Attributes
- Form
- Dosage mg
- Pack
- Description en
- Senade Generic Name Senosides Tablets 13.5 mg Composition Each film-coated tablet contains: Senna extract, equivalent to 13.5 mg of Sennosides A and B in the form of calcium salts Excipients with known effects: Lactose and methyl hydroxybenzoate. See blog: Senade - a laxative for children and adults Dosage form Tablets Pharmacology Pharmacodynamics Pharmaco-therapeutic group: Contact laxatives. ATC code: A06AB06. 1,8-dihydroxyanthracene derivatives have a laxative effect, i.e. they soften the stool or thin the mass. β-O-linked glycosides (sennosides) are not absorbed in the upper intestine; they are converted by the large intestine into an active metabolite (rhein anthrone). There are two distinct mechanisms of action: Stimulation of colonic motility leads to accelerated colonic transit. Effect on secretion has two simultaneous mechanisms - inhibition of water and electrolyte (Na+, Cl-) absorption in colonic epithelial cells (anti-absorptive effect) and increased permeability of tight junctions and stimulation of water and electrolyte secretion into the colonic lumen (secretagogue effect), leading to improved concentrations of fluid and electrolytes in the colonic lumen. Defecation begins 6-10 hours after administration of senoside, as this time is required for intestinal transport and metabolism into the active compound. β-O-linked glycosides (sennosides) are not absorbed in the upper intestine, nor are they degraded by human digestive enzymes. They are converted by colonic bacteria into an active metabolite (rhein anthrone). The aglycone is absorbed in the upper gastrointestinal tract. Radio-labeled rhein anthrone administered directly into the cecum in animal experiments showed absorption of <10%. Upon contact with oxygen, rhein anthrone is oxidized to rhein and sennidins, which are found in the blood, mainly in the form of glucuronides and sulfates. Systemic bioavailability of sennosides A is <5%. Intestinal action/laxative effect begins 8-10 hours after administration of the preparation. 3-6% of metabolites are excreted in the urine after oral administration of sennosides; some are excreted in bile. The majority of sennosides (approximately 90%) are excreted in the feces in the form of polymers (polyquinones) along with 2-6% unchanged sennosides, sennidins, rhein anthrone, and rhein. In human pharmacokinetic studies, with senna powder (20 mg sennosides) taken orally for 7 days, a maximum concentration of 100 ng rhein/mL was detected in the blood. No accumulation of rhein was observed. Active metabolites, such as rhein, are transferred in small amounts into breast milk. Animal experiments have shown that placental transfer of rhein is low. Toxic effects Most data relate to senna extracts containing 1.4-3.5% anthranoids, corresponding to 0.9-2.3% potential rhein, 0.05-0.15% potential aloe-emodin, and 0.001-0.006% potential emodin or isolated active components, e.g., rhein or sennosides A and B. Acute toxicity of senna, its specific extracts, as well as sennosides in rats and mice was low after oral treatment. In studies with parenteral administration in mice, extracts were likely to have higher toxicity than purified glycosides, likely due to the content of aglycones. In a 90-day study in rats, senna was administered at doses from 100 mg/kg to 1,500 mg/kg. The tested preparation contained 1.83% sennosides A-D, 1.6% potential rhein, 0.11% potential aloe-emodin, and 0.014% potential emodin. Mild colonic epithelial hyperplasia was observed in all groups, which was reversible during an 8-week rehabilitation period. Hyperplastic lesions of the forestomach epithelium were also reversible. At doses of 300 mg/kg/day or higher, dose-dependent renal tubular basophilia and epithelial hypertrophy were observed without affecting function. These changes were also reversible. Storage of brown tubular pigment caused dark discoloration of the kidney surface and was still mild after the rehabilitation period. No changes were observed in the enteric nervous plexus. No insignificant level of exposure was observed in this study. In 104-week studies in rats of both sexes, no carcinogenic effects were detected with the same senna preparations at oral doses up to 300 mg/kg. Furthermore, a specific senna extract was not carcinogenic in male and female rats when administered orally for 2 years. The extract studied contained approximately 40.8% anthranoids, of which 35% were sennosides, corresponding to approximately 25.2% potential rhein, 2.3% potential aloe-emodin, and 0.007% potential emodin, and 142 ppm free aloe-emodin and 9 ppm free emodin. In subsequent 2-year studies in female and male rats and mice, no evidence of carcinogenic activity was observed with emodin in male rats and female mice, and equivocal evidence in female rats and male mice. Sinoside showed no specific toxicity in dogs for 4 weeks at doses up to 500 mg/kg and in rats for 6 months at doses up to 100 mg/kg. No evidence of