Description overdue on 06/24/2014

• Composition
• Product form
• Pharmacological action
• Indications Novigana
• Pharmacodynamics and pharmacokinetics
• Contraindications
• Side effects
• Instructions for use Novigana (method and dosage)
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Cautions
• Newborns
• With alcohol
• During pregnancy (and lactation)
• Reviews
• Price, where to buy

Composition

In the 1 tablet contains active substance: 5 mg hydrochloride pitofenone , 400mg ibuprofen , 0, 1 mg bromide fenpiveriniya .

Excipients: 76mg of corn starch, 5 mg of colloidal silicon dioxide 4 mg magnesium stearate , MCC 55mg, 12mg talc, 2, 9mg glycerol .

Composition of film coating shell: 1, 124mg of macrogol 6000, 1, 059mg of titanium dioxide, 0, 058mg sorbic acid 5, 686mg hypromellose 6 cps, 1, 957mg talc, 0, 058mg of polysorbate 80, 0, 058mg dimethicone .

Product form

The drug is available in the form of coated tablets of 10 pieces in a blister. The cardboard package contains 2, 10 or 20 blister packs of pills, as well as instructions for use.

There is the form of tablets, film-coated. In a blister has 10 tablets. In a cardboard package for instructions on use of the drug, as well as one or two blisters.

Pharmacological action

Tablets have anti-inflammatory . analgesic   and antispasmodic action .

Indications Novigana

Novigan tablets are indicated for:

• moderately or weakly expressed pain syndrome, is observed when the smooth muscles of internal organs exposed spasms   - Intestinal, biliary and renal colic And in the case biliary dyskinesia ;
• dysmenorrhea ;
• headache, including migraine, and having a character;
• symptomatic short-term treatment with the neuralgia . myalgia . sciatica   and pain in the joints.

Pharmacodynamics and pharmacokinetics

Novigan - a combination preparation which has a spasmolytic, anti-inflammatory and analgesic actions. The drug suppresses prostaglandin synthesis . As part of the preparation contains Ibuprofen , Is a nonsteroidal anti-inflammatory agent, bromide fenpiveriniya   - M-anticholinergic agent having peripheral and central actions and myotropic antispasmodic hydrochloride pitofenone .

Hydrochloride pitofenone   causes relaxation of the muscles of the internal organs, giving it direct myotropic action.

Ibuprofen (derived from phenylpropionic acid ) Possesses an analgesic, antiinflammatory and antipyretic action. The main effect of the substance is reduced to the inhibition of synthesis prostaglandins Are modulators of thermoregulation, pain sensitivity and inflammation in peripheral tissues and CNS . Women suffering from primary dysmenorrhea Reduced level prostaglandins   at myometrium Thereby reducing the heart rate and intrauterine pressure.

Fenpiveriniya bromide   It provides additional smooth muscle relaxing effect due to its anticholinergic action.

Combining these three main components reinforce each other pharmacological effects.

The components that make up the well-absorbed into Novigana GI . Upon reception, after about 1-2 hours, plasma   It reached a peak concentration of the drug. Ibuprofen, the main component of the drug almost completely (99%) associated with plasma proteins It may also be in its accumulation synovial fluid . This component metabolized   in the liver and 90% was excreted in the urine as conjugates   and metabolites . A minor part of Novigana together with bile eskretiruetsya. Half-life of plasma - 2 hours.

Contraindications

The drug is contraindicated in:

• anamnesis of attack rhinitis . hives . bronchoobstruction   after administration acetylsalicylic acid   or any other NSAID (for the full or partial syndrome of intolerance atsetilsolitsilovoy acid - hives . asthma . rhinosinusitis . polyps   nasal mucous membrane);
• inflammatory bowel diseases which are in the acute phase, including ulcerative colitis ;
• erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, as well as active bleeding in the gastrointestinal tract;
• active liver disease or hepatic insufficiency ;
• progressive kidney disease or renal failure   ( Cl creatinine   less than 30 ml / min);
• Hemophilia   or any other bleeding disorders (including hypocoagulation ) hemorrhagic diathesis ;
• confirmed hyperkalemia ;
• acute intermittent porphyria ;
• violations of blood;
• tachyarrhythmia ;
• deficit glucose-b-phosphate ;
• granulocytopenia ;
• angle-closure glaucoma ;
• prostatic hyperplasia ;
• bowel obstruction;
• diseases optic nerve ;
• lactation or pregnancy;
• a period after it was held coronary artery bypass grafting ;
• are hypersensitive to the components contained in the product;
• patient age of 16 years.

