INSTRUCTION

for medical use of the preparation

MEFENAMIC ACID

Composition of the medicinal preparation:

Active substance: mefenamic acid;

1 capsule contains mefenamic acid BP – 250 mg or 500 mg;

Auxiliary substances:

for 250 mg capsules: talc, lactose monohydrate, corn starch, sodium lauryl sulphate, colloidal silicon dioxide, magnesium stearate;

for 500 mg capsules: talc, stearic acid, corn starch, sodium lauryl sulphate, crospovidone.

Medicinal form. Capsules.

Hard gelatin capsules, size “0”, with light-blue cap and light-yellow body or vice versa; content of the capsule: white or off-white powder.

Name and Address of the Manufacturer. Flamingo Pharmaceuticals Ltd.

7/1, Corporate Park, Sion-Trombay Road, Chembur, Mumbai – 400 071, India

E-28, MIDS, Taloja, Mumbai 410208, India.

Pharmacotherapeutical group. Nonsteroidal anti-inflammatory and antirheumatic preparations. Fenamates. ATC code M01A G01.

It is a nonsteroidal anti-inflammatory drug (NSAID). It has anti-inflammatory, analgetic and antipyretic action. It inhibits synthesis of inflammation mediators (prostaglandin, serotonin and kinins), it also reduces the activity of lysosome proteases, which take part in the inflammatory reaction. It influences the phases of exudation and proliferation. It stabilizes protein ultra structures and cell membranes, decreases vessel penetrability and tissue edemas. It inhibits cell proliferation in the nidus of inflammation; it also increases cell resistance and stimulates wound healing. Its antipyretic action is conditioned by inhibition of prostaglandin synthesis and influence on the centre of thermoregulation. It stimulates interferon formation.

After oral intake, it is rapidly and almost entirely absorbed in the digestive tract. Its maximal concentration in blood is achieved in 2-4 hours. Its level in blood is dose-dependent. In bloodstream it is bound to albumins. Its half-life is 3 hours. It forms a number of metabolites in the live. 67% of the administrated dose is excreted unchanged with urea, and 20-25% - with feces.

Indications.

Acute respiratory viral infections and influenza.

Primary dysmenorrhea. Dysfunctional menorrhagias.

Inflammatory diseases of the musculoskeletal system: rheumatic arthritis, rheumatism, Bechterew's disease.

Pain syndrome of low and medium intensity: muscular, joint, traumatic, toothache, headache of different etiology, postoperative and postnatal pain.

Contraindications. Hypersensitivity to the components of the preparation. Bronchospasm, Quincke's edema, bronchial asthma or urticaria in patient’s medical history, which delepoed after use of acetylsalicylic acid or other NSAIDs. Concomitant use of COX-2 inhibitors. Gastric and duodenal ulcer, present or in patient’s medical history, inflamatory diseases of the gastro-intestinal tract, diseases of hemopoietic organs, severe cardiac insufficiency, severe liver or kidney dysfunctions, gastro-intestinal bleedings or perforation caused by NSAIDs’ intake.

Proper safety measures at use.

The preparation is indicated with caution to patients with acute cardiovascular insufficiency, hypertension, ishemic heart disease.

The preparation is indicated with caution to patients with epilepsy.

There are no special recommendations as for the use of the preparation in case of moderate liver or kidney dysfunctions.

NSAIDs should be taken with caution by those patients, who have a history of with diseases of the gastro-intestinal tract (ulcerative colitis, Crohn's disease), as an acute condition of these diseases is possible.

Eldery patients usually have an increased risk of side effect development from the side of gastro-intestinal tract, so treatment should be initiated with the smallest dose.

In patients with systemic lupus erythematosus and mixed conective tissue diseases there may be an increased risk of aseptic meningitis development.

Therpy with mefenamic acid should be discontinued in case of first signs of skin rash, injury of the mucous membrane or in any other case of hypersensitivity manifestation.

Therpy with mefenamic acid can lead to disturbance of female fertility and is not recommended for women who try to become pregnant.

Mefenamic acid in 250 mg capsules contains lactose, so it should not be used in patients with rare hereditary forms of galactose intolerance, lactose insufficiency or glucose-galactose malabsorption symptom.

Special precautions.

Use during pregnancy and lactation.

The preparation is not used in women during pregnancy.

The preparation is not used in women during lactation period.

Ability to influence reaction rate when driving or working with other mechanisms.

Patients should be careful when driving or working with other mechanisms, which require increased attention, as sometimes use of the preparation may cause drowsiness, visual blurring, cramps.

Children.

The preparation is contraindicated in children under 5 years old.

Way of introduction and doses.

The preparation is indicated for oral intake after meals.

Adults and children over 12 years old are indicated 250–500 mg 3–4 times a day. If needed, daily dose may be increased up to 3 g a day. After achieving therapeutic effect, daily dose should be decreased to 1 g.

Children of 5 - 12 years old are indicated 250 mg 3–4 times a day.

