AGUA DEL CARMEN ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

AGUA DEL CARMEN oral solution

Read the entire package leaflet carefully because it contains important information for

you.

This medication can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.

Keep this package leaflet, as you may need to read it again.

If you need advice or more information, consult your pharmacist.

If the symptoms worsen or persist after a few days, you should consult a doctor.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If the symptoms worsen or persist after a few days, you should consult a doctor.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

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

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

AGUA DEL CARMEN has been traditionally used in the treatment of symptoms related to stress, such as gastrointestinal and nervous disorders, as well as for the 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 ingredients or to any of the other components of AGUA DEL CARMEN.

Be careful with AGUA DEL CARMEN

• This medication is harmful to people who suffer from alcoholism (see "Important information about some of the components of AGUA DEL CARMEN").

Use of other medications

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

The amount of alcohol in this medication may alter the effects of other medications (see "Important information about some of the components of AGUA DEL CARMEN").

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women (see "Important information about some of the components of AGUA DEL CARMEN").

Driving and using machines

The amount of alcohol in this medication may decrease 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 medication contains 55% v/v ethanol (alcohol), which corresponds to an amount of 2.2 g per 5 ml, equivalent to 55 ml of beer or 23 ml of wine.

• This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take AGUA DEL CARMEN

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

AGUA DEL CARMEN can be administered by adding it to an infusion, or with sugared water, or directly by adding a few drops of the product to a sugar cube.

The normal dose is 2 to 3 teaspoons (each teaspoon contains 5 ml) diluted in an infusion (such as tila, chamomile, etc.) or in sugared water, administered 2 to 4 times a day.

If you take more AGUA DEL CARMEN than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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 forgotten doses.

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

4. Possible side effects

Like all medications, AGUA DEL CARMEN can have side effects, although not everyone experiences them.

If the indicated doses are exceeded and in prolonged treatments, dependence or habit may appear.

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 package 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 expiration date shown on the container, after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewage system or in the trash. Deposit the containers and medications you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of AGUA DEL CARMEN

The composition per unit dose (5 ml teaspoon) is:

• The active ingredient is 3.75 ml of the fluid 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. (Linden inflorescence), Coriandrum sativum L. (Coriander fruit), Cinnamomum zeylanicum N. (Ceylon cinnamon bark), Angelica archangelica L. (Angelica root), Myristica fragans H. (Nutmeg fruit), and Hyssopus officinalis L. (Hyssop floral tips).

And from the following essences: Melissa officinalis L. (Lemon balm), Citrus aurantium L. peel (Orange), Citrus limon L. (Lemon), Lippia triphilla O. (Lemon verbena), Citrus aurantium L. flower (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 almond), and Mentha piperita L. (Peppermint).

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

The minimum content of essential oils is higher than 0.14% expressed as citral, and that of ethanol is 55% v/v.

Appearance of the product and container contents

It is presented in containers that contain 100 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 updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/