Novigan indications for use reviews. Is Novigan effective for toothache? Novigan - side effects

Spasms and pain that often accompany them cause a lot of discomfort to a person. Such conditions can arise under the influence of various causes, but first of all require symptomatic elimination. To combat symptoms, various medications can be used, usually in a complex composition for the most effective impact on the problem. One of the most commonly used products is Novigan tablets, the specifics of which we propose to consider.

Composition of the drug

This drug belongs to the group of antispasmodic analgesics, and this effect is achieved thanks to the active basis of the product - a combination of three active substances:

• ibuprofen (at a concentration of 400 mg per tablet) is a non-steroidal anti-inflammatory drug that has an analgesic effect and helps reduce fever;
• pitofenone hydrochloride (5 mg) – has an analgesic and antispasmodic effect, acting as a derivative of pyrazolone. Affects smooth muscles directly, causing them to relax;
• 0.1 mg fenpiverinium bromide - the substance also has an analgesic effect and relieves spasms.

The components of the product include many excipients, in particular: cellulose, corn starch, silicon dioxide, talc, magnesium stearate and glycerol. Separately, we can highlight the components that make up the tablet shell: macrogol, talc, titanium dioxide, sorbic acid, hypromellose and dimethicone. The drug is produced in blisters of 10 tablets, packed in cardboard boxes with instructions.

Pharmacological actions

The combined drug has an effect in three directions at once, which is due to the action of its constituent components: analgesic, antispasmodic and anti-inflammatory effects. The main mechanism of action of the substance ibuprofen is the inhibition of the production of prostaglandins, which are responsible for maintaining inflammatory processes and pain activity. It is this component that can reduce the pressure inside the uterus and the frequency of its contractions in women. The other two main components have similar activity, which leads to a mutually reinforcing effect.
All components of the product are quickly absorbed in the digestive system, and the maximum concentration is reached within an hour after administration. Components are excreted through the liver and kidneys.

What tablets help with: indications for use

The specificity of the constituent components of the composition determines a rather clear and limited range of application of the tablets:

• pain syndrome that accompanies muscle spasms of any internal organs, including the stomach, kidneys, intestines, etc.;
• painful sensations during menstruation in women caused by intense spasms of the uterus;
• headache of any type;
• symptomatic therapy for pain in joints, muscles, etc., for cystitis and other inflammatory diseases;
• sometimes the product is also used as part of the treatment of colds as a means to reduce fever.

Do pills help with toothache and headaches?

All drugs based on the substance ibuprofen are widely used to eliminate pain of various etiologies. Thus, the complex composition of Novigan gives even more pronounced results for headaches and toothaches, since it has an anti-inflammatory effect supported by other components and relieves spasms.

Considering that dental discomfort is usually very painful and intense, a single-component product may not provide the desired relief, but the combination of three active substances in the drug in question is guaranteed to alleviate the patient’s condition. Thus, the tablets help with both headaches and dental pain, and with a high rate of effectiveness.

Use during menstruation

Painful periods in medicine are called dysmenorrhea, the boundaries of which are usually described as some time before the onset of menstruation, and the first one or two days after its onset. The pain can be very diverse: aching, cramping, radiating to the lumbar region. Severe forms of this condition can cause a number of additional symptoms, so it is customary to deal with the problem. A drug that relieves spasms and has a pronounced analgesic effect is exactly what is best suited, therefore the drug in question is very often prescribed specifically for dysmenorrhea, and this is indicated in the list of indications for use.

Instructions for use of Novigan and dosage

In order to avoid irritating effects on the gastric mucosa, the tablets are taken only after meals, but if an urgent need arises, it will be enough to wash the drug down with milk. If there is no doctor's prescription, then to relieve pain you can take only one tablet no more than three times a day, not exceeding this maximum dosage. In this case, the course can last no more than five days in a row.

If the drug is prescribed by a doctor, then higher dosages and longer course periods can be prescribed if the patient’s problem requires it. As part of therapy, you should stop drinking alcohol.

Overdose and side effects

It is immediately worth noting that if you follow the instructions and the doctor’s recommendations, the risk of an adverse reaction of the body is minimal. In some cases, the following may occur: the appearance of ulcers on the oral mucosa, inflammation of the gums, shortness of breath, confusion, dizziness, drowsiness, headache, tachycardia, increased blood pressure, visual impairment, etc.

Typical symptoms of a drug overdose include nausea, abdominal pain, vomiting, tinnitus, decreased blood pressure, impaired renal function, and even coma. As part of the treatment of a dangerous condition, the stomach is washed, activated charcoal is prescribed and symptomatic treatment is carried out. There is no specific antidote.

