Tutukon oral solution: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tutukon oral solution

Aqueous distillate of Equisetum arvense L. (Horsetail), Spergularia rubra Dietrich (Red Sandwort), Peumus boldus Molina (Boldo), Opuntia ficus-indica Miller (Prickly pear), Sideritis angustifolia L. (Cat's tail), Rosmarinus officinalis L. (Rosemary), Cynodon dactylon L. (Bermuda grass), Melissa officinalis L. (Lemon balm).

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to refer to it again.
If you need advice or further information, consult your pharmacist.
If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
You should consult a doctor if you worsen or do not improve after 7 days.

Contents of the leaflet

What Tutukon oral solution is and what it is used for
What you need to know before taking Tutukon oral solution
How to take Tutukon oral solution
Possible adverse effects
How to store Tutukon oral solution
Contents of the container and other information

1. What Tutukon oral solution is and what it is used for

Tutukon oral solution is a traditional herbal medicinal product used to facilitate renal elimination of fluids.

Based exclusively on traditional use.

Tutukon oral solution is indicated for adults (from 18 years of age).

You should consult a doctor if symptoms worsen or do not improve after 7 days.

2. What you need to know before starting to take Tutukon oral solution

Do not take Tutukon oral solution

if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
if you have conditions where increased fluid intake is contraindicated, such as certain heart or kidney diseases.
if you have gastritis.
if you have prostatitis.
in case of biliary duct obstruction, gallstones, liver diseases, or other biliary disorders requiring medical supervision.

Warnings and precautions

If you suffer from recurrent urinary tract infections or have swollen legs (edema), consult your doctor or pharmacist before starting to take Tutukon oral solution.

Children and adolescents

Due to insufficient clinical data, the use of this medicine is not recommended in children and adolescents under 18 years of age.

Taking Tutukon oral solution with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. As a general precaution and due to the lack of clinical data, this medicine should not be taken during pregnancy or while breastfeeding.

Driving and using machines

The effect of Tutukon on the ability to drive and operate machinery is none or negligible.

3. How to take Tutukon oral solution

Follow exactly the administration instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults: 7 ml of Tutukon oral solution three times a day.

The recommended duration of treatment is 2 weeks. Do not continue treatment without first consulting your doctor about the appropriateness of continuing. Take into account the warnings and precautions described in section 2.

Use in children and adolescents

Due to insufficient data, the use of Tutukon oral solution is not recommended in children and adolescents under 18 years of age.

Method of administration:

This medicine is administered orally.

Take the medicine undiluted, measuring the recommended dose using the dosing cup (measuring device) provided.

Use the measuring cup supplied in the package to accurately measure the recommended dose.

To achieve the best treatment results, it is recommended to drink one to two liters of water per day in order to ensure adequate flushing of the urinary tract.

If you take more Tutukon oral solution than you should

Cases of overdose have not been reported.

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

If you forget to take Tutukon oral solution

Do not take a double dose to make up for missed doses. Continue taking the medicine as indicated in this leaflet or according to your doctor's instructions.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

At the recommended doses and treatment duration, no adverse effects have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tutukon oral solution

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton and on the label of the bottle. The expiry date refers to the last day of the month indicated. After opening the bottle, use the contents within 12 days of the opening date. Write the date you opened the container in the blank box provided on the carton.

Medicines must not be disposed of via wastewater or in household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Tutukon oral solution

The active substance is an aqueous distillate (3.35/1.94/1.65/1/1/1/1/1) of the following plants, per 100 ml: 4.74 g of sterile aerial parts of Equisetum arvense L. (horsetail), 2.74 g of flowering aerial parts of Spergularia rubra Dietrich (red sandspurry), 2.33 g of leaves of Peumus boldus Molina (boldo), 1.41 g of flowers of Opuntia ficus-indica Miller (prickly pear), 1.41 g of flowering tops of Sideritis angustifolia L. (cat's tail), 1.41 g of leaves of Rosmarinus officinalis L. (rosemary), 1.41 g of rhizome of Cynodon dactylon L. (Bermuda grass), 1.41 g of leaves of Melissa officinalis L. (lemon balm).
* The extraction solvent is water.
Other excipients: Polyethylene glycol 400, Polysorbate 20, Sodium benzoate, Potassium sorbate, Anhydrous citric acid, Sucralose.

Product appearance and contents of the container

Amber glass bottle closed with an aluminum cap. Contents: 250 ml.

Each sealed unit is supplied with a graduated 7 ml measuring cup.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

SETONDA, S. L.

Joaquín Costa, 18, 1º

08390 Montgat (Barcelona)

Spain

Manufacturer

Miquel y Garriga, S. L.

Joaquín Costa, 18

08390 Montgat (Barcelona)

Spain

Date of the most recent revision of this leaflet: November 2017

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