Mephenamine instructions. Mefenamic acid is the most effective drug for relieving pain and fever during acute respiratory infections and influenza. The ability to influence the reaction rate when driving vehicles or other mechanisms

Attention! The information is provided for informational purposes only. This instruction should not be used as a guide to self-medication. The need for prescription, methods and doses of the drug are determined exclusively by the attending physician.

general characteristics

international and chemical names: mefenamic acid, N-(2,3-dimethylphenyl) anthranilic acid;

basic physical and chemical properties: flat-cylindrical tablets, grayish white with a slightly yellowish or greenish tint (marbling is allowed), odorless;

compound: 1 tablet contains mefenamic acid - 0.5 g;

Excipients: potato starch, methylcellulose, talc.

Release form. Pills.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drugs. ATS code M01A G01.

Pharmacological properties

Pharmacodynamics. Mefenamic acid-Darnitsa has anti-inflammatory, antipyretic and analgesic properties.
Affects phases (Phase- a homogeneous, physically independent and separable part of a complex system) exudation and proliferation (Proliferation(from lat. proles - offspring, offspring and fero - carry) - proliferation of body tissue through new formation (reproduction) of cells. Can be physiological (e.g. normal regeneration, proliferation of mammary gland cells during pregnancy and lactation) and pathological (e.g. tumors)) with inflammation. The mechanism of anti-inflammatory action is due to the ability to inhibit the synthesis mediators (Mediator- a substance that transfers excitation from a nerve ending to a working organ and from one nerve cell to another) inflammation (prostaglandins, serotonin (Serotonin- a derivative of the amino acid tryptophan. It is synthesized mainly in the central nervous system and chromaffin cells of the gastrointestinal tract. A mediator of nerve impulse transmission through a synapse. Neurons of the vertebrate brain, using serotonin as a mediator, are involved in the regulation of many forms of behavior, sleep processes, thermoregulation, etc. As a hormone, serotonin also regulates the motility of the gastrointestinal tract, mucus secretion, causes spasm of damaged blood vessels, etc. ), kinins (Kinins- substances with a wide range of biological activity. Kinins relax vascular smooth muscle, lower blood pressure, increase capillary permeability, cause painful sensations, contract or relax the smooth muscles of isolated organs) etc.), reduce the activity of lysosomal enzymes (Enzymes- specific proteins that can significantly accelerate chemical reactions, occurring in the body without being part of the final reaction products, i.e. are biological catalysts. Each type of enzyme catalyzes the transformation of certain substances (substrates), sometimes only a single substance in a single direction. Therefore, numerous biochemical reactions in cells are carried out by a huge number of different enzymes. Enzyme preparations are widely used in medicine), which take part in the inflammatory response. Mefenamic acid-Darnitsa stabilizes protein ultrastructures and cell membranes, reduces vascular permeability, uncouples oxidative phosphorylation, inhibits the synthesis of mucopolysaccharides, inhibits cell proliferation at the site of inflammation, increases resistance (Resistance- body stability, immunity to any external factors. In particular, nonspecific resistance is called means of innate immunity. The term is more often used in relation to microorganisms (the emergence of mechanisms of immunity to antimicrobial drugs, antibiotics) or plants (to diseases). In relation to humans and animals, the term immunity is more often used) cells and stimulates wound healing.
Antipyretic properties are associated with the ability to inhibit the synthesis of prostaglandins and influence the thermoregulation center. In the mechanism of analgesic action, along with the influence on the central mechanisms of pain sensitivity, a significant role is played by the local effect on the site of inflammation and the ability to inhibit the formation of algogens (kinins, histamine (Histamine- a derivative of the amino acid histidine. Contained in an inactive, bound form in various organs and tissues, it is released in significant quantities during allergic reactions, shock, and burns. Causes dilation of blood vessels, contraction of smooth muscles, increased secretion of hydrochloric acid in the stomach, etc.), serotonin).
Unlike most other non-steroidal anti-inflammatory drugs, Mefenamic acid-Darnitsa stimulates the formation of interferon.

