NOVIGAN film-coated tablets No. 10

The combined drug Novigan quickly eliminates the painful symptoms of algomenorrhea, colic in the stomach and abdominal cavity, and can be used for fever and migraines. The formula of the drug provides improved well-being with cramps, elevated body temperature, and headaches of various origins.

Composition, dosage form

Novigan is available in the form of tablets for oral use: film-coated, packaged in metallized blisters. Each pill contains:

• ibuprofen: 0.4 g;
• fenpiverinium bromide: 0.005 g;
• pitofenone: 0.1 g.

Auxiliary compounds that stabilize the state of the drug and give it shape:

• glycerol;
• talc;
• starch;
• magnesium stearate;
• polysorbate and others.

The secondary cardboard packaging of the medicine contains from 2 to 10 blisters with tablets and detailed instructions included.

The mechanism of action of the drug Novigan

Novigan tablets effectively relieve various types of pain and physical discomfort. The drug is used as an analgesic, antispasmodic and anti-inflammatory. Ibuprofen in its composition provides a blockade of prostaglandins, including those in the peripheral nervous system and tissues of internal organs. At the same time, the substance affects the thermoregulation center, reducing fever and associated discomfort.

Pitophenone hydrochloride is a myotropic antispasmodic that relaxes smooth muscle fibers. Its use helps relieve painful contractions of vascular walls and cavitary organs. Fenpiverinium bromide complements and prolongs its action, having an anticholinergic effect.

The tablet shell quickly dissolves in the stomach cavity, the active substances are absorbed into the blood and distributed in the body fluids, partially binding to plasma proteins. The maximum concentration is usually achieved within 1 hour, and the pharmacological effect develops within 15–20 minutes after administration. The drug is transformed by liver cells, metabolites leave the body along with urine. Residues of the drug remain in tissues and blood for no more than 12 hours.

Novigan has a symptomatic effect, reducing the painful manifestations of pathological conditions. It does not affect the course and causes of chronic diseases.

Novigan (N20)

INSTRUCTIONS for use of the medicinal product for medical use NOVIGAN®

Registration number: P N 008846 Trade name: Novigan ® International non-proprietary or generic name of the drug ibuprofen + pitofenone + fenpiverinium bromide Dosage form film-coated tablets Composition 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: combined analgesic antispasmodic agent. ATC code: MO1AE51 Pharmacological properties Pharmacodynamics A combined drug that has analgesic, anti-inflammatory and antispasmodic effects. Suppresses the synthesis of prostaglandins (Pg). The drug contains a non-steroidal anti-inflammatory drug - ibuprofen, a myotropic antispasmodic drug - pitofenone hydrochloride and an 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, has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation.

Phenpiverinium bromide, due to its m-anticholinergic effect, 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 The components of Novigan ® are well absorbed from 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: Elderly 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 ulcer 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 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).

Method of administration 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. In the absence of special doctor's instructions, it is recommended to take Novigan ® for spastic pain, 1 tablet up to 3 times a 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.

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 In recommended doses, Novigan ® does not cause side effects. From the gastrointestinal tract: NSAID gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation; ulceration of the mucous membrane of the gastrointestinal tract, which in some cases are complicated by perforation and bleeding; irritation or dryness of the mucous membrane membranes of the oral cavity, 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 sensory organs: 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), paresis of accommodation. 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. Other: 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® 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 (an increase in the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent is possible after starting to take the drug Novigan). 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 at a temperature not exceeding 25 °C. Keep out of the reach of children!

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

Conditions for dispensing from pharmacies Without a prescription.

Manufacturer Dr. Reddy's Laboratories Ltd. Hyderabad, Andhra Pradesh, India.

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

Send consumer complaints to the following address: Representative office 115035, Moscow, Ovchinnikovskaya embankment, 20, building 1 tel, 783-29-01 fax

Indications for use

It is recommended to take Novigan for any pain syndrome, including those accompanied by spasms or colic:

• for painful menstruation: active components significantly reduce the production of prostaglandins in the female myometrium, relieve pressure in the vessels of the uterus and appendages, help get rid of cramping attacks before the start of the cycle and throughout menstruation;
• with inflammatory processes in the pelvic and abdominal organs: adnexitis, renal colic, pain in the liver, intestines, gall bladder;
• with cystitis;
• for tension headaches caused by poor circulation due to cervical osteochondrosis, for migraines, and meteosensitivity;
• with myositis;
• with neuralgic syndrome;
• for inflammation and degenerative processes in the joints and spine: arthritis, osteoarthrosis, sciatica, lumbodynia;
• for mechanical injuries of joint structures and muscles: bruises, pinching, dislocations, sprains and torn ligaments;
• during the recovery period after surgical interventions.