embryolethal, teratogenic, or fetotoxic effects was observed in rats or rabbits after oral treatment with senoside. Furthermore, no effect on postnatal development, growth, or fertility in male or female young rats was observed. Data for herbal preparations are not available. The extract and aloe-emodin were mutagenic in in-vitro tests, while sennoside A, B, and rhein showed negative results. Comprehensive in vivo studies of a defined senna extract were negative. Chronic use of laxatives as a risk factor for colorectal cancer has been studied in several clinical trials. Some studies have shown a risk of colorectal cancer associated with the use of anthranoid-containing laxatives, while others have not. However, the risk has also been identified in relation to constipation itself and underlying dietary habits. Further studies are needed to assess carcinogenic risk. Temporary use of senna fruit is recommended and considered safe. Indications • Chronic constipation • Regulation of defecation in hemorrhoids, proctitis, and anal fissures. • Preparation for radiological examination. Dosage and administration Usually taken once daily in the evening, before bedtime. Adults and children over 12 years of age: 1 tablet before bedtime, with water or any drink. Maximum daily dose - 3 tablets. Children aged 6-12 years: ½ tablet before bedtime. Maximum daily dose 2 tablets. When selecting, take the same dose for several days and gradually increase by 1/2 tablet. If defecation does not occur within 3 days of reaching the maximum dose, consult a doctor. Contraindications Senoside tablets should not be used in the following cases: · Hypersensitivity to the active substance or any of the excipients listed in point 6. · Intestinal obstruction and stenosis, atony, appendicitis, inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), · Abdominal pain of unknown origin, severe dehydration with disorders of water and electrolyte metabolism. · Children under 6 years of age. Warnings and precautions Caution is advised in patients taking cardiac glycosides, antiarrhythmics, medicinal products known to prolong the QT interval, diuretics, adrenocorticosteroids, or licorice root concomitantly. Like all laxatives, this product should not be taken by patients with fecal impaction and undiagnosed, acute, or persistent gastrointestinal complaints, e.g., abdominal pain, nausea, and vomiting, unless advised by a doctor, as these symptoms may be signs of potential or existing intestinal blockage (ileus). If laxative use is required daily, it is necessary to determine the cause of constipation. Caution is advised with long-term use of laxatives. Prolonged use of stimulant laxatives beyond a short treatment period may lead to impaired bowel function and laxative dependence. This medicinal product should only be taken if therapeutic effect cannot be achieved by dietary changes or by taking bulk-forming agents. When this medicinal product is used by adults with incontinence, diapers should be changed more frequently to prevent prolonged skin contact with feces. Not recommended for long-term use (longer than 1 week) without prescription, due to the possible development of diarrhea, dehydration, and intestinal atony. Caution is advised in patients with renal or hepatic insufficiency due to the possible development of electrolyte imbalance. Excipients Lactose Since the tablets contain lactose, this product should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Methylparaben The preparation contains methylparaben. This may cause allergic reactions (possible delayed). Interactions with medicinal products Long-term use of laxatives may cause hypokalemia, which may potentiate the effects of cardiac glycosides and interact with antiarrhythmics that cause reversal of sinus rhythm (e.g., quinidine), and cause QT interval prolongation. Concomitant administration with agents causing hypokalemia (such as diuretics, adrenocorticosteroids, and licorice root) may potentiate electrolyte imbalance. It is not recommended to use within two hours of taking another medication, as sennoside can reduce the absorption and efficacy of other medications. Fertility, pregnancy, and lactation Pregnancy There are no reports of adverse or harmful effects on pregnancy and fetal development when used at recommended doses. Nevertheless, due to experimental data on the genotoxic risk of several anthranoids, such as emodin and aloe-emodin, use is not recommended in the first trimester of pregnancy. After prescription, use with great caution in the second and third trimesters temporarily in cases where lifestyle and dietary changes or bulk-forming agents do not yield results. Lactation Use during breastfeeding is not recommended, as there is insufficient data on the excretion of metabolites into breast milk. Small amounts of active metabolites are excreted into breast milk. No laxative effect was observed in breastfed infants. Adverse effects The adverse effects listed below are classified by frequency and system organ class. Frequency categories are defined according to MedDRA: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people), not known (frequency cannot be estimated from available data). Hypersensitivity reactions (itching, urticaria, localized or generalized exanthema) have been observed. Products containing senna may cause abdominal pain of the colic type, spasms with liquid stools, bloating, nausea, and vomiting, especially in patients with irritable bowel. However, these symptoms are associated with individual overdose. In such cases, the preparation should be discontinued or a dose reduction is required. Chronic use may cause disturbances in fluid balance and electrolyte metabolism and consequently lead to secondary dehydration, hypotension, especially in the elderly, albuminuria, hematuria, and uremia. In addition, chronic use may cause pigmentation of the intestinal mucosa, which usually subsides upon discontinuation of the preparation. During treatment, yellow or reddish-brown discoloration of the urine may be observed, depending on the pH. A characteristic of overdose is hypokalemia. The etiology of hypokalemia is multifactorial: hypokalemia causes cardiac problems and muscle weakness by increasing intestinal electrolyte transport, especially when used with cardiac glycosides, diuretics, increased plasma renin levels, secondary aldosteronism, and decreased absorption. These changes are usually reversible upon discontinuation of laxatives. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorization of the medicinal product is important. This allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions through the local reporting system. Overdose Symptoms Symptoms of overdose/abuse include abdominal pain and severe diarrhea with subsequent loss of fluid and electrolytes, requiring rehydration. Diarrhea, in particular, can cause asthenia, especially when taken concomitantly with cardiac glycosides, diuretics, adrenocorticosteroids, or licorice root. Management Treatment should be supportive with large amounts of fluid. Monitoring of electrolytes, especially potassium, is necessary. This is particularly important in the elderly. Chronic intake of overdose of anthranoid-containing medicinal products may cause toxic hepatitis. Incompatibilities Not applicable. Shelf life 3 years. Storage and usage instructions Store in a dry place, at a temperature not exceeding 25 0 C. Keep out of reach of children! Dispensing category: Pharmaceutical product group III, available without prescription
- Active
- sennoside a+b
What is it?
Senade Generic Name Senosides Tablets 13.5 mg Composition Each film-coated tablet contains: Senna extract, equivalent to 13.5 mg of Sennosides A and B in the form of calcium salts Excipients with known effects: Lactose and methyl hydroxybenzoate. See blog: Senade - a laxative for children and adults Dosage form Tablets Pharmacology Pharmacodynamics Pharmaco-therapeutic group: Contact laxatives. ATC code: A06AB06. 1,8-dihydroxyanthracene derivatives have a laxative effect, i.e. they soften the stool or thin the mass. β-O-linked glycosides (sennosides) are not absorbed in the upper intestine; they are converted by the large intestine into an active metabolite (rhein anthrone). There are two distinct mechanisms of action: Stimulation of colonic motility leads to accelerated colonic transit. Effect on secretion has two simultaneous mechanisms - inhibition of water and electrolyte (Na+, Cl-) absorption in colonic epithelial cells (anti-absorptive effect) and increased permeability of tight junctions and stimulation of water and electrolyte secretion into the colonic lumen (secretagogue effect), leading to improved concentrations of fluid and electrolytes in the colonic lumen. Defecation begins 6-10 hours after administration of senoside, as this time is required for intestinal transport and metabolism into the active compound. β-O-linked glycosides (sennosides) are not absorbed in the upper intestine, nor are they degraded by human digestive enzymes. They are converted by colonic bacteria into an active metabolite (rhein anthrone). The aglycone is absorbed in the upper gastrointestinal tract. Radio-labeled rhein anthrone administered directly into the cecum in animal experiments showed absorption of <10%. Upon contact with oxygen, rhein anthrone is oxidized to rhein and sennidins, which are found in the blood, mainly in the form of glucuronides and sulfates. Systemic bioavailability of sennosides A is <5%. Intestinal action/laxative effect begins 8-10 hours after administration of the preparation. 