Pharmacokinetics. After oral administration, mefenamic acid is quickly and fairly completely absorbed from the digestive tract. The maximum concentration in the blood is observed 2-4 hours after administration. The blood level is proportional to the dose. The equilibrium concentration (20 mcg/ml) is determined on the 2nd day of use (1 g 4 times a day).
Contacts albumins (Albumin- simple globular proteins contained in blood serum are determined in the laboratory during a biochemical blood test) blood. In the liver it forms metabolites by oxidation, hydrolysis, glucuronidation. Half-life (Half-life(T1/2, synonymous with half-elimination period) - the period of time during which the concentration of a drug in the blood plasma decreases by 50% from the initial level. Information about this pharmacokinetic indicator is necessary to prevent the creation of a toxic or, conversely, ineffective level (concentration) of the drug in the blood when determining the intervals between administrations) from the blood is about 3 hours. It is excreted from the body unchanged and in the form of metabolites mainly by the kidneys (67% of the dose), with feces (20-25%).

Indications for use

Mefenamic acid-Darnitsa is prescribed for the treatment of acute rheumatism, rheumatoid polyarthritis, ankylosing spondylitis (Ankylosing spondylitis– a chronic inflammatory disease of the joints and joints of the spine, especially the sacroiliac, intervertebral joints, costovertebral joints and joints of the vertebral processes, which tends to ankylosis (immobility of the joints)). Used for headaches, toothaches, arthralgia, myalgia (Myalgia- muscle pain caused by spasm, compression, inflammation or muscle ischemia), fever (Fever– a special reaction of the body that accompanies many diseases and is manifested by an increase in body temperature. A febrile reaction most often occurs with infectious diseases, with the introduction of medicinal serums and vaccines, with traumatic injuries, crushed tissue, etc.), infectious-allergic myocarditis (Myocarditis– inflammatory disease of the heart muscle of an infectious, allergic or toxic-allergic nature), dysmenorrhea (Dysmenorrhea- a cyclical pathological process in which severe pain in the lower abdomen appears on the days of menstruation. These pains may be accompanied by other symptoms: general weakness, nausea, vomiting, headache, dizziness, lack of appetite, dry mouth, drooling, bloating, etc.), premenstrual syndrome (Premenstrual syndrome(premenstrual tension syndrome) - cyclical changes in mood and physical condition women, occurring 2-3 days or more before menstruation, disrupting the usual way of life or work and alternating with a period of remission associated with the onset of menstruation, lasting at least 7-12 days), acute respiratory (Respiratory- respiratory, pertaining to breathing) viral infections and influenza.

Directions for use and doses

Mefenamic acid-Darnitsa is taken orally after meals (it is recommended to take it with milk).
Adults and children over 14 years of age are prescribed 0.25-0.5 g 3-4 times a day.
If necessary, the daily dose can be increased to 3 g per day.
After achieving a therapeutic effect, the daily dose is reduced to 1 g.
Children aged 5 to 14 years are prescribed 0.25 g 3-4 times a day.
The duration of the course of treatment is 20-45 days (if necessary - 2 months or more).

Side effect

Nausea, heartburn, diarrhea (Diarrhea- frequent discharge of liquid feces, associated with accelerated passage of intestinal contents due to increased peristalsis, impaired absorption of water in the large intestine and the release of a significant amount of inflammatory secretion by the intestinal wall), abdominal pain, anorexia, flatulence (Flatulence- accumulation of gases in the digestive tract with bloating, rumbling, belching, cramping pain), gastrointestinal bleeding, constipation, general weakness, drowsiness, irritability, insomnia, visual disturbances, albuminuria, allergic reactions ( itching (Itching- a modified feeling of pain caused by irritation of the nerve endings of pain receptors), edema (Edema– tissue swelling as a result of a pathological increase in the volume of interstitial fluid) face, rash, etc.). With prolonged use (2 months or more) may develop hemolytic anemia (Hemolytic anemia– anemia caused by increased hemolysis (destruction of red blood cells), which occurs due to a defect in the structure of red blood cell membranes), decrease in hematocrit, hematopoietic disorders. When the concentration of the drug in the blood is 100-200 mcg/l or higher, muscle twitching, convulsions, and vomiting may be observed.

