Maxigan

Metamizole sodium + Pitofenone + Fenpiverinium bromide.

Sodium metamizole ((1,5-dimethyl-3-oxo-2-phenyl-2,3-dihydro-1-H-pyrazol-4-yl) (methyl) amino) sodium methanesulfonate, monohydrate. Pitofenone hydrochloride. Methyl ether 2-(4-[2-(1-piperidyl)ethoxy] benzoyl) benzoic acid hydrochloride. Fenpiverinium bromide 1-(3-carbamoyl-3,3-diphenylpropyl)-1-methylpiperidinium bromide.

tablets.

Each tablet contains:
active ingredients: metamizole sodium - 500 mg,
pitofenone hydrochloride - 5 mg,
fenpiverinium bromide - 0.1 mg;
excipients:
pregelatinized starch - 25.0 mg,
lactose monohydrate - 134.9 mg,
colloidal silicon dioxide - 3.0 mg,
magnesium stearate - 6.0 mg, talc - 6.0 mg.

white or off-white round, flat, bevelled tablets with scoreline. A slight white off color is allowed.

analgesic non-narcotic and antispasmodic agent.

ATC Code: N02BB52

Pharmacodynamics
The agent composition includes: non-narcotic analgesic metamizole sodium, myotropic antispasmodic agent pitofenone and m-anticholinergic agent fenpiverinium bromide.
Metamizole is a pyrazolone derivative. It has analgesic, antipyretic and anti-inflammatory effects. Pitofenone, like Papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation.
Fenpiverinium due to its m-anticholinergic effect has an additional relaxing effect on smooth muscles.
The combination of the three agent components results in pain relief, relaxation of smooth muscles, and a fever decrease.
Pharmacokinetics
Metamizole sodium is well and quickly absorbed in the gastrointestinal tract. It is hydrolyzed with the formation of an active metabolite in the intestinal wall: the unchanged sodium metamizole is absent in the blood (its insignificant concentration is found in the plasma only after intravenous administration). The connection of the active metabolite with proteins is 50-60%. It is metabolized in the liver, excreted by the kidneys. It passes into the breast milk in the therapeutic doses.
After peroral administration of pitofenone it is rapidly reabsorbed from the gastrointestinal tract. The maximum plasma concentration is reached within 30-60 minutes and is 0.34 - 1 mMol/L. It is excreted in the urine. The half-life is 1.8 hours.
Fenpiverinium bromide is rapidly absorbed from the gastrointestinal tract and reaches its maximum concentration in blood plasma within 1 hour.
It is excreted by the kidneys 32.4 - 40.4% unchanged, 2.5 - 5.3% of the substance is excreted in the bile.

Weak or moderate pain syndrome with spasms of smooth muscles of internal organs; renal and hepatic colic, spastic pain along the intestines, algodysmenorrhea. It can be used for short-term symptomatic treatment of joint pain, neuralgia, sciatica, myalgia.
As an adjuvant agent it can be used to relieve pain after the surgical and diagnostic interventions.
If necessary the agent can be used to reduce elevated body temperature in case of colds and infectious as well as inflammatory diseases.

Hypersensitivity to pyrazolone derivatives and other agent components. Bone-marrow hemopoiesis supression, stable and unstable angina pectoris, chronic heart failure in the decompensation stage, hepatic and/or renal failure; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmias; angle-closure glaucoma; hyperplasia of the prostate with a tendency to urinary retention; intestinal obstruction and megacolon; bronchial asthma, urticaria or acute rhinitis provoked by the intake of acetylsalicylic acid, salicylates and other non-steroidal anti-inflammatory drugs, granulocytopenia, pregnancy; lactation period. Maxigan® in this dosage form is not recommended for prescription to children under the age of 5 years.
With caution and under the physician's supervision, it should be used in patients with impaired liver or kidney function; with a tendency to arterial hypotension (systolic pressure below 100 mm Hg); and bronchospasm. In violation of hematopoiesis as a result of cytostatical treatment.
If you have one of the listed diseases, be sure to consult your doctor before start of the therapy.

