Plenolagin - instructions for use, dose, side effects, contraindications

Excipients: calcium hydrophosphate 100 mg, corn starch 25.645 mg, sodium carboxymethyl starch 30 mg, povidone 8 mg, talc 5 mg, magnesium stearate 5 mg, silicon dioxide colloid 1 mg.

** pawn with a 5% excess to compensate for losses in the production process

Description:

Round flat cylindrical tablets of white color with a risk.

Pharmacotherapeutic group:Analgesic combined (analgesic non-narcotic remedy + antispasmodic)

ATX: & nbsp

N.02.B.B.52 Metamizole sodium in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Megamizol sodium, a derivative of pyrazolone, has an analgesic, antipyretic and weak anti-inflammatory effect, the mechanism of which is associated with inhibition of prostaglandin synthesis due to nonselective inhibition of cyclooxygenase.

Pitophenone - myotropic antispasmodic - has a direct effect on the smooth muscles of the internal organs, causing it to relax.

Fenpiverinia bromide - m-holinoblokator has an additional spasmolytic effect on smooth muscles.

Pharmacokinetics:

Metamizole sodium is well and quickly absorbed from the gastrointestinal tract (GIT). In the intestinal wall it hydrolyzes with the formation of an active metabolite - unchanged metamizol sodium in the blood is absent (only after intravenous administration, its insignificant concentration is detected in the plasma). The association of the active metabolite with plasma proteins is 50-60%. Metabolized in the liver, excreted by the kidneys. In therapeutic concentrations penetrates into breast milk.

Pitophenone is rapidly absorbed from the digestive tract; the maximum concentration in the plasma is reached within 30-60 minutes; quickly distributed in organs and tissues and quickly removed with urine. The half-life is 1.8 hours.

Fentiverinia bromide is rapidly absorbed! from the gastrointestinal tract and reaches a maximum concentration in the blood plasma for 1 hour. It is excreted by the kidneys 32,4-40,4 % in unchanged form, intestine - 2,5-5,3%.

Indications:Plenolgin is effective for mild or moderate pain syndrome, with spasms of smooth muscles of the internal organs: biliary colic, spasms of smooth muscles of the gastrointestinal tract, dyskinesia of the bile ducts in the hyperkinetic type, algodismenorea.

Contraindications:

-hypersensitivity to the drug components (as well as to other pyrazolone derivatives);

- severe dysfunction of the liver and / or kidney;

- decompensation of chronic heart failure;

- severe angina;

- tachyarrhythmia;

- deficiency of glucose-6-phosphate dehydrogenase;

- angle-closure glaucoma;

- hyperplasia of the prostate (with clinical manifestations);

- oppression of bone marrow hematopoiesis (in granulocytopenia);

- intestinal obstruction;

- megacolon;

- collapse;

- acute porphyria;

- pregnancy and lactation;

- children's age (up to 8 years).

Carefully:

- renal and / or hepatic insufficiency of mild and moderate degree;

- propensity to arterial hypotension, bronchospasm;

increased sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics (incl.an indication in the history of a complete or incomplete combination of bronchial asthma, nasal polyposis and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs).

Pregnancy and lactation:The use of the drug during pregnancy and during breast-feeding is contraindicated.

Dosing and Administration:

Inside, not liquid, squeezed a small amount of liquid.

Adults and adolescents older than 15 years - 1-2 tablets 2-3 times a day; the maximum daily dose should not exceed 6 tablets.

Children 13-15 years: 1 tablet 2-3 per day.

Children 8-12 years: 1/2 tablet 2-3 times a day.

The course of treatment should not exceed 5 days.

Side effects:

Allergic reactions: skin rash, itching, urticaria (including conjunctiva, and mucous membranes of the nasopharynx), angioedema; malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, anaphylactic shock.

From the central nervous system: headache, dizziness.

From the side of the organ of vision: blurred vision, paresis of accommodation.

