Russian

FANIGAN

General characteristic:

general physico-chemical properties: tablets of capsules form, orange with white impregnation;

composition: paracetamol – 500 mg, diclofenac sodium – 50 mg;

other ingredients: starch, polyvinylpyrrolidone K30, croscarmellose sodium, methylparaben sodium, propylparaben sodium, microcrystalline cellulose, color Sunset yellow supra, magnesium stearate.

Pharmaceutical Form. Tablets.

Pharmacotherapeutic group. Nonsteroidal antiinflammatory and antirheumatic agent.

Code ATC M01A B55.

Pharmacological properties.

Pharmacodynamics.

Fanigan – combined agent with definite antiinflammatory, analgetic and antipyretic action. Pharmacological activity of this medicine is explained by the properties of paracetamol and diclofenac sodium, which are contained of Fanigan. The main mechanism of the diclofenac action is to slow down prostaglandin synthesis – endogenous substances, which play a significant role in the genesis of the inflammation, pain, and fever. Paracetamol is the nonsteroidal antiinflammatory preparation, paraaminophenol derivative. Analgetic and antipyretic action of paracetamol is explained by its influence on the brain hypothalamic centers.

Antiinflammatory and analgetic properties of Fanigan provide the clinical efficacy in rheumatic diseases, which are characterized by joint pain, morning stiffness and joint edema decrease and by joint function improvement.

In posttraumatic and postoperative reactions Fanigan eliminates the pain quickly and postoperative inflammatory edema decreases.

Fanigan is effective in nonrheumatic pain syndrome, namely, in primary algodismenorrhea and migraine attacks.

Pharmacokinetics.

After oral usage of Fanigan diclofenac and paracetamol are  absorbed entirely and quickly. The food doesn’t have any influence on the absorbtion.

Active substance concentrations in plasma have a linearity rate from the dosage, maximum levels are reached after 60 – 90 minutes after Fanigan usage. Connection of diclofenac with plasma protein (generally with albumin) is reached 99,7 %. Imaginary volume of division is 0,12 – 0,17 l / kg. Diclofenac permeates into the synovial fluid, in which its maximal level is reached on 2 – 4 hours later, than in plasma. The period of half life from the synovial fluid is 3 – 6 hours.

Diclofenac metabolism is realized by glucuronisation of unaltered molecule and etherification, by which a several phenol metabolites are generated, their biological activity is lower than  activity of final substances.

Total plasma clearanse of diclofenac is approximately 300 ml / min. The terminal period of half life is of 1 – 2 hours.60 % of taking dose is excreted in the urine as  glucuronic conjugate of intact diclofenac, the last part - in the bile and faeces.

Metabolism of paracetamol is carry out in the liver and is excreted, mainly, in the urine.

After repeated usage of Fanigan  its pharmaceutical data are not change. If it is to follow the recommended intervals between аdministration of the medicine the cumulation will not begin.

Indications.

• Pain syndrome in inflammation and degeneration forms of rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthrothis, spondyloarthrothis);

• Pain syndrome in spinal diseases;

• Acute podagra attack;

• posttraumatical and postoperative pain syndrome , which are accompanied by inflammation and edema;

• Severe attacks of migraine;

• Renal and biliary colic;

• Ginecology diseases, which are accompanied by pain syndrome and inflammation (primary algodismenorrhea, adnexitis etc.);

• Severe inflammatory disease of ear, throat, nose with pain sensation (pharyngitis, tonsillitis, otitis, etc).

Administration and Dosage:

The dosage are designated for each patient individually, according with age, disease character, tolerance of the drug and its efficacy.

At the beginning of the treatment for adults and adolescence with weight more than 60 kg it is recommended to administer 2 –3  tablet of Fanigan every day.

When symptoms of disease are mildly or the therapy is longed it is sufficient of 2 tablets per diem one by morning, one by evening. In such conditions maximum dosage would not exceed 3 tablets.

In primary algodismenorrhea the initial dosage would be from 1 to 3 tablets , but if it is necessary, during one day the dosage can be exceed up to 4 tablets per diem.

Period of usage of the drug is 5 –7 days and it is depended from symptoms dynamic.

Maximum dosage of Fanigan is 3 tablets per diem.

For children of 6 – 12 years old the days dosage would not exceed 0,5 – 2 mg/kg weight, it would be divide on 2 –3 dose. For the treatment of juvenile rheumatic arthritis dosage of diclofenac can be exceed up to 3 mg/kg. Maximum dosage of the drug for children is calculated by diclofenac content and it is 3 mg/kg weight.

Side effects.

