Diclofenac-FPO pills 50mg, 20pcs

Composition

Active ingredient:

diclofenac sodium – 50 mg.

Auxiliary substances:

colloidal silicon dioxide (aerosil),

potato starch,

crospovidone,

calcium stearate,

microcrystalline cellulose.

Excipients for the shell:

methacrylic acid and ethyl acrylate copolymer (Collicutin P 100), povidone (Collidone 30), brown iron oxide, propylene glycol, talc, titanium dioxide, hydroxypropylmethylcellulose (hypromellose).

Pharmacological action

Nonsteroidal anti-inflammatory drug, a derivative of phenylacetic acid; has anti-inflammatory, analgesic and antipyretic effects. Indiscriminately inhibiting cycloxygenase 1 and cycloxygenase 2, it disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins in the focus of inflammation. It is most effective for inflammatory pain. Like all nonsteroidal anti-inflammatory drugs, the drug has an antiplatelet effect. In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac significantly reduces the severity of pain, morning stiffness, and joint swelling, which improves the functional state of the joint. In case of injuries, in the postoperative period, diclofenac reduces pain and inflammatory edema.

Indications

Joint syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), degenerative and chronic inflammatory diseases of the musculoskeletal system (osteochondrosis, osteoarthritis, periarthropathies), post-traumatic inflammation of the soft tissues and musculoskeletal system (sprains, bruises).

Pain in the spine, neuralgia, myalgia, arthralgia, pain and inflammation after operations and injuries, pain in gout, migraine, algodismenorrhea, pain in adnexitis, proctitis, colic (biliary and renal), pain in infectious and inflammatory diseases of ENT organs.

For topical application: inhibition of miosis during cataract surgery, prevention of cystoid macular edema associated with lens removal and implantation, non-infectious eye inflammation, post-traumatic inflammatory process in penetrating and non-penetrating eyeball wounds.

Contraindications

• Hypersensitivity to the Active ingredient or auxiliary components;
• Anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome – rhinosinusitis, urticaria, nasal mucosal polyps, asthma);
• Erosive and ulcerative changes in the gastric or duodenal mucosa, active gastrointestinal bleeding;
• Inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
• The period after coronary artery bypass grafting;
• the third trimester of pregnancy, the period of breastfeeding;
• Uncompensated heart failure;
• Cerebrovascular bleeding or other bleeding and hemostatic disorders;
• Severe liver failure or active liver disease;
• Severe renal insufficiency (creatinine clearance less than 30 ml / min), progressive kidney diseases, including confirmed hyperkalemia;
• Children under 6 years of age for tablets of 25 mg, tablets of 50 mg are contraindicated in children under 15 years of age.

With caution:

Anemia, asthma, cerebrovascular disease, ischemic heart disease, congestive heart failure, hypertension, peripheral artery disease, edematous syndrome, hepatic or renal failure, dyslipidemia/hyperlipidemia, diabetes, Smoking, inflammatory bowel disease, condition after extensive surgery induced porphyria, elderly age, diverticulitis, systemic connective tissue disease, pregnancy I-II trimester, creatinine clearance less than 60 ml/min.

Side effects

From the digestive system:  nausea, vomiting, anorexia, pain and discomfort in the epigastric region, flatulence, constipation, diarrhea; in some cases – erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract; rarely-impaired liver function. Rectal use resulted in isolated cases of inflammation of the colon with bleeding, and exacerbation of ulcerative colitis.

From the central nervous system and peripheral nervous system:  dizziness, headache, agitation, insomnia, irritability, fatigue; rarely-paresthesia, visual disturbances (blurred vision, diplopia), tinnitus, sleep disorders, convulsions, irritability, tremor, mental disorders, depression.

From the hematopoietic system:  rarely-anemia, leukopenia, thrombocytopenia, agranulocytosis.

From the urinary system:  rarely-impaired renal function; in predisposed patients, edema is possible.

Dermatological reactions:  rarely – hair loss.

Allergic reactions:  skin rash, pruritus; when applied in the form of eye drops – itching, redness, photosensitization.

Interaction

Concomitant use of antihypertensive drugs with diclofenac may weaken their effect.

There have been isolated reports of seizures in patients taking concomitant NSAIDs and quinolone-type antibacterial drugs.