Contraindications

Peptic ulcer of the stomach and duodenum, inflammatory diseases digestive tract, kidney disease and hematopoietic organs.

Overdose

In case of an overdose, muscle twitching, convulsions, vomiting, and breathing problems may occur.

Features of application

Mefenamic acid-Darnitsa can cause a negative effect on the cardiovascular system of the fetus, therefore its use in pregnant women is not recommended.
The drug is able to penetrate into breast milk, therefore its use during the period lactation (Lactation- secretion of milk from the mammary gland) should be limited.
Caution is required when using the drug in persons with impaired renal function, in patients with bronchial asthma, as well as in persons with a history of gastric and duodenal ulcers.

Interaction with other drugs

When used simultaneously with analgin, the anti-inflammatory effect of Mefenamic acid-Darnitsa increases. Concomitant use with other non-steroidal anti-inflammatory drugs increases the likelihood of side effects from the gastrointestinal tract.
Thiamine, pyridoxine hydrochloride, barbiturates, phenothiazine derivatives, narcotics analgesics (Analgesics- medications that relieve or eliminate pain. Opium preparations, its alkaloids, and their synthetic substitutes are called narcotic analgesics; analgin, paracetamol, acetylsalicylic acid, etc. - non-narcotic analgesics), caffeine, diphenhydramine increase the analgesic effect of the drug. Mefenamic acid-Darnitsa increases activity oral (Orally- route of administration of the drug through the mouth (per os)) anticoagulants.

General Product Information

Conditions and shelf life. Store in a dry place, protected from light and out of reach of children. Shelf life - 5 years.

Vacation conditions. Over the counter.

Package. 10 tablets per blister pack.

Manufacturer.CJSC "Pharmaceutical Firm "Darnitsa".

Location. 02093, Ukraine, Kiev, st. Boryspilskaya, 13.

Website. www.darnitsa.ua

This material is presented in free form on the basis of official instructions for medical use drug.

The drug is produced in the form of tablets containing mefenamic acid – 500 mg + methylcellulose, magnesium stearate, potato starch, croscarmellose sodium, octadecanoic acid.

The medicine is also sold in capsules of 250 or 500 mg mefenamic acid + talc, lactose monohydrate, corn starch, colloidal silicon dioxide, crospovidone, sodium lauryl sulfate, crospovidone.

Another product can be purchased in the form of a powder for preparing medicines.

Release form

Mefenamic acid – white or gray-white powder, bitter in taste, odorless.

The substance is sold in round film-coated tablets, in contour cells of 10 pieces, in cardboard packaging of 10 or 20 tablets.

The product is also available in small, hard gelatin capsules. The lid is light blue, and the body is yellow color. There are 10 capsules in a blister and 2 blisters in a cardboard box.

pharmachologic effect

Anti-inflammatory, analgesic, antipyretic .

Pharmacodynamics and pharmacokinetics

The active substance of the drug is a derivative anthranilic acid , belongs to the group NSAIDs and antirheumatic drugs. Thanks to its chem. properties have analgesic, anti-inflammatory, antipyretic effects.

The drug is able to reduce the intensity of the body's production of specific inflammatory mediators - and. The drug affects both the processes occurring in periphery , and on the central mechanisms of increasing pain sensitivity, reduces activity lysosome proteases .

Mefenamic acid stabilizes protein ultrastructures and cell membranes, relieves swelling and reduces capillary permeability.

The antipyretic effect of the drug is due to the ability of the acid to influence the thermoregulation center in the brain and reduce the synthesis of inflammatory mediators.

The drug also has a moderate antiviral effect, stimulating the production, increasing the content T helper cells , T lymphocytes .

3 hours after oral administration, the active substance reaches a maximum concentration of . There is a linear relationship between the dose taken and the drug concentration in . The medicine binds very well to proteins and undergoes reactions in the liver.

The half-life ranges from 120 to 240 minutes. The product is excreted in feces and urine.

Indications for use

The drug has a fairly wide range of applications:

  • acute respiratory infections , viruses , ;
  • diseases musculoskeletal system , ;
  • primary and dysfunctional menorrhagia ;
  • pain, inflammation after operations and injuries.

Also mefenamic acid prescribed at temperature and.

Contraindications

The product is contraindicated:

  • when on its components;
  • if after taking or other NSAIDs the patient developed bronchospasm , or ;
  • combine with specific COX-2 inhibitors ;
  • at or duodenum , including medical history;
  • pregnant and lactating women;
  • for inflammatory bowel diseases, diseases of the hematopoietic organs;
  • children under 5 years old;
  • if the patient suffers from severe heart failure, liver or kidney disease;
  • at perforation or gastrointestinal bleeding.

The medicine is prescribed with caution to patients ulcerative colitis And Crohn's disease (and medical history).

Elderly people are at risk and are more likely to develop side effects increases significantly.

Side effects

Mefenamic acid may cause:

  • , weakness, irritability, convulsions , blurred vision;
  • pain in the abdomen or stomach, nausea, vomiting;
  • increased liver levels;
  • , enterocolitis , jaundice , ;
  • increase, ;
  • , peptic ulcers without bleeding or with bleeding;
  • dyspnea ,bronchospasm ;
  • skin rashes, peripheral edema, Stevens-Johnson syndrome , photosensitivity , anaphylaxis ;
  • rarely – congestive heart failure, swelling of the periphery , heartbeat, ;
  • capillary necrosis , polyuria ;
  • aseptic meningitis , violation of tolerance to glucose in patients;
  • , dysuria , hematuria , nephrotic syndrome ;
  • aplastic anemia , decreased blood clotting, leukopenia , thrombocytopenia ,pancytopenia , neutropenia ;
  • hyponatremia , hyperkalemia , ;
  • ringing in the ears, loss of color vision (reversible), eye irritation.

Instructions for Mefenamic acid (method and dosage)

The medicine is prescribed orally, after meals.

It is not advisable to split the capsules; it is better to swallow them whole.

Adults are usually prescribed 250 or 500 mg of the drug 3-4 times a day. The maximum daily dosage is 3 grams. As a rule, after achieving the desired effect, the daily dosage is reduced to one gram.

The course of treatment is determined by the attending physician. For example, for fever or for the treatment of pain, the duration of therapy is up to 7 days. The course of treatment for joint diseases ranges from 20 to 60 days.

Instructions for Mefenamic acid for children

The drug should not be prescribed to children under 5 years of age.

The dosage for children aged 5 to 12 years should not exceed one gram. As a rule, take 250 mg 3 or 4 times a day.

The course of treatment is determined by the doctor.

Overdose

In case of overdose the following symptoms are observed: abdominal pain, nausea, vomiting, gastrointestinal bleeding , respiratory depression, convulsions, decreased...

The medicine is not specific. As therapy, gastric lavage is indicated, taking enterosorbents , forced, acidification of urine. Methotrexate .

Combined use with cardiac glycosides may increase the degree of heart failure, increase the level glycosides in blood.

Diuretics and increase nephrotoxicity mefenamic acid , the diuretic effect of diuretics .

The interval between reception and Meth. acids should be at least 8-12 days.

When combining the drug with corticosteroids , selective serotonin reuptake inhibitors or antiplatelet agents the risk of developing gastrointestinal bleeding increases and perforations .

Caution should be exercised when combining medication with lithium preparations , zidovudine , oral anticoagulants , others NSAIDs .

Terms of sale

No prescription required.

Storage conditions

Store capsules in a dark, cool place, at a temperature no higher than 30 degrees.

Best before date

The shelf life of the powder for the preparation of dosage forms is 5 years.

special instructions

For skin rashes, damage to the mucous membrane or other manifestations hypersensitivity reactions acids should be discontinued and consult a doctor.

Taking the drug may cause problems fertility in women, so it should not be prescribed to women who are trying to conceive.

While taking the medicine, it is best to refrain from driving or operating machinery.

In order to reduce the likelihood of developing side effects from the gastrointestinal tract, it is recommended to take tablets or capsules with milk.

Analogs

Genospa, Mefenamic acid-Darnitsa .

For children

The drug is contraindicated for children under 5 years of age.

