AGIOLAX OS FREE BAR 250G

AGIOLAX GRANULATION

active ingredients

100 g of granulate contain Active ingredients: - Ispagula seed 52 g; - Ispagula cuticle 2,2 g; - Seine fruit 6,74 - 13,15 g equivalent to 300 mg of hydroxyantracene derivatives calculated as sennoside B. Excipients with known effects: sucrose For the full list of excipients, see paragraph 6.1

Excellent

Talco, arabic rubber, comin essence, sage essence, mint essence, liquid paraffin, solid paraffin, E 172, sucrose.

Therapeutic indications

Short-term treatment of occasional constipation

Contraindications

• hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1 • acute or unknown abdominal pain • nausea or vomiting • intestinal obstruction • esophagous stenosis or gastrointestinal • rectal bleeding of unknown origin • severe dehydration status • disfagy, iatal hernia) or conditions that involve the risk of regunate

Population

Population The correct dose is sufficient to produce an easy evacuation of soft feces. It is recommended to initially use the minimum doses provided. When necessary, the dose can be increased. Do not exceed the recommended maximum daily dose. Adults: 1-2 tablespoons (corresponding to 5 - 10 g granulate) morning and evening. In stubborn cases 2 tablespoons each 6 hours for 1-3 days. 1-2 sachets from 5 g morning and evening. In stubborn cases 2 sachets every 6 hours for 1-3 days. Children over 10 years: 1 tablespoon dispenser (corresponding to 5 g granulate) per day 1 sachet from 5 g per day. A unit dose of 5 g granulate contains: 2,6 g of Ispagula seed, 0.11 g of Ispagula cuticle, 0.34 - 0,66 g of Seine fruit. Method of administration For oral use. The granulate should not be chewed or loose, but must be placed on the tongue and swallowed drinking a plentiful glass of water. Agiolax must always be taken with liquids. Without sufficient liquids, the product can inflate and obstruct the pharynx or esophagus, creating the risk of suffocation (see paragraph 4.4). It can be taken regardless of meals. In case of a single daily dose, preferably take in the evening, an hour before bedtime. Duration of treatment Laxatives must be used as frequently as possible and should not be used for more than seven days. Prolonged use should be established after proper clinical evaluation.

Conservation

Container from 100 g, 250 g, 400 g: Store at a temperature below 25°C Store at a temperature below 30°C. Keep in the original packaging to protect the medicine from moisture.

Warnings

Warnings Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with certain medicines (see paragraph 4.5). The abuse of laxatives especially those of contact (stimulating laxatives), can cause dependence (possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). During treatment with Agiolax it is necessary to ingest a abundant amount of water (6-8 glasses per day) to prevent the emergence of a bowel obstruction. Agiolax should only be used if it is not possible to obtain a therapeutic effect by changing the diet or administering volume laxatives. The use of laxatives in conjunction with thyroid hormones can make the dose adjustment of thyroid hormones necessary. Considered the risk of gastrointestinal obstruction, Agiolax should not be used together with medicines known to inhibit peristaltic movement (see paragraph 4.5). After oral intake or contact with Agiolax skin may cause hypersensitivity reactions (see paragraph 4.8). Abdominal pain, spasms and diarrhea may occur especially in case of pre-existing irritable colon (see paragraph 4.8). Such symptoms may also arise as a result of overdose; (see paragraph 4.9). Important information about some Agiolax excipients contains sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose mal absorption, or isomaltase sucrasis failure, should not take this medicine.

Interactions

Hypokaliemia (derived by long-term laxative abuse) enhances the effects of cardiac glycosides and interacts with antiarthmic medicines, with medicines that induce the reversal of the sinus rhythm (e.g. chinidine) and with medicines that induce the extension of the QT tract. Concurrent use of diuretics, corticosteroids and licorice root can increase electrolytic imbalance. Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid ingesting laxatives and other drugs at the same time: let spend a range of at least 2 hours before or after taking laxative and another medicine. Agiolax can enhance the risk of occlusion from reduced peristalsis induced by opioids (see paragraph 4.4).

Effects

The undesirable effects are reported according to the classification by organs and systems according to MedDRA. Undesirable effects are listed using the MedDRA Convention on Frequency: very common (≥1/10); common (≥1/100, Organic systemic classification Very common ≥1/10 Common ≥1/100 to ≤1/10 Not common from ≥1/1.000 to ≤1/100 Rares from ≥ 1/10.000 to ≤ 1/1.000 Very rare ≤1/10.000 Not known Gastrointestinal diseases       Abdominal colics*Flatulence abdomen extension Gastrointestinal obstruction Fecaloma Osophagus obstruction Nausea Vomito Diarrea Kidney and urinary pathologies       Chromatography   It is not recommended to use this product Immune system pathologies           Reactions of hypersensitivity, Anaphylactic reactions Prurito *more frequently in case of severe constipation or irritable colon; ** from prolonged use; [bleep] this color is due to the presence in the urine of components of the bucket and is not clinically significant. Moreover, it was reported melanosis of the colon that withdraws after the suspension of the medicinal product. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Excessive doses can cause abdominal spasms, abdominal pain, flatulence, intestinal obstruction and severe diarrhea, in such case suspending treatment and the consequent losses of liquids and electrolytes must be replenished. Prolonged use of high doses of anthraquinone-containing medicines can cause toxic hepatitis.

Pregnancy

The use during pregnancy is contraindicated due to the genotoxicity known for the anthraquinones contained in the bucket (see paragraph 4.3).

Food

Small amounts of active metabolites of anthraquinans, such as rhine are excrete in breast milk, therefore the use of Agiolax during breast milk lactation is contraindicated.

Fertility

No fertility studies have been conducted.

Source: Farmadati