Laxante salud 7,5 mg comprimidos recubiertos con pelÍcula

PATIENT INFORMATION LEAFLET

Laxative Salud 7.5 mg Film-Coated Tablets

Extract ofCassia angustifolia leaves

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.
• You should consult a doctor if you get worse or do not improve after 4 days.

Sen is a stimulant laxative that increases intestinal movement. Laxative effects are produced by a mechanism of increased colon movement and stimulation of fluid secretion processes, promoting evacuation.

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

Do not take Laxante Salud:

• if you areallergic(hypersensitive) to Dried 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 haveintestinal problemssuch as: rectal bleeding; intestinal obstruction; hemorrhoids; severe liver disease; inflammatory abdominal diseases (such as Crohn's disease and ulcerative colitis); intestinal atony; water and electrolyte metabolism disorders.
• if you havecongestive heart failure(the heart does not pump enough blood).
• Do not administer tochildren under 12 years.

Warnings and precautions

• Do not take more than the indicated doses in the "3-How to take" section.
• Prolonged treatments may cause tolerance (habituation) to the laxative effect and dependence (need) on it to achieve evacuation, as well as disorders in water and electrolyte metabolism.
• Do not use for more than 6 days without consulting a doctor. After 4 days, if symptoms worsen or persist, consult your doctor.

Laxante Salud interaction with other medications

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

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

• Antibiotics (used to treat infections).
• Medications to treat stomach acid (antacids) such as cimetidine, famotidine, and ranitidine.
• Diuretics (medications that increase urine production).
• Potassium supplements.
• Cardiotonic glycosides such as digoxin (used to treat certain heart diseases).

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

Pregnancy and lactation

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 medication.

It is not recommended to use during pregnancy or lactation.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Laxante Salud is administered byoral route.

The normal dose in adults and children over 12 years old 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 a doctor.

Instructions for correct administration of the preparation:

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

Laxante Salud should be taken one hour after dinner, preferably before going to bed; the laxative effect will generally be observed the next morning.

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

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

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 loss of water and salts. If severe, it can cause confusion, cardiac arrhythmia, cramps, fatigue, or weakness, which may be more pronounced in the elderly.

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

If you forgot to take Laxante Salud

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

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

Like all medications, Laxante Salud may produce adverse effects, although not everyone will experience them.

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

Prolonged use of this medication may lead to electrolyte imbalance disorders, dehydration, albuminuria, and hematuria. Urine may appear dark (tending to brown) due to compounds being eliminated. This has no clinical significance and will disappear upon discontinuing treatment.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://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.

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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Laxante Salud

The active principles are: 12.5mg of leaf extract of Cassia angustifoliacontaining 7.5 mg of Total Sennosides, expressed as Sennoside B.

The other components are:

• Tablet core: 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 content of the packaging

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

Each package of Laxante Salud contains 6 or 30 tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization

Pharmaceutical Innovation Services, S.L.

c/ Luis Martinez Feduchi, 32

Ático A. 28055 - Madrid

Spain

Responsible for manufacturing

Toll Manufacturing Services S.L.

c/ Aragoneses 2

28108 - Alcobendas, Madrid

Spain

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

Apotheke Laboratorios S.L.

Paseo de la Castellana nº40, 8th floor

28046 Madrid. Spain

Date of the last version of this prospectus: October 2011

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/