X-PREP SYRUP 75ML BOTTLE
TECHNICAL SHEET RCP DRUGS FROM DATABASE
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MEDICINAL NAME"style =" fancy "icon =" chevron-circle "]
X-PREP 2 mg / ml, powder and solvent for oral solution.
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QUALITATIVE AND QUANTITATIVE COMPOSITION"style =" fancy "icon =" chevron-circle "]
One 75ml bottle contains:
Separator cap:
Active ingredient: Concentrated senna extract corresponding to sennosides 0.150 g.
Excipients with known effects: sucrose, propyl para-hydroxybenzoate, methyl para-hydroxybenzoate, ethanol.
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PHARMACEUTICAL FORM"style =" fancy "icon =" chevron-circle "]
Powder and solvent (75 ml) for oral solution.
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THERAPEUTIC INDICATIONS"style =" fancy "icon =" chevron-circle "]
Short-term treatment of occasional constipation.
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DOSAGE AND METHOD OF ADMINISTRATION"style =" fancy "icon =" chevron-circle "]
One or two coffee spoons in the evening, after a meal. The action of X-Prep occurs after 6-12 hours. Preferably take in the evening, the effect appears the next morning. The correct dose is the minimum sufficient to produce easy evacuation of soft faeces. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated.
Laxatives should be used as infrequently as possible and for no more than 7 days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.
Swallow with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicine.
Method of preparation of the solution:
Opening the bottle: exert a slight pressure on the capsule, while at the same time turning it anticlockwise;
Preparation of the solution: press the separator cap fully, shake until completely dissolved, then remove the separator cap.
The ready-to-use solution must be used within three months of its preparation.
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CONTRAINDICATIONS"style =" fancy "icon =" chevron-circle "]
Hypersensitivity to the active substance or to any of the excipients.
Laxatives are contraindicated in people with:
acute abdominal pain or of unknown origin,
appendicitis,
nausea or vomiting,
intestinal obstruction or stricture or ileus,
inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis),
rectal bleeding of unknown origin,
severe state of dehydration.
Contraindicated in children under 10 years of age.
Contraindicated during pregnancy and lactation.
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[su_spoiler title = "
WARNINGS AND PRECAUTIONS FOR USE"style =" fancy "icon =" chevron-circle "] Warnings
Laxatives containing sennosides should be used with caution in patients suffering from fecal impaction.
Do not use laxatives if abdominal pain, nausea, vomiting are present as these symptoms may be signs of an intestinal blockage or potential or present ileus.
The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, minerals (especially potassium) and other essential nutritional factors. In severe cases, the onset of dehydration or hypokalaemia is possible which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with other drugs or herbal substances known to induce hypokalaemia such as cardiac glycosides, diuretics or corticosteroids, licorice root.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
The medicine contains sucrose, this should be taken into account in case of diabetes or low calorie diets.
After a short period of treatment without noticeable results or if bleeding occurs, consult your doctor.
Precautions for use
The treatment of chronic or recurrent constipation always requires the intervention of the doctor for the diagnosis, the prescription of drugs and the surveillance during the course of therapy.
Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristic of bowel movements) that has lasted for more than 2 weeks and when the use of the laxative fails to produce effects. Laxatives should not be used for longer than 1 week, unless otherwise advised by the doctor.
It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine.
NOTE: For patients on a low sodium diet: only small amounts of sodium are present in the sennosides and in the sodium sennoside and docusate combinations.
X-prep contains:
sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicine.
propyl para-hydroxybenzoate, methyl para-hydroxybenzoate which can cause allergic reactions (including delayed)
ethanol: this medicine contains 7.36 vol % ethanol, e.g. up to 590 mg per serving, equivalent to 14.75 ml of beer, 4.91 ml of wine per serving.
It can be harmful to alcoholics.
Use with caution in high-risk patients such as people with liver disease or epilepsy. [/ Su_spoiler]
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INTERACTIONS"style =" fancy "icon =" chevron-circle "]
Precautions in the simultaneous use of digitalis and other drugs or herbal substances known for the induction of hypokalemia as they increase potassium depletion.
Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative.