The duration of the treatment course in case of arthropathy may last from 20 days to 2 months and longer. The duration of the treatment course in case of pain syndrome lasts up to 7 days.

Overdose.

Symptoms: pain in epigastria region, nausea, vomiting, drowsiness. In severe cases: gastro-intestinal bleedings, depression of breathing, arterial hypertension, twitching of separate groups of muscles, coma.

Treatment: There is no specific antidote. Gastric lavage with activated charcoal suspension. Urea alkalinization, forced diuresis. Symptomatic treatment. Hemosorption and hemodialysis are not effective due to strong binding of mefenamic acid with blood proteins.

Side effects.

From the side of gastro-intestinal tract: pain in epigastria region, anorexia, heartburn, nausea, meteorism, vomiting, enterocolitis, colitis, steatorrhea, cholestatic jaundice, hepatitis, pancreatitis, hepatorenal syndrome, haemorrhagic gastritis, peptic ulcer with or without bleeding. Gastro-intestinal bleedings, dyspepsia, constipation, diarrhea. Increased level of liver enzymes in plasma.

From the side of cardiovascular system: arterial hypertension, arrhythmia, seldom – congestive heart failure, peripheric edemas, syncope, arterial hypotension, increased heart rate, and dyspnea.

From the side of respiratory system: dyspnea, bronchospasm.

From the side of urinary tracts: dysuria, cystitis. Kidney dysfunction, albuminuria, hematuria, oliguria or polyuria, renal insufficiency, including papillary necrosis, acute interstitial nephritis, nephrotic syndrome, allergic glomerulonephritis, hyponatremia, hyperkaliemia.

From the side of blood system: aplastic anemia, autoimmune hemolytic anemia, increased time of bleeding, eosinophilia, leucopenia, thrombocytopenia, decrease of hematocrit, thrombocytopenic purpura, agranulocytosis, neutropenia, pancytopenia, bone marrow hypoplasia.

From the side of nervous system: sleepiness or insomnia, weakness, irritation, agitation, headache, visual blurring, cramps.

From the side of sence organs: ringing in the ears, otalgia, sight disorders, reversible loss of the ability to distinguish colors, eye irritation.

Allergic reactions: skin rash, skin itching, face edema, allergic rhinitis, angioneurotic edema, larynx edema, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, urticaria, bullous pemphigus, photosensitivity, asthma, anaphylactic reaction.

Other: disorders of glucose-tolerance in diabetic patients, aseptic meningitis.

Interaction with other drugs and other forms of interaction.

Thiamine, pyridoxine hydrochloride, barbiturates, phenothiazine derivatives, narcotic analgesics, caffeine, dimedrol enhance analgesic effect of the preparation.

In case of concomitant use of mefenamic acid and methotrexate, toxic effects of the latter increase.

Antihypertensives (angiotensin-converting enzyme inhibitors and antagonists ofangiotensin ІІ receptors): decrease of antihypertensive effect.

Diuretics: decrease of diuretic effect. Diuretics can increase nephrotoxicity of NSAIDs.

Cardiac glycosides: NSAIDs can enhance cardiac insufficiency, decrease the rate of glomerular filtration and increase the level of cardiac glycosides in plasma.

Cyclosporines: increased risk of nephrotoxicity development.

Mifepristone: NSAIDs should not be taken for 8-12 days after mifepristone administration, NSAIDs may decrease the action of mifepristone.

Corticosteroids: increased risk of the development of gastrointestinal ulcers and bleedings.

Antiaggregants and selective serotonin re-uptake inhibitors: increased risk of gastrointestinal bleedings.

Fluoroquinolone: NSAIDs increase the risk of cramps development.

Aminoglycosides: NSAIDs increase the risk of nephrotoxic effect development.

Tacrolimus: possible increased risk of nephrotoxic effect development.

Zidovudine: NSAIDs increase the risk of hematologic toxicity development. There is an increased risk of haemorrhage of the joint and hematoma in HIV-positive patients with hemophilia, who receive concomitant treatment with zidovudine.

Lithium preparations: decreased lithium excretion and increased risk of lithium toxicity development.

Mefenamic acid increases the activity of oral anticoagulants, so in case of their concomitant use there is an increases risk of bleedings.

In case of concomitant use of the preparation with other nonsteroidal anti-inflammatory drugs, anti-inflammatory effect of mefenamic acid is enhanced and there is a possibility of side effect development from the side of gastrointestinal tract.

Shelf life. 3 years.

Storage conditions. Keep out of the reach of children, in a dry protected from light place at temperature below 30ºC.

Packing. 10 capsules in a blister; 2 blisters in a carton.

Terms of dispensing. Without prescription.

The date of the last revision.

Name and location of the marketing company. Ananta Medicare Ltd.

Suite 1, 2 Station Court, Imperial Wharf, Townmead Road, Fulham, SW6 2PY, London, United Kingdom.