasms in a stomach, feeling of overflow
– gastrointestinal tract diseases which can be followed by ulcerations mucous that in rare instances leads to emergence of blood in a chair or a hematemesis or to a diarrhea, the followed severe pains in epigastriums
– increase in level of transaminases in serum
– stomatitis, inflammations of language, an ulcer of a gullet, the complaint to pains in the bottom of a stomach (the nonspecific bleeding inflammations of a large intestine, exacerbation of Crohn’s disease or ulcer colitis), constipations, inflammation of a pancreas (pancreatitis)
– hepatitis with or without jaundice are predisposed to such reactions, in some cases – with a lightning course without prodromal syndrome
– the renal failure, a proteinuria, a hamaturia or damage of kidneys (interstitial nephrite, a nephrotic syndrome, necrosis of nipples)
is rare – reduction of volume of the emitted urine, swell, the general feeling of weakness, symptoms of a renal failure
– an itching, rash, it is rare – urticaria, a hair loss, hypersensitivity to light, eczemas, an erythema, dot hemorrhages in skin, is even more rare – a syndrome Stephens-Johnson, a Lyell’s disease
– hemopoiesis disturbance (anemia, a leukopenia, an agranulocytosis, thrombocytopenia) – is rare (the first signs can be – fervescence, a sore throat, superficial wounds in a mouth, complaints to a grippopodobny state, bleedings from a nose and skin, prostration, in some cases – hemolytic anemia)
– reactions of supersensitivity to diclofenac in the form of face edemas, swelling of language, swelling of a throat with narrowing of air ways, breath difficulty, up to an attack of asthma and threat of shock
– deterioration in a course of inflammatory processes, caused by an infection (for example, development of a necrotizing fascitis), it is perhaps connected with the mechanism of effect of non-steroidal anti-inflammatory drugs
– other side effects: peripheral swell, it is rare – heartbeat, stethalgias, increase in blood pressure, heart failure.
– the known supersensitivity to diclofenac, or to other components of medicine
– disturbances of a picture of blood of not clear genesis
– a peptic ulcer of a stomach and/or intestines
– the III trimester of pregnancy
– children’s and youthful age (up to 15 years)
– a proctitis, hemorrhoids.
After careful assessment of a ratio advantage/risk drug can be appointed at the following states:
– the induced porphyria
– a system lupus erythematosus and the mixed collagenoses
– the I and II trimesters of pregnancy
– the feeding period a breast
– diseases of digestive tract and/or inflammatory and ulcer
diseases of digestive tract (ulcer colitis, Crohn’s disease) in the anamnesis
– the previous injuries of kidneys and/or heavy abnormal liver functions (in these cases the reduction of doses or lengthening of time between receptions is required)
– high arterial blood pressure and/or heart failure
– senile age
– directly right after heavy surgical intervention
– carefully to use drug at patients with bronchial asthma, allergic rhinitis, polyps mucous a nose and also in chronic obstructive respiratory diseases and persistent infections of airways in connection with danger of emergence of an attack of asthma, Quincke’s edema or urtikariya. Similar precautions are necessary also at patients who had allergic reactions (skin reactions, an itching, urticaria) to analgetic and anti-inflammatory drugs.
At simultaneous use of diclofenac and:
– digoxin, Phenytoinum or drugs of lithium the level of content in plasma of these medicines can increase,
– diuretics and antihypertensives action of these means can be weakened,
– kaliysberegayushchy diuretics the hyperpotassemia can appear,
– other non-steroidal anti-inflammatory drugs or glucocorticoids the risk of emergence of by-effects from digestive tract increases,
– acetylsalicylic acid lowering of the level of concentration of diclofenac in blood serum can appear,
– cyclosporine toxic impact of the last on kidneys can increase.
– a methotrexate can lead to increase in concentration of a methotrexate and to strengthening of its toxic action.
– antidiabetic means can cause the necessity of increase in dosages of the last. Therefore at such combined treatment the control of level of sugar in blood is necessary.
instructions Diclofenac slows down aggregation of thrombocytes that demands constant control of a hemostasis from patients with disturbances of blood clotting.
Therefore if at use of Diclofenac there are symptoms of an infection or deterioration in already available infectious disease, urgent medical inspection for the purpose of detection of indications is necessary for therapy by antibiotics.
Use during pregnancy and during feeding by a breast.
Now there is no sufficient experience of use of diclofenac for pregnant women and the feeding women.
Features of vliyaniyalekarstvenny means on ability to run the vehicle or potentially dangerous mechanisms.
In some cases the ability to drive the car or other moving objects because of developing of dizziness and feeling of fatigue can be broken. These phenomena amplify at a concomitant use of alcohol.
Symptoms: The clinical picture is defined by disturbances from the central nervous system (a headache, dizziness, hyperexcitability, the hyperventilation phenomena with the increased convulsive readiness, children have myoclonic spasms) and gastrointestinal disturbances (abdominal pain, nausea, vomiting). There can be bleedings in digestive tract and/or abnormal liver functions and/or kidneys.
Treatment: Specific antidote does not exist. In case of overdose it is necessary to cause vomiting, to appoint antacids and activated carbon. Symptomatic drug treatment.
A form of release and packing
On 5 suppositories in blister strip packaging from a film of polyvinylchloride and printing aluminum foil.
On the 2nd planimetric packing together with the instruction for medical use in the state and Russian languages put in a box of cardboard.
To Store storage conditions at a temperature not over 25 ºС.
To store out of children’s reach!
not to apply a period of storage after expiry date!
According to the prescription
Merkle GmbH Producer, Germany
the Owner of the registration certificate
“ratiofarm 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 ratiofarm Kazakhstan LLP, Almaty, Al-Farabi Ave., 13, BC Nurly-Tau, 1B, office 305, ph. (727) 311 10 66/68/73/75, fax (727) 311 10 69, e-mail:
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