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FERTILITY, PREGNANCY AND BREASTFEEDING"style =" fancy "icon =" chevron-circle "]
Pregnancy
There are no adequate and well-controlled studies on the use of the medicine in pregnancy or breastfeeding.
There have been no reported side effects or harmful effects during pregnancy or in the fetus associated with senna preparations when used according to the recommended posology.
However, based on experimental data on the genotoxic risk associated with various anthraquinones (e.g. emodin and aloe-emodin) use during pregnancy is contraindicated.
Feeding time
Use during lactation is contraindicated as there are insufficient data on the excretion of metabolites in breast milk. Small amounts of the active metabolites of sennosides (rein) pass into breast milk.
No laxative effects have been reported in breast-fed infants.
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EFFECTS ON THE ABILITY TO DRIVE VEHICLES"style =" fancy "icon =" chevron-circle "]
This medicine does not affect the ability to drive or use machines.
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SIDE EFFECTS"style =" fancy "icon =" chevron-circle "]
Adverse reactions are listed below by system organ classes and frequency. Frequencies are defined as:
Very common (≥ 1/10)
Common (≥ 1/100 e
Uncommon (≥1 / 1,000 and
Rare (≥ 1 / 10,000 e
Very rare (
Not known (frequency cannot be estimated from the available data)
Gastrointestinal disorders
Common: Abdominal pain
Uncommon: Stool discoloration
Nausea
Rectal haemorrhage
He retched
Not known: Diarrhea
Disorders of the immune system
Uncommon: Urticaria
Very rare: Anaphylactic reaction
Anaphylactoid reaction
Not known: Hypersensitivity
Renal and urinary disorders
Uncommon: Chromaturia
Skin and subcutaneous tissue disorders
Uncommon: R.ash erythematous
Maculopapular rash
Perianal irritation
Not known: itch
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation. Paralysis of the intestinal musculature can also occur exceptionally.
In clinical trials involving approximately 9,000 patients, adverse effects were observed in approximately 4% of cases: however, in about one third of these the effects were ascribed to too high doses. For the most part, these undesirable effects consisted of abdominal cramps and / or pain, in many cases described as mild, moderate, or occasional in intensity and which can be considered to be related to bowel movements during bowel movement. Only in 18 cases (0.21% of the total) were reported as severe cramps; in some cases this led to discontinuation of treatment.
Due to the presence of chrysophanic acid in natural senna, laxatives containing sennosides can cause staining of stool and / or pH-dependent staining of urine (yellow-brown color of acid urine and red-violet color of alkaline urine). This staining is devoid of pathological significance.
Urine staining, if present, may interfere with the interpretation of laboratory tests.
Prolonged use of senna-containing preparations can cause reversible colon pigmentation, for example melanosis coli.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed on the Italian Medicines Agency website:
http://www.agenziafarmaco.gov.it/it/responsabili.
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OVERDOSE"style =" fancy "icon =" chevron-circle "]
Prolonged use or an overdose of any stimulant laxative, including those containing senna, can cause abdominal pain and severe diarrhea leading to excessive fluid loss and possible electrolyte imbalance (eg hypokalaemia). The resulting loss of fluids and electrolytes must be replaced. Electrolytes, especially potassium, need to be monitored. This is particularly important in the elderly.
Excessively prolonged use or incorrect use of these products can also lead to the appearance of colon atony.
In case of accidental overdose, seek professional assistance.
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LIST OF EXCIPIENTS"style =" fancy "icon =" chevron-circle "]
In the separator cap: sucrose.
In the bottle: sucrose, ethanol, propyl para-hydroxybenzoate, methyl para-hydroxybenzoate, chocolate flavor, cocoa flavor, purified water.
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[su_spoiler title = "STORAGE"style =" fancy "icon =" chevron-circle "]
This medicine does not require any special storage conditions.
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[su_spoiler title = "MARKETING AUTHORIZATION HOLDER"style =" fancy "icon =" chevron-circle "] Meda Pharma SpA, Via Felice Casati, 20 - 20124 Milan
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AUTHORIZATION NUMBER - MINSAN"style =" fancy "icon =" chevron-circle "]
AIC n. 024514022.
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