Panatus 20 mg 10 pcs. film-coated tablets

Pharmacological properties of the drug Panatus forte

butamirate citrate is a medicinal substance with a central mechanism of action for the symptomatic treatment of cough. Prevents the appearance of a dry and irritating cough, reduces tension in the bronchial muscles and, at the same time, stimulates expectoration, facilitates breathing and eliminates chest pain. This has a positive effect on respiratory function and the concentration of gases in the blood. In terms of its chemical structure and pharmacological activity, butamirate differs from opiate antitussives and does not cause addiction. After oral administration, it is quickly absorbed into the gastrointestinal tract. After 2 hours, butamirate is no longer detectable in blood plasma. The maximum concentration in the blood serum is achieved 30–60 minutes after administration. Butamirate disintegrates quickly. The main metabolites (2-phenylbutyric acid and p-hydroxy-2-phenylbutyric acid) also have an antitussive effect. The binding of butamirate citrate and its metabolites to plasma proteins is 92%, which provides a long-lasting antitussive effect. Half-life in blood plasma is 21.6 hours. Volume of distribution is 11.5 liters. More than 90% of metabolites are excreted by the kidneys, and the remainder by the lungs and feces. The half-life from the body is 12.4 hours, clearance is 11 ml/min (0.183 ml/s).

Use of the drug Panatus forte

The dose of the drug depends on the patient’s age, frequency and intensity of cough. Usual doses are given in the tables: For syrup

1 scoop = 5 ml syrup = 7.5 mg butamirate citrate. The syrup should be taken (or given to children) before or immediately after meals. You need to measure the syrup using the measuring spoon included. The syrup should be taken with liquid. Treatment period is 5–7 days.

For tablets

The tablets should be taken before or immediately after meals. They should be swallowed whole with a small amount of liquid. Treatment period is 5–7 days.

