Leaflet: Information for the user.

Laxor 320 mg tablets

Rhamnus purshianusD.C.

6. Contents of the pack and additional information

A plant-based medication for short-term use in cases of occasional constipation.

Consult a doctor or pharmacist if symptoms persist during use of the medication.

Do not take Laxor

If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

Do not use this medication during pregnancy and breastfeeding or in children under 12 years old.

If you have unknown abdominal pain.

In severe dehydration with decreased water and electrolyte levels.

In case of intestinal obstruction and stenosis, atony, appendicitis, inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Laxor:

-If you are taking medications such as cardiac glycosides, antiarrhythmic medications, medications that induce QT prolongation, diuretics, adrenocorticosteroids or licorice root

-If you have undiagnosed, acute or persistent gastrointestinal symptoms, such as abdominal pain, nausea and vomiting, as these symptoms may be signs of potential or existing intestinal obstruction (ileus).

Long-term use of stimulant laxatives should be avoided, as prolonged use may lead to intestinal function deterioration and dependence on laxatives. If daily laxative use is necessary, the cause of constipation should be investigated. Senna preparations should only be used if a therapeutic effect cannot be achieved through dietary changes or the administration of volume-forming agents.

When administering senna preparations to adults with incontinence, diapers should be changed more frequently to avoid prolonged skin contact with feces.

Patients with renal disorders should be aware of the possible electrolyte imbalance.

If symptoms worsen during medication use, consult a doctor or pharmacist.

Children and adolescents

Do not administer to children under 12 years old.

Other medications and Laxor

Inform your pharmacist or doctor if you are taking, have taken recently or may need to take any other medication.

Hypokalemia (resulting from long-term laxative abuse) potentiates the action of cardiac glycosides and interacts with antiarrhythmic medications.

Concomitant use with diuretics, adrenocorticosteroids and licorice root may increase potassium loss.

Laxor with food, drinks and alcohol

Foods, drinks and alcohol do not affect the medication's effect.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Use during pregnancy is contraindicated due to experimental data on the genotoxic risk of various anthranoids, such as 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 operating machines

No effects on the ability to drive and use machines have been described.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adolescents, adults, and elderly people: 1 tablet per day, before bedtime with a glass of water.

Do not use for more than one week. The dosage should be adjusted according to need, usually it is sufficient to take this medication 2-3 times during the week.

Laxor needs between 6-12 hours after administration to take effect, so it is recommended to take at night.

If symptoms persist during use of the medication, consult a doctor or pharmacist.

Use in children and adolescents

Do not administer to children under 12 years old without a doctor's prescription.

If you take more Laxor than you should

The main symptoms of overdose/abuse are sharp pain and severe diarrhea with consequent loss of fluids and electrolytes. Supportive treatment should be provided with generous amounts of fluid.

Electrolytes, especially potassium, should be monitored. This is especially important in elderly people.

Chronic overdoses of medications containing anthranoids may cause toxic hepatitis.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20 indicating the medication and the amount ingested.

If you forgot to take Laxor

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Laxor

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Hypersensitivity:

Reactions of hypersensitivity (pruritus, urticaria, localized or generalized exanthema) may occur.

Gastrointestinal Disorders:

This medication may produce abdominal pain and cramping and the passage of liquid stools, particularly in patients with irritable colon. However, these symptoms may also occur generally as a result of an individual overdose. In such cases, the dose should be reduced.

Additionally, long-term use may cause intestinal mucosa pigmentation (pseudomelanosis coli), which usually subsides when the patient stops taking the preparation.

Renal and Urinary Tract Symptoms:

Prolonged use may lead to a water and electrolyte imbalance and may result in albuminuria and hematuria.

During treatment, a yellowish or brown-red discoloration (dependent on pH) of the urine by metabolites may occur, which is not clinically significant.

Frequency is unknown.

If other adverse reactions not mentioned previously occur, a doctor or qualified healthcare professional should be consulted.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Laxor

Composition per tablet:

The active principle is 320 mg of bark fromRhamnus purshianusDC. (Senna)

(Content in hydroxyanthracene glycosides expressed as sennoside 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 packaging

Presented in a cardboard container containing 24 tablets of 400 mg in a PVC/PVDC/AL blister.

Holder of the marketing authorization and responsible for manufacturing

Soria natural S.A.

Polígono La Sacea nº 1.

Garray. (42162). Soria.

Tel: 975252046

Fax: 975252267

e-mail:[email protected]

Date of the last review of this leaflet:December 2021

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/