ROALAX TISANE (Herbal Tea)

Introduction

Package 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 you start taking Roalax Tisana
3. How to take Roalax Tisana
4. Possible side effects
5. Storage of Roalax Tisana
6. Contents of the pack and further information

1. What Roalax Tisana is and what it is used for

Roalax Tisana is a vegetable stimulant laxative.

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

You should consult a doctor if it worsens or does not improve after 4 days.

2. What you need to know before you start taking Roalax Tisana

Do not take Roalax Tisana:

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

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

Warnings and precautions

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

A intake of stimulant laxatives for a period longer than the brief application time may cause a worsening of constipation. This preparation should only be used when no therapeutic effect has been achieved with a change in dietary habits or with bulk-forming laxative preparations.

Children

Children under 12 years cannot take Roalax Tisana.

Use of Roalax Tisana with other medicines:

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

Prolonged use of laxatives can cause a decrease in potassium levels, which can increase the action of other medicines administered for the heart (antiarrhythmics, diuretics, corticosteroids, and/or licorice root).

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

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 any medicine.

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

Use in elderly patients:

Due to your age and depending on your physical condition, you may be more sensitive to the effects of the medicine. Consult your doctor or pharmacist before using this medicine and if you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet.

When using this medicine in incontinent patients, greater care should be taken when changing diapers to avoid contact with feces.

Driving and using machines:

No special precautions are necessary.

3. How to take Roalax Tisana

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

In case of doubt, ask your doctor or pharmacist.

Roalax Tisanais a medicine that is taken orally.

The recommended dose is:

Adults and adolescents over 12 years: Once a day, take ½ to 1 measuring spoon of Roalax Tisana. The correct individual dose is the minimum required to achieve an evacuation.

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

The maximum daily dose should not exceed 30 mg of hydroxyanthracene derivatives, i.e., 1 measuring spoon (1.3 g of powder) of Roalax Tisana.

Mode of use:

Pour boiling water into a glass or cup ½ to 1 measuring spoon of Roalax Tisana.

The medicine usually takes 8 to 12 hours to produce its laxative action, so it is recommended to take it once at night, so that the effect occurs in the morning.

Duration of treatment:

Stimulant laxatives should not be taken without medical indication for a long period (more than 6 days).

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

If after 4 days of treatment, defecation has not occurred, the treatment should be suspended immediately and your doctor consulted.

If you think the action of Roalax Tisanais too strong or too weak, tell your doctor or pharmacist.

If you take more Roalax Tisana than you should:

Taking much higher doses than recommended may cause intestinal cramps and severe diarrhea with consequent loss of water and salt, as well as possible gastrointestinal pain. However, the possibility of intoxication from consuming the tea is very low.

If you have taken more Roalax Tisanathan you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Roalax Tisana:

Do not take a double dose to make up for the forgotten dose, but continue with the intake as indicated by your doctor or as described in the leaflet.

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

4. Possible side effects

Like all medicines, Roalax Tisana can cause side effects, although not everyone gets them.

Occasionally, abdominal pain and spasms, bloating (presence of gas in the abdomen), nausea, mucous stools, and/or diarrhea, skin rashes, allergic reactions may occur. The urine may turn yellow-red-brown, although this has no clinical significance. All these symptoms disappear when treatment is stopped.

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

5. Storage of Roalax Tisana

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

No special storage conditions are required.

Do not use Roalax Tisana after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Expiration after opening the package: 6 months

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines 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 medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bekunis Lax Tisana:

The active substance is:

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

The other components are excipients: cut hibiscus flowers, cut peppermint leaves, cut licorice root.

Appearance of the product and contents of the pack:

Bekunis Lax Tisana is a tea that comes in 60 g packages.

Marketing authorization holder and manufacturer:

roha arzneimittel GmbH

Rockwinkeler Heerstraße 100

D-28355 Bremen, Germany

Phone: +49 421 2579-0

Fax: +49 421 2579-300

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

FAES FARMA, S.A.,

Máximo Aguirre, 14

48940 Leioa – Bizkaia - Spain

Date of the last revision of this leaflet: May 2012

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