Panatus forte tablet p o film 50 mg x10

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION, INSTRUCTIONS for the use of the medicinal product for medical use Panatus forte Panatus, forte, Registration number: Trade name: Panatus forte International nonproprietary or generic name: butamirate Dosage form: film-coated tablets, Composition per tablet: Active ingredient : Butamirate citrate 50.00 mg Excipients: lactose, monohydrate, 285.00 mg, povidone, K-25, 5.00 mg, hypromellose, K15M, Premium, 20.00 mg, talc , 5.00 , mg, , magnesium , stearate , 4.00 , mg , colloidal silicon dioxide 1.00 mg Shell , film: , hypromellose , 6 , mPas , 7.50 , mg , , titanium dioxide , (E171 ) , 1.10, mg, iron dye red oxide (E172) 0.70 mg, talc 0.70 mg, propylene glycol 0.50 mg, Description Round, biconvex, tablets, beveled, film-coated , red-brown in color. Appearance on the fracture: white, rough, mass, with a filmy shell, red-brown in color. , Pharmacotherapeutic group: centrally acting antitussive ATC code: R05DB13 , Pharmacological properties Pharmacodynamics Butamirate, the active substance of the drug Panatus forte, is a centrally acting antitussive, not related to opium alkaloids either chemically or pharmacologically. Suppresses cough, having a direct effect on the cough center. It has a bronchodilator effect. Promotes easier breathing, improving spirometry (reduces airway resistance), and blood oxygenation. Pharmacokinetics Butamirate is rapidly and completely absorbed when taken orally. With repeated use of butamirate, its concentration in plasma and blood remains linear and no accumulation is observed. Hydrolysis of butamirate, initially, to 2-phenylbutyric acid and diethylaminoethoxyethanol, begins in the blood. These metabolites also have antitussive activity. Butamirate and its metabolites have an almost maximum (about 95%) degree of binding to plasma and blood proteins, which determines their long half-life (T 1/ 2), and long-term antitussive action. Metabolites are excreted primarily by the kidneys, with acidic metabolites largely associated with glucuronic acid. T 1/2 is 6 hours. , Indications for use Dry , cough , of any , etiology , including , with , whooping cough , for , suppression , of cough , in the preoperative and postoperative period , during surgical interventions and bronchoscopy . , Contraindications Increased , sensitivity , to , components , of the drug , pregnancy , (I , trimester), period , breast , feeding , , children , age , up to , 12 , years , , lactase deficiency , lactose intolerance , glucose-galactose syndrome malabsorption. , With caution Pregnancy (II-III trimesters). , Use during pregnancy and breastfeeding There is no data on the safety of using the drug Panatus forte during pregnancy and its passage through the placental barrier. The drug is not recommended for use in the first trimester of pregnancy. During the II and III trimesters of pregnancy, it is possible to use the drug only after consulting a doctor. Considering the lack of data on the release of butamirate into maternal milk, the use of the drug Panatus Forte during breastfeeding is not recommended. , Method of administration and dosage: Orally, before meals. Children over 12 years old: 1 tablet 1-2 times a day, adults: 1 tablet 2-3 times a day. If the cough persists for more than 5-7 days, you should consult a doctor. , Side effect Classification , frequency , development , side , effects , World , Health Organization (WHO): very often , , , , , , ≥ 1/10 often , , , , , , , , , , , , , , , , from ≥ 1/100 to <, 1/10 uncommon , , , , , , , , , , , , from ≥ 1/1000 to <, 1/100 rare , , , , , , , , , , , , , , , ≥ 1/10000 to <, 1/1000 very rare , , , , , , ≥ 1/100000, including isolated reports. From the central nervous system (CNS): rarely: drowsiness, dizziness. From the digestive system: rarely: nausea, vomiting, diarrhea. From the skin: rarely: exanthema. Other: allergic reactions may develop. , Overdose Symptoms: , drowsiness, , dizziness, , nausea, , vomiting, , abdominal pain, , diarrhea, irritability, , impaired coordination , movements, , decreased , blood pressure. , Treatment: , rinse , the stomach , , prescribe , activated , charcoal , , laxatives , medications , and also , carry out , measures , to , maintain , the , function of the , cardiovascular , and respiratory systems . There is no antidote. Treatment is symptomatic. , Interaction with other drugs No drug interactions have been described for butamirate. Due to the fact that butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided to avoid the accumulation of sputum in the respiratory tract. During the period of use of the drug Panatus Forte, the use of ethanol, as well as drugs, CNS depressants (hypnotics, neuroleptics, tranquilizers, etc.) is not recommended. , Special instructions One , film-coated tablet contains , 285 , mg , of lactose. At each dose of the drug, in accordance with the instructions for use, the patient takes up to 285 mg of lactose. The drug Panatus forte is not used in patients with lactase deficiency, lactose deficiency, glucose-galactose malabsorption syndrome. If, after 5-7 days of using the drug, Panatus, Forte, the cough does not stop, you should consult a doctor. , The influence , on , the , ability , of , performing , potentially , dangerous , activities , requiring , special , attention , and , quick , reactions , (for example, driving a vehicle, working with moving mechanisms) The drug , Panatus , forte , can cause , drowsiness, therefore, it is necessary to be careful when , driving , vehicles , and , working , with , complex technical , devices , requiring , increased , concentration , attention , and speed of psychomotor reactions . , Release form: Film-coated tablets, 50 mg. 10 tablets are placed in a blister made of PVC/Al foil. 1 blister is placed in a cardboard pack along with instructions for use. , Storage conditions At a temperature not exceeding 25 ºС, in the original packaging. Keep out of the reach of children. .. Shelf life 5 years. Do not use the drug after the expiration date. , Dispensing conditions Dispensed without a prescription. , , Šmarješka cesta 6, 8501 Novo mesto, Slovenia, Representative office of JSC "KRKA, d.d., Novo mesto" in the Russian Federation / Organization accepting consumer complaints: 125212, Moscow, Golovinskoe highway, building 5, building 1 Tel. , Fax ,

Special instructions for the use of the drug Panatus forte

Panatus Forte should be used with caution in severe renal impairment. If the cough does not stop after 5–7 days of treatment, you should consult a doctor. During treatment with the drug, drinking alcoholic beverages is not recommended. Pregnancy and lactation The drug should not be prescribed in the first trimester of pregnancy. For use later in pregnancy, the benefit to the mother must be weighed against the potential risk to the fetus. Not recommended for use during breastfeeding. Influence on the ability to drive a car and other mechanisms. Does not affect.

TabletsPanatus®

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

INSTRUCTIONS FOR MEDICAL ADMINISTRATION

Registration number: Trade name: Panatus® International nonproprietary or generic name: butamirate Dosage form: film-coated tablets

Composition per tablet: Active ingredient: Butamirate citrate 20.00 mg

Excipients: lactose monohydrate, povidone K-25, quinoline yellow dye (E104), hypromellose 15000 mPas, talc, magnesium stearate, colloidal silicon dioxide Film shell: hypromellose 6 mPas, titanium dioxide (E171), red iron oxide dye (E172) , iron oxide yellow dye (E172), talc, propylene glycol

Description Round, biconvex tablets with a chamfer, film-coated yellow-brown color. Fracture appearance: yellow rough mass with a yellow-brown film shell.