3-6% of metabolites are excreted in the urine after oral administration of sennosides; some are excreted in bile. The majority of sennosides (approximately 90%) are excreted in the feces in the form of polymers (polyquinones) along with 2-6% unchanged sennosides, sennidins, rhein anthrone, and rhein. In human pharmacokinetic studies, with senna powder (20 mg sennosides) taken orally for 7 days, a maximum concentration of 100 ng rhein/mL was detected in the blood. No accumulation of rhein was observed. Active metabolites, such as rhein, are transferred in small amounts into breast milk. Animal experiments have shown that placental transfer of rhein is low. Toxic effects Most data relate to senna extracts containing 1.4-3.5% anthranoids, corresponding to 0.9-2.3% potential rhein, 0.05-0.15% potential aloe-emodin, and 0.001-0.006% potential emodin or isolated active components, e.g., rhein or sennosides A and B. Acute toxicity of senna, its specific extracts, as well as sennosides in rats and mice was low after oral treatment. In studies with parenteral administration in mice, extracts were likely to have higher toxicity than purified glycosides, likely due to the content of aglycones. In a 90-day study in rats, senna was administered at doses from 100 mg/kg to 1,500 mg/kg. The tested preparation contained 1.83% sennosides A-D, 1.6% potential rhein, 0.11% potential aloe-emodin, and 0.014% potential emodin. Mild colonic epithelial hyperplasia was observed in all groups, which was reversible during an 8-week rehabilitation period. Hyperplastic lesions of the forestomach epithelium were also reversible. At doses of 300 mg/kg/day or higher, dose-dependent renal tubular basophilia and epithelial hypertrophy were observed without affecting function. These changes were also reversible. Storage of brown tubular pigment caused dark discoloration of the kidney surface and was still mild after the rehabilitation period. No changes were observed in the enteric nervous plexus. No insignificant level of exposure was observed in this study. In 104-week studies in rats of both sexes, no carcinogenic effects were detected with the same senna preparations at oral doses up to 300 mg/kg. Furthermore, a specific senna extract was not carcinogenic in male and female rats when administered orally for 2 years. The extract studied contained approximately 40.8% anthranoids, of which 35% were sennosides, corresponding to approximately 25.2% potential rhein, 2.3% potential aloe-emodin, and 0.007% potential emodin, and 142 ppm free aloe-emodin and 9 ppm free emodin. In subsequent 2-year studies in female and male rats and mice, no evidence of carcinogenic activity was observed with emodin in male rats and female mice, and equivocal evidence in female rats and male mice. Sinoside showed no specific toxicity in dogs for 4 weeks at doses up to 500 mg/kg and in rats for 6 months at doses up to 100 mg/kg. No evidence of embryolethal, teratogenic, or fetotoxic effects was observed in rats or rabbits after oral treatment with senoside. Furthermore, no effect on postnatal development, growth, or fertility in male or female young rats was observed. Data for herbal preparations are not available. The extract and aloe-emodin were mutagenic in in-vitro tests, while sennoside A, B, and rhein showed negative results. Comprehensive in vivo studies of a defined senna extract were negative. Chronic use of laxatives as a risk factor for colorectal cancer has been studied in several clinical trials. Some studies have shown a risk of colorectal cancer associated with the use of anthranoid-containing laxatives, while others have not. However, the risk has also been identified in relation to constipation itself and underlying dietary habits. Further studies are needed to assess carcinogenic risk. Temporary use of senna fruit is recommended and considered safe. Indications • Chronic constipation • Regulation of defecation in hemorrhoids, proctitis, and anal fissures. • Preparation for radiological examination. Dosage and administration Usually taken once daily in the evening, before bedtime. Adults and children over 12 years of age: 1 tablet before bedtime, with water or any drink. Maximum daily dose - 3 tablets. Children aged 6-12 years: ½ tablet before bedtime. Maximum daily dose 2 tablets. When selecting, take the same dose for several days and gradually increase by 1/2 tablet. If defecation does not occur within 3 days of reaching the maximum dose, consult a doctor. Contraindications Senoside tablets should not be used in the following cases: · Hypersensitivity to the active substance or any of the excipients listed in point 6. · Intestinal obstruction and stenosis, atony, appendicitis, inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), · Abdominal pain of unknown origin, severe dehydration with disorders of water and electrolyte metabolism. · Children under 6 years of age. Warnings and precautions Caution is advised in patients taking cardiac glycosides, antiarrhythmics, medicinal products known to prolong the QT interval, diuretics, adrenocorticosteroids, or licorice root concomitantly. Like all laxatives, this product should not be taken by patients with fecal impaction and undiagnosed, acute, or persistent gastrointestinal complaints, e.g., abdominal pain, nausea, and vomiting, unless advised by a doctor, as these symptoms may be signs of potential or existing intestinal blockage (ileus). If laxative use is required