What are the contraindications?

Patients with the following problems and conditions should avoid using this drug:

• ulcers in the digestive tract, bleeding;
• exacerbation of inflammatory processes in the digestive system;
• intolerance to the components of the composition;
• active liver disease and impaired liver function;
• problems with blood clotting;
• disrupted blood cell formation processes;
• arrhythmias;
• Angle-closure glaucoma and various diseases of the optic nerve;
• intestinal obstruction;
• children's age (up to 16 years).

During early pregnancy, as well as during lactation, the use of the drug is prohibited. The product exhibits normal compatibility with other drugs used, but only if safe dosages are observed.

Analogues of Medicine Novigan

There are several drugs that completely repeat the basic composition of the tablets considered. We are talking about the drugs Novospasm and Spazgan Neo. In addition, you can use ibuprofen as the main active ingredient of Novigan:

• Arviprox;
• Arthrocol;
• Bofen;
• Dexalgin;
• Ibuklin;
• Ibuprom;
• Has;
• Modafen, etc.

Novigan is suitable for relieving pain and spasms. The drug has an effect on the smooth muscles of organs, promotes their relaxation.

The effectiveness of the drug is due to the fact that it is a combination of three antispasmodic and analgesic substances. They combine harmoniously with each other, leaving no chance for pain.

In this article we will look at why doctors prescribe Novigan, including instructions for use, analogues and prices for this drug in pharmacies. Real REVIEWS of people who have already used Novigan can be read in the comments.

Composition and release form

The drug Novigan is available in the dosage form of tablets, film-coated, enteric-coated. They have a round shape, biconvex surface and white color.

They contain several active ingredients with varying concentrations of each of them in one tablet:

• Ibuprofen – 400 mg;
• Pitophenone hydrochloride – 5 mg;
• Phenpiverinium bromide – 0.1 mg.

Clinical and pharmacological group: spasmoanalgesic.

What does Novigan help with?

The drug Novigan has certain indications for use associated with pain of various types. It helps in such cases:

1. Headaches, as well as during migraines.
2. For dysmenorrhea, that is, severe pain during menstruation in women.
3. For short-term pain in joints and other body systems. And also neuralgia, myalgia.
4. Pain that is accompanied by spasms: with renal and intestinal colic, also biliary dyskinesia and other similar problems.

Novigan is a combination drug that has antispasmodic, anti-inflammatory and analgesic effects.

pharmachologic effect

The drug has an analgesic, antispasmodic (relieves spasms), and anti-inflammatory effect. These processes occur due to the inclusion of ibuprofen, pitofenone hydrochloride, and fenpiverinium bromide in the composition of the drug.

• Ibuprofen is a non-steroidal anti-inflammatory drug that relieves pain and fever.
• Pitophenone hydrochloride - has a direct effect on the smooth muscle cells of hollow organs, thereby reducing smooth muscle tone and spasm.
• Phenpiverinium bromide - affects cholinergic receptors, blocks them, which leads to additional relaxation of smooth muscles.

The above three substances in combination enhance each other's effects.

Instructions for use

Novigan should be taken orally 2 hours before or 3 hours after meals. In case of irritation from the gastrointestinal tract, the tablets can be washed down with milk or taken immediately after meals.

• The average recommended therapeutic dose for the drug is 1 tablet 2-3 times a day. The maximum daily dose should not exceed 3 tablets per day.
• The course of treatment should not exceed 5 days; the need for further use of Novigan tablets is determined by the doctor.

Long-term use of the drug requires periodic monitoring of laboratory parameters of the functional state of red bone marrow, peripheral blood, liver and kidneys.

Contraindications

The drug should not be used in the following cases:

1. “Aspirin” asthma;
2. Collaptoid states;
3. Periods of pregnancy and lactation;
4. Intestinal obstruction, erosive and ulcerative lesions of the gastrointestinal tract in the acute phase;
5. Hypersensitivity or individual intolerance to Novigan or its components.

Use with caution:

1. Blood clotting disorders;
2. Erosive and ulcerative lesions of the gastrointestinal tract in the medical history;
3. Simultaneous use with oral anticoagulants;
4. Severe heart and/or renal failure.

Side effects

The drug "Novigan", instructions for use and reviews indicate this, can cause negative reactions in the body. After taking the medication, the following may develop:

• allergy;
• accommodation;
• proteinuria;
• kidney dysfunction;
• paresis;
• oliguria;
• urinary retention;
• tachycardia;
• staining of urine;
• nephritis;
• anuria;
• dry mouth.