Mefenamic acid Children from 5 to 12 years old are prescribed a daily dosage of no more than 1 gram. Usually they drink 250 mg 3-4 times a day. The duration of the appointment is determined by the doctor.

Mefenamic acid (Acidum mefenamicum)

Compound

The active substance is mefenamic acid.
1 tablet contains acidum mefenamicum - 500 mg
Excipients: potato starch, methylcellulose, croscarmellose Na, octadecanoic acid, magnesium stearate.

pharmachologic effect

Mefenamic acid belongs to the group of NSAIDs and is a derivative of anthranilic acid, has analgesic, anti-inflammatory and antipyretic properties. Inhibits the synthesis of prostaglandins and serotonin, providing an anti-inflammatory effect. It affects both the central mechanisms of pain sensitivity and the peripheral ones, causing a decrease in local inflammation in the area. Stabilizes protein structures and cell membranes, reducing the permeability of the vascular wall. Reduces cell proliferation in the inflammatory focus, which stimulates healing.
The antipyretic effect is due to the effect on the thermoregulation center and a decrease in the production of prostaglandins.

Antiviral effect – stimulates the formation of interferon, increases the ratio of T-helper cells, increases the activity of T-lymphocytes.
When taken orally, the drug is quickly absorbed into the gastrointestinal tract. The peak is observed after 2-4 hours, the increase in blood concentration is directly proportional to the dose taken. There is a high connection with blood proteins (albumin) up to 90%. Metabolized in the liver. Period T ½ 120-240 minutes. Eliminated in urine and partially in feces.

Changes in the respiratory system are accompanied by bronchospasm and dyspnea.
Changes in the urinary system: dysuric manifestations, nonspecific inflammation of the kidneys, impaired renal function, albuminuria, hematuria.
CNS changes: very rarely, sleep disturbance and irritability.
Allergic reactions are manifested by hives and skin rashes.

Contraindications

- Individual intolerance to the drug;
- peptic ulcer of the stomach and duodenum;
- inflammatory processes of the gastrointestinal tract;
- dysfunction of the liver and kidneys;
- blood diseases;
- pregnancy;
- lactation period;
- children's age group up to 5 years.

Pregnancy

Pregnancy and breastfeeding are contraindications for the use of mefenamic acid.

Drug interactions

Mefenamic acid affects platelet function, which may enhance the effect of anticoagulant therapy and vitamin K antagonists.
Dicoumarin, opioid analgesics, vitamin B6, B1, phenothiazine derivatives can enhance the effect of mefenamic acid.
Methotrexate has more pronounced negative effects when taken simultaneously with mefenamic acid.

NSAIDs, warfarin in combination with the use of mefenamic acid increase the risk of developing gastrointestinal disorders.
Antacids increase the bioavailability of mefenamic acid, which increases its side effects.

Overdose

Mefenamic acid in overdose has a strong tendency to provoke acute erosions or ulcers of the gastrointestinal mucosa, and in rare cases, tonic-clonic convulsions. Treatment: symptomatic therapy, sorbents, gastric lavage, forced diuresis, urine alkalization. There is no specific antidote. Hemodialysis is not effective due to the strong connection of the drug with albumin.

Release form

Tablets p/o 500 mg in contour cells No. 10.
Cardboard packaging No. 10, No. 20.

Storage conditions

Stored at temperature conditions no more than 25 degrees Celsius.

Active substance:

Mefenamic acid

Additionally

Mefenamic acid should not be used in patients who are allergic to aspirin or NSAIDs, have had heart surgery, have severe heart failure, ulcers, intestinal perforations, or severe liver cirrhosis.
Patients who may experience complications during treatment: the elderly, manifestations of dehydration, epilepsy, allergies, asthma, risk of stroke, angina pectoris, circulatory disorders, diabetes mellitus, bleeding disorders, porphyria, or decreased liver or kidney function. These situations may require dose reduction or treatment changes.

To reduce irritation of the gastric mucosa, the dose of the drug may be reduced, and it is also recommended to take mefenamic acid with meals.
Therapy with the drug should be discontinued if symptoms of diarrhea or skin rashes occur.
With long-term therapy, it is necessary to monitor blood counts and liver and kidney function.
Mefenamic acid reduces the rate of reactions and driving is not recommended during therapy. Not applicable to children under 5 years of age.

Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Consumers are aware of numerous anti-inflammatory and pain-relieving drugs that they actively use. Only a small number of people know that mefenamic acid has similar properties, which perfectly relieves pain, helps fight the flu and has a wide spectrum of action.

What are mefenamic acid tablets for?

The drug mefenamic acid, the indications for which are very extensive, allows you to quickly relieve unpleasant symptoms. Dosage form prescribed for:

  • ARVI and influenza infection (as a complex treatment);
  • pain of various origins;
  • swelling, pain, inflammatory process after surgery or injury;
  • rheumatism, ankylosing spondylitis, arthritis;
  • large blood loss during menstruation;
  • high temperature (fever);
  • pain during menstruation (dysmenorrhea).

Mefenamic acid at temperature

Among the large number of medications that reduce high fever, mefenamic acid has a special place. She not only copes with the task “perfectly” in a short time, but also relieves any pain at the same time. In addition, the medicine reduces the temperature of both adults and children, so it is an excellent remedy for a home first aid kit.

Mefenamic acid for colds

Although the remedy helps with various ailments, it is most often prescribed for colds. The use of mefenamic acid in acute and subacute periods significantly facilitates the course of the disease and leads to rapid recovery and restoration of the body. This remedy affects immune system, giving her an impetus to activate. It is important to start taking pills as early as possible, as soon as you feel unwell. In this case, complications after the disease are much less common, and the effect of use is more pronounced.


When using mefenamic acid in treatment, it is important to drink it correctly. After all, like most drugs, it has its own characteristics. The use of mefenamina, as it is also called, is allowed only after meals in order to minimize possible negative effects on the digestive system. The second, important condition is to take the tablet not with water, but with milk. This refers to precautions - the stomach, especially in children and sensitive people, tolerates treatment better this way. If the patient does not drink milk or is intolerant to this product, then it can be replaced with water.

Mefenamic acid, the use of which is effective for different age categories, naturally also has contraindications, which include:

  • individual increased sensitivity to the composition of mefenamic acid;
  • patient age is less than 5 years;
  • disease of the kidneys, stomach (ulcer), and liver;
  • period of lactation and pregnancy;
  • tendency to Quincke's edema;
  • intestinal inflammation.

In addition to contraindications, this highly effective remedy has some side effects. Before taking the pills, you should read this list to be fully prepared, especially if you are taking the medicine for the first time:

  • indigestion - bloating, nausea, belching;
  • pain in the pit of the stomach or in the stomach area;
  • indigestion;
  • high arterial pressure, edema, tachycardia, arrhythmia;
  • bronchospasm and shortness of breath;
  • anemia and other abnormalities in the blood picture;
  • kidney inflammation, hematuria, disturbances in the urinary system;
  • sleep disorder and irritability;
  • all kinds of skin rashes, including urticaria.

Mefenamic acid - dosage

The effect of any medicine will be more effective if it is taken according to the instructions or doctor's prescription. The dosage of mefenamic acid depends on the age of the patient. There are two forms of release - tablets of 250 mg and 500 mg. Adults and children over 12 years of age are prescribed 250-500 mg 3-4 times a day. If there are no side effects and there is a need to increase the dosage, it is increased to 3000 mg or 6 tablets of 500 mg. After visible improvements have occurred, the dosage is reduced to 1000 mg. Children aged 5 to 12 years are prescribed a dosage of 250 mg 3-4 times a day.

Paracetamol and mefenamic acid

There are situations when the temperature stubbornly persists and does not want to decrease. If no changes occur within an hour after taking mefenamic acid, some doctors recommend taking half the dose of paracetamol. This applies only to adults; such a combination of drugs is undesirable for children, although these two drugs belong to different groups, and enhance each other's influence. However, children should avoid their simultaneous use.

If it turns out that an overdose has occurred, then traditional symptomatic therapy is carried out:

  • gastric lavage;
  • accelerated diuresis;
  • reception of sorbents.