If necessary, Novigan can be used to relieve toothache. Ibuprofen in its composition reduces the sensitivity of nerves, reducing unpleasant symptoms.

Who should take it?

Novigan is used as an anti-inflammatory, antispasmodic and antipyretic medicine in women.

Dysmenorrhea occurs, according to various sources, in 60 - 70% of girls. Moreover, sometimes the fact of pain during menstruation is often taken as the norm, since all women in the family may have it. Novigan is suitable for the treatment of both primary and secondary dysmenorrhea.

They can also stop attacks of pain in the lower abdomen on the eve of menstruation.

If you experience discomfort in the middle of the cycle due to ovulation, you can use this drug.

Caution should be exercised in the following conditions:

• If the pain is unusual, more intense, and localized in an atypical location.
• If there is much more discharge, you can even say that it is bleeding.
• If you suspect an acute abdominal pathology, for example, appendicitis, etc. There is severe bloating and other symptoms.
• If the pain is accompanied by severe nausea, vomiting, diarrhea.

Contraindications

The use of the drug is prohibited for the following health conditions:

• bronchial asthma;
• hypersensitivity to acetylsalicylic acid and other NSAIDs;
• for disorders of blood coagulation and composition, pathologies of the hematopoietic organs;
• for diseases and dystrophy of the optic nerve, glaucoma;
• gastric ulcer, acute colitis, pancreatitis, gastritis, erosive lesions of the gastrointestinal mucosa;
• with a tendency to internal bleeding;
• in the period after heart surgery, with acute cardiac arrhythmias.

Novigan is also not applicable in the early stages of pregnancy - in the first trimester, and in the last month before childbirth. It is contraindicated for nursing women and children under 14 years of age.

The drug is prescribed with caution to the elderly, patients with diabetes mellitus, angina pectoris, hypertension, renal or liver failure.

Side effects

While taking the drug, reactions from the gastrointestinal tract and nervous system are possible:

• loss of appetite, dry mouth, unpleasant taste, nausea, epigastric pain;
• dizziness, insomnia or increased drowsiness;
• decreased urine volume;
• increased sweating;
• visual disturbances;
• increased level of leukocytes in the blood, decreased clotting;
• bronchospasm;
• tachycardia, increased blood pressure.

Possible signs of an allergy to the drug: swelling of the mucous membranes of the eyes and eyelids, lacrimation, urticaria, itching, aphthous stomatitis, vasomotor rhinitis, laryngeal edema. In such cases, immediate discontinuation of the medication is required.

How to use Novigan: instructions

It is recommended to take the drug in short courses: no more than 5 days in a row. The maximum dose of tablets is 3 pieces: 1 three times a day. If well tolerated, Novigan can be taken between meals: 2–3 hours after meals or 1 hour before meals. If you have stomach problems, it is not advisable to take the tablets on an empty stomach. It is safer to take them with food.

Treatment should not be combined with taking tranquilizers, other NSAIDs, drinking alcohol or caffeine-containing products. This may increase side effects and cause intoxication.

Options for taking the drug

Novigan is a drug with high bioavailability, i.e. it easily penetrates into “sore spots”. Within 1 - 1.5 hours its maximum values ​​are recorded in the blood. Based on the pharmacokinetics of the drug, the method of its use is formed. Novigan belongs to medications with a long period of action (up to six hours), this group is recommended for the fight against dysmenorrhea.

The product can be taken without a doctor's prescription. The maximum daily dose is three tablets. The course of treatment is 3 - 5 days. These recommended parameters should not be exceeded, as this increases the risk of adverse reactions.

It is advisable to take Novigan before meals or three hours after, but in case of stomach pathology (for example, an ulcer or gastritis in the acute stage), you can drink them immediately after meals. In this way, you can further protect the gastric mucosa.

We recommend reading the article about the pain reliever ketan during menstruation. From it you will learn about the causes of pain, the action of the drug, its effectiveness during painful periods, and compatibility with other medications.