daily, it is necessary to determine the cause of constipation. Caution is advised with long-term use of laxatives. Prolonged use of stimulant laxatives beyond a short treatment period may lead to impaired bowel function and laxative dependence. This medicinal product should only be taken if therapeutic effect cannot be achieved by dietary changes or by taking bulk-forming agents. When this medicinal product is used by adults with incontinence, diapers should be changed more frequently to prevent prolonged skin contact with feces. Not recommended for long-term use (longer than 1 week) without prescription, due to the possible development of diarrhea, dehydration, and intestinal atony. Caution is advised in patients with renal or hepatic insufficiency due to the possible development of electrolyte imbalance. Excipients Lactose Since the tablets contain lactose, this product should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Methylparaben The preparation contains methylparaben. This may cause allergic reactions (possible delayed). Interactions with medicinal products Long-term use of laxatives may cause hypokalemia, which may potentiate the effects of cardiac glycosides and interact with antiarrhythmics that cause reversal of sinus rhythm (e.g., quinidine), and cause QT interval prolongation. Concomitant administration with agents causing hypokalemia (such as diuretics, adrenocorticosteroids, and licorice root) may potentiate electrolyte imbalance. It is not recommended to use within two hours of taking another medication, as sennoside can reduce the absorption and efficacy of other medications. Fertility, pregnancy, and lactation Pregnancy There are no reports of adverse or harmful effects on pregnancy and fetal development when used at recommended doses. Nevertheless, due to experimental data on the genotoxic risk of several anthranoids, such as emodin and aloe-emodin, use is not recommended in the first trimester of pregnancy. After prescription, use with great caution in the second and third trimesters temporarily in cases where lifestyle and dietary changes or bulk-forming agents do not yield results. Lactation Use during breastfeeding is not recommended, as there is insufficient data on the excretion of metabolites into breast milk. Small amounts of active metabolites are excreted into breast milk. No laxative effect was observed in breastfed infants. Adverse effects The adverse effects listed below are classified by frequency and system organ class. Frequency categories are defined according to MedDRA: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people), not known (frequency cannot be estimated from available data). Hypersensitivity reactions (itching, urticaria, localized or generalized exanthema) have been observed. Products containing senna may cause abdominal pain of the colic type, spasms with liquid stools, bloating, nausea, and vomiting, especially in patients with irritable bowel. However, these symptoms are associated with individual overdose. In such cases, the preparation should be discontinued or a dose reduction is required. Chronic use may cause disturbances in fluid balance and electrolyte metabolism and consequently lead to secondary dehydration, hypotension, especially in the elderly, albuminuria, hematuria, and uremia. In addition, chronic use may cause pigmentation of the intestinal mucosa, which usually subsides upon discontinuation of the preparation. During treatment, yellow or reddish-brown discoloration of the urine may be observed, depending on the pH. A characteristic of overdose is hypokalemia. The etiology of hypokalemia is multifactorial: hypokalemia causes cardiac problems and muscle weakness by increasing intestinal electrolyte transport, especially when used with cardiac glycosides, diuretics, increased plasma renin levels, secondary aldosteronism, and decreased absorption. These changes are usually reversible upon discontinuation of laxatives. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorization of the medicinal product is important. This allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions through the local reporting system. Overdose Symptoms Symptoms of overdose/abuse include abdominal pain and severe diarrhea with subsequent loss of fluid and electrolytes, requiring rehydration. Diarrhea, in particular, can cause asthenia, especially when taken concomitantly with cardiac glycosides, diuretics, adrenocorticosteroids, or licorice root. Management Treatment should be supportive with large amounts of fluid. Monitoring of electrolytes, especially potassium, is necessary. This is particularly important in the elderly. Chronic intake of overdose of anthranoid-containing medicinal products may cause toxic hepatitis. Incompatibilities Not applicable. Shelf life 3 years. Storage and usage instructions Store in a dry place, at a temperature not exceeding 25 0 C. Keep out of reach of children! Dispensing category: Pharmaceutical product group III, available without prescription