Label: information for the patient

Tutukon oral solution

Distilled aqueous extract ofEquisetum arvenseL. (Mare's tail),Spergularia rubraDietrich (Arenaria),Peumus boldusMolina (Boldo),Opuntia ficus-indicaMiller (Prickly pear),Sideritis angustifoliaL.(Wild marjoram),Rosmarinus officinalisL. (Rosemary),

Cynodon dactylonL. (Bermuda grass),Melissa officinalisL (Lemon balm).

Read this label carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions of the medication contained in this label or those indicated by your doctor or pharmacist.

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

Tutukon oral solution, is a traditional plant-based medicine used tofacilitate renal elimination of liquids.

Based exclusively on its traditional use.

Tutukon oral solution is indicated for adults(18 years and older).

Consult a doctor if it worsens or does not improve after 7 days.

Do not take Tutukon oral solution

• if you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
• if you have diseases in which it is contraindicated to increase fluid intake, such as certain heart or kidney diseases.
• if you have gastritis.
• if you have prostatitis.
• in case of bile duct obstruction, gallstones, liver diseases, or other biliary disorders that require medical supervision.

Warnings and precautions

If you have 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 information, it is not recommended to use this medication in children and adolescents under 18 years old.

Taking Tutukon oral solution with other medications

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

Pregnancy and breastfeeding

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

Driving and operating machines

The influence of Tutukon on the ability to drive and operate machines is negligible or insignificant.

Follow exactly the administration instructions of the medication contained 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 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. Note the warnings and precautions in section 2.

Use in children and adolescents

Since there is not enough data, the use of Tutukon oral solution is not recommended in children and adolescents under 18 years old.

Administration form:

This medication is administered orally.

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

Use the measuring cup provided in the package to take the medication with precision.

To obtain the best results with treatment, it is recommended to drink from one to two liters of water per day to achieve sufficient urinary tract flushing.

If you take more Tutukon oral solution than you should

No cases of overdose have been described.

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 Tutukon oral solution

Do not take a double dose to compensate for the missed doses. Continue taking the medication as indicated in this 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.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacistorpharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tutukon oral solution

• The active principle is a water 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 ofEquisetum arvenseL.(horse tail), 2.74 g of flowering aerial parts ofSpergularia rubraDietrich(arenaria), 2.33 g of leaf ofPeumus boldusMolina(boldo), 1.41 g of flowers ofOpuntia ficus-indicaMiller(prickly pear), 1.41 g of flowering tops ofSideritis angustifoliaL.(cat's claw),1.41 g of leaves ofRosmarinus officinalisL.(rosemary), 1.41 g of rhizome ofCynodon dactylonL.(bentgrass), 1.41 g of leaf ofMelissa officinalisL.(lemon balm).
• * The extraction solvent is water.

• The other excipients are Polietilenglicol 400, Polisorbato 20, Benzoate sodium, Potassium sorbate, Anhydrous citric acid, Sucralose.

Appearance of the product and contents of the packaging

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

Closed units are covered with a graduated vial for 7 ml.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

SETONDA, S. L.

Joaquín Costa, 18, 1st floor

08390 Montgat (Barcelona)

Spain

Manufacturer

Miquel y Garriga, S. L.

Joaquín Costa, 18

08390 Montgat (Barcelona)

Spain

Last review date of this leaflet:November2017

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