Laxor 320 mg tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user.
Laxor 320 mg tablets
Rhamnus purshianus D.C.
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you. Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
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Package leaflet:
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What Laxor is and what it is used for
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What you need to know before taking Laxor
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How to take Laxor
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Possible side effects
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How to store Laxor
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Contents of the pack and other information
1. What Laxor is and what it is used for
A herbal medicinal product for short-term use in cases of occasional constipation.
You should consult a doctor or pharmacist if symptoms persist during use of the medicine.
2. What you need to know before taking Laxor
Do not take Laxor
If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
Do not use this medicine during pregnancy and breastfeeding or in children under 12 years of age.
If you have abdominal pain of unknown origin.
In case of severe dehydration with reduced water and electrolytes.
In case of intestinal obstruction and stenosis, atony, appendicitis, or inflammatory bowel diseases (for example; Crohn's disease, ulcerative colitis).
Warnings and precautions
Consult your doctor or pharmacist before taking Laxor:
- If you are taking medicines such as cardiac glycosides, antiarrhythmic drugs, drugs that induce QT prolongation, diuretics, adrenocorticosteroids, or licorice root.
- If you have fecal impaction or undiagnosed, acute or persistent gastrointestinal discomfort, such as abdominal pain, nausea, and vomiting, as these symptoms may be signs of a potential or existing intestinal obstruction (ileus).
Long-term use of stimulant laxatives should be avoided, as use beyond a short treatment period may lead to deterioration of intestinal function and laxative dependence. If daily use of laxatives is required, the underlying cause of constipation should be investigated. Senna bark preparations should only be used if a therapeutic effect cannot be achieved through dietary changes or administration of bulk-forming agents.
When administering senna bark preparations to adults with incontinence, pads/diapers should be changed more frequently to avoid prolonged skin contact with feces.
Patients with kidney disorders should be aware of the possible electrolyte imbalance.
If symptoms worsen during use of the medicine, consult a doctor or pharmacist.
Children and adolescents
Do not administer to children under 12 years of age.
Other medicines and Laxor
Inform your pharmacist or doctor if you are taking, have recently taken, or might need to take any other medicines.
Hypokalemia (resulting from long-term laxative abuse) enhances the action of cardiac glycosides and interacts with antiarrhythmic drugs.
Concomitant use with diuretics, adrenocorticosteroids, and licorice root may increase potassium loss.
Taking Laxor with food, drinks and alcohol
Food, drinks, and alcohol do not affect the medicine's action.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Use during pregnancy is contraindicated due to experimental data on the genotoxic risk of various anthranoids, for example, emodin and aloe-emodin.
Use during breastfeeding is contraindicated because, after administration of anthranoids, active metabolites such as rhein are excreted in breast milk in small amounts.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
3. How to take Laxor
Follow exactly the dosing instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adolescents, adults and elderly patients: 1 tablet per day, taken before bedtime with a glass of water.
It should not be used for longer than one week. The dosage should be adjusted according to need; usually, taking this medicine 2–3 times per week is sufficient.
Laxor takes between 6–12 hours to produce an effect after administration; therefore, it is recommended to take it at night.
If symptoms persist during treatment, consult a doctor or pharmacist.
Use in children and adolescents
Do not administer to children under 12 years of age without medical prescription.
If you take more Laxor than you should
The main symptoms of overdose/abuse are sharp abdominal pain and severe diarrhea, with consequent loss of fluids and electrolytes. Treatment should be supportive, with generous fluid intake.
Electrolytes, especially potassium, must be monitored. This is particularly important in elderly patients.
Chronic overdoses of medications containing anthranoids may lead to toxic hepatitis.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91.562.04.20, indicating the name of the medicine and the amount ingested.
If you forget to take Laxor
Do not take a double dose to make up for missed doses.
If you stop taking Laxor
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Hypersensitivity:
Hypersensitivity reactions (pruritus, urticaria, localized or generalized rash) may occur.
Gastrointestinal disorders:
This medicine may cause abdominal pain and cramps, and passage of liquid stools, particularly in patients with irritable bowel syndrome. However, these symptoms may also occur generally as a consequence of individual overdose. In such cases, the dose should be reduced.
In addition, chronic use may cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually resolves when the patient stops taking the preparation.
Renal and urinary tract symptoms:
Long-term use may lead to water and electrolyte imbalance and may result in albuminuria and hematuria.
During treatment, yellow or brown-red discoloration of the urine (pH-dependent) may occur due to metabolites, which is not clinically significant.
Frequency is unknown.
If any adverse reactions not listed above occur, a doctor or qualified healthcare professional should be consulted.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Laxor Storage
Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Laxor
Composition per tablet:
The active substance is 320 mg of bark of Rhamnus purshianus DC. (Cascara sagrada)
(Content of hydroxyanthracene glycosides expressed as cascaroside A: 26.88 mg/tablet).
The other components (excipients) are microcrystalline cellulose, magnesium stearate and sodium croscarmellose.
Appearance of the product and contents of the pack
Presented in a cardboard pack containing 24 tablets of 400 mg in PVC/PVDC/AL blisters.
Marketing Authorization Holder and Manufacturer
Soria natural S.A.
Polígono La Sacea nº 1.
Garray. (42162). Soria.
Tel: 975252046
Fax: 975252267
e-mail: [email protected]
Date of the most recent review of this leaflet: December 2021
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/