LAXANTE SALUD 7.5 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Laxante Salud 7.5 mg film-coated tablets

extract of leaves of Cassia angustifolia

Read all of this leaflet carefully because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet.
• You should consult a doctor if your symptoms worsen or do not improve after 4 days.

Contents of the package leaflet:

1. What is Laxante Salud and what is it used for
2. What you need to know before taking Laxante Salud
3. How to take Laxante Salud
4. Possible side effects
5. Storage of Laxante Salud
6. Contents of the pack and further information

1. What is Laxante Salud and what is it used for

Laxante Salud is a stimulant laxative that increases bowel movement. The laxative effects are produced by a mechanism of increased movement of the colon and stimulation of fluid secretion processes, favoring evacuation.

Laxante Salud is used for the symptomatic and temporary treatment of occasional constipation.

2. What you need to know before taking Laxante Salud

Do not take Laxante Salud:

• if you are allergic(hypersensitive) to dry extract of Cassia angustifolia(Sen) or to any of the other components of Laxante Salud.
• if you have appendicitis or symptoms of appendicitis (nausea, vomiting, cramps, or abdominal pain);
• if you have intestinal problemssuch as: rectal bleeding; intestinal obstruction; hemorrhoids; severe liver disease; abdominal inflammatory diseases (such as Crohn's disease and ulcerative colitis); intestinal atony; disorders of water and electrolyte metabolism.
• if you have congestive heart failure(the heart does not pump enough blood).
• Do not administer to children under 12 years.

Warnings and precautions

• Do not use more than the recommended dose.
• Prolonged treatments can produce tolerance (accustoming) to the laxative effect and dependence (need) for it to achieve evacuation, as well as disorders of water and electrolyte metabolism.
• Do not use for more than 6 days without consulting a doctor. If symptoms worsen or persist after 4 days, consult your doctor.

Interaction of Laxante Salud with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Do not take this medicine with other medications, especially:

• Antibiotic medications (used to treat infections).
• Medications to treat stomach acidity (antacids) such as cimetidine, famotidine, and ranitidine.
• Medications that increase urine production (diuretics).
• Potassium supplements.
• Cardiac glycosides such as digoxin (used to treat certain heart diseases).

If you are taking any medication, consult your doctor or pharmacist.

Pregnancy and breastfeeding

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

It is not recommended to use during pregnancy or breastfeeding.

3. How to take Laxante Salud

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Laxante Salud is administered orally.

The normal dose in adults and children over 12 years is: 1 to 3 tablets per day taken at night with a sufficient amount of liquid, without chewing.

Do not use for more than 6 days without consulting a doctor.

Instructions for correct administration of the preparation:

Take the medicine without chewing with a sufficient amount of liquid (water, juices).

Laxante Salud is taken 1 hour after dinner, preferably before bedtime; the laxative effect will be observed generally the next morning.

It is recommended to ingest at least 6-8 glasses of liquid per day to favor the laxative effect and prevent dehydration.

Use in children:do not use in children under 12 years.

Use in the elderly:consult a doctor.

If you take more Laxante Salud than you should

The symptoms of overdose are mainly manifested by massive diarrhea with water and salt loss. If severe, it can produce confusion, cardiac arrhythmia, cramps, fatigue, or weakness, which can be more pronounced in the elderly.

In case of overdose or accidental ingestion, go to a Medical Center or consult the Toxicology Information Service, Telephone 915 620 420, indicating the product and the amount ingested.

If you forget to take Laxante Salud

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

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

4. Possible side effects

Like all medicines, Laxante Salud can cause side effects, although not everyone will experience them.

At high doses or in cases of great sensitivity to the components of this medicine, allergic reactions of a cutaneous type may appear. If a larger amount than recommended is taken, abdominal pain and liquid stools may occur. The same effects occur at the recommended doses in patients with irritable colon.

Prolonged use of this medicine can lead to disorders of electrolyte balance, dehydration, albuminuria, and hematuria. The urine may appear dark (tending to brown) due to the compounds that are eliminated. This has no clinical significance and will disappear when treatment is interrupted.

Reporting of side effects

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

5. Storage of Laxante Salud

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

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that are no longer needed at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Laxante Salud

The active principles are: 12.5mg of extract of leaves of Cassia angustifoliawith a content of 7.5 mg of Total Sennosides, expressed as Sennoside B.

The other components are:

• Core of the tablet: Microcrystalline cellulose, calcium phosphate, glycerol behenate.
• Coating: Sepifilm LP 770 (hydroxypropyl methylcellulose, microcrystalline cellulose, stearic acid, and titanium dioxide (E-171)).

Appearance of the product and contents of the pack

Laxante Salud is a medicine that is administered orally and is presented in white or grayish-white, biconvex tablets in PVC/Aluminum blisters.

Each pack of Laxante Salud contains 6 or 30 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Pharmaceutical Innovation Services, S.L.

Luis Martinez Feduchi, 32

Ático A. 28055 - Madrid

Spain

Manufacturer

Toll Manufacturing Services S.L.

Aragoneses 2

28108 - Alcobendas, Madrid

Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Apotheke Laboratorios S.L.

Paseo de la Castellana nº40, 8ª planta

28046 Madrid. Spain

Date of the last version of this leaflet: October 2011

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