Novigan: instructions for use. Novigan - instructions for use, analogs, reviews and release forms (tablets) of the drug for the treatment of headaches and toothaches, during menstruation in adults, children and pregnancy. Composition of the painkiller Novigan - side effects

For headaches and migraines, you can take the drug Novigan - it will quickly eliminate the discomfort. The medicine is also useful for various colics and spasms, because it has a combined composition.

Description and effect of the medicine

Novigan belongs to drugs with analgesic and anti-inflammatory effects and is included in the group of combined NSAIDs. Manufacturer: Reddys Laboratories (India), tablets in a pack of 10 cost 140 rubles. The composition is represented by several active substances:

The tablets are white, round, convex, and have a special embossing (“NOVIGAN”). The pills are coated with a film. The composition also contains auxiliary components - starch, macrogol, sorbic acid and others. Novigan Neo is also commercially available; it contains only 400 mg of ibuprofen.

The therapeutic effects of Novigan are antispasmodic, analgesic, anti-inflammatory.

The drug inhibits the production of prostaglandins due to the presence of ibuprofen, a derivative of propionic acid. As the content of pain mediators decreases, thermoregulation normalizes (body temperature returns to normal), pain sensitivity and inflammation of tissues in the periphery are suppressed. With painful periods, the high level of myometrial prostaglandins is reduced, pressure in the uterus and the frequency of organ contractions are minimized. All this helps reduce pain.

The myotropic antispasmodic pitofenone gives a direct myotropic effect, relaxes the smooth muscle fibers of the internal organs. The M-anticholinergic drug fenpiverinium bromide works in a similar way through central, peripheral effects. All components of the drug exhibit synergism, mutually enhancing the therapeutic effects.

Novigan's indications and contraindications

The medicine is used for pain of varying severity, mainly of moderate severity. Novigan copes well with spasms of blood vessels in the head, eliminating pain, feelings of pressure, bloating, and acute symptoms. It is also used for migraine pain.

The medicine can be used for any gynecological diseases as a symptomatic remedy for pain, as well as for primary and secondary algodismenorrhea.

Novigan is used to quickly eliminate pain in the joints, spine due to osteochondrosis, arthrosis and other pathologies.

Indications for the use of Novigan tablets also include renal and biliary colic, intestinal spasms, which lead to painful sensations. The drug is used for gastrointestinal motility disorders and biliary dyskinesia.

How many and what contraindications are there? Here is the main list of prohibitions on treatment:

The pharmaceutical product is allowed to be taken only from the age of sixteen. It is prohibited during pregnancy and lactation. Take the pills with caution if you have heart disease, metabolic disorders, Helicobacter pylori infection, or a history of gastrointestinal diseases. Only under the supervision of a doctor should Novigan be taken with simultaneous treatment with hormones, anticoagulants, and antiplatelet agents.

Novigan instructions

The medicine is taken orally, it should be washed down with water, without using juices or hot drinks. In people prone to irritation of the stomach walls, milk can be used to wash down the tablets. It is recommended to drink the drug one hour before meals, or 2 hours after, but if there are disturbances in the gastrointestinal tract, this can be done immediately after meals. Recommendations for the dosage regimen are as follows:

It is advisable to carry out the minimum possible course of therapy, given the increasing risk of side effects as treatment is prolonged. It is strictly forbidden to exceed the specified amount of the drug per day. A longer course is possible only under the supervision of a specialist, taking into account regular blood tests and monitoring the function of the hepatobiliary system.

Side effects

Usually, a single dose of Novigan does not cause side effects; in recommended doses, it is also well tolerated in a short course. But negative effects are still possible due to the individual reaction of the body or the presence of various chronic pathologies. Most often, problems arise from the gastrointestinal tract - stomach pain, abdominal pain, appetite disturbances, heartburn and diarrhea, constipation.

In severe cases, ulcers and erosions of the gastrointestinal tract were recorded, in complicated situations - perforation of ulcers, bleeding, acute pancreatitis.