When using an increased dose of the drug, inhibition of reaction, drowsiness, acidosis, and tinnitus occur. Patients experience nausea, vomiting, abdominal pain and headache. There may be a decrease in blood pressure and disturbances in the rhythm of the heart. The severe consequences of an overdose include coma, respiratory arrest, and liver disease.

Analogues

Structural analogues of the active substance: Novospaz.

Prices

The average price of NOVIGAN, tablets in pharmacies (Moscow) is 110 rubles.

Conditions for dispensing from pharmacies

The drug is approved for use as a means of OTC.

Novigan is a combination drug with analgesic, antispasmodic and anti-inflammatory effects.

Ibuprofen, which is included in the composition, has several properties - anesthetizes, relieves inflammation and fever. In gynecology it is used to reduce pressure inside the uterus and reduce the number of contractions.

The active substance pitofenone hydrochloride, which relaxes smooth muscles, has a positive effect, as does fenpiverinium bromide, which is also the active component of Novigan.

Clinical and pharmacological group

Spasmoanalgesic.

Conditions for dispensing from pharmacies

Dispensed without a doctor's prescription.

Prices

How much does Novigan cost in pharmacies? The average price is 120 rubles.

Release form and composition

Dosage form – film-coated tablets: round, convex on both sides, white, with “NOVIGAN” embossed on one side (10 pieces in a blister, 1 or 2 blisters in a cardboard box).

Active substances in the tablet:

• Ibuprofen – 400 mg;
• Pitophenone hydrochloride – 5 mg;
• Phenpiverinium bromide – 0.1 mg.

Additional substances: glycerol, microcrystalline cellulose, magnesium stearate, corn starch, talc and colloidal silicon dioxide.

Film shell composition: macrogol 6000, hypromellose 6 cps, polysorbate 80, titanium dioxide, sorbic acid, dimethicone, talc.

Pharmacological effect

The drug is a complex remedy that can relieve inflammation, have an analgesic and antispasmodic effect. It suppresses prostaglandin production. Among the components are fenpiverinium bromide, which acts as an m-anticholinergic substance, pitofenone hydrochloride, which has a myotropic antispasmodic effect, and ibuprofen, which is a non-steroidal anti-inflammatory drug.

Fenpiverinium bromide relaxes smooth muscles due to its anticholinergic properties. Pitophenone hydrochloride has a myotropic effect on the muscles of the internal organs, relaxing it and relieving spasms. Ibuprofen, which is a derivative of phenylpropionic acid, relieves fever, inflammation, and inhibits the production of prostaglandins, which are responsible for thermoregulation, inflammatory processes, and pain. The drug has an effect on the central nervous system and peripheral tissues.

With primary dysmenorrhea in women, the content of prostaglandins in the myometrium decreases, intrauterine pressure and heart rate decrease. Acting together, the components of the drug reinforce each other. They are easily absorbed by the intestines, reaching maximum levels in the blood after 1-2 hours. Almost all ibuprofen is bound to blood plasma proteins, processed by the liver, and excreted in the urine. The drug is excreted along with bile.

Indications for use

What does it help with? Novigan is used to relieve mild to moderate pain due to spasms of the smooth muscles of internal organs. It is recommended for use for biliary and renal colic, as well as for severe menstrual pain. In addition, it is effective for myalgia, radiculitis, neuralgia, moderate or severe joint pain, bursitis, and tendinitis. The drug quickly relieves toothache and headache (this list includes migraine).

Novigan received positive reviews in the treatment of colds and infectious and inflammatory diseases. This remedy lowers the temperature and reduces fever.

Contraindications

Contraindications to the use of Novigan are children under 16 years of age, pregnancy and lactation, as well as individual intolerance to any component included in the drug. When prescribing the drug, you should also take into account information about a history of attacks of intolerance to acetylsalicylic acid.

Also, the use of Novigan is contraindicated for the following diseases, disorders and conditions:

• granulocytopenia;
• tachyarrhythmia;
• acute intermittent porphyria;
• deficiency of glucose-6-phosphate dehydrogenase;
• angle-closure glaucoma;
• prostatic hyperplasia;
• intestinal obstruction, gastrointestinal bleeding, erosive and ulcerative damage to the mucous membrane of the stomach and duodenum, ulcerative colitis and other inflammatory bowel diseases that occur in the acute stage;
• liver and/or kidney failure, as well as progressive kidney diseases;
• dysfunctions of the hematopoietic system, hemophilia and other bleeding disorders, hemorrhagic diathesis;
• confirmed hyperkalemia;
• optic nerve diseases.

