Olfen-50 лактаб

General characteristics. Structure:

Active ingredient: diclofenac of sodium of 50 mg

Excipients: starch sodium glycollate, cellulose microcrystallic, the sodium stearylfumarating silicon dioxide colloid, talc, a gidroksipropilmetiltsellyuloz.

Structure of a cover: methacrylic acid copolymer of type 9, triethyl citrate, titanium dioxide yellow (E171), talc, quinoline yellow (E104), ferrous oxide yellow (E172), macrogoal 6000.

Pharmacological properties:

NPVS derivative of phenylacetic acid. Renders the expressed antiinflammatory, analgeziruyushchy and moderate febrifugal action. The mechanism of action is connected with oppression of activity of TsOG - the main enzyme of metabolism of arachidonic acid, being the predecessor of prostaglandins which play a major role in a pathogeny of an inflammation, pain and fever. Analgeziruyushchy action is caused by two mechanisms: peripheral (indirectly, through suppression of synthesis of prostaglandins) and central (at the expense of inhibition of synthesis of prostaglandins in the central and peripheral nervous system).

Inhibits synthesis of proteoglycan in cartilages.

At rheumatic diseases drug, thanks to antiinflammatory and analgeziruyushchy action, reduces joint pains at rest and at the movement, and also morning constraint and a swelling of joints, promotes increase in volume of movements.

At posttraumatic and postoperative inflammations of Olfen™-50 Laktab promotes bystry simplification of spontaneous pains and an oxycinesia, and also reduces inflammatory hypostases.

Drug shows analgeziruyushchy effect at moderate and severe pain of not rheumatic genesis.

At primary dysmenorrhea drug has analgeziruyushchy effect.

Pharmacokinetics. Absorption

At intake it is absorbed from a GIT. Meal slows down absorption speed, extent of absorption at the same time does not change. About 50% of active agent are metabolized at "the first passing" through a liver. Tmax in plasma makes 2-4 h.

Distribution

Does not kumulirut. Linkng with proteins of plasma makes 99.7%. Gets into synovial fluid where Cmax is reached on 2-4 h later, than in plasma.

Removal

T1/2 from plasma is 1-2 h, from synovial fluid - 3-6 h.

Pharmacokinetics in special clinical cases

The pharmacokinetics does not change depending on age of the patient.

Indications to use:

— chronic polyarthritises, arthritises, arthroses;

— degenerative spondylarthrites;

— ankylosing spondylites;

— rheumatic joint and extraarticular inflammations;

— bursitis;

— tendovaginitis;

— tendinites;

— lumbago, sciatica;

— cervical syndrome;

— gout;

— pains and hypostases after injuries and surgeries;

— pains and/or inflammations of female generative organs (including primary dysmenorrhea, adnexitis);

— as supportive application at the treatment of acute infectious and inflammatory diseases of a throat, nose or ears which are followed by pain, for example, of pharyngotonsillites, otitises;

— migraine.

Route of administration and doses:

The adult drug appoint in an initial dose 100-150 mg / At prolonged treatment drug accept 50 mg (1 tablets) 1 or 2

In not hard cases and at long therapy the daily dose makes 50-100 mg (in 2-3 receptions).

Pill is taken before food, without chewing and washing down with a glass of water.

To prevent emergence of pain at night and morning constraint, Laktab within a day it is possible to combine reception of Olfen™-50 using Olfen™-100 Rektokaps before going to bed (to the maximum daily dose of 150 mg). The course of treatment proceeds usually 5-6 weeks.

At primary dysmenorrhea the daily dose which is picked up individually makes from 50 mg to 150 mg; the initial dose has to be 50-100 mg and if it is necessary, it can be increased during several menstrual cycles to the maximum daily dose of 200 mg. Therapy should be begun at emergence of the first symptoms of a disease and to continue some more days, depending on a condition of the patient.

Features of use:

During treatment of Olfenom-50 Laktab, as well as other NPVS, it is necessary to control indicators of function of a liver regularly. Treatment should be stopped in case of an abnormal liver function if clinical symptoms of a disease of a liver (for example, hepatitis) or other manifestations appeared (including an eosinophilia, skin rashes).

With care it is necessary to apply Olfen™-50 Laktab at patients with a hepatic porphyria.

Fever is not the indication for use of this drug.

The patients with dysfunctions of heart, kidneys weakened to patients and elderly people during treatment need observation of the doctor.

For treatment of the weakened patients of advanced age and with small body weight drug is recommended to be used in the smallest effective dose.

At prolonged use of Olfena-50 Laktab is recommended monitoring of functions of kidneys, a liver, and also a picture of peripheral blood.

Олфен™-50 Laktab, as well as other NPVS, can cause temporary oppression of aggregation of thrombocytes. Therefore patients with disturbance of coagulation need strict control of the doctor.

Before purpose of the drug Olfen™-50 Laktab is required careful medical examination of patients with the instruction in the anamnesis on a round ulcer, patients with gastrointestinal disturbances of not clear genesis, with damages of kidneys or a liver, at increase in the ABP, patients of advanced age.