The liver may respond to a course of therapy with the development of drug-induced hepatitis, the respiratory system - with bronchospasm, attacks of shortness of breath and exacerbation of bronchial asthma. The following symptoms are also possible:

If you are intolerant to the components, there is a risk of headaches, migraines, dizziness; some people experience irritability, sleep problems, anxiety, and nervousness. Occasionally, there is hyperexcitability, confusion, hallucinations, and in especially severe cases, meningitis (the latter usually occurs in the presence of complex autoimmune pathologies). Also, during therapy, pressure and heart rate may change with the occurrence of arrhythmias.

There is a danger of kidney damage, the development of nephrotic syndrome, and organ dysfunction. The hematopoietic organs can react with a decrease in hemoglobin, red blood cells, platelets, and leukopenia. The most common allergic reactions are skin reactions, and occasionally erythema multiforme, bronchospasm, and systemic pathologies.

special instructions

With long-term use, you need to take tests to monitor the functioning of your kidneys and liver. The dose should be minimally effective - this way the risk of negative effects is lower. If, during therapy, signs of pathology of the stomach or other digestive organs appear, it is important to conduct a full examination to exclude peptic ulcer disease (including FGS). Research also includes:

During the period of therapy, it is prohibited to drink alcohol, which increases the risk of developing a gastric ulcer. Due to possible side effects, you should stop driving and using machinery during treatment. In case of an overdose, abdominal pain and vomiting, fainting, and severe dizziness occur. Taking a large dose can cause coma and even death from severe forms of arrhythmia and respiratory arrest. Treatment is carried out only in the hospital!

Analogues and interaction

If you need to replace the drug due to intolerance or if Novigan is not available in the pharmacy, there are a number of drugs with similar composition:

Tricyclic antidepressants increase the release of Novigan metabolites, which increases the risk of poisoning. Diuretics may reduce the effect of Novigan therapy. The medicine enhances the effect of corticosteroids, and antacids reduce the concentration of ibuprofen in the blood.

Tradename: Novigan ®

International nonproprietary or generic name of the drug

ibuprofen + pitofenone + fenpiverinium bromide

Dosage form

film-coated tablets

Compound

Each film-coated tablet contains:

Active substances: ibuprofen 400 mg, pitofenone hydrochloride 5 mg, fenpiverinium bromide 0.1 mg.

Excipients: microcrystalline cellulose 55 mg, corn starch 76 mg, glycerol 2.9 mg, colloidal silicon dioxide 5 mg, talc 12 mg, magnesium stearate 4 mg; shell: hypromellose 6 cps 5.686 mg, macrogol 6000 1.124 mg, talc 1.957 mg, titanium dioxide 1.059 mg, polysorbate 80 0.058 mg, sorbic acid 0.058 mg, dimethicone 0.058 mg.

Description

Round, biconvex, white film-coated tablets with NOVIGAN embossed on one side. Cross-sectional appearance: white to almost white.

Pharmacotherapeutic group:

ATX code: MO1AE51

Pharmacological properties

Pharmacodynamics

The combined drug has analgesic, anti-inflammatory and antispasmodic effects. Suppresses the synthesis of prostaglandins (Pg). The drug contains the non-steroidal anti-inflammatory drug ibuprofen, the myotropic antispasmodic drug pitofenone hydrochloride and the m-anticholinergic drug of central and peripheral action fenpiverinium bromide.

Ibuprofen is a derivative of phenylpropionic acid. It has analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is inhibition of the biosynthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation in the central nervous system and peripheral tissues. In women with primary dysmenorrhea, it reduces the increased level of prostaglandins in the myometrium, thereby reducing intrauterine pressure and the frequency of uterine contractions.

Pitophenone hydrochloride , like papaverine, it has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation.

Phenpiverinium bromide due to its m-anticholinergic effect, it has an additional relaxing effect on smooth muscles.

The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action.

Pharmacokinetics

Components of the drug Novigan ® are well absorbed in the gastrointestinal tract. Peak plasma concentrations are reached approximately 1-2 hours after taking the drug. The main component of the drug, ibuprofen, is 99% bound to plasma proteins, can accumulate in synovial fluid, is metabolized in the liver and is excreted 90% in the urine in the form of metabolites and conjugates. A small part of the drug is excreted in bile. The half-life from blood plasma is 2 hours.

Indications for use

Mild or moderate pain syndrome due to spasms of smooth muscles of internal organs: renal and biliary colic, biliary dyskinesia, intestinal colic.