The drug should be prescribed with caution to the following categories of patients:

• elderly patients;
• patients with diabetes mellitus, dyslipidemia or hyperlipidemia, nephrotic syndrome, severe somatic diseases;
• patients with blood diseases;
• patients suffering from congestive heart failure, arterial hypertension, cerebrovascular diseases, coronary heart disease, peripheral arterial diseases;
• patients with a history of Helicobacter Pylori infection, gastritis, colitis, enteritis, gastric and duodenal ulcers;
• patients with hyperbilirubinemia and creatinine Cl levels from 30 to 60.

The use of Novigan should be limited in dosage and frequency of doses when treating patients suffering from nicotine and alcohol addiction, as well as taking antiplatelet agents, anticoagulants, SSRIs and oral corticosteroids.

Use during pregnancy and lactation

During pregnancy, the drug is contraindicated (you should especially refrain from using it in the first trimester and in the last six weeks of pregnancy), and it is also not recommended to take Novigan during breastfeeding.

Dosage and method of administration

The instructions for use indicate that Novigan is taken orally, 1 hour before or 3 hours after meals. To avoid irritating the stomach, you can take the drug immediately after meals or wash it down with milk.

• In the absence of special doctor's instructions, it is recommended to take 1 tablet for spastic pain. up to 3 times/day. The maximum daily dose is 3 tablets. Do not exceed the indicated dose!

The course of treatment with Novigan, without consulting a doctor, should not exceed 5 days. Longer use is possible under the supervision of a physician with monitoring of peripheral blood parameters and the functional state of the liver.

Side effects

1. For the hepabolic system: hepatitis.
2. For the respiratory system: bronchospasm, shortness of breath.
3. For the cardiovascular system: tachycardia, increased blood pressure, heart failure.
4. For the peripheral and central nervous system: anxiety, dizziness, confusion, insomnia, irritability and nervousness, depression, hallucinations, psychomotor agitation, headache, drowsiness, as well as aseptic meningitis, which is most often observed in patients suffering from autoimmune diseases.
5. For the gastrointestinal tract: pain in the mouth, aphthous stomatitis, ulcerations of the gastrointestinal mucosa, sometimes complicated by bleeding and perforation, ulceration of the gum mucosa, NSAID gastropathy (nausea, heartburn, vomiting, loss of appetite, abdominal pain, flatulence, diarrhea, constipation), in The oral cavity may experience dryness and irritation of the mucous membrane, pancreatitis.
6. For the sense organs: visual impairment - blurred visual perception, irritation and dryness of the eyes, scotoma, swelling of the eyelids and conjunctiva, accommodation paresis, as well as hearing impairment - its deterioration, as well as ringing or tinnitus.

Overdose

If the recommended therapeutic dose of Novigan tablets is significantly exceeded, abdominal pain, nausea, vomiting, heartburn, flatulence, lethargy, drowsiness, headache, metabolic acidosis (a shift in the reaction of the blood environment to the acidic side), acute renal failure, impaired consciousness up to the development of coma develop. , a decrease in the level of systemic blood pressure, disturbances in the rhythm and frequency of heart contractions, respiratory failure up to its absence.

Treatment of an overdose with Novigan tablets consists of washing the stomach and intestines, taking intestinal sorbents (activated carbon), as well as carrying out symptomatic therapy in a medical hospital.

special instructions

Before you start using the drug, read the special instructions:

1. During the treatment period you should refrain from drinking alcohol.
2. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.
3. With long-term use, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary.
4. To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin and hematocrit, and a stool test for occult blood.

During the treatment period, the patient should refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug interactions

When using the drug, it is necessary to take into account interactions with other medications:

1. Enhances the hypoglycemic effect of sulfonylurea derivatives.
2. Antacids and cholestyramine reduce the absorption of ibuprofen.
3. The drug increases the concentration of digoxin, lithium preparations, methotrexate in the blood.
4. Enhances the effect of m-anticholinergic blockers, histamine H1 receptor blockers, butyrophenones, phenothiazines, amantadine and quinidine.
5. Concomitant administration of other NSAIDs increases the incidence of side effects.
6. Caffeine enhances the analgesic effect.
7. At therapeutic doses, Novigan does not interact significantly with commonly used drugs.
8. Microsomal oxidation inhibitors reduce the risk of hepatotoxicity.
9. The drug reduces the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide.
10. Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia when administered simultaneously.
11. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.
12. Cyclosporine and gold preparations enhance the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity.
13. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.
14. Inducers of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe intoxications.
15. Reduces the effectiveness of uricosuric drugs.
16. Strengthens the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding).
17. Increases the side effects of mineralocorticoids, glucocorticoids (increases the risk of gastrointestinal bleeding), estrogens, ethanol.
18. When administered simultaneously, it reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting to take Novigan).
19. Drugs that block tubular secretion reduce excretion and increase plasma concentrations.

