TUTUKON ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Tutukon Oral Solution

Aqueous distillate of EquisetumarvenseL. (Horsetail), SpergulariarubraDietrich (Sandspurry), PeumusboldusMolina (Boldo), Opuntiaficus‑indicaMiller (Prickly Pear), SideritisangustifóliaL. (Ironwort), RosmarinusofficinalisL. (Rosemary),

CynodondactylonL. (Bermudagrass), Melissa officinalisL (Lemon Balm).

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by 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 you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Tutukon Oral Solution is and what it is used for
2. What you need to know before taking Tutukon Oral Solution
3. How to take Tutukon Oral Solution
4. Possible side effects
5. Storage of Tutukon Oral Solution
6. Package Contents and Additional 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 its traditional use.

Tutukon Oral Solution is indicated for adults (from 18 years of age).

You should consult a doctor if your condition worsens or does not improve after 7 days.

2. What you need to know before taking Tutukon Oral Solution

Do not take Tutukon Oral Solution

• if you are allergic to the active substances or to any of the other components of this medication (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 bile duct obstruction, gallstones, liver disease, or other biliary disorders that require medical supervision.

Warnings and Precautions

If you have recurrent urinary tract infections or swollen legs (edema), consult your doctor or pharmacist before taking Tutukon Oral Solution.

Children and Adolescents

Due to the lack of sufficient clinical information, the use of this medication is not recommended in children and adolescents under 18 years of age.

Taking Tutukon Oral Solution with Other Medications

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. As a precautionary measure and due to the lack of clinical information, this medication should not be taken during pregnancy or breastfeeding.

Driving and Using Machines

The influence of Tutukon on the ability to drive and use machines is negligible.

3. How to Take Tutukon Oral Solution

Follow the administration instructions for the medication contained in this package leaflet or as 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 3 times a day.

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

Use in Children and Adolescents

Since there is not enough data available, the use of Tutukon Oral Solution is not recommended in children and adolescents under 18 years of age.

Method of administration:

This medication is administered orally.

Take the medication undiluted, measuring the recommended dose in the dosing cup (measurer).

Use the measuring cup provided with the package to take the recommended dose accurately.

In order to obtain the best results with the treatment, it is recommended to drink 1 to 2 liters of water per day to achieve sufficient flushing of the urinary tract.

If You Take More Tutukon Oral Solution Than You Should

No cases of overdose have been reported.

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 Tutukon Oral Solution

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

At the recommended doses and treatment period, no side effects have been reported.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tutukon Oral Solution

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the box and label of the bottle. The expiration date is the last day of the month indicated. Once the bottle is opened, use its contents within 12 days of the opening date. Write the opening date of the package on the white box provided.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tutukon Oral Solution

• The active principle is an aqueous distillate (3.35/1.94/1.65/1/1/1/1) of the following plants, per 100 ml: 4.74 g of sterile aerial parts of Equisetum arvenseL. (Horsetail), 2.74 g of flowering aerial parts of SpergulariarubraDietrich (Sandspurry), 2.33 g of leaf of Peumus boldusMolina (Boldo), 1.41 g of flowers of Opuntia ficus-indicaMiller (Prickly Pear), 1.41 g of flowering tops of Sideritis angustifóliaL. (Ironwort), 1.41 g of leaves of Rosmarinus officinalisL. (Rosemary), 1.41 g of rhizome of Cynodon dactylonL. (Bermudagrass), 1.41 g of leaf of MelissaofficinalisL. (Lemon Balm).
• * The extraction solvent is water.

• The other excipients are Polyethylene Glycol 400, Polysorbate 20, Sodium Benzoate, Potassium Sorbate, Anhydrous Citric Acid, Sucralose.

Appearance of the Product and Package Contents

Ambber-colored bottle closed with an aluminum cap. The contents are 250 ml.

The closed units are covered with a 7 ml graduated 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 Last Revision of this Package Leaflet:November 2017

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