Mefenamic acid - trade names

The drug mefenamic acid may be included in the composition as the main active substance into medicines under different names. They are sold in pharmacy outlets under the following names:

  • Mefenamic acid tablets:
  • Mefenaminka;
  • mefenamic acid capsules;
  • mephenamine sodium salt.

Mefenamic acid – analogues


active substance: mefenamic acid;

1 capsule contains mefenamic acid B.F. 250 mg or 500 mg;

Excipients:

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

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

Dosage form

Hard gelatin capsules of size “0”, with a light blue cap and a light yellow body, or vice versa, the contents of the capsules are white or almost white powder.

Manufacturer name and location

Flamingo Pharmaceuticals Ltd.

7/1, Corporate Park, Sion-Trombai Road, Chembur, Mumbai - 400071, India.

E-28, MIDS, Taloja, Mumbai 410 208, India.

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

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

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory and antirheumatic drugs. Fenamati. ATS code M01A G01.

Non-steroidal anti-inflammatory drug (NSAID). Has anti-inflammatory, analgesic and antipyretic effects. Inhibits the synthesis of inflammatory mediators (prostaglandin, serotonin, kinins), reduces the activity of lysosome proteases involved in the inflammatory response. Affects the phases of exudation and proliferation. Stabilizes protein ultrastructures and cell membranes, reduces vascular permeability and tissue swelling. Inhibits cell proliferation at the site of inflammation, increases cell resistance and stimulates wound healing. The antipyretic effect is due to the inhibition of prostaglandin synthesis and the effect on the thermoregulation center. Stimulates the formation of interferon.

After oral administration, it is quickly and almost completely absorbed from the digestive tract. The maximum concentration in the blood is reached after 2-4 hours. The blood level is proportional to the dose. In the vascular bed it binds to albumin. The half-life is 3 hours. Forms a number of metabolites in the liver. 67% of the dose taken is excreted unchanged in the urine, 20-25% in feces.

Indications for use

Acute respiratory viral infections and influenza.

Primary dysmenorrhea. Dysfunctional menorrhagia.

Inflammatory diseases of the musculoskeletal system: rheumatoid arthritis, rheumatism, ankylosing spondylitis.

Pain syndrome of low and medium intensity: muscle, joint, traumatic, dental, headaches of various etiologies, postoperative and postpartum pain.

Contraindications

Hypersensitivity to the components of the drug. Bronchospasm, Quincke's edema, rhinitis, bronchial asthma or a history of urticaria that occurred after the use of acetylsalicylic acid or other NSAIDs. Simultaneous administration of specific COX-2 inhibitors. Peptic ulcer of the stomach and duodenum, present or in history, inflammatory bowel diseases, diseases of the hematopoietic organs, severe heart failure, severe liver or kidney dysfunction, gastrointestinal bleeding or perforation caused by taking non-steroidal anti-inflammatory drugs.

Proper safety precautions for use

The drug is prescribed with caution to patients with acute cardiovascular failure, arterial hypertension, coronary disease hearts.

The drug is prescribed with caution to patients with epilepsy.

For moderate impairment of liver or kidney function, there are no special recommendations regarding the use of the drug.

NSAIDs should be taken with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), since exacerbation of the disease is possible.

Elderly patients usually have an increased risk of developing side effects from the gastrointestinal tract, so treatment should be started with the lowest dosage.

Patients with systemic lupus erythematosus and mixed connective tissue diseases may be at increased risk of aseptic meningitis.

Mefenamic acid should be discontinued at the first appearance of skin rash, mucosal damage, or any other manifestation of hypersensitivity.

Taking mefenamic acid may impair female fertility and is not recommended for women who are trying to conceive.

Mefenamic acid 250 mg capsules contain lactose, so patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.

Use during pregnancy or breastfeeding

The drug is not used by women during pregnancy.

The drug is not used by women during breastfeeding.

The ability to influence the reaction rate when driving a vehicle or working with other mechanisms.

You should be careful when driving vehicles or working with mechanisms that require increased attention, as sometimes the use of the drug can cause drowsiness, blurred vision, and convulsions.

Children

The drug is contraindicated in children under 5 years of age.