Gynecological diseases: dysmenorrhea.

Headache, including migraine type.

Short-term symptomatic treatment for joint pain, neuralgia, sciatica, myalgia.

Contraindications for use

Hypersensitivity to any of the ingredients included in the drug; erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; inflammatory bowel diseases in the acute phase, including ulcerative colitis; anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria, after taking acetylsalicylic acid or another non-steroidal anti-inflammatory drug - NSAID (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma); liver failure or active liver disease; renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease; confirmed hyperkalemia; hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis; period after coronary artery bypass surgery; acute "intermittent" porphyria; granulocytopenia; hematopoietic disorders; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmia; angle-closure glaucoma; optic nerve diseases; prostatic hyperplasia; intestinal obstruction; pregnancy and breastfeeding, age up to 16 years.

Precautions for use

Older age, congestive heart failure, cerebrovascular disease, arterial hypertension, coronary heart disease, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, nephrotic syndrome, creatinine clearance less than 30-60 ml/min, hyperbilirubinemia, gastric and duodenal ulcers ( history), presence of infection Helicobacter pylori, gastritis, enteritis, colitis, long-term use of NSAIDs, blood diseases of unknown etiology (leukopenia, anemia), smoking, frequent alcohol consumption (alcoholism), severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).

Directions for use and dosage regimen

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.

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.

Symptoms of overdose, measures to help with overdose

Do not exceed the indicated dose. If you have exceeded the dose, contact your doctor or the nearest medical facility immediately. Take the drug package with you.

Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only within an hour after administration), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of acid-base status, blood pressure). There is no specific antidote.

Possible side effects when using the drug

From the gastrointestinal tract: NSAID gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation; ulcerations of the gastrointestinal mucosa, which, in some cases, are complicated by perforation and bleeding; irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis.

From the hepatobiliary system: hepatitis.

From the respiratory system: shortness of breath, bronchospasm.

From the senses: hearing impairment: hearing loss, ringing or tinnitus; visual impairment: toxic damage to the optic nerve, blurred visual perception, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), accommodation paresis.

From the central and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).

From the cardiovascular system: heart failure, tachycardia, increased blood pressure.

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, red staining of urine.

Allergic reactions: skin rash (usually erythematous or urticaria), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

From the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Others: increased or decreased sweating.

From the laboratory parameters: bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), serum creatinine concentration (may increase), liver transaminase activity (may increase).

If the drug causes a change in your usual condition, stop taking it and call your doctor immediately.

Interaction with other drugs and (or) food products

At therapeutic doses, Novigan Ò does not interact significantly with commonly used drugs.

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.

Microsomal oxidation inhibitors reduce the risk of hepatotoxicity.

Reduces the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs. Strengthens the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding).

Increases the side effects of mineralocorticosteroids, glucocorticosteroids (increases the risk of gastrointestinal bleeding), estrogens, ethanol; enhances the hypoglycemic effect of sulfonylurea derivatives.

Antacids and cholestyramine reduce the absorption of ibuprofen.

Increases the blood concentration of digoxin, lithium and methotrexate.

Enhances the effect of M-anticholinergic blockers, H1-histamine blockers, butyrophenones, phenothiazines, amantadine and quinidine.

Concomitant administration of other NSAIDs increases the incidence of side effects.

Caffeine enhances the analgesic (pain-relieving) effect.

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 Ò).

Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia when administered simultaneously.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Cyclosporine and gold preparations enhance the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.

Drugs that block tubular secretion reduce excretion and increase plasma concentrations of ibuprofen.

special instructions

With long-term use, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

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.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

During the treatment period you should refrain from drinking alcohol.

Impact on the ability to drive vehicles and machinery

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

Release form

Film-coated tablets. 10 tablets in PVC/aluminum blister. 1 or 2 blisters with instructions for use in a cardboard pack.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Best before date

5 years. Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies

Over the counter.

Manufacturer

Dr Reddy's Laboratories Ltd.

Hyderabad, Andhra Pradesh, India.

Address of production place

Plot No. 137, 138 and 146, Sri Venkateswara Cooperative Industrial Complex, Bollaram, Jinaram Mandal, Medak District, Andhra Pradesh, India.

