Panatus® forte tablets
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
INSTRUCTIONS FOR MEDICAL ADMINISTRATION
Registration number: Trade name: Panatus® forte International nonproprietary name: butamirate Dosage form: film-coated tablets
Composition per tablet: Active ingredient: Butamirate citrate 50.00 mg Excipients: lactose monohydrate, povidone K-25, hypromellose K15M Premium, talc, magnesium stearate, colloidal silicon dioxide Film coating: hypromellose 6 mPas, titanium dioxide (E171), red iron oxide dye (E172), talc, propylene glycol
Description Round, biconvex tablets with a chamfer, film-coated, red-brown in color. Fracture appearance: white rough mass with a red-brown film shell.
Pharmacotherapeutic group: centrally acting antitussive ATC code: R05DB13
Pharmacological properties Pharmacodynamics Butamirate, the active ingredient of the drug Panatus® forte, 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 12 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® forte 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® forte during breastfeeding is not recommended.
Directions for use 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 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® forte, 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 285 mg of lactose. Each time the drug is taken 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, or glucose-galactose malabsorption syndrome. If after 5-7 days of using Panatus® forte the cough does not stop, you should consult a doctor.
Effect on the ability to drive vehicles and machinery The drug Panatus® forte can cause drowsiness, so care must be taken when driving vehicles and working with complex technical devices that require increased concentration 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.
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 the finished dosage form JSC "KRKA, d.d., Novo mesto", Novomeška 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
Panatus forte syrup 7.5 mg/5 ml 200 ml x1
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 non-proprietary or generic name: butamirate Dosage form: syrup, Composition per 5 ml of syrup Active ingredient: Butamirate citrate 7 50 mg Excipients: citric acid, monohydrate 12.50 mg, sorbitol, liquid 1750.00 mg, glycerol 1250.00 mg, sodium saccharin 6.25 mg, sodium benzoate 5.00 mg, lemon flavor 10.00 mg, sodium hydroxide 2.50 mg, purified water to 5.00 ml, Description Transparent, liquid, colorless to light yellow, color, with a characteristic lemon odor. , 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 quickly and completely absorbed when taken orally. After taking 150 mg of butamirate, the maximum plasma concentration of the main metabolite (2-phenylbutyric acid) is reached after about 1.5 hours and is 6.4 μg/ml. 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 the components of the drug, pregnancy (first trimester), breastfeeding period, children under 3 years of age, fructose intolerance. , 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 from 3 to 6 years old: 5 ml 3 times a day, children from 6 to 12 years old: 10 ml 3 times a day, children over 12 years old: 15 ml 3 times a day, adults: 15 ml 4 times in a day. Use measuring spoon (provided). 1 scoop = 5 ml. 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 The syrup contains, in quality, sweeteners, saccharin, sodium, and sorbitol, therefore, can be used in patients with diabetes. 5 ml of syrup (1 measuring spoon) contain 1.75 g of sorbitol. With each single dose of the drug, the patient receives either 5.25 g of sorbitol (3 scoops), or 3.5 g of sorbitol (2 scoops), or 1.75 mg sorbitol (1 scoop). , The drug Panatus forte is not used in patients with fructose intolerance. 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 Syrup, 7.5 mg/5 ml. 200 ml of syrup in a dark glass bottle, sealed with a plastic stopper, with a liquid divider, and a plastic lid, with control of the first opening. , 1 bottle is placed in , a cardboard pack , together with , a measuring , spoon , and , 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 4 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 ,