Adults and children over 15 years of age are taken orally (preferably after meals), usually 1-2 tablets BID/TID, without chewing, with a small amount of liquid.
The daily dose should not exceed 6 tablets.
The treatment course should not exceed 5 days.
A daily dose increase or the treatment course duration is possible only after the recommendation and under the physician's supervision.
Dosages for children. In children the agent is prescribed only after the doctor's consultation.
Children 12-14 years old: single dose - 1 tablet, maximum daily dose is 6 tablets (1.5 tablets 4 times a day),
8-11 years old - 0.5 tablets, the maximum daily dose is 4 tablets (1 tablet 4 times a day),
5-7 years old - 0.5 tablets, the maximum daily dose is 2 tablets (0.5 tablets 4 times a day).

The frequency of the adverse reactions listed below was determined according to the following positions (classification by the World Health Organization):
very often - more than 1/10,
often - from more than 1/100 to less than 1/10,
infrequently - from more than 1/1000 to less than 1/100,
rarely - from more than 1/10000 to less than 1/1000,
very rarely - from less than 1/10000, including individual messages.
Allergic reactions:
urticaria, angioedema, rarely - malignant exudative erythema (Stevens–Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock.
From the urinary system:
impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, urine red staining.
From the cardiovascular system:
blood pressure decrease.
From the hematopoietic organs:
thrombocytopenia, leukopenia, agranulocytosis (may be manifested with the following symptoms: unmotivated fever, chills, sore throat, difficulties with swallowing, stomatitis, as well as the development of vaginitis or proctitis).
Anticholinergic effects:
dry mouth, decreased sweating, paresis of accommodation, tachycardia, difficulty urinating.
If you experience any adverse effects, please consult your doctor as soon as possible.
If any of the listed in the instructions side effects are aggravated, or you notice any other unlisted in the instructions side effects, please inform your doctor.

In case of an overdose the following symptoms may occur: vomiting, a feeling of dry mouth, changes in sweating, impaired accommodation, decreased blood pressure, drowsiness, confusion, impaired liver and kidney function, convulsions.
Treatment:
gastric lavage, saline laxatives, activated charcoal, forced diuresis, hemodialysis, with the development of convulsive syndrome - intravenous Diazepam and fast-acting barbiturates.

The m-anticholinergic action may be enhanced by the co-administration together with H1-histamine blockers, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine and quinidine.
It enhances the effects of ethanol; the co-administration with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.
The tricyclic antidepressants, oral contraceptives, and allopurinol increase the agent toxicity.
Phenylbutazone, barbiturates and other hepatoinducers reduce the effectiveness of metamizole sodium during the co-administration.
Sedative and anxiolytic medicines (tranquilizers) enhance the analgesic effect of metamizole sodium.
X-ray contrast agents, colloidal blood substitutes and penicillin should not be used during the treatment with drugs containing metamizole sodium.
With the co-administration of cyclosporine the concentration of the latter in the blood decreases. Metamizole sodium can increase its effectiveness displacing oral hypoglycemic agents, indirect anticoagulants, GCS and indomethacin from the connection with protein. Thiamazole and cytostatics increase the risk of leukopenia developing.
The effect is enhanced by codeine, blockers of H2-histamine receptors and propranolol (it slows down the inactivation of sodium metamizole).
If the co-administration of these and other drugs is really necessary, please, consult your doctor.

During the therapy period, it is not recommended to take ethanol. With prolonged (more than a week) treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver. If you suspect agranulocytosis or if you have thrombocytopenia, you should terminate the treatment.
It is unacceptable to use the agent to relieve acute abdominal pain (until the cause is clarified).
If it is necessary to use the agent during lactation, the latter should be discontinued.
Intolerance is very rare, but the threat of anaphylactic shock after intravenous administration is relatively higher than after the peroral intake. Patients with atopic bronchial asthma and pollinosis have an increased risk of allergic reactions developing.
When treating patients with co-administration of cytostatic agents, the intake of metamizole sodium should be carried out only under the physician's supervision.
The red urine staining is possible due to the metabolite release (no clinical significance).
Influence on the ability to drive vehicles and other complex mechanisms: during the treatment course, please, carefully drive vehicles and be engaged in potentially hazardous activities that require a quick physical and psychomotor reaction.

10 tablets in a PVC and aluminum foil blister. 1, 2 or 10 blisters with instructions for use are placed in a cardboard pack.
10 cardboard packs of 1 blister are placed in a cardboard box.

In a dry, dark place at a temperature not exceeding 25˚С.
Keep out of the reach of children.

3 years.
Do not use later than the date printed on the package.

Available without a prescription.