Consumer complaints should be sent to:
Representative office of Dr. Reddy's Laboratories Ltd.
115035, Moscow, Ovchinnikovskaya embankment, 20, building 1

Instructions for use:

Novigan is an anti-inflammatory drug.

pharmachologic effect

Novigan has an analgesic, anti-inflammatory and antispasmodic effect due to its constituents ibuprofen, pitofenone hydrochloride, fenpiverinium bromide.

Ibuprofen is a non-steroidal anti-inflammatory drug that relieves fever and pain. Pitophenone hydrochloride and fenpiverinium bromide relax the smooth muscles of internal organs.

All three components in combination enhance each other's effect.

Release form

Novigan tablets are produced.

Indications for use of Novigan

Novigan is used to relieve mild to moderate pain resulting from spasms of the smooth muscles of internal organs during biliary, renal, intestinal colic, bile duct dyskinesia, and menstrual pain.

The drug is also effective for radiculitis, myalgia, neuralgia, joint pain, tendinitis, bursitis, it relieves dental pain, headaches, incl. migraine.

Good reviews about Novigan, used for colds, infectious and inflammatory diseases - the product lowers the temperature and relieves fever.

Directions for use and doses

Novigan tablets are taken 1-2 tablets about 4 times a day. The maximum permissible daily dosage is 6 tablets.

For menstrual pain caused by pathologies of the female genital organs, physical and inflammatory in nature, take one tablet every four hours.

According to the instructions, Novigan is best taken 1 hour before meals or 3 hours later. after. You can take the drug on your own, without a doctor’s prescription, only for five days.

To prevent gastrointestinal irritation, Novigan should be taken with milk.

Side effects

There are reviews of Novigan, which causes allergies, renal dysfunction, proteinuria, oliguria, anuria, nephritis, dry mouth, tachycardia, urinary retention, paresis, accommodation.

After using Novigan, red coloration of urine is also noted.

When taking high doses of the drug, nausea, abdominal pain, vomiting occur, and vision is impaired. To treat intoxication, the stomach is washed, an adsorbent is taken, and standard symptomatic treatment is carried out.

Contraindications

According to the instructions, Novigan is contraindicated for: pathologies of the optic nerve, severe impairment of renal function, liver, angle-closure glaucoma, acute porphyria, tachyarrhythmia, prostatic hyperplasia, bronchial “aspirin” asthma, gastrointestinal lesions of an ulcerative and erosive nature, acute intestinal obstruction, hypersensitivity to the drug and other non-steroidal drugs.

Novigan should not be used by nursing, pregnant women, or children under 16 years of age.

The drug is prescribed with caution to patients with chronic heart failure, gastrointestinal ulcers or ulcerative colitis in the past, blood clotting disorders, and a tendency to bronchospasms.

Novigan tablets can reduce the diuretic effect of furosemide, hypothiazide, and increase the activity of fibrinolytics, antiplatelet agents, insulin and oral hypoglycemic agents.

The absorption of ibuprofen is reduced by cholestyramine and antacid. When combining the drug with potassium-sparing agents, the risk of developing hyperkalemia increases, and with other non-steroids - negative reactions from the gastrointestinal tract.

Judging by the reviews, Novigan affects the speed of mental and physical reactions and enhances the effect of alcohol.

It is known that it is dangerous to relieve painful sensations without finding out their exact cause. At the same time, there are situations when the pain is difficult to endure, and you have to self-medicate. The main thing in such cases is to find out more information about the medicine. Let's look at what the analgesic Novigan is and the indications for use of this drug.

Novigan - composition

The drug Nogvigan is produced by an Indian pharmaceutical company in tablet form. These are round tablets with a film coating on top. In their composition they contain three active ingredients at once, acting differently and thereby ensuring maximum effectiveness for pain of a different nature. The composition of the Novigan tablet according to the active ingredients is as follows:

• ibuprofen;
• pitofenone hydrochloride;
• fenpiverinium bromide.

