Alfa normix tablets p / o 200mg, No. 12

• Treatment of gastrointestinal infections caused by bacteria susceptible to rifaximin, such as acute gastrointestinal infections, traveler's diarrhea, intestinal overgrowth syndrome, hepatic encephalopathy, symptomatic uncomplicated diverticular colon disease and chronic intestinal inflammation.

• Prevention of infectious complications in colorectal surgery.

Adults and children over 12 years of age: from 1 tablet every 8 hours to 2 tablets every 8-12 hours (corresponds to 600 - 1200 mg of rifaximin).

The duration of treatment should not exceed 7 days and is determined by the clinical condition of the patients.

If necessary, a second course of treatment should be carried out no earlier than 20-40 days later.

The total duration of treatment is determined by the clinical condition of the patients.

On the recommendation of a doctor, the doses and frequency of their administration can be changed.

Each film-coated tablet contains:

Active substance:
rifaximin with a polymorphic structure alpha -200 mg.

Excipients:
sodium carboxymethyl starch, glyceryl palmitostearate, colloidal silicon dioxide, talc, microcrystalline cellulose.

Film sheath:
hypromellose, titanium dioxide, disodium edetate, propylene glycol, red iron oxide (E 172).
Round, pink biconvex film-coated tablets.

• Hypersensitivity to rifaximin or other rifamycins or to any of the components that make up Alfa normix;

• Intestinal obstruction (including partial);

• Severe ulcerative bowel injury

With caution
During pregnancy and lactation, the drug should be taken only if absolutely necessary and under the direct supervision of a physician.

Composition:

Each film-coated tablet contains:

Active substance:
rifaximin with a polymorphic structure alpha -200 mg.

Excipients:
sodium carboxymethyl starch, glyceryl palmitostearate, colloidal silicon dioxide, talc, microcrystalline cellulose.

Film sheath:
hypromellose, titanium dioxide, disodium edetate, propylene glycol, red iron oxide (E 172).
Round, pink biconvex film-coated tablets.

Pharmacotherapeutic group:

antibiotic, rifaximin.

Pharmacological properties

Pharmacodynamics.
Rifaximin, a broad-spectrum antibiotic, is a semisynthetic derivative of rifamycin SV, like other representatives of the rifamycin group of antibiotics, irreversibly binds the beta subunits of the bacterial enzyme, DNA-dependent RNA polymerase and, therefore, inhibits the synthesis of RNA and bacterial proteins. As a result of irreversible binding to the enzyme, rifaximin exhibits bactericidal properties against susceptible bacteria.
The drug has a broad spectrum of antimicrobial activity, including most gram-negative and gram-positive, aerobic and anaerobic bacteria that cause gastrointestinal infections, including traveler's diarrhea:
Gram-negative:
Aerobic: Salmonella spp .; Shigella spp .; Escherichia coli, enteropathogenic strains; Proteus spp .; Campylobacter app .; Pseudomonas spp .; Yersinia spp .; Enterobacter spp .; Klebsiella spp .; Helicobacter pylori;
Anaerobes: Bacteroides spp., Including Bacteroides fragilis; Fusobacterium nucleatum;
Gram-positive:
Aerobes: Streptococcus spp .; Enterococcus spp. Including Enterococcus fecalis; Staphylococcus spp .;
Anaerobes: Clostridium spp., Including Clostridium difficile and Clostridium perfrigens; Peptostreptococcus spp.
The broad antibacterial spectrum of rifaximin helps to reduce the pathogenic intestinal bacterial load, which causes some pathological conditions.

The drug reduces:

• the formation of ammonia and other toxic compounds by bacteria, which, in the case of severe liver disease, accompanied by a violation of the detoxification process, are involved in the pathogenesis and sympathology of hepatic encephalopathy;

• increased proliferation of bacteria in the syndrome of overgrowth of microorganisms in the intestine;

• the presence of bacteria in the colon diverticulum, which may be involved in inflammation in and around the diverticular sac and possibly play a key role in the development of symptoms and complications of diverticular disease;

• antigenic stimulus, which, in the presence of genetically determined defects in mucosal immunoregulation and / or in protective function, can initiate or permanently maintain chronic intestinal inflammation;

• the risk of infectious complications during colorectal surgery.

Pharmacokinetics.

Rifaximin is poorly absorbed when taken orally (less than 1%) and has an intra-intestinal effect; very high concentrations of the antibiotic are created in the gastrointestinal tract (GIT), which are significantly higher than the MIC for tested enteropathogenic microorganisms.
The drug is not detected in plasma after taking therapeutic doses (detection limit <0.5 - 2 ng / ml) or is found in very low concentrations (less than 10 ng / ml in almost all cases) in both healthy volunteers and patients with damaged intestinal mucosa (as a result of ulcerative colitis or Crohn's disease).
Rifaximin found in urine is no more than 0.5% of the oral dose.
In fact, almost 100% of rifaximin ingested is located in the intestinal tract, where very high concentrations of the drug are achieved (concentrations in the feces of 4000-8000 ?g / g are achieved after 3 days of treatment with a daily dose of 800 mg).