From the digestive system: dry mouth, heartburn, constipation.

From the urinary system: - renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, urine staining red (due to metamizol sodium metabolites), difficulty urinating.

From the cardiovascular system: decrease in arterial pressure, tachycardia, cyanosis.

From the hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis (unmotivated rise in body temperature, chills, sore throat, soreness on swallowing, stomatitis, as well as the development of vaginitis or proctitis phenomena may manifest as the following symptoms).

Overdose:

Cases of overdose are possible if the dosage regimen specified in the section "Method of administration and dose" is not followed.

Symptoms: dry mouth, nausea, vomiting, abdominal pain, lowering blood pressure, impaired sweating, drowsiness, paresis of accommodation, confusion, impaired liver and kidney function, convulsions.

Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.

Interaction:

Radiocontrast agents, colloidal blood substitutes and penicillin should not used during treatment with drugs containing metamizol sodium.

With the simultaneous use of metamizole sodium with cyclosporine decreases the concen- tration of the latter in the blood.

Metamizole sodium, displacing from the connection with plasma proteins, oral hypoglycemic medicines, indirect anticoagulants, glucocorticosteroids and indomethacin increases their effect.

Phenylbutazone, barbiturate and other inducers of microsomal liver enzymes at simultaneous use reduce the effectiveness of metamizole sodium.

Simultaneous use with non-narcotic analgesics, tricyclics antidepressants, hormonal contraceptives and allopurinol may cause to increase the toxicity of metamizole sodium.

Sedation and anxiolytic drugs (tranquilizers) enhance analgesic effect of metamizole sodium.

Thiamazole and cytostatics increase the risk of developing leukopenia against the background of preparations containing metamizol sodium.

The effect of sodium metamizole increases codeine, H2-histamine receptor blockers and propranolol (slows metabolism).

Myelotoxic drugs increase manifestations of hematotoxicity metamizole sodium.

Derivatives of butyrophenone, phenothiazine, tricyclic antidepressants, blockers H2-gistaminovyh receptors, amantadine and quinidine strengthen m-holinoblocking action fenpiverinia bromide.

With simultaneous application fenpiveriniya bromide minutes phenothiazine derivatives (e.g., chlorpromazine) developing severe hyperthermia may occur.

Metamizole sodium enhances the effect of ethanol.

Special instructions:

During treatment with the drug is not recommended to take ethanol.

In patients receiving Plenalgina (due to contained therein Metamizole) may develop agranulocytosis, and therefore, the detection of unmotivated lifting fever, chills, sore throat, difficulty swallowing, stomatitis, phenomena of vaginitis, or proctitis, as well as the detection of thrombocytopenia required immediate cancellation of the drug.

Acceptance of the drug in patients with atopic asthma and hay fever increases the risk of allergic reactions.

It is unacceptable (to determine the causes of pain) use of the drug for the purpose of relief of acute abdominal pain.

Effect on the ability to drive transp. cf. and fur:Care should be taken during vehicle administration for drivers of vehicles and for persons involved in potentially hazardous activities that require an increased concentration of attention and speed of the psychomotor reaction.

Form release / dosage:

For 10 tablets in a blister of PVC / aluminum. 1.2 or 10 blisters in a cardboard box with instructions for use.

Packaging:blister (1) / One blister in a cardboard bundle along with instructions for use ./- Cardboard tutu (10)
blister (10) / Ten blisters in a cardboard pack together with instructions for use ./- Cardboard tutu
blister (2) / Two blisters in a cardboard bundle together with instructions for use / -Carton pack

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001007

Date of registration:18.10.2011

The owner of the registration certificate:Plethiko Pharmaceuticals Co., Ltd. Plethiko Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

PLETHICO PHARMACEUTICALS, Ltd. India

Representation: & nbspREZLOV ZAO REZLOV ZAO Kazakhstan

Information update date: & nbsp18.10.2011

Illustrated instructions

Instructions

Plenlangin (Plenalgin)