As auxiliary components that are used in the manufacture of the drug shell and added to the active substances to ensure the chemical and mechanical stability of the drug, its better susceptibility by the body, etc., Novigan contains:

• starch;
• cellulose;
• talc;
• silica;
• titanium dioxide;
• glycerol;
• magnesium stearate;
• polysorbate 80;
• macrogol 6000;
• hypromellose;
• Dimethicone

Novigan - action

Novigan tablets are quickly absorbed and exhibit their therapeutic effect one to two hours after administration. After 24 hours, the drug is completely eliminated from the body, mainly through the urinary system. Novigan works, the indications for use of which include different types of pain, due to the properties of each of the active substances separately and due to their interaction, which enhances the overall effect. Let's look at what these components are and how they affect pain:

1. Ibuprofen (400 mg)– a non-steroidal anti-inflammatory substance, a derivative of phenylpropionic acid. By suppressing the biosynthesis of prostaglandins (hormone-like substances that at the biochemical level cause pain), pain is reduced, as well as inflammation, swelling, and elevated body temperature.
2. Pitophenone hydrochloride (5 mg)– a compound that has a direct effect on spasmodic smooth muscle tissue of internal organs, eliminating spasm. Muscle tension, which provokes compression of blood vessels and nerve fibers, often causes intense pain, which recedes when relaxation occurs.
3. Phenpiverinium bromide (0.1 mg)– this component belongs to the group of m-anticholinergic drugs that “turn off” the receptors of internal organs that respond to the neurotransmitter acetylcholine. Due to this, a decrease in smooth muscle tone and pain relief are achieved.

What does Novigan help with?

Novigan, the indications for use of which are listed in the attached instructions, is recommended for pain of moderate and low intensity, but for debilitating, unbearable pain syndrome it will not show the desired effect. Let's look at Novigan's indications:

• pain associated with spasm of the smooth muscles of internal organs - kidneys, liver, gallbladder and bile ducts, etc.;
• spastic pain syndrome with dysmenorrhea;
• headaches of various origins, including;
• pain in the joints, lower back, nerves, skeletal muscles (as short-term pain relief therapy).

The above symptoms are the main ones for prescribing this anesthetic and in most cases are successfully eliminated by taking a standard dosage. As directed by the attending physician, Novigan can also be used in some other pathological situations associated with painful sensations not mentioned in the instruction leaflet.

How to take Novigan?

The drug Novigan, the use of which must occur in accordance with certain rules, is an intensely active drug. It is recommended to take it an hour before a meal or three hours after it, which will ensure the highest effectiveness. At the same time, in order to avoid potential negative effects on the walls of the stomach, it is permissible to take these tablets immediately after eating. A reduction in the risk of irritation to the mucous membranes of the digestive tract is also achieved by drinking the drug with milk rather than water.

The standard dosage of Novigan is 1 tablet three times a day with an interval of at least 4-6 hours between doses. The duration of use of the drug should be as short as possible and not exceed five days for self-treatment. Longer use of these tablets is permissible only under the supervision of specialists and with the performance of certain tests.

Novigan for toothache

Pain caused by damage to dental tissues or gums causes great discomfort, so it must be stopped in a timely manner. This is an acceptable solution in cases where it is not possible to immediately see a dentist. The drug Novigan helps effectively, but the analgesic effect is due to one component - ibuprofen.

The other two active components of the drug, which act on spasmodic muscle tissue, do not help in this case. Therefore, it is more rational to take other one-component tablets with ibuprofen for toothache, but if there is nothing else at hand, it is better to use Novigan. In this case, it is recommended to combine the analgesic with the use of a local antiseptic for the oral cavity.

Novigan for headaches

The drug Novigan, the main indications for use of which include headaches of various origins, is very effective and quickly relieves painful sensations. This is achieved through a combination of tablet components that act in different directions on several mechanisms of pain. The drug Novigan is recommended mainly for tension headaches associated with stress, anxiety, or overstrain of the neck and head muscles caused by prolonged stay in an uncomfortable position. Copes with moderate migraine syndrome.

Novigan for menstrual pain

Painful sensations in the lower abdomen during menstruation plague many women, often accompanied by bloating and intestinal upset, headaches, and nausea. It is worth understanding that these symptoms may indicate pathological disorders of the reproductive system that require examination and treatment. Because in this case, the source of pain is the spasming uterus; Novigan helps a lot with menstruation. To further help yourself with this, you should lie down with a warm heating pad on your stomach, which helps relieve the spasm.