Pharmacotherapeutic group: centrally acting antitussive ATC code: R05DB13

Pharmacological properties Pharmacodynamics Butamirate, the active ingredient of the drug Panatus®, is a centrally acting antitussive agent that is not related to opium alkaloids either chemically or pharmacologically. Suppresses cough, having a direct effect on the cough center. Has a bronchodilator effect. Promotes easier breathing by improving spirometry (reduces airway resistance) and blood oxygenation. Pharmacokinetics Butamirate is rapidly and completely absorbed when taken orally. With repeated use of butamirate, its concentration in the blood plasma remains linear and no accumulation is observed. Hydrolysis of butamirate, initially to 2-phenylbutyric acid and diethylaminoethoxyethanol, begins in the blood. These metabolites also have antitussive activity. Butamirate and its metabolites have an almost maximum (about 95%) degree of binding to plasma proteins, which determines their long half-life (T1/2) and long-term antitussive effect. Metabolites are excreted primarily by the kidneys, with acidic metabolites largely associated with glucuronic acid. T1/2 is 6 hours.

Indications for use Dry cough of any etiology, including whooping cough, to suppress cough in the preoperative and postoperative period, during surgical interventions and bronchoscopy.

Contraindications Hypersensitivity to the components of the drug, pregnancy (first trimester), breastfeeding period, children under 6 years of age, lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

With caution Pregnancy (II-III trimesters).

Use during pregnancy and breastfeeding There is no data on the safety of using the drug Panatus® during pregnancy and its passage through the placental barrier. The drug is not recommended for use in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the drug can be used only after consultation with a doctor. Given the lack of data on the release of butamirate into breast milk, the use of Panatus® during breastfeeding is not recommended.

Directions for use and dosage : Orally, before meals. Children from 6 to 12 years: 1 tablet 2 times a day; children over 12 years old: 1 tablet 3 times a day; adults: 2 tablets 2-3 times a day. If the cough persists for more than 5-7 days, you should consult a doctor.

Side effects World Health Organization (WHO) classification of the frequency of side effects:

very common ≥ 1/10 common ≥ 1/100 to < 1/10 uncommon ≥ 1/1000 to < 1/100 rare ≥ 1/10000 to < 1/1000 very rare ≥ 1/100000, including isolated reports .

From the central nervous system (CNS): rarely: drowsiness, dizziness. From the digestive system: rarely: nausea, vomiting, diarrhea. From the skin: rarely: exanthema. Other: allergic reactions may develop.

Overdose Symptoms: drowsiness, dizziness, nausea, vomiting, abdominal pain, diarrhea, irritability, impaired coordination of movements, decreased blood pressure. Treatment: rinse the stomach, prescribe activated charcoal, laxatives, and take measures to maintain the function of the cardiovascular and respiratory systems. There is no antidote. Treatment is symptomatic.

Interaction with other drugs No drug interactions have been described for butamirate. Due to the fact that butamirate suppresses the cough reflex, the simultaneous use of expectorants should be avoided to avoid the accumulation of sputum in the respiratory tract. During the period of use of the drug Panatus®, the use of ethanol, as well as drugs that depress the central nervous system (hypnotics, antipsychotics, tranquilizers, etc.) is not recommended.

Special instructions One film-coated tablet contains 314.90 mg of lactose. With each dose of the drug in accordance with the instructions for use, the patient takes up to 629.8 mg of lactose. The drug Panatus® is not used in patients with lactase deficiency, lactose deficiency, or glucose-galactose malabsorption syndrome. If after 5-7 days of using Panatus® the cough does not stop, you should consult a doctor.

Effect on the ability to drive vehicles and machinery The drug Panatus® can cause drowsiness, so care must be taken when driving vehicles and with complex technical devices that require increased concentration and speed of psychomotor reactions.

Release form: Film-coated tablets, 20 mg. 10 tablets are placed in a blister made of PVC/Al foil. 1 blister is placed in a cardboard pack along with instructions for use.

Storage conditions At a temperature not exceeding 25 ºС, in the original packaging. Keep out of the reach of children.

Shelf life: 3 years. Do not use the drug after the expiration date.

Conditions of release Dispensed without a prescription.

Name and address of the holder (owner) of the registration certificate JSC "KRKA, d.d., Novo mesto", Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Production of finished dosage form JSC "KRKA, d.d., Novo mesto", Novomeshka cesta, 22, 8310 Sentierney, Slovenia

Primary packaging JSC Krka d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Secondary/consumer packaging JSC Krka d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer (Release quality control) JSC "KRKA, d.d., Novo mesto", Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Name and address of the organization receiving consumer complaints Representative office of JSC “KRKA, d.d., Novo mesto”, 125212, Moscow, Golovinskoe highway, building 5, building 1 Tel., fax