AGUA DEL CARMEN ORAL SOLUTION

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

AGUA DEL CARMEN oral solution

Read the entire leaflet carefully because it contains important information for you.

This medicine is available without a prescription. However, to achieve the best results, it must be used correctly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If symptoms worsen or persist after a few days, you should consult a doctor.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What AGUA DEL CARMEN is and what it is used for
2. Before taking AGUA DEL CARMEN
3. How to take AGUA DEL CARMEN
4. Possible side effects
5. How to store AGUA DEL CARMEN
6. Further information.

1. What AGUA DEL CARMEN is and what it is used for

AGUA DEL CARMEN has traditionally been used in the treatment of symptoms related to stress, such as gastrointestinal and nervous disorders, as well as for relief of discomfort associated with menstruation.

2. BEFORE TAKING AGUA DEL CARMEN

Do not take AGUA DEL CARMEN

• If you are allergic (hypersensitive) to the active substances or to any of the other components of AGUA DEL CARMEN.

Take special care with AGUA DEL CARMEN

• This medicine is harmful for people suffering from alcoholism (see “Important information about some of the components of AGUA DEL CARMEN”).

• The alcohol content should be taken into account in children and high-risk groups such as patients with liver disease or epilepsy (see “Important information about some of the components of AGUA DEL CARMEN”).

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

The amount of alcohol in this medicine may alter the effects of other medicines (see “Important information about some of the components of AGUA DEL CARMEN”).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

The alcohol content should be taken into account in pregnant women or those who are breastfeeding (see “Important information about some of the components of AGUA DEL CARMEN”).

Driving and using machines

The amount of alcohol in this medicine may reduce the ability to drive or operate machinery (see “Important information about some of the components of AGUA DEL CARMEN”).

Important information about some of the components of AGUA DEL CARMEN

• This medicine contains 55% v/v ethanol (alcohol), corresponding to 2.2 g per 5 ml, equivalent to 55 ml of beer or 23 ml of wine.

• This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. HOW TO TAKE AGUA DEL CARMEN

Follow exactly the administration instructions for AGUA DEL CARMEN indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

AGUA DEL CARMEN may be administered by adding it to an infusion, to sweetened water, or directly by placing a few drops of the product onto a sugar cube.

The usual dose is 2 to 3 teaspoonfuls (each teaspoon contains 5 ml) diluted in an infusion (lime blossom, chamomile, etc.) or in sweetened water, administered 2 to 4 times daily.

If you take more AGUA DEL CARMEN than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take AGUA DEL CARMEN

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, AGUA DEL CARMEN may have adverse effects, although not everyone will experience them.

If the recommended doses are exceeded or if treatment is prolonged, dependence or habituation may occur.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of AGUA DEL CARMEN

Keep out of the reach and sight of children.

No special storage conditions are required. Keep the container tightly closed.

Do not use AGUA DEL CARMEN after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

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

6. ADDITIONAL INFORMATION

Composition of AGUA DEL CARMEN

Composition per dose unit (teaspoon of 5 ml):

• The active ingredient consists of 3.75 ml of the liquid extract obtained by hydroethanolic distillation from the following medicinal plants: Melissa officinalis L. (Lemon balm leaf), Matricaria chamomilla L. (Chamomile flower), Lippia triphilla O. (Lemon verbena leaf), Tila tomentosa M. (Tilia blossom), Coriandrum sativum L. (Coriander fruit), Cinnamomum zeylanicum N. (Ceylon cinnamon bark), Angelica archangelica L. (Angelica root), Myristica fragans H. (Nutmeg fruit), and Hissopus officinalis L. (Flowering top of Hyssop).

And from the following essential oils: Melissa officinalis L. (Lemon balm), Citrus aurantium L. bark (Orange), Citrus limon L. (Lemon), Lippia triphilla O. (Lemon verbena), Citrus aurantium L. flower (Bitter orange blossom), Origanum majorana L. (Marjoram), Cinnamomum zeylanicum N. (Cinnamon), Citrus bergamia R. (Bergamot), Pimpinella anisum L. (Anise), Vanilla planifolia A. (Vanilla), Rosmarinus officinalis L. (Rosemary), Eucalyptus globulus L. (Eucalyptus), Thymus vulgaris L. (Thyme), Prunus amygdalus S. (Bitter almonds), and Mentha piperita L. (Peppermint).

• The other components (excipients) are sucrose, purified water, and ethanol.

The minimum essential oil content is greater than 0.14%, expressed as citral, and the ethanol content is 55% v/v.

Product appearance and contents of the container

Presented in containers containing 100 ml and 200 ml of oral solution.

Marketing Authorization Holder and Manufacturer

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A.

Grassot, 16 - 08025 Barcelona (Spain)

This package leaflet was approved in November 2002

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