Laxante Salud 7.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Laxante Salud 7.5 mg film-coated tablets

Cassia angustifolia leaf extract

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

Follow exactly the instructions for taking this medicine contained in this leaflet or those given 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet.
• You must consult a doctor if you get worse or do not improve after 4 days.

Leaflet contents:

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

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

Senna is a stimulant-type laxative that increases intestinal movement. Its laxative effects are produced by enhancing colon motility and stimulating fluid secretion processes, thereby promoting bowel evacuation.

Laxante Salud is used for the symptomatic and short-term treatment of occasional constipation.

2. What you need to know before starting to take Laxante Salud

Do not take Laxante Salud:

• if you are allergic (hypersensitive) to the 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, abdominal cramps or pain);
• if you suffer from intestinal disorders such as: rectal bleeding; intestinal obstruction; hemorrhoids; severe liver disease; inflammatory abdominal diseases (such as Crohn's disease and ulcerative colitis); intestinal atony; disturbances in 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 of age.

Warnings and precautions

• Do not use higher doses than those indicated in section “3-How to take”.
• Prolonged treatments may lead to tolerance (accustoming) to the laxative effect and dependence (need) on it for bowel evacuation, as well as disturbances in water and electrolyte metabolism.
• Do not use for more than 6 days without consulting your doctor. If symptoms worsen or persist after 4 days, consult your doctor.

Interaction of Laxante Salud with other medicines

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

Do not take this medicine with other drugs, especially with:

• Antibiotic medicines (used to treat infections).
• Medicines to treat stomach acidity (antacids) such as cimetidine, famotidine and ranitidine.
• Medicines that increase urine production (diuretics).
• Potassium supplements.
• Cardiotonic glycosides such as digoxin (used to treat certain heart conditions).

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

Pregnancy and breastfeeding

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

Its use is not recommended during pregnancy or breastfeeding.

3. How to take Laxante Salud

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Laxante Salud is administered orally.

The usual dose for adults and children over 12 years of age is: 1 to 3 tablets per day, taken at night with sufficient liquid, without chewing.

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

Instructions for correct administration of the preparation:

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

Laxante Salud should be taken one hour after dinner, preferably before going to bed; the laxative effect is usually observed the following morning.

It is recommended to drink at least 6–8 glasses of liquid per day to enhance the laxative effect and prevent dehydration.

Use in children: Do not use in children under 12 years of age.

Use in elderly patients: Consult your doctor.

If you take more Laxante Salud than you should

Symptoms of overdose are mainly characterized by massive diarrhea with loss of water and electrolytes. If severe, it may cause confusion, cardiac arrhythmia, cramps, fatigue, or weakness, which may be more pronounced in elderly patients.

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

If you forget to take Laxante Salud

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

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

4. Possible adverse effects

Like all medicines, Laxante Salud may produce adverse effects, although not everyone experiences them.

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

Prolonged use of this medicine may lead to disturbances in electrolyte balance, dehydration, albuminuria, and hematuria. The urine may appear dark (tending to brown) due to excreted compounds. This has no clinical significance and will disappear upon discontinuation of treatment.

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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Laxante Salud

Keep this medicine out of sight and reach of children.

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.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Laxante Salud

The active substances are: 12.5 mg of leaf extract of Cassia angustifolia containing 7.5 mg of total sennosides, expressed as sennoside B.

The other components are:

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

Appearance of the product and contents of the pack

Laxante Salud is a medicine administered orally, presented as white or white-greyish biconvex tablets in PVC/aluminum blisters.

Each Laxante Salud pack contains 6 or 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Pharmaceutical Innovation Services, S.L.

c/ Luis Martinez Feduchi, 32

Ático A. 28055 - Madrid

Spain

Manufacturer

Toll Manufacturing Services S.L.

c/ Aragoneses 2

28108 - Alcobendas, Madrid

Spain

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

Apotheke Laboratorios S.L.

Paseo de la Castellana nº40, 8th floor

28046 Madrid, Spain

Date of the most recent version of this leaflet: October 2011

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