Directions for use and doses

Used orally, the drug is taken after meals.

Adults and children over 12 years of age are prescribed 250-500 mg 3-4 times a day. If necessary, the daily dose can be increased to 3 g per day. After achieving a therapeutic effect, the daily dose should be reduced to 1 g.

Children aged 5 to 12 years are prescribed 250 mg 3-4 times a day.

The course of treatment for joint diseases can last from 20 days to 2 months or more. When treating pain syndrome, the course of treatment lasts up to 7 days.

Overdose

Symptoms: pain in the epigastric region, nausea, vomiting, drowsiness. In severe cases - gastrointestinal bleeding, respiratory depression, arterial hypertension, twitching of individual muscle groups, coma.

Treatment: There is no specific antidote. Gastric lavage with suspension activated carbon. Urine leakage, forced diuresis. Symptomatic therapy. Hemosorption and hemodialysis are ineffective due to the strong binding of mefenamic acid to blood proteins.

Side effects

From the gastrointestinal tract: epigastric pain, anorexia, heartburn, nausea, flatulence, vomiting, enterocolitis, colitis, steatorrhea, cholestatic jaundice, hepatitis, pancreatitis, hepatorenal syndrome, hemorrhagic gastritis, peptic ulcer with/or without bleeding. Gastrointestinal bleeding, dyspepsia, constipation, diarrhea. Increased levels of liver enzymes in blood plasma.

From the cardiovascular system: arterial hypertension, arrhythmia, rarely - congestive heart failure, peripheral edema, syncope, arterial hypotension, palpitations, shortness of breath.

From the respiratory system: dyspnea, bronchospasm.

From the urinary system: dysuria, cystitis. Impaired renal function, albuminuria, hematuria, oliguria or polyuria, renal failure, including papillary necrosis, acute interstitial nephritis, nephrotic syndrome, allergic glomerulonephritis, hyponatremia, hyperkalemia.

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

From the nervous system: drowsiness or insomnia, weakness, irritability, agitation, headache, blurred vision, convulsions.

From the senses: ringing in the ears, otalgia, visual disturbances, reversible loss of color vision, eye irritation.

Allergic reactions: skin rashes, itchy skin, facial swelling, allergic rhinitis, angioedema, laryngeal edema, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, urticaria, bullous pemphigus, photosensitivity, asthma, anaphylaxis.

Others: impaired glucose tolerance in patients with diabetes mellitus, aseptic meningitis.

Interaction with other drugs and other types of interactions

Thiamine, pyridoxine hydrochloride, barbiturates, phenothiazine derivatives, narcotic analgesics, caffeine, diphenhydramine increase the analgesic effect of the drug.

When used concomitantly with mefenamic acid and methotrexate the toxic effects of methotrexate are enhanced.

Antihypertensives (ACE inhibitors and angiotensin II receptor antagonists): decreased antihypertensive effect.

Diuretics: decreased diuretic effect. Diuretics may increase the nephrotoxicity of NSAIDs.

Cardiac glycosides: NSAIDs may worsen heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides. Cyclosporini: increased risk of developing nephrotoxicity.

Mefipristone: NSAIDs should not be taken within 8-12 days after taking mefipristone; NSAIDs may reduce the effect of mefipristone.

Corticosteroids: increased risk of developing gastrointestinal ulcers and bleeding. Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

Fluoroquinolones: NSAIDs increase the risk of seizures. Aminoglycosides: NSAIDs increase the risk of nephrotoxicity. Tacrolimus: there may be an increased risk of developing a nephrotoxic effect.

Zidovudine: NSAIDs increase the risk of hematological toxicity. The risk of joint hemorrhage and hematoma increases in HIV-positive hemophiliacs who are simultaneously treated with zidovudine.

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

Mefenamic acid increases activity oral anticoagulants, therefore, their simultaneous use increases the risk of bleeding.

Concomitant use with other non-steroidal anti-inflammatory drugs increases the anti-inflammatory effect and the likelihood of side effects from the gastrointestinal tract.

Best before date

Storage conditions

Store out of reach of children, in a dry, dark place at a temperature not exceeding 30 °C.