PATIENT INFORMATION LEAFLET

AGUA DEL CARMEN oral solution

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

You.

This medicine can be purchased without a prescription. However, to achieve the best results, it must be used properly.

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

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

- If symptoms worsen or persist after a few days, you must consult a doctor.

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

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

2.Before taking AGUA DEL CARMEN

3.How to take AGUA DEL CARMEN

4.Possible adverse effects

5.Storage of AGUA DEL CARMEN

6.Additional information.

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

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 especially careful with AGUA DEL CARMEN

-This medicine is harmful to people who suffer from alcoholism (see “Important information about some of the components of AGUA DEL CARMEN

”).

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

”).

Use of other medications

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

The amount of alcohol in this medicine 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 women or those breastfeeding (see “Important information about some of the components of AGUA DEL CARMEN

”).

Driving and operating machinery

The amount of alcohol in this medicine may decrease your ability to drive or operate machinery (see “Important information about some of the components of AGUA DELCARMEN

”).

Important information about some of the components of AGUA DEL CARMEN

• This medicine contains 55% v/v of 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 medicine contains saccharose. If your doctor has told you that you suffer from intolerance to certain sugars, consult with him before taking this medicine.

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

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

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

If you take more AGUA DEL CARMEN than you should you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take AGUA DEL CARMEN

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

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

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

Keep out of 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of AGUA DEL CARMEN

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

• The active principle 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. (Hierba Luisa Leaf), Tilia tomentosa M. (Tilia Inflorescence), Coriandrum sativum L. (Coriander Fruit), Cinnamomum zeylanicum N. (Ceylon Cinnamon Bark), Angelica archangelica L. (Angelica Root), Myristica fragrans H. (Nutmeg Fruit) and Hyssopus officinalis L. (Hyssop Flowering Tops).

And the following essential oils:essential oils:Melissa officinalis L. (Melissa), Citrus aurantium L. bark (Orange), Citrus limon L. (Lemon), Lippia triphilla O. (Hierba Luisa), Citrus aurantium L. flower (Bitter Orange Blossom), Origanum majorana L. (Sweet 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 content of essential oils is greater than 0.14% expressed as citral and that of ethanol is 55% v/v.

Appearance of the product and contents of the container

It is presented in containers containing 100 and 200 ml of oral solution.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio de Aplicaciones Farmacodinámicas, S.A.

Grassot, 16 - 08025 Barcelona (Spain)

This prospectus was approved in November 2002

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