LAXOR 320 mg TABLETS

Introduction

Package Leaflet: Information for the User.

Laxor 320 mg Tablets

Rhamnus purshianusD.C.

Contents of the Package Leaflet:

1. What Laxor is and what it is used for
2. What you need to know before taking Laxor
3. How to take Laxor
4. Possible side effects
5. Storage of Laxor

1. Contents of the Package and Additional Information

1. What Laxor is and what it is used for

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

You should consult a doctor or pharmacist if symptoms persist during the use of the medication.

2. What you need to know before taking Laxor

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 of age.

If you have abdominal pain of unknown origin.

In cases of severe dehydration with decreased water and electrolytes.

In cases 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 fecal retention and undiagnosed gastrointestinal discomfort, acute or persistent, such as abdominal pain, nausea, and vomiting, as these symptoms may be signs of potential or existing intestinal obstruction (ileus).

The long-term use of stimulant laxatives should be avoided, as use for more than a brief treatment period can lead to deterioration of intestinal function and dependence on laxatives. If the use of laxatives is needed every day, the cause of constipation should be investigated. Preparations of cascara sagrada bark should only be used if a therapeutic effect cannot be achieved through dietary changes or the administration of bulk-forming agents.

When preparations of cascara sagrada bark are administered to adults with incontinence, diapers/pads 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 the use of the medication, consult a doctor or pharmacist.

Children and Adolescents

Do not administer to children under 12 years of age without a medical prescription.

Other Medications and Laxor

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

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

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 effect of the medication.

Pregnancy, Breastfeeding, and Fertility

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

The use during pregnancy is contraindicated due to experimental data related to the genotoxic risk of various anthranoids, such as emodin and aloe-emodin.

The use during breastfeeding is contraindicated because after the 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 and use machines have been reported.

3. How to Take Laxor

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

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

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

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

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

Use in Children and Adolescents

Do not administer to children under 12 years of age without a medical 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. Treatment should be supportive with generous amounts of fluid.

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

Chronic overdoses of medications containing anthranoids can cause toxic hepatitis.

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

If You Forget to Take Laxor

Do not take a double dose to make up for forgotten doses.

If You Stop Taking Laxor

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Hypersensitivity:

Hypersensitivity reactions (pruritus, urticaria, localized or generalized exanthema) may occur.

Gastrointestinal Disorders:

This medication may cause abdominal pain and spasms and the passage of liquid stools, particularly in patients with irritable colon. However, these symptoms can also occur as a consequence of individual overdose. In these cases, it is necessary to reduce the dose.

Additionally, chronic use can cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually resolves when the patient stops taking the preparation.

Kidney and Urinary Tract Symptoms:

Long-term use can lead to an imbalance of water and electrolytes and may result in albuminuria and hematuria.

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

The frequency is unknown.

If other adverse reactions not mentioned above occur, consult a doctor or qualified healthcare professional.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Laxor

Keep this medication out of sight and reach of children.

Store in the original packaging.

Do not use this medication after the expiration date shown on the packaging after Exp. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Package and Additional Information

Composition of Laxor

Composition per tablet:

The active ingredient is 320 mg of Rhamnus purshianusDC. (Cascara sagrada) bark.

(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 Package

It is presented in a cardboard box 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 Last Revision of this Package Leaflet:December 2021

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