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GRANULAR 1 400 G PAPER/AL CONTAINER WITH MEASURING SPOONPackage Leaflet - Directions - What itis and what it is used forThis medicine contains Ispagula seed, Ispagula cuticle and Senna fruit, and belongs to a group of medicines called laxatives. Agiolax
GRANULAR 1 400 G PAPER/AL CONTAINER WITH MEASURING SPOONPackage Leaflet - Directions - What itis and what it is used forThis medicine contains Ispagula seed, Ispagula cuticle and Senna fruit, and belongs to a group of medicines called laxatives. Agiolax is used for the short-term treatment of occasional constipation in adults and adolescents over the age of 12. Talk to your doctor if you do not feel better or feel worse after 7 days.Contraindications - What you need to know before taking the medicineDo not use AGIOLAX - if you are allergic to Ispagula semen, Ispagula cuticula and Senna fruit or any of the other ingredients of this medicine (listed in section 6) - if you suffer from abdominal pain also of unknown origin, - if you have episodes of nausea or vomiting, - if you have an intestinal obstruction, - if you have a stricture (narrowing) of the esophagus (food channel from the throat to the stomach) or gastrointestinal tract (stomach and intestine), - if you have blood loss from the rectum of unknown origin, - if you are suffering from a severe state of dehydration (excessive loss of water from the body), - if you suffer from dysphagia (difficulty swallowing), hiatal hernia (protrusion of a portion of the stomach that moves upwards) or conditions that carry the risk of regurgitation (for example if you are forced to lie in bed), - if you suffer from a loss of normal bowel functions (atonia of the colon) or have a hard, bulky stool mass in your intestine caused by constipation (faecaloma), - if you are pregnant or breastfeeding (see section Pregnancy and breastfeeding), - if you suffer from inflammatory bowel diseases (Crohn's disease, ulcerative colitis or appendicitis), - if the subject to be treated is less than 12 years oldSpecial warnings and precautions for use - Warnings and precautionsTalk to your doctor or pharmacist before using Agiolax. Health Education Notes First of all, it should be borne in mind that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruits) can solve the problem of constipation permanently. Many people think they suffer from constipation if they can't evacuate every day. This is a mistaken belief as this situation is quite normal for a large number of individuals. Consider, however, that constipation occurs when bowel movements are reduced compared to your own personal habits and are associated with the emission of hard stools. If episodes of constipation occur repeatedly, the doctor should be consulted. Overuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhoea resulting in loss of water, mineral salts (especially potassium) and other essential nutritional factors. In more severe cases, dehydration (excessive loss of water from the body) or hypokalaemia (decreased potassium in the blood) may occur, which can cause problems with the heart or muscles, especially if you are taking certain medicines at the same time (see Other medicines and Agiolax). Laxative abuse can cause dependence (and, therefore, the possible need to progressively increase the dosage), chronic constipation and intestinal atony (loss of normal bowel functions). During treatment with Agiolax it is necessary to ingest an abundant amount of water (6-8 glasses per day) to prevent the onset of an intestinal obstruction. Agiolax should only be used if a therapeutic effect cannot be obtained by modifying the diet or by administering volume laxatives. Tell your doctor if you are taking thyroid medicines. After oral intake or skin contact Agiolax may cause hypersensitivity reactions (allergies), see Possible side effects. Abdominal pain, spasms and diarrhoea may occur especially in case of pre-existing irritable bowel (impaired bowel mobility), see Possible side effects. Some symptoms may also occur as a result of overdose, in which case the dose should be reduced (see If you take more AGIOLAX than you should).Interactions - Side Effects - Possible Side EffectsLike all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following symptoms, STOP using Agiolax immediately and contact your doctor or the nearest hospital where you will undergo appropriate and specific treatment - - Hypersensitivity reactions (allergic reactions) - Anaphylactic reactions (severe allergic reactions) - Skin rash and itching. Abdominal colic (painful contractions of the visceral muscles) may occur. The latter occur more frequently in case of severe constipation or irritable bowel (condition of altered motility of the intestine) The following side effects may also occur - Rare (may affect up to 1 in 1000 people) - - Flatulence (emission of intestinal gas from the anus) - Abdominal distension (swollen belly) - Chromaturia (abnormal staining of the urine), due to the presence of components of the senna Very rare (may affect up to 1 in 10,000 people) - - Obstruction of the esophagus (alimentary canal from the throat to the stomach) Not known (frequency cannot be determined based on available data) - Nausea - Vomiting - Diarrhea - Albuminuria [loss of albumin (a protein) with urine], from prolonged use - Haematuria (blood in urine), for prolonged use. In addition, melanosis of the colon (staining of the intestinal mucosa) which recedes after discontinuation of the medicinal product has been reported. Reporting of undesirable effects If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at - https - //www.aifa.gov.it/content/segalazionireazioni-avverse. By reporting side effects you can help provide more information about the safety of this medicine.Recommendations on how to store - Container of 100 g, 250 g, 400 g - Store at a temperature below 25°C Sachets - Store at a temperature below 30°C. Keep in the original packaging to protect from moisture.Active ingredients - 100 g of granules contain Active ingredients - - Ispagula seed 52 g - Ispagula cuticle 2.2 g - Senna fruit 6.74 - 13.15 g equivalent to 300 mg of hydroxyanthracene derivatives calculated as sennoside B Excipients with known effects - sucrose For the full list of excipients, see section 6.1Excepents - Talc, gum arabic, cumin essence, sage essence, mint essence, liquid paraffin, solid paraffin, E 172, sucrose.Therapeutic Indications - Short-term treatment of occasional constipation in adults and adolescents over the age of 12.Contraindications - • hypersensitivity to the active substances or to any of the excipients listed in section 6.1 • sudden irregularity of bowel functions that persists for more than 2 weeks • acute abdominal pain or of unknown origin • nausea or vomiting • intestinal obstruction • oesophageal or gastrointestinal stenosis • rectal bleeding of unknown origin • failure to defecate following the use of laxatives• severe state of dehydration • dysphagia, hiatal hernia or conditions involving the risk of regurgitation • atonia of the colon • megacolon • faecaloma • children under 12 years of age • pregnancy and breastfeeding (see section 4.6) • Crohn's disease, ulcerative colitis and appendicitisPosology - Posology The correct dose is the minimum sufficient to produce an easy evacuation of soft faeces. It is recommended to initially use the minimum doses provided. When necessary, the dose can be increased. Do not exceed the maximum recommended daily dose. Adults and adolescents over 12 years of age - The recommended dose is 5 g or 10 g of granules (corresponding to 1 - 2 measuring spoons) once a day. 1-2 sachets of 5 g once a day. Do not exceed the maximum recommended daily dose. Children Agiolax is contraindicated in children below 12 years of age (see section 4.3). A unit dose of 5 g of granules contains - 2.6 g of Ispagula seed 0.11 g of Ispagula cuticle 0.34 - 0.66 g of Senna fruit Method of administration For oral use. The granules should not be chewed or dissolved, but should be placed on the tongue and swallowed, standing upright, drinking a large glass of water. Agiolax should always be taken with liquids. Without sufficient fluids, the product may swell and obstruct the pharynx or oesophagus, creating the risk of suffocation (see section 4.4). It can be taken regardless of meals. Preferably take in the evening, one hour before bedtime. Use the graduated measuring spoon supplied with the package. Duration of treatment Laxatives should be used as infrequently as possible and should not be used for more than 7 days. If after 3 days no improvements are observed or abdominal pain or bowel irregularities arise, re-evaluate the clinical picture. Prolonged use should be established after appropriate clinical evaluation.Warnings - Warnings The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhoea resulting in loss of water, mineral salts (especially potassium) and other essential nutritional factors. In the most severe cases, dehydration or hypokalaemia may occur, which may result in cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with certain medicinal products (see section 4.5). The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (possible need to gradually increase the dosage), chronic constipation and loss of normal bowel functions (intestinal atony). During treatment with Agiolax it is necessary to ingest an abundant amount of water (6-8 glasses per day) to prevent the onset of an intestinal obstruction. Agiolax should only be used if a therapeutic effect cannot be obtained by modifying the diet or by administering volume laxatives. Use of laxatives in conjunction with thyroid hormones may necessitate dose adjustment of thyroid hormones. Given the risk of gastrointestinal obstruction, Agiolax should not be used together with medicinal products known to inhibit peristaltic movement (see section 4.5). After oral intake or skin contact Agiolax may cause hypersensitivity reactions (see section 4.8). Abdominal pain, spasms and diarrhoea may occur, especially in the case of pre-existing irritable bowel syndrome (see section 4.8). These symptoms may also arise as a result of overdose; in this circumstance it is necessary to reduce the dose (see section 4.9). Important information about some of the ingredients Agiolax contains sucrose - patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.Interactions - Hypokalaemia (resulting from long-term laxative abuse) potentiates the effects of cardiac glycosides and interacts with antiarrhythmic drugs, drugs that induce sinus rhythm reversal (e.g. quinidine), and drugs that induce QT prolongation. Concomitant use of diuretics, corticosteroids and licorice root may increase electrolyte imbalance. Laxatives may reduce the residence time in the intestine, and thus the absorption, of other drugs administered simultaneously orally (e.g. vitamin B12, coumarin derivatives, lithium and carbamazepine). Concomitant administration of antidiabetics may increase the risk of hypoglycaemia. Avoid taking laxatives and other medicines at the same time - allow an interval of at least 2 hours to elapse before or after taking the laxative and another medicine. Agiolax may increase the risk of opioid-induced reduced peristalsis occlusion (see section 4.4).Undesirable effects - The undesirable effects are reported according to the classification for organs and systems according to MedDRA. Side effects are listed using the MedDRA frequency convention - very common (≥1/10); common (≥1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare ≥ 1/10,000, < 1/1000); very rare (
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