Sinecod Cough Sedative 5mg Butamirate citrate 18 Tablets
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Minsan
021483096
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WARNINGS
Due to the inhibition of the cough reflex by butamirate, concomitant use with expectorants should be avoided, as it can cause mucus stagnation in the respiratory tract with an increased risk of bronchospasm and respiratory tract infection. In subjects suffering from severe renal and / or hepatic insufficiency, the drug was administered only in case of actual need and under the direct supervision of the doctor, taking into account that the effective plasma rates of butamirate citrate may be higher and / or longer lasting than in subjects with normal hepatic and / or renal function. 2 mg / ml oral drops, solution contains ethanol: this medicine contains small amounts of ethanol (about 0.54%,). Each dose contains up to approximately 0.095 g of alcohol. It is harmful for those suffering from liver disease, alcoholism, epilepsy, brain diseases as well as for pregnant women and children. It can modify or enhance the effects of other drugs; glycerol: it is harmful in high doses. It can cause headaches, gastric disturbances and diarrhea; parahydroxybenzoates and their esters: it is known that they can cause urticaria. In general it can cause delayed reactions such as contact dermatitis; rarely immediate reactions with urticaria and bronchospasm; sucrose: this medicine contains about 19.5 g / 100 ml of sugar (sucrose). When taken according to the recommended dosage, each dose (15 drops) provides about 0.13 g of sugar (sucrose). Patients with rare hereditary problems of fructose intolerance, glucose malabsorption. or insufficiency of sucrase isomaltase, they should not take this medicine. 3 mg / 10 g Syrup contains ethanol: attention this medicine contains small quantities of ethanol (about 0.47%). Each dose contains up to approximately 0.07 g of alcohol. It is harmful for those suffering from liver disease, alcoholism, epilepsy, brain diseases as well as for pregnant women and children. It can modify or enhance the effects of other drugs; glycerol: it is harmful in high doses. It can cause headaches, gastric disturbances and diarrhea; parahydroxybenzoates and their esters: it is known that they can cause hives. In general they can cause delayed-type reactions such as contact dermatitis; rarely immediate reactions with urticaria and bronchospasm; sorbitol: this medicine contains approximately 40.7 g / 100ml of sorbitol. When taken according to the recommended dosage, each dose (5 ml) provides approximately 2 g of sorbitol. Patients with certain hereditary problems of fructose intolerance should not take this medicine. It can cause stomach upset and diarrhea.
PHARMACOTHERAPEUTIC CATEGORY
Cough suppressants.
STORAGE
Oral drops, solution and syrup: this medicine does not require any special storage conditions. Tablets: do not store at temperatures above 30 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. Pads: children under the age of 12. Syrup and drops: children under 6 years of age.
NAME
SINECOD COUGH SEDATIVE
EXCIPIENTS
2 mg / ml oral drops, solution: glycerol; sucrose; anethole; vanillin; 96 percent ethanol; methyl parahydroxybenzoate; purified water. 3 mg / 10 g syrup: citric acid; glycerol; sorbitol; anethole; vanillin; methyl parahydroxybenzoate; ethanol; purified water. 5 mg tablets: isomalt; mint essence; levomenthol; acesulfame potassium; neohesperidin dihydrocalcone; mixture of vegetable oils and fats and dimais starch.
SIDE EFFECTS
Adverse reactions are listed below by organ system class and frequency. Frequencies are defined as: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000; <1 / 1,000); very rare (<1 / 10,000); granny. Nervous system disorders. Rare: somnolence, dizziness. Gastrointestinal disorders. Rare: nausea, diarrhea. Skin and subcutaneous tissue disorders. Rare: urticaria. Disorders of the immune system. Not known: hypersensitivity reactions'. Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING
The safety of use during pregnancy and lactation has not been evaluated in specific studies. Use should be avoided during the first three months of pregnancy. During the rest of pregnancy the drug should be used only if it is strictly necessary. It is not known whether the active substance and / or one of its metabolites are excreted in breast milk. For security reasons, as a general rule, Before taking the product while breastfeeding, the risks and benefits must be carefully evaluated.
INDICATIONS
Cough suppressant.
INTERACTIONS
No specific interaction studies have been conducted. Concomitant use with expectorants should be avoided.
DOSAGE
Sugar-free tablets. Adults: 1 tablet every 6 hours (as a maximum dose, 1 tablet every 4 hours; it is possible to use two tablets consecutively at bedtime, in order to have a more prolonged effect during the night hours). Children (over 12 years old): 1 tablet every 12 hours. The lozenges should be sucked or chewed in the mouth. Drops. School-age children (6-12 years): 20 drops every 8-6 hours. Adults: 40 drops every 6-5 hours. The drops should be administered in a little water or milk. Syrup. School-age children (6-12 years): 10 ml every 8-6 hours. Adults: 15 ml every 8-6 hours. Wash and dry the measuring cup after each use and after use between different patients. Do not exceed the recommended dose. Prolonged use of cough suppressants is not justified. Treatment will be limited to the symptomatic period. If the cough persists for more 'than 7 days, in the presence of fever, dyspnoea or chest pain, the doctor should be consulted. Pediatric population: the tablets are contraindicated in children under the age of 12 years. The syrup and the drops are contraindicated in children under the age of 6 years.
ACTIVE PRINCIPLES
2 mg / ml oral drops, solution: 1 g of solution (equal to 20 drops) contains 2 mg butamirate citrate (equivalent to about 1.3 mg butamirate). 3 mg / 10 g syrup: 100 g of syrup contain 0.0345 g butamirate citrate (equivalent to about 21.3 mg butamirate). 5 mg tablets: one tablet contains 5 mg butamirate citrate (equivalent to approx 3.1 mg butamirate).