When used concomitantly with corticosteroids, the risk of side effects from the digestive system increases.

Concomitant use of diuretics may reduce the diuretic effect. When used concomitantly with potassium-sparing diuretics, it is possible to increase the concentration of potassium in the blood.

Concomitant use with other NSAIDs may increase the risk of side effects.

Hypoglycaemia or hyperglycaemia have been reported in diabetic patients treated with diclofenac concomitantly with hypoglycaemic drugs.

When used concomitantly with acetylsalicylic acid, it is possible to reduce the concentration of diclofenac in blood plasma.

Although clinical studies have not established the effect of diclofenac on the action of anticoagulants, isolated cases of bleeding with simultaneous use of diclofenac and warfarin have been described.

With simultaneous use, it is possible to increase the concentration of digoxin, lithium and phenytoin in blood plasma.

Absorption of diclofenac from the gastrointestinal tract decreases with simultaneous use with colestyramine, to a lesser extent-with colestipol.

With simultaneous use, it is possible to increase the concentration of methotrexate in blood plasma and increase its toxicity.

Concomitant use of diclofenac may not affect the bioavailability of morphine, but the concentration of the active morphine metabolite may remain elevated in the presence of diclofenac, which increases the risk of side effects of the morphine metabolite, including respiratory depression.

When used concomitantly with pentazocin, a case of a large convulsive seizure has been described; with rifampicin, the concentration of diclofenac in blood plasma may decrease; with ceftriaxone, the excretion of ceftriaxone with bile increases; with cyclosporine, the nephrotoxicity of cyclosporine may increase.

How to take, course of use and dosage

Inside, without chewing, during or after a meal, with a small amount of water. Adults and adolescents from 15 years of age – 25-50 mg 2-3 times a day.

When the optimal therapeutic effect is achieved, the dose is gradually reduced and switched to maintenance treatment at a dose of 50 mg / day. The maximum daily dose is 150 mg.

For children over 6 years of age and adolescents,25 mg tablets are used; the daily dose is 2 mg/kg of the child’s body weight, divided into 2-3 doses. In juvenile rheumatoid arthritis, the daily dose can be increased to 3 mg / kg of body weight. Tablets should be taken whole, without chewing, on an empty stomach, with a small amount of liquid.

Overdose

Symptoms: dizziness, headache, hyperventilation of the lungs, blurred consciousness, in children-myoclonic convulsions, nausea, vomiting, abdominal pain, bleeding, impaired liver and kidney function.

Treatment: gastric lavage, activated charcoal, symptomatic therapy aimed at eliminating increased blood pressure, impaired renal function, convulsions, gastrointestinal irritation, respiratory depression. Forced diuresis and hemodialysis are ineffective.

Special instructions

With extreme caution, it is used for diseases of the liver, kidneys, gastrointestinal tract in the anamnesis, dyspeptic phenomena, bronchial asthma, arterial hypertension, heart failure, immediately after serious surgical interventions, as well as in elderly patients.

If a history of allergic reactions to NSAIDs and sulfites is indicated, diclofenac is used only in urgent cases. In the course of treatment, systematic monitoring of liver and kidney function, peripheral blood picture is necessary.

Rectal use is not recommended in patients with a history of anorectal diseases or anorectal bleeding. Externally, it should be applied only on undamaged areas of the skin.

Avoid contact with diclofenac in the eyes (with the exception of eye drops) or on the mucous membranes. Patients using contact lenses should apply eye drops no earlier than 5 minutes after removing the lenses.

It is not recommended for use in children under 6 years of age.

During the period of treatment with dosage forms for systemic use, alcohol consumption is not recommended.

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, the rate of psychomotor reactions may decrease. If visual clarity is impaired after applying eye drops, do not drive a car or engage in other potentially dangerous activities.

Form of production

Enteric coated tablets.

Active ingredient

Diclofenac

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults, Pregnant women in the first and second trimester as prescribed by a doctor, Children over 15 years of age

Indications

Osteoarthritis, Swelling after injuries and operations, Osteoarthritis, Sciatica, Lumbago, Bursitis, Migraines, Arthritis, Tendon Inflammation, Adnexitis, Periarthritis