Compound

Active ingredients: ibuprofen, p-piperidinoetoxin o carbomethoxybenzophenone hydrochloride, alpha-piperidinoyldiphenylacetamide methobromide;

1 film-coated tablet contains ibuprofen 400 mg p-piperidinotoxin o carbomethoxybenzophenone hydrochloride 5 mg, alpha-piperidinoyldiphenylacetamide methobromide 0.1 mg

Excipients: microcrystalline cellulose, corn starch, glycerin, colloidal silicon dioxide, talc, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide (E 171), polysorbate 80, sorbic acid, dimethicone.

Dosage form

Film-coated tablets.

Basic physical and chemical properties: white, round, biconvex, film-coated tablets, smooth on one side and embossed “NOVIGAN” on the other side.

Pharmacological group

Non-steroidal anti-inflammatory drugs. Ibuprofen, combinations. ATX code M01A E51.

Pharmacological properties

Pharmacological.

Novigan ® is a combination drug that belongs to the group of analgesic and antispasmodic drugs. The composition of the drug includes: ibuprofen - an NSAID (NSAID), p-piperidinoetoxin o carbomethoxybenzophenone hydrochloride - a myotropic antispasmodic agent and alpha-piperidinoetyldiphenylacetamide methobromide - an anticholinergic agent of central and peripheral action.

The main mechanism of pharmacological action of ibuprofen is the inhibition of prostaglandin synthesis. Non-selective non-steroidal anti-inflammatory drugs, which include ibuprofen, act as systemic inhibitors (peripheral and central) of the synthesis of prostaglandin G/H enzymes, also known as cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). These enzymes are responsible for the conversion of arachidonic acid to various tissue-specific prostaglandins and thromboxanes. COX-1 is constitutively expressed in all tissues and is responsible for the production of prostaglandins, which support organ function, protect the integrity of the gastric mucosa, and generate thromboxin, which is responsible for platelet aggregation and vasoconstriction. During inflammation, COX-2 is induced, which produces prostaglandins that mediate pain and inflammatory processes.

P-piperidinotoxins and carbomethoxybenzophenone hydrochloride have a direct myotropic effect on the smooth muscles of internal organs. Inhibits phosphodiesterase, causes the accumulation of cAMP and a decrease in calcium content in the cell, weakens the smooth muscles of blood vessels and internal organs.

Alpha-piperidinoyldiphenylacetamide methobromide, due to its ganglion-blocking and parasympathetic effects, reduces the tone and motility of the smooth muscles of the stomach, intestines, biliary and urinary tracts.

Pharmacokinetics.

Ibuprofen is well absorbed from the gastrointestinal tract when taken orally. The maximum concentration in blood plasma is achieved 1-2 hours after application. About 99% of ibuprofen is bound to plasma proteins. It is excreted primarily in the urine unchanged or in the form of oxidized inactive metabolites. It is completely eliminated from the body within 24 hours.

The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action, which leads to pain relief, relaxation of smooth muscles, and a decrease in elevated body temperature.

Indications

Mild or moderate pain syndrome due to spasms of the smooth muscles of internal organs - renal or hepatic colic, biliary dyskinesia, intestinal spasms, spastic dysmenorrhea and other spastic conditions of the smooth muscles of internal organs. Headache, including migraine. Short-term symptomatic treatment of joint pain, neuralgia, sciatica, myalgia. To reduce elevated body temperature during colds and infectious and inflammatory diseases.

Contraindications

• Hypersensitivity to the components of the drug and other NSAIDs.
• Hypersensitivity reactions (eg asthma, rhinitis, angioedema or urticaria) that have previously been observed after the use of ibuprofen, acetylsalicylic acid (aspirin) or other NSAIDs.
• Novigan ® is contraindicated in patients who have a history of erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding or perforation after the use of NSAIDs.
• Severe liver and kidney dysfunction, heart failure.
• The use of ibuprofen, especially in high doses, together with other non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors, should be avoided due to the possibility of additive effects and the development of adverse reactions from the heart, stroke.
• The drug is also contraindicated in hepatic porphyria, hereditary glucose-6-phosphate dehydrogenase deficiency, tachyarrhythmia, optic nerve damage, hematopoietic or blood clotting disorders, blood diseases, angle-closure glaucoma, heart failure, prostatic hypertrophy, mechanical obstruction of the gastrointestinal tract or megacolon.
• Cerebrovascular or other bleeding.
• Severe dehydration.
• Last trimester of pregnancy and breastfeeding period.
• Age up to 16 years.