Due to the inhibition of the cough reflex by butamirate, concomitant use with expectorants should be avoided, as it can cause mucus stagnation in the respiratory tract with an increased risk of bronchospasm and respiratory tract infection. In subjects suffering from severe renal and / or hepatic insufficiency, the drug was administered only in case of actual need and under the direct supervision of the doctor, taking into account that the effective plasma rates of butamirate citrate may be higher and / or longer lasting than in subjects with normal hepatic and / or renal function. 2 mg / ml oral drops, solution contains ethanol: this medicine contains small amounts of ethanol (about 0.54%,). Each dose contains up to approximately 0.095 g of alcohol. It is harmful for those suffering from liver disease, alcoholism, epilepsy, brain diseases as well as for pregnant women and children. It can modify or enhance the effects of other drugs; glycerol: it is harmful in high doses. It can cause headaches, gastric disturbances and diarrhea; parahydroxybenzoates and their esters: it is known that they can cause urticaria. In general it can cause delayed reactions such as contact dermatitis; rarely immediate reactions with urticaria and bronchospasm; sucrose: this medicine contains about 19.5 g / 100 ml of sugar (sucrose). When taken according to the recommended dosage, each dose (15 drops) provides about 0.13 g of sugar (sucrose). Patients with rare hereditary problems of fructose intolerance, glucose malabsorption. or insufficiency of sucrase isomaltase, they should not take this medicine. 3 mg / 10 g Syrup contains ethanol: attention this medicine contains small quantities of ethanol (about 0.47%). Each dose contains up to approximately 0.07 g of alcohol. It is harmful for those suffering from liver disease, alcoholism, epilepsy, brain diseases as well as for pregnant women and children. It can modify or enhance the effects of other drugs; glycerol: it is harmful in high doses. It can cause headaches, gastric disturbances and diarrhea; parahydroxybenzoates and their esters: it is known that they can cause hives. In general they can cause delayed-type reactions such as contact dermatitis; rarely immediate reactions with urticaria and bronchospasm; sorbitol: this medicine contains approximately 40.7 g / 100ml of sorbitol. When taken according to the recommended dosage, each dose (5 ml) provides approximately 2 g of sorbitol. Patients with certain hereditary problems of fructose intolerance should not take this medicine. It can cause stomach upset and diarrhea.
PHARMACOTHERAPEUTIC CATEGORY
Cough suppressants.
STORAGE
Oral drops, solution and syrup: this medicine does not require any special storage conditions. Tablets: do not store at temperatures above 30 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. Pads: children under the age of 12. Syrup and drops: children under 6 years of age.
NAME
SINECOD COUGH SEDATIVE
EXCIPIENTS
2 mg / ml oral drops, solution: glycerol; sucrose; anethole; vanillin; 96 percent ethanol; methyl parahydroxybenzoate; purified water. 3 mg / 10 g syrup: citric acid; glycerol; sorbitol; anethole; vanillin; methyl parahydroxybenzoate; ethanol; purified water. 5 mg tablets: isomalt; mint essence; levomenthol; acesulfame potassium; neohesperidin dihydrocalcone; mixture of vegetable oils and fats and dimais starch.
SIDE EFFECTS
Adverse reactions are listed below by organ system class and frequency. Frequencies are defined as: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000; <1 / 1,000); very rare (<1 / 10,000); granny. Nervous system disorders. Rare: somnolence, dizziness. Gastrointestinal disorders. Rare: nausea, diarrhea. Skin and subcutaneous tissue disorders. Rare: urticaria. Disorders of the immune system. Not known: hypersensitivity reactions'. Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING
The safety of use during pregnancy and lactation has not been evaluated in specific studies. Use should be avoided during the first three months of pregnancy. During the rest of pregnancy the drug should be used only if it is strictly necessary. It is not known whether the active substance and / or one of its metabolites are excreted in breast milk. For security reasons, as a general rule, Before taking the product while breastfeeding, the risks and benefits must be carefully evaluated.
INDICATIONS
Cough suppressant.
INTERACTIONS
No specific interaction studies have been conducted. Concomitant use with expectorants should be avoided.
DOSAGE
Sugar-free tablets. Adults: 1 tablet every 6 hours (as a maximum dose, 1 tablet every 4 hours; it is possible to use two tablets consecutively at bedtime, in order to have a more prolonged effect during the night hours). Children (over 12 years old): 1 tablet every 12 hours. The lozenges should be sucked or chewed in the mouth. Drops. School-age children (6-12 years): 20 drops every 8-6 hours. Adults: 40 drops every 6-5 hours. The drops should be administered in a little water or milk. Syrup. School-age children (6-12 years): 10 ml every 8-6 hours. Adults: 15 ml every 8-6 hours. Wash and dry the measuring cup after each use and after use between different patients. Do not exceed the recommended dose. Prolonged use of cough suppressants is not justified. Treatment will be limited to the symptomatic period. If the cough persists for more 'than 7 days, in the presence of fever, dyspnoea or chest pain, the doctor should be consulted. Pediatric population: the tablets are contraindicated in children under the age of 12 years. The syrup and the drops are contraindicated in children under the age of 6 years.
ACTIVE PRINCIPLES
2 mg / ml oral drops, solution: 1 g of solution (equal to 20 drops) contains 2 mg butamirate citrate (equivalent to about 1.3 mg butamirate). 3 mg / 10 g syrup: 100 g of syrup contain 0.0345 g butamirate citrate (equivalent to about 21.3 mg butamirate). 5 mg tablets: one tablet contains 5 mg butamirate citrate (equivalent to approx 3.1 mg butamirate).
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