Indications for use

• Treatment of gastrointestinal infections caused by bacteria susceptible to rifaximin, such as acute gastrointestinal infections, traveler's diarrhea, intestinal overgrowth syndrome, hepatic encephalopathy, symptomatic uncomplicated diverticular colon disease and chronic intestinal inflammation.

• Prevention of infectious complications in colorectal surgery.

Contraindications

• Hypersensitivity to rifaximin or other rifamycins or to any of the components that make up Alfa normix;

• Intestinal obstruction (including partial);

• Severe ulcerative bowel injury

With caution
During pregnancy and lactation, the drug should be taken only if absolutely necessary and under the direct supervision of a physician.

Method of administration and dosage

Adults and children over 12 years of age: from 1 tablet every 8 hours to 2 tablets every 8-12 hours (corresponds to 600 - 1200 mg of rifaximin).

The duration of treatment should not exceed 7 days and is determined by the clinical condition of the patients.

If necessary, a second course of treatment should be carried out no earlier than 20-40 days later.

The total duration of treatment is determined by the clinical condition of the patients.

On the recommendation of a doctor, the doses and frequency of their administration can be changed.

Side effect

Side effects that have at least a possible connection with taking rifaximin are classified by frequency and organ / organ systems as follows: very frequent (> 10%), frequent> 1% <10%, infrequent> 0.1% <1 %, rare> 0.01% <0.1%, very rare <0.01%. Listed below are side effects that have been observed in double-blind, placebo-controlled clinical trials. Most side effects, especially from the gastrointestinal tract, can be symptoms of a disease for which treatment was prescribed during the period of clinical trials and which are reported with the same frequency in patients receiving placebo.

From the side of the cardiovascular system:
Infrequent: palpitations, flushes of blood to the skin of the face, increased blood pressure.
Blood disorders:
Infrequent: lymphocytosis, monocytosis, neutropenia.
From the side of the central nervous system:
Frequent: dizziness, headache.
Uncommon: loss of taste, hypesthesia, migraine, insomnia, pathological dreams.
From the side of the organ of vision:
Uncommon: diplopia.
From the side of the inner ear:
Infrequent: systemic dizziness.
Respiratory system:
Infrequent: shortness of breath, dry throat, nasal congestion, pain in the laryngopharyngeal region.
From the gastrointestinal tract and liver:
Frequent: bloating, abdominal pain, constipation, diarrhea, flatulence, nausea, tenesmus, vomiting, urge to defecate.
Uncommon: anorexia, ascites, dyspepsia, impaired motility of the gastrointestinal tract, secretion of mucus and blood with stools, dry lips, 'hard' stools, increased activity of aspartate aminotransferase.
From the urinary system:
Uncommon: glucosuria, polyuria, pollakiuria, hematuria.
On the part of the skin and subcutaneous tissue system:
Uncommon: rash, macular rash, cold sweat.
From the musculoskeletal system:
Uncommon: back pain, muscle spasm, muscle weakness, myalgia.
Infections:
Infrequent: candidiasis.
General symptoms:
Frequent: fever
Uncommon: asthenia, chest pain, chest discomfort, chills, fatigue, flu-like symptoms, peripheral edema.
Reproductive system disorders
: Uncommon : polymenorrhea.
In the marketing experience of rifaximin, diarrhea, abdominal pain, heartburn, nausea, peripheral edema, facial edema, laryngeal edema, neutropenia, fainting, hypersensitivity reactions, agitation, headache, angioedema, purpura, generalized pruritus, genital itching were observed. erythema, palmar erythema, exanthema, allergic dermatitis, erythematous rash, urticaria, measles-like rash.

Overdose

There were no cases of drug overdose.

Interaction with other medicinal products

No interactions have been established to date.
Due to the negligible absorption in the gastrointestinal tract of rifaximin when taken orally (less than 1%), drug interactions at the systemic level are unlikely.

special instructions

During prolonged treatment with high doses or in case of damage to the intestinal mucosa, small amounts of Alpha normix (less than 1%) can be absorbed, which can cause urine staining reddish: this is due to the active substance rifaximin, which, like most antibiotics of this series (rifamycins) , has a reddish-orange color.
With the development of superinfection with microorganisms insensitive to rifaximin, Alfa normix should be discontinued and appropriate therapy should be prescribed.
Granules for the preparation of a suspension for oral administration contain sucrose, therefore, Alpha normix in this dosage form cannot be prescribed for hereditary fructose intolerance, impaired absorption of glucose-galactose, sucrase-isomaltase deficiency.

Release form

Film-coated tablets, 200 mg . 12 tablets in PVC / Al blister. 1 blister with instructions for use in a cardboard box.
Granules for preparation of oral suspension 100 mg / 5 ml. A dark glass bottle, closed with a screw-on screw cap, together with a measuring cup and instructions for use in a cardboard box.

Storage conditions

At a temperature not higher than 30 ? C. Keep out of the reach of children.

Shelf life

3 years.
Shelf life of the prepared suspension: 7 days at room temperature not higher than 30 ? C.
Do not use later than the date indicated on the package.

Conditions of dispensing from pharmacies

On prescription.