Interaction with other drugs and other types of interactions

Concomitant use of Novigan ® with other non-steroidal anti-inflammatory drugs (NSAIDs) or non-narcotic analgesics can lead to a double increase in toxic effects.

Novigan ® should be used with caution in combination with the following drugs:

Anticoagulants NSAIDs may enhance the effect of anticoagulants such as warfarin.

Antihypertensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the therapeutic effect of these drugs. In some patients with impaired renal function (for example, dehydrated patients or elderly patients with weakened renal function), concomitant use of an ACE inhibitor or angiotensin II antagonist and drugs that inhibit COX may lead to a further deterioration of renal function, including possible acute renal failure. usually has a reversible nature. Therefore, such combinations should be prescribed with caution, especially in elderly patients. If long-term treatment is necessary, adequately hydrate the patient and consider monitoring renal function at the beginning of combination treatment, as well as at regular intervals thereafter.

Diuretics may increase the risk of nephrotoxicity from NSAIDs.

Corticosteroids: Increased risk of ulceration and bleeding in the gastrointestinal tract.

Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

Cardiac glycosides - with simultaneous use with NSAIDs, exacerbation of heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma are possible.

Lithium preparations - with simultaneous use, the elimination of lithium preparations decreases and their toxicity and concentration in the blood plasma increases.

Methotrexate - with simultaneous use, the elimination of methotrexate decreases and its toxicity and concentration in the blood plasma increases.

Cyclosporine - when used simultaneously with NSAIDs, nephrotoxicity increases.

Mifepristone - the use of NSAIDs is allowed only 8-12 days after discontinuation of mifepristone, since NSAIDs reduce the effect of mifepristone.

Quinolone antibiotics - NSAIDs - may increase the risk of developing quinolone-associated seizures.

Zidovudine - there is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients receiving concomitant treatment with zidovudine and ibuprofen.

Tacrolimus - the risk of nephrotoxicity increases when NSAIDs are used concomitantly with tacrolimus.

The herbal preparation ginkgo biloba may increase the risk of bleeding when using non-steroidal anti-inflammatory drugs.

Features of application

The drug should be used with caution under the supervision of a physician to treat patients with moderate impairment of liver or kidney function, with a tendency to arterial hypertension, bronchospasm, with systemic lupus erythematosus and other systemic connective tissue diseases - an increased risk of aseptic meningitis; history of heart failure, which was accompanied by fluid retention and edema when using non-steroidal anti-inflammatory drugs.

Effect on the cardiovascular and cerebrovascular system.

Clinical trial and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg per day), as well as long-term use, may lead to a slight increase in the risk of arterial thrombotic complications (eg, myocardial infarction or stroke). In general, data from epidemiological studies do not suggest that low-dose ibuprofen (eg, ≤ 1200 mg per day) may lead to an increased risk of myocardial infarction. For patients with uncontrolled hypertension, congestive heart failure, diagnosed coronary artery disease, peripheral arterial disease and/or cerebrovascular disease, long-term treatment should only be prescribed by a physician after careful analysis. In patients with significant risk factors for cardiovascular complications (such as hypertension, hyperlipidemia, diabetes mellitus, smoking), long-term treatment with NSAIDs should be prescribed only after careful consideration.

Effects on the respiratory system.

Bronchospasm can occur in patients suffering from bronchial asthma or allergic diseases, or have a history of these diseases.

Other NSAIDs.

The simultaneous use of ibuprofen with other NSAIDs, including selective COX-2 inhibitors, should be avoided, as this increases the risk of adverse reactions.

Effect on the kidneys.

Risk of renal failure due to deterioration of renal function; long-term use of NSAIDs can lead to a dose-dependent decrease in prostaglandin synthesis and provoke the development of renal failure. Patients with impaired renal function, cardiac disorders, impaired liver function, patients taking diuretics, and elderly patients are at high risk of this reaction. In such patients, renal function must be monitored.

Effect on fertility in women.

There is limited evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may interfere with ovulation. This process is reversible after stopping treatment. Long-term use (applies to a dose of 2400 mg per day, as well as a treatment duration of more than 10 days) of ibuprofen can impair female fertility and is not recommended for women who are trying to become pregnant. Women who have problems getting pregnant or are undergoing examination due to infertility should discontinue this drug.