In addition, the drug should be taken with caution in:

• elderly patient;
• cerebrovascular   diseases;
• congestive heart failure;
• giperlipimedii / dyslipidemia ;
• hypertension ;
• diabetes ;
• Cl creatinine 30-60 ml / min;
• coronary heart disease;
• nephrotic syndrome ;
• hyperbilirubinemia ;
• congestive heart failure;
• peripheral arterial disease;
• duodenal ulcer and stomach (in history);
• the presence of infection Helicobacter pylori ;
• colitis ;
• gastritis ;
• Esther ;
• prolonged use of nonsteroidal anti-inflammatory agents;
• heavy somatic diseases ;
• alcoholism or smoking;
• blood diseases of unknown etiology ( anemia . leukopenia );
• concomitant therapy using anticoagulants   (eg,   Warfarin ), Oral GCS   (eg, Prednisolone )   antiplatelet agents   ( Clopidogrel . atsetilsolitsilovoy acid   and so forth.), as well as using SSRIs   (eg, Fluoxetine . Sertraline . Citalopram . Paroxetine ).

Side effects

In case the drug at the recommended dosages side effects should not occur.

For GI:   pain in the mouth, thrush , Ulceration of the gastrointestinal mucosa, sometimes complicated by bleeding and perforation, ulceration of the mucous membrane of the gums, NSAID-gastropathy   (nausea, heartburn, vomiting, loss of appetite, abdominal pain . flatulence . diarrhea . constipation ), In the oral cavity can occur dryness and irritation of the mucous membrane, pancreatitis .

For respiratory system: bronchospasm , Shortness of breath.

For gepabolitarnoy system: hepatitis .

For the peripheral and central nervous system:   anxiety, dizziness, confusion, insomnia, irritability and nervousness, depression , Hallucinations, psychomotor agitation , Headache, drowsiness, and a septic   meningitis , Which is often observed in patients suffering autoimmune   diseases.

For the cardiovascular system: tachycardia , Increased blood pressure, heart failure .
For the senses: blurred vision - blurred vision, irritation, and dryness of the eyes, scotoma, swelling of the eyelids and conjunctiva, paresis of accommodation As well as hearing loss - its deterioration, and ringing or noise in the ears.

For the blood: leukopenia . anemia   (including also haemolytic aplastic ) agranulocytosis . thrombocytopenic purpura   and thrombocytopenia .

For the urinary system:   acute renal failure, allergic nephritis . oliguria . proteinuria Nephrotic syndrome (edema) anuria . polyuria And the urine is colored red.

Allergic reactions: fever . anaphylactoid reactions . dyspnea   or bronchospasm , Pruritus, erythema multiforme exudative   (including Stevens-Johnson syndrome ) eosinophilia , Skin rash (usually hives   or erythematous ) anaphylactic shock . angioedema . toxic epidermal necrolysis . nasal allergy .

Laboratory findings:   may decrease in the serum concentration Glucose May increase bleeding time may be reduced clearance creatinine May occur lowering of Hemoglobin   or hematocrit Can be increased activity of liver transaminases And may be increased serum concentration creatinine .

Other side effects:   decreased or increased sweating.

If in the normal state while taking the drug has changed, you need to immediately stop taking the drug without delay and seek medical advice.

Instructions for use Novigana (method and dosage)

The drug is taken orally one hour before a meal or after a meal three hours. To avoid adverse drug irritating to the stomach, it is possible to make the reception Novigana immediately after a meal, or you can drink milk tablets.

In the absence of any doctor's instructions for receiving, at spastic pain   Novigan recommended to take three times a day one tablet. The maximum dose of the drug per day - three tablets Novigan.

Instructions for use also warns that without consulting a doctor course of taking the pills should not last more than five days. If you want to use the drug for a longer time, this is only done under a doctor's care and the strict control of the functional state of the liver and peripheral blood.

Overdose

Symptoms of overdose are confusion, nausea, abdominal pain, drowsiness, vomiting, depression . metabolic acidosis , Tinnitus, decrease in blood pressure, Atrial fibrillation , headache, acute renal failure , Respiratory arrest, and coma .

As treatment is used: alkaline water, gastric lavage (maximum - 3 hours) forced diuresis As well as activated charcoal or used symptomatic therapy (adjusted blood pressure, acid-base status). Thus there is no specific antidote   drug, which could be applied in cases of overdose.

In the case of exceeding the recommended dosage should be immediately contact a doctor. At itself a must-have product packaging.

Cooperation

When taken in therapeutic doses Novigana with other commonly used drugs, there is no significant interactions.