With bronchial asthma, hay fever, a chronic respiratory disease, polyps in a nose or in the presence of allergic reactions to analgetics or antirheumatic means of all types use of Olfena-50 Laktab can cause attacks of asthmatic character in patients.

Influence on ability to driving of motor transport and to control of mechanisms

Patients with a rotatory vertigo (вертиго) or other frustration of TsNS (including with vision disorders) have to refrain from driving of vehicles and work with mechanisms during treatment of Olfenom-50 Laktab.

Side effects:

From the alimentary system: pains in epigastric area, nausea, vomiting, diarrhea, spasms in a stomach, dyspepsia, a meteorism, anorexia, gastrointestinal bleedings (a hematemesis, a melena, diarrhea with blood), a round ulcer without bleeding and perforation, nonspecific hemorrhagic colitis and an exacerbation of ulcer colitis or a disease Krone, aphthous stomatitis, a glossitis, an esophagitis, pancreatitis, a lock, an exacerbation of hemorrhoids, increase in activity of aminotransferases in blood serum sometimes to moderate or high degree with/without jaundice; in some cases – fulminant hepatitis.

From TsNS and peripheral nervous system: headache, dizziness, вертиго, fatigue, disturbance of touch, paresthesia, tremor, memory disturbance, disorientation, sleeplessness, irritability, concern, depression, dreadful dreams, psychotic reactions, aseptic meningitis.

From sense bodys: visual disturbances (sight illegibility, diplopia), hearing disorder, sonitus, taste disturbance.

From cardiovascular system: in isolated cases – tachycardia, a stethalgia, arterial hypertension, heart failure.

From an urinary system: acute renal failure, hamaturia, proteinuria, intersticial nephrite, nephrotic syndrome, necrotizing papillitis.

From system of a hemopoiesis: thrombocytopenia, leukopenia, agranulocytosis, hemolitic anemia, aplastic anemia.

Dermatological reactions: skin rash, it is rare – violent rashes, eczema, an erythrosis (exfoliative dermatitis), a hair loss, a photosensitization, a purpura.

Allergic reactions: seldom – a small tortoiseshell, a mnogoformny erythema, Stephens-Johnson's syndrome, a Lyell's disease (a toxic epidermal necrolysis), an allergic purpura, a bronchospasm, anaphylactic/anaphylactoid reactions (including arterial hypotension).

Interaction with other medicines:

At simultaneous use of diclofenac with drugs of lithium or digoxin increase in concentration of lithium and digoxin in a blood plasma is possible.

Олфен™-50 Laktab can reduce efficiency of diuretics. At simultaneous use with kaliysberegayushchy diuretics development of a hyperpotassemia is possible (regular control of content of potassium in serum is necessary).

At simultaneous use of other NPVS or GKS for system use increase in risk of gastrointestinal bleedings is possible.

Олфен™-50 Laktab does not interact with anticoagulants. However in need of simultaneous use as a precautionary measure it is necessary to carry out control of indicators of a blood coagulation for assessment of development of anticoagulating effect. Sodium diclofenac in a high dose (200 mg) can oppress reversibly aggregation of thrombocytes.

Олфен™-50 Laktab it is possible to apply together with peroral hypoglycemic means, at the same time medicinal interaction is not observed. Hypoglycemic and hyper glycemic reactions after drug Olfen™-50 use Laktab are in some cases possible that demands correction of his dose or a dose of hypoglycemic means.

With care it is necessary to apply NPVS during 24 h to or after treatment by a methotrexate as concentration of a methotrexate in blood and its toxicity can raise.

At simultaneous use with Olfen™-50 Laktab increase in nephrotoxicity of cyclosporine is possible.

Contraindications:

— peptic ulcer of a stomach and duodenum;

— attacks of bronchial asthma, urticaria, acute rhinitis after reception of acetylsalicylic acid and other NPVS in the anamnesis;

— proctites;

— pregnancy;

— period of a lactation (breastfeeding);

— children's age up to 12 years (because of the high content of active agent);

— hypersensitivity to diclofenac and other components of drug.

 

Use of the drug OLFEN™-50 LAKTAB at pregnancy and feeding by a breast

Drug is contraindicated at pregnancy and in the period of a lactation (breastfeeding).

Overdose:

Typical clinical symptoms of overdose of diclofenac of sodium are unknown. Arterial hypotension, a renal failure, spasms, irritation of a GIT, breath difficulty are possible.

Treatment: after intake of an overdose of drug for prevention of its absorption it is necessary to carry out as soon as possible a gastric lavage and to appoint absorbent carbon. At development of the listed above symptoms carry out a symptomatic and maintenance therapy.

Because of high extent of linkng of diclofenac with proteins of plasma and his intensive metabolism in a liver such measures as an artificial diuresis, dialysis or hemoperfusion, apparently, are ineffective for removal of NPVS from an organism.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature from 0 °C to 25 °C. A period of validity – 5 years.

Issue conditions:

According to the recipe

Packaging:

10 - blisters (2) - boxes cardboard.