Effect on the gastrointestinal tract.

NSAIDs should be used with caution in patients with chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated. There are reports of cases of gastrointestinal bleeding, perforation, ulcers, which can be fatal, that occurred at any stage of treatment with NSAIDs, regardless of the presence of warning symptoms or a history of severe gastrointestinal disorders.

Increasing the dose of NSAIDs, older age and a history of peptic ulcers are at risk of adverse reactions from the digestive tract. During treatment in such cases, it is recommended to use the minimum effective dose of the drug.

Use with caution in patients receiving medications that may increase the risk of gastric and duodenal ulcers or bleeding, in particular oral corticosteroids, anticoagulants, warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid. Patients who have experienced gastrointestinal disorders, especially the elderly, should stop treatment and consult a doctor if any undesirable symptoms (especially bleeding from the digestive tract) occur.

From the skin and subcutaneous tissue.

Very rarely, severe forms of skin reactions may occur while taking NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The highest risk of such reactions occurs in the early stages of therapy, in most cases the onset of such reactions occurs during the first month of treatment. Ibuprofen should be discontinued at the first sign of skin rash, pathological changes in the mucous membranes, or any other signs of hypersensitivity.

With long-term (more than a week) use of the drug, it is necessary to monitor peripheral blood parameters and the functional state of the liver.

The drug can affect the psychophysiological state of patients when taken simultaneously with alcohol and central nervous system depressants.

Long-term and uncontrolled use of painkillers, especially a combination of various analgesic active ingredients, can lead to chronic kidney damage with the risk of developing renal failure (analgesic nephropathy).

The drug should not be used in the presence of hereditary intolerance to galactose and dairy products, or lactase deficiency.

As with other nonsteroidal anti-inflammatory drugs, taking ibuprofen may mask signs of infection.

Use during pregnancy or breastfeeding

Suppression of prostaglandin synthesis may negatively affect pregnancy and/or embryonic/fetal development. Data from epidemiological studies indicate an increased risk of miscarriage and birth defects after the use of prostaglandin synthesis inhibitors in the early stages of pregnancy. The risk is believed to increase with increasing dose and duration of therapy. During the first and second trimesters of pregnancy, the use of the drug should be avoided.

During the third trimester of pregnancy, when using any prostaglandin synthesis inhibitors, possible effects on the fetus include cardiopulmonary toxicity (premature closure of the fetal ductus arteriosus with pulmonary hypertension) and impaired renal function, which can progress to renal failure with the manifestation of oligohydroamnion.

Ibuprofen is contraindicated in the third trimester of pregnancy due to the possibility of inhibition of uterine contractility, which can lead to an increase in the duration of labor with a tendency to increase bleeding in the mother and child, even when using low doses.

Breastfeeding should be stopped during treatment.

The ability to influence the reaction rate when driving vehicles or other mechanisms

Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Directions for use and doses

The lowest effective dose needed to treat symptoms should be used for the shortest period of time. If symptoms persist more than 5 days from the start of treatment or worsen, you should consult a doctor.

It is advisable to take Novigan ® either 1:00 before a meal or 3:00 after a meal. Take the tablets with water, do not chew them. To prevent irritation to the stomach, it should be taken immediately after meals or washed down with milk.

Repeat the dose if necessary after 4-6 hours. Exceed the dose of 1200 mg of ibuprofen per day.

Elderly people do not need special dosing.

Children

Do not prescribe the drug to children under 16 years of age.

Overdose

Symptoms. Manifests itself in the form of gastrointestinal disorders (diarrhea, nausea, vomiting, anorexia, pain in the epigastric region), manifestations of hepatotoxicity, and impaired consciousness.

Tinnitus, headache, and gastrointestinal bleeding may also occur. In severe poisoning, toxic damage to the central nervous system is observed, manifested by drowsiness, sometimes by an excited state and disorientation or comma. Sometimes patients develop seizures. In more severe poisoning, metabolic acidosis and an increase in PT/INR (probably through interaction with coagulation factors circulating in the bloodstream) may occur. Acute kidney failure and liver damage may occur. Patients with bronchial asthma may experience an exacerbation of asthma.

Treatment. Symptomatic and supportive therapy is indicated, including maintaining the airway and monitoring cardiac function and vital signs until the patient's condition returns to normal. Within an hour after taking a large dose, gastric lavage, taking activated charcoal. It is necessary to ensure proper urination and monitor the status of kidney and liver function. After taking potentially toxic doses, patients should be observed for at least 4 hours. If seizures occur, intravenous diazepam or lorazepam can be used. In case of bronchial asthma, bronchodilators should be used.