Generally, the preparation is tolerated well. If some patients have increased sensitiveness to diclofenac and paracetamol such symptoms can appear:

Gastrointestinal tract: sometimes, nausea, vomiting, diarrhea, in single cases – constipation, hemorrhagic colitis, exacerbation of the nonspecific ulcerative colitis;

Central nervous system: sometimes, headache, vertigo, rarely – drowse, in single cases – disorder of sensitivity, insomnia, irritability.

Sense organs: in single cases, dimness of the vision and taste.

Dermatological reactions: sometimes, skin rash, rarely, urticaria.

Liver: increase of aminotransferase levels in plasma.

Hypersensitivity reactions: rarely, bronchismus, system anaphylactic reactions, including hypotension.

Cardio-vascular system: in single cases, tachycardia, pain in the chest, arterial hypertension, congestive heart failure.

Contraindications. Fanigan is contraindicated:

• In cases of hypersensitivity to diclofenac, paracetamol or other components of this drug;

• For patients, which have earlier bronchial asthma attacks (bronchismus), urticaria, acute rhinitis or other allergic reactions as a result of diclofenac, paracetamol or other NSAID usage;

• In cases of peptic ulcer of the stomach or intestines;

• In cases of liver and / or kidney decompensation;

• In cases of glucose-6-phosphatdegidroginase;

• Children for 6 years old, pregnant women, and nursing mother.

Overdose.

Symptoms: arterial hypotension, breath depression, convulsions, renal insufficiency, gastrointestinal disorders.

Treatment: urgent symptomatic therapy.

Artificial diuresis, hemodialisys or hemoperfusion are noneffective because of well connection of active ingredients with plasma protein.

Special indications.

During Fanigan usage it is necessary to keep the patients with gastrointestinal diseases, with the anamnesis of ulcer of the stomach or intestines, ulcerative colitis, Crohn’s disease, disorders of the liver.

During Fanigan usage, as well as other NSAID, activity of the one or several liver enzymes can increase. Therefore, during prolonged therapy of Fanigan it is recommend regulatory liver function exploration, as the method of prevention. In case of functional disorders grow or symptoms of liver disease appear, or other side effects arise (eosinophilia, eruption etc) Fanigan may be abolish.

In case of hepatic porphyria it is necessary to wary administer of Fanigan because of its possibility of provocation of disease.

Prostaglandins play an important role in renal blood flow, therefore it is necessary to carefully treatment by Fanigan patients with renal or cardiac disorders, elderly, patients, which diuretics receive, and patients with volume of blood circulation deficit (for example, after surgical operations).In such cases when Fanigan is administed it is recommend regulatory liver function exploration, as the method of prevention. Discontinuance of preparation usage, as usual, return kidney function to initial level. In case of prolonged therapy of Fanigan, as well as other NSAID, it is necessary to systematic peripheral blood control.

Fanigan can depress temporarily thrombocyt aggregation. Therefore it is necessary to control carefully laboratory data of patients, which have a hemostasis disorders. It is necessary to wary administration of Fanigan to elderly, weak health and patients with low weight. It is recommend to administer them the drug in minimal effective dose.

During lactation application.

Diclofenac and paracetamol penetrate to the human milk therefore in the case of administration of Fanigan during lactation period it can be decide previously about ablactation.

Influence on ability to drive a car and to operate any other machines.

Patients, who have dizzy or vision disorders during Fanigan usage, mustn’t drive a car and other technical facilities.

Drug interactions.

Lithium, digoxin. Fanigan can increase the concentration of Lithium and digoxin in plasma.

Diuretics. Fanigan can activity of diuretics reduce. In a case of simultaneous usage of potassium-sparing diuretics the increase of potassium can take a place. (In a case of such united administration this index have to control oft.)

NSAID. United administration of NSAID and Fanigan can increase the risk of side effects of Fanigan.

Anticoagulants. Single occurrence about increase of the risk of bleeding of such patients, who use at the same time anticoagulants and Fanigan are determined to regular control of data of blood coagulation system.

Methotrexate. It is necessary to wary administer of Fanigan less than the 24 hours or after the dose of Methotrexate, because of increase of it concentration in blood and intensification of it toxicity.

Cyclosporine. Because of Fanigan inflammation to prostaglandin synthesis in kindly it is possible the intensification of nephrotoxicity of Cyclosporine.

Storage and Shelf-life. Store at room temperature, in a dry place. Keep out of reach of children. Shelf-life – 3 years. Do not use the drug after the ended of shelf-life, which is marked on the package.

Conditions of issue:

№4 – without prescription.

№100 – on prescription.

Presentation. №4 in blisters, 25 blisters in a cardboard box (№4 x 25).

Name of Manufacturer. Kusum Healthcare Pvt. Ltd., India.

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