Leaflet: Information for the User

roalax Tisana

Cassia angustifolia Vahl

In this leaflet:

1. What roalax Tisana is and what it is used for
2. What you need to know before starting to take roalax Tisana
3. How to take roalax Tisana
4. Possible side effects
5. Storage of roalax Tisana
6. Contents of the pack and additional information

roalax Tisana is a stimulating plant laxative.

It is indicated for adults and children over 12 years old for the short-term treatment of occasional constipation.

Consult a doctor if it worsens or does not improve after 4 days.

Do not take Roalax Tisana:

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

If you have ileus, appendicitis, chronic inflammatory intestinal diseases such as, for example, Crohn's disease or ulcerative colitis; in case of unknown abdominal pain, as well as in cases of severe dehydration with water and salt loss.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Roalax Tisana.

A laxative intake exceeding the brief period of application intended may cause a worsening of constipation. This preparation should be used only when a therapeutic effect has not been achieved with a change in eating habits or with intestinal bulk-increasing laxatives.

Children

Children under 12 years old cannot take Roalax Tisana.

Use of Roalax Tisana with other medications:

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

The prolonged use of laxatives may cause a decrease in potassium levels that may increase the action of other medications administered for the heart (antiarrhythmics, diuretics, corticosteroids, and/or licorice root).

The action of this medication on intestinal transit may modify the levels of other medications taken at the same time orally.

Pregnancy, breastfeeding, and fertility:

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

Due to insufficient toxicological investigations, Roalax Tisana cannot be ingested by pregnant women or during breastfeeding.

Use in elderly patients:

Due to your age and physical condition, you may be more sensitive to the effects of the medication. Consult your doctor or pharmacist before using this medication and if you consider any of the adverse effects you experience to be severe or if you appreciate any adverse effect not mentioned in this prospectus.

When using this medication, incontinent patients should be more careful in changing diapers to avoid contact with feces.

Driving and operating machines:

No special precautions are necessary.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor.

In case of doubt, ask your doctor or pharmacist.

roalax Tisanais a medication taken orally.

The recommended dose is:

Adults and adolescents over 12 years old: Take ½ to 1 measuring spoon of roalax Tisana once a day. The correct individual dose is the minimum required to achieve evacuation.

The measuring spoon is 5 ml (which corresponds to 1.3 g of product) and has a mark indicating half of its capacity (2.5 ml).

The maximum daily dose should not exceed 30 mg of hydroxyanthracene derivatives, that is, 1 measuring spoon (1.3 g of powder) of roalax Tisana.

Method of use:

Pour boiling water over ½ to 1 measuring spoon of roalax Tisana in a glass or cup.

The medication usually takes 8 to 12 hours to produce its laxative effect, so it is recommended to take a single dose at night, so that the effect occurs in the morning.

Treatment duration:

Stimulant laxatives should not be taken without a doctor's indication for a long period of time (over 6 days).

Generally, it is enough to take the medication 2 or 3 times a week to achieve the desired effect.

If after 4 days of treatment no defecation has occurred, treatment should be suspended immediately and the doctor consulted.

If you estimate that the action ofroalax Tisanais too strong or weak, inform your doctor or pharmacist.

If you take more roalax Tisana than you should:

The ingestion of much larger doses than the recommended product can cause intestinal cramps and severe diarrhea with consequent water and salt loss, as well as possible gastrointestinal pain. However, the possibility of poisoning from consuming the teas is very low.

If you have taken moreroalax Tisanathan you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take roalax Tisana:

Do not take a double dose to compensate for the missed dose, but continue taking it as indicated by your doctor or as described in the leaflet.

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

Like all medications, Roalax Tisana may produce adverse effects, although not all people will experience them.

Occasionally, stomach pain and spasms, meteorism (presence of gas in the abdomen), nausea, mucous stools, and/or diarrhea, skin rashes, allergic reactions may occur. A yellow-brown urine discoloration may appear, although this has no clinical significance. All these symptoms disappear when treatment is discontinued.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

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

No special storage conditions are required.

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

Expiration date after opening the packaging: 6 months

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

Composition of Bekunis Lax Tisana:

The active principle is:

1 spoonful (1.3 g) of Bekunis Lax Tisana contains 1.04 g of Cassia angustifolia Vahl. cut leaves, with a content of 30 mg of hydroxyanthracenic derivatives expressed as sennoside B.

The other components are excipients: Hibiscus flowers cut, Menta leaves cut, Licorice root cut.

Appearance of the product and contents of the packaging:

Bekunis Lax Tisana is a tea presented in 60 g packaging.

Holder of the marketing authorization and responsible for manufacturing:

roha arzneimittel GmbH

Rockwinkeler Heerstraße 100

D-28355 Bremen, Germany

Telephone: +49 421 2579-0

Telefax: +49 421 2579-300

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

FAES FARMA, S.A.,

Máximo Aguirre, 14

48940 Leioa – Bizkaia - Spain

Last review date of this leaflet May 2012

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