Inhibitors of microsomal oxidation of reduced risk that will be developed hepatotoxic effects .

The liver enzyme inducers of microsomal oxidation ( ethanol . flumetsinol . phenylbutazone . fenitonin . rifampicin . tricyclic antidepressants . barbiturates ) Increases the production of hydroxylated active metabolites , Thereby increasing the risk that a heavy intoxication   will develop.

Decreases natriuretic effect hydrochlorothiazide   and furosemide , and hypotensive activity of vasodilators .

Effectiveness urikozuricheskih   drugs reduced.

Increased risk of bleeding that will be developed in view of the strengthening of drug action fibrinolitikov , Indirect anticoagulants   and antiplatelet agents .

Absorption   ibuprofen reduced kolestiraminom   and antacids .

The drug increases the chance of side effects estrogen . ethanol . GCS   (increases the risk that any gastrointestinal bleeding) mineralokortikosteroidov ; derivatives sulfonylureas   the interaction with the drug enhance your hypoglycemic effect .

Concentration Digoxin   in the blood, as well as preparations metotrekstata and lithium increases.
Simultaneous administration of the drug with other NSAIDs increases the frequency of possible side effects.

Enhances the action butirofenonov . quinidine . phenothiazines Blockers H1-histamine receptors . amantadine . Mr. holinoblokatorov .

The interaction of the drug with caffeine   increases analgesic effect .

In case of simultaneous reception acetylsalicylic acid   reduced its antiplatelet   and anti-inflammatory action   (in patients receiving low-dose aspirin as antiplatelet agents, after applying acute Novigana coronary insufficiency   may occur with increased frequency).

Manifestations gematotoksichnosti drug increases Myelotoxic drugs .

In the case of simultaneous application with Novigana cefoperazone . valproic acid . Tsefamandol . tsefotetanom   or plicamycin   increased incidence of gipoprotrombinemii .

Gold preparations and cyclosporine   enhance the effect of the substance on ibuprofen PG synthesis in kidney, the effect of which is manifested in the increase nephrotoxicity . Plasma concentrations of cyclosporine And the likelihood that it will develop hepatotoxic effects, increased ibuprofen.

Drugs that block tubular secretion , Increase the plasma concentration of ibuprofen material and reduce its excretion.

Terms of sale

The preparation is available in pharmacies without a prescription.

Storage conditions

The drug should be stored out Novigan availability of children in a dark, dry place. Storage temperature must not exceed 25 ° C.

Shelf life

5 years.

Cautions

In the case of long-term use of the drug requires careful monitoring picture of the functional state of the liver and kidney, and peripheral blood.

To reduce the risk of adverse effects for the gastrointestinal tract is necessary to take the minimum effective dose. In the case of the onset of symptoms gastropathy   It requires careful monitoring, which includes fecal occult blood, blood test, which includes a definition hematocrit   and Hemoglobin And holding esophagogastroduodenoscopy .

If you want to define 17-ketosteroids , You need to stop taking the drug 48 hours before the start of the study.

During treatment Noviganom need to abstain from alcohol.

Patients receiving the drug should refrain from potentially hazardous activity that requires the speed of psychomotor reactions and increased concentration of attention (driving vehicles, etc.).

Newborns

The drug is contraindicated for infants under the age of 4 months.

With alcohol

During the course of treatment Novigan should refrain from drinking alcoholic beverages.

During pregnancy and lactation

The drug is contraindicated during pregnancy (especially should refrain from applying in the first trimester and in the last six weeks of pregnancy), and should not take Novigan during breastfeeding.

Reviews Novigane

Most often, women are taking the drug during spasms   during monthly . It is noted that the product copes with its task, the difference is only in time, how many medication takes effect: it helps one within just 10-20 minutes after administration, and some are waiting for the effect of about an hour. But most say the effectiveness of the tablets Novigan.

What does the drug also helps, because it is from headache . Although there are reviews, which say that migraine medication did not help. Yet often mark its efficiency in all types of pain, including headaches.

Also some say that after the application starts nagging pain in the heart, although these reviews units - usually all happens without any side effects.

Online a lot of reviews, from which tablets Novigan, but there are also a lot of concerns about the side effects that are "in the appendage" to the benefits that provides the drug. But the majority still said that they were baseless fears - often side effects when taking was observed.

Price Novigana where to buy

Buy Novigana on packaging 10 tablets   It can be as low as 81 to 115r.

The cost of preparation of packaging for Novigan 20 tablets   It ranges from 105 to 165 rubles per pack.