Novigan - side effects

Due to the presence of several active components in the composition of the medication in question, Novigan has a significant number of side effects. We list the main complaints that may be presented when pain is eliminated with these tablets:

• lowering blood pressure;
• tachycardia;
• pain in the stomach;
• stool disorder;
• dry mouth;
• dry skin;
• visual disturbances;
• dizziness;
• drowsiness;
• irritability;
• weakness;
• convulsions;
• allergic manifestations.

Novigan - contraindications

Like any other medications, Novigan tablets have limited use. Let's consider in what cases using them to relieve pain is undesirable and dangerous:

• ulcers and erosions of the walls of the gastrointestinal tract;
• acute inflammatory bowel diseases;
• intestinal obstruction;
• a history of allergic reactions in response to taking non-steroidal anti-inflammatory drugs;
• severe liver or kidney disease;
• disorders of blood clotting and hematopoiesis;
• granulocytopenia;
• tachyarrhythmia;
• optic nerve diseases;
• severe dehydration;
• heart failure;
• severe somatic diseases;
• concomitant use of certain medications (anticoagulants, glucocorticosteroids, antiplatelet agents, etc.);
• arterial hypertension;
• pregnancy;
• age up to 16 years, etc.

Is it possible to drink Novigan during pregnancy?

The instructions for use indicate that Novigan is prohibited from being prescribed during pregnancy, and this applies to all periods of gestation. Taking this drug can negatively affect not only the condition of a pregnant woman, but also jeopardizes the normal development of the unborn child. In addition, pain cannot be relieved with this remedy during breastfeeding.

Novigan and alcohol - compatibility

As with most systemic medications, Novigan and alcohol should not be used together. Therefore, during the treatment period it is recommended to refrain from drinking even small doses of low-alcohol drinks. It is worth remembering that some medications may contain alcohol, so their use simultaneously with Novigan is dangerous.

Spasmoanalgesic

Active ingredients

Release form, composition and packaging

◊ Film-coated tablets white, round, biconvex, with "NOVIGAN" embossed on one side; Cross-sectional appearance: white to almost white.

Excipients: microcrystalline cellulose - 55 mg, corn starch - 76 mg, glycerol - 2.9 mg, colloidal silicon dioxide - 5 mg, talc - 12 mg, magnesium stearate - 4 mg.

Shell composition: hypromellose 6 cps - 5.686 mg, macrogol 6000 - 1.124 mg, talc - 1.957 mg, titanium dioxide - 1.059 mg, polysorbate 80 - 0.058 mg, sorbic acid - 0.058 mg, dimethicone - 0.058 mg.

10 pieces. - blisters (1) - cardboard packs.
10 pieces. - blisters (2) - cardboard packs.

pharmachologic effect

The combined drug has analgesic, anti-inflammatory and antispasmodic effects. Suppresses the synthesis of prostaglandins. The drug contains the NSAID ibuprofen, the myotropic antispasmodic drug pitofenone hydrochloride and the m-anticholinergic drug of central and peripheral action fenpiverinium bromide.

Ibuprofen is a derivative of phenylpropionic acid. It has analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is inhibition of the synthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation in the central nervous system and peripheral tissues. In women with primary dysmenorrhea, it reduces the increased level of prostaglandins in the myometrium and thereby reduces intrauterine pressure and the frequency of uterine contractions.

Pitophenone hydrochloride has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation.

Phenpiverinium bromide due to its anticholinergic effect, it has an additional relaxing effect on smooth muscles.

The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action.

Pharmacokinetics

Suction and distribution

When taken orally, the components of Novigan are well absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved in approximately 1-2 hours. The main component of the drug, ibuprofen, is 99% bound to blood proteins and accumulates in the synovial fluid.

Metabolism and excretion

Ibuprofen is metabolized in the liver and is excreted 90% in the urine in the form of metabolites and conjugates. A small portion of ibuprofen is excreted in bile. T1/2 from blood plasma is 2 hours.

