LABDIC

Instructions for use of the medicinal product

Trade name of the drug : Labdic.

Active ingredient (INN) : Polycomponent agent.

Dosage form : tablets.

Compound

One tablet contains:

active substances : diclofenac sodium BP 50 mg

paracetamol BP 500 mg

magnesium trisilicate BP 100 mg

chlorphenamine maleate BP 4 mg

excipients: fillers qs

Pharmacotherapeutic group and ATC code : Diclofenac sodium - non-steroidal anti-inflammatory drugs (NSAIDs), (M01AB05);

Paracetamol - analgesic and antipyretic (N02BE01);

Magnesium trisilicate - (A02AA05);

Chlophenamine maleate is a histamine H1 receptor antagonist (R06AB04).

Pharmacological properties

Pharmacodynamics

Diclofenac sodium is an NSAID that performs anti-inflammatory, analgesic and antipyretic functions. The mechanism of action of diclofenac sodium is not fully understood, but it may be related to inhibition of prostaglandin synthetase.

Paracetamol is a non-narcotic analgesic/antipyretic with analgesic, antipyretic and mild anti-inflammatory effects. Inhibits the synthesis of COX, mainly in the central nervous system, affecting the centers of pain and thermoregulation. A slight effect on the formation of prostaglandins in peripheral tissues causes pracetamol to have no negative effect on water-salt metabolism (sodium and water retention in the body) and the mucous membrane of the digestive tract.

Magnesium trisilicate has adsorbing, coating and anti-acid properties.

Chlorphenamine maleate is a blocker of histamine H1 receptors, has an antiserotonin, antihistamine, weak anticholinergic, sedative effect. Reduces the severity of allergic reactions mediated by the action of histamine, reduces capillary permeability, constricts blood vessels.

Pharmacokinetics

Diclofenac sodium is well absorbed after oral administration, its maximum plasma concentrations are usually reached after 2-3 hours. Absorption occurs more rapidly when the drug is taken on an empty stomach. The plasma half-life is about 2-3 hours. It should be noted that the half-life of diclofenac sodium from synovial fluid is approximately three times the half-life of diclofenac sodium from plasma. Excreted 65% - through the urine and approximately 35% - in the bile, as the compound diclofenac sodium in unchanged form plus metabolites.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract, mainly in the small intestine. After a single dose of 500 mg, the maximum plasma concentration reaches 10-60 minutes. About 25% of paracetamol binds to blood proteins. The plasma half-life is about 2 hours after oral administration. It is metabolized by the microsomal enzymatic system of the liver. The elimination half-life varies from 1 to 4 hours.

Magnesium trisilicate , under the influence of gastric juice, in the stomach passes into a gel-like state, forming hydrogenated silicone dioxide, which serves as an adsorbent for toxins, protects the surface of the ulcer from the digestive influence of pepsin and hydrochloric acid. The antacid action of magnesium trisilicate is carried out slowly: the neutralization of hydrochloric acid occurs without the formation of gases and a subsequent increase in the secretion of gastric juice.

Chlorphenamine maleate after oral administration is relatively slowly absorbed from the gastrointestinal tract. Cmax reaches in 2.5-6 hours. Bioavailability is low - 25-50%. It undergoes a "first pass" effect through the liver. Plasma protein binding is about 70%. Chlorphenamine is widely distributed in the organs and tissues of the body, penetrates into the central nervous system. Intensively metabolized in the liver. The unchanged drug and its metabolites are excreted primarily in the urine. Excretion is dependent on urine pH and urine flow rate. In feces, only trace amounts of chlorphenamine are determined. Chlorphenamine is characterized by significant interindividual variability in pharmacokinetic parameters: T 1-2 varies from 2 to 43 hours. In children, there is a faster absorption of chlorphenamine, a higher clearance and a shorter T1 / 2.

Indications for use

Feverish syndrome (colds and infectious diseases), sinusitis, rhinorrhea (acute rhinitis, allergic rhinitis);

Headache, periodic toothache, post-traumatic pain due to sprains, strains and bruises;

Rheumatism, arthritis, lumbago, sciatica, bursitis, spondylosis;

Infectious diseases and SARS.

Contraindications

Hypersensitivity to any of the components of the drug, severe atherosclerosis of the coronary arteries, arterial hypertension (severe course), diabetes mellitus (severe course), serious liver disease, pregnancy, lactation, children under 12 years of age.

Dosage and administration

Method of application: inside, the tablets should be swallowed whole, without chewing, with a sufficient amount of liquid.

Dosage regimen: for adults and children over 12 years old, 1 tablet every 6-8 hours. The maximum daily dose is 4 tablets. The course of treatment is not more than 7 days.

Side effects

Allergic reactions (urticaria, angioedema); nausea, stomach pain; anemia, thrombocytopenia, agranulocytosis; irritability, dizziness, increased blood pressure, sleep disturbance; mydriasis, paresis of accommodation, increased intraocular pressure, dry mouth, urinary retention.

With prolonged use in high doses - hepatotoxic or nephrotoxic effects, hemolytic or aplastic anemia.

special instructions

Control of indicators of peripheral blood and the functional state of the liver. During the treatment period, it is contraindicated to take sleeping pills and tranquilizers. Do not take with medicines containing paracetamol.

The drug is contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

When taking the drug, it is desirable to refrain from driving vehicles and other mechanisms.

Combining this drug with alcohol may increase the risk of stomach bleeding.

Interaction with drugs

Enhances the effects of MAO inhibitors, sedative drugs, ethanol, potassium-sparing diuretics, digoxin.

Antidepressants, antiparkinsonian and antipsychotic drugs, incl. phenothiazine derivatives increase the risk of urinary retention, dry mouth, and constipation.

Glucocorticosteroids increase the risk of developing glaucoma.

Chlorphenamine in combination with MAO inhibitors, incl. furazolidone, can lead to a hypertensive crisis, excitation.

Storage conditions

Store in a dry and dark place, at a temperature not exceeding 25°C.

Keep out of reach of children.

Best before date

3 years. Do not use after the expiration date.

Release form

10 tablets / blister / instructions for use / packaging.

Terms of dispensing from pharmacies

On prescription.