Adverse reactions

The following adverse reactions have been observed with short-term use of ibuprofen in doses not exceeding 1200 mg/day. When treating chronic diseases and with long-term use, other adverse reactions may occur.

Adverse reactions associated with the use of ibuprofen, classified by organ system and frequency. Frequency is defined as follows: very common ≥1/10; often: ≥1/100 and<1/10; нечасто ≥1 / 1000 и <1/100; редко ≥1 / 10000 и <1/1000; очень редко <1/10000, частота неизвестна (невозможно оценить частоту по имеющимся данным).

From the gastrointestinal tract.

Possible abdominal pain, dyspepsia, nausea.

Rarely - diarrhea, flatulence, constipation, vomiting.

Very rarely - peptic ulcers, perforation or gastrointestinal bleeding, heartburn, ground, hematemesis (sometimes fatal), ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease, gastritis, esophagitis.

From the blood and lymphatic systems.

Very rare: hematopoietic disorder 1.

1 Includes anemia, leukopenia, thrombocytopenia, pancytopenia and agranulocytosis. The first signs of such disorders are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe exhaustion, bleeding and bruises of unknown etiology.

From the cardiovascular system. Rarely, tachycardia, shortness of breath, cerebrovascular complications, arterial hypotension, palpitations.

Very rarely: edema, arterial hypertension, heart failure.

With long-term use and in high doses (2400 mg/day), the risk of arterial thrombotic complications (for example, stroke or myocardial infarction) may increase and the effectiveness of antihypertensive drugs may decrease.

General disorders. Very rare: nonspecific allergic reactions and anaphylactic shock, asthma or worsening asthma, bronchospasm, rash, itching, urticaria, purpura, angioedema.

From the nervous system. Uncommon: headache.

Very rarely, optic neuritis, paresthesia, nervousness, dizziness, drowsiness, irritability, ringing in the ears, depression, insomnia, anxiety, psychomotor agitation, emotional instability, convulsions. Frequency unknown: hallucinations, confusion.

From the immune system.

Uncommon: hypersensitivity reactions accompanied by urticaria and itching 2. Very rare: severe hypersensitivity reactions, symptoms of which may include swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).

2 Hypersensitivity reactions may include: (a) nonspecific allergic reactions and anaphylaxis, (b) airway reactivity, including asthma, exacerbation of asthma, bronchospasm and dyspnea, or (c) various forms of skin reactions, including pruritus, urticaria, purpura, angioedema , and less commonly - exfoliative and bullous dermatosis, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme.

In patients with systemic lupus erythematosus and mixed connective tissue diseases, taking ibuprofen, in rare cases, can lead to symptoms of aseptic meningitis, namely, stiff neck, headache, vomiting, high fever or confusion.

From the hematopoietic organs and lymphatic system. Very rare: hematopoietic disorders (hemolytic anemia, aplastic anemia, thrombocytopenia, neutropenia, eosinophilia, decreased hematocrit and hemoglobin level, pancytopenia, agranulocytosis). The first signs are high fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising. Reversible platelet aggregation, alveolitis, pulmonary eosinophilia.

From the organs of vision. Very rarely, blurred vision, changes in color perception, toxic amblyopia. Frequency unknown: visual impairment.

From the digestive system. Very rare: liver dysfunction, hepatitis, jaundice, duodenitis, pancreatitis, hepatorenal syndrome, liver failure, hepatonecrosis.

From the skin and subcutaneous tissue. Rarely, skin peeling, alopecia, photosensitivity, various skin rashes. Very rarely, bullous lesions, including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis.

From the kidneys and urinary system. Very rarely, papilonecrosis, cystitis, hematuria, nephrotic syndrome, oliguria, polyuria, tubular necrosis, glomerulonephritis, renal dysfunction, toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure, acute renal failure. 3

3 Especially with long-term use of NSAIDs, in combination with an increase in serum urea levels and the appearance of edema. Also includes papilonecrosis.

Other effects. Rarely: dry mucous membranes of the eyes and mouth, stomatitis, high temperature, poor health, weakness, increased fatigue, hearing impairment, ulcerative stomatitis.

Very rare: changes in the endocrine system and metabolism, decreased appetite.

Laboratory research.

Very rare: decreased hemoglobin levels.

Best before date

Storage conditions

Store out of reach of children, in a dry, dark place at a temperature not exceeding 25 ° C.

Package

10 tablets in a blister, 1 blister in a cardboard box.