Indications

- mild or moderate pain syndrome due to spasms of smooth muscles of internal organs: renal and biliary colic, biliary dyskinesia, intestinal colic;

- dysmenorrhea;

- headache, incl. migraine nature;

- short-term symptomatic treatment for joint pain, neuralgia, sciatica, myalgia.

Contraindications

- erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;

- inflammatory bowel diseases in the acute phase, incl. ulcerative colitis;

- anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria, after taking or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);

- liver failure or active liver disease;

- renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease;

- confirmed hyperkalemia;

- hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis;

— the period after coronary artery bypass grafting;

- acute intermittent porphyria;

- granulocytopenia;

- hematopoietic disorders;

- deficiency of glucose-6-phosphate dehydrogenase;

- tachyarrhythmias;

- angle-closure glaucoma;

- diseases of the optic nerve;

- prostatic hyperplasia;

- intestinal obstruction;

- pregnancy;

- lactation period (breastfeeding);

— age up to 16 years;

- hypersensitivity to any component of the drug.

WITH caution:

- elderly age;

- congestive failure;

- cerebrovascular diseases;

- arterial hypertension;

— dyslipidemia/hyperlipidemia;

- diabetes;

— diseases of peripheral arteries;

- nephrotic syndrome;

— CC less than 30-60 ml/min;

- hyperbilirubinemia;

- peptic ulcer of the stomach and duodenum (history);

— presence of Helicobacter pylori infection;

— gastritis, enteritis, colitis;

- long-term use of NSAIDs;

— blood diseases of unknown etiology (leukopenia, anemia);

- smoking;

- frequent consumption of alcohol (alcoholism);

- severe somatic diseases;

- concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral corticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).

Dosage

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 instructions from a doctor, Novigan is recommended to be taken when spastic pain 1 tab. 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

From the digestive system: NSAID gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation, ulcerations of the gastrointestinal mucosa, which, in some cases, are complicated by perforation and bleeding; irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis), pancreatitis, hepatitis.

From the respiratory system: shortness of breath, bronchospasm.

From the central nervous system and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).

On the part of the hearing organ: hearing loss, hearing loss, ringing in the ears.

From the side of the organ of vision: visual impairment (toxic damage to the optic nerve, blurred visual perception, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), accommodation paresis).

From the cardiovascular system: heart failure, tachycardia, increased blood pressure.

From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, red staining of urine.

Allergic reactions: skin rash (usually erythematous or urticaria), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

From the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Others: increased or decreased sweating.

From the laboratory parameters: bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), serum creatinine concentration (may increase), liver transaminase activity (may increase).

Overdose

Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only within an hour after administration), alkaline drinking, forced diuresis, symptomatic therapy (correction of acid-base status, blood pressure). There is no specific antidote.

Drug interactions

At therapeutic doses, Novigan does not interact significantly with commonly used drugs.

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.

Microsomal oxidation inhibitors reduce the risk of hepatotoxicity.

The drug reduces the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs.

Strengthens the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding).

Increases the side effects of mineralocorticoids, glucocorticoids (increases the risk of gastrointestinal bleeding), estrogens, ethanol.

Enhances the hypoglycemic effect of sulfonylurea derivatives.

Antacids and cholestyramine reduce the absorption of ibuprofen.

The drug increases the concentration of digoxin, lithium preparations, methotrexate in the blood.

Enhances the effect of m-anticholinergic blockers, histamine H1 receptor blockers, butyrophenones, phenothiazines, amantadine and quinidine.

Concomitant administration of other NSAIDs increases the incidence of side effects.

Caffeine enhances the analgesic effect.

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).

Cefamandole, cefoperazone, cefotetan, plicamycin increase the incidence of hypoprothrombinemia when administered simultaneously.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Cyclosporine and gold preparations enhance the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity.

Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.

Drugs that block tubular secretion reduce excretion and increase plasma concentrations of ibuprofen.

special instructions

With long-term use, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

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.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

During the treatment period you should refrain from drinking alcohol.

Impact on the ability to drive vehicles and operate machinery

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

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Use in childhood

Contraindicated in children under 16 years of age

For impaired renal function

Storage conditions and periods

The drug should be stored in a dry place, protected from light, out of reach of children, at a temperature not exceeding 25°C. Shelf life - 5 years.