Prospect: information for the patient

Cysturol film-coated tablets

Extract ofArctostaphylos uva-ursi, Extract ofBetula pendulay/oBetula pubescens,
Extract ofSolidago gigantea

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

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

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

1. What is Cysturol and for what it is used

2. What you need to know before starting to take Cysturol

3. How to take Cysturol

4. Possible adverse effects

5. Storage of Cysturol

6. Contents of the package and additional information

Cysturolcontains extracts of gayuba leaf, birch leaf, and gold rod. These extracts have a mild anti-inflammatory and disinfectant effect and stimulate urine production.

Cysturolis a traditional herbal medicine used in adult women for the treatment of mild symptoms of lower urinary tract infections (e.g. bladder infection), such as burning sensation while urinating and/or frequent need to urinate, provided that the doctor has ruled out the presence of serious conditions.

This product is a traditional herbal medicine for use in the specified indication, based exclusively on a long-standing use.

You should consult a doctor if it worsens or does not improve after 4 days.

Cysturolis indicated for adult women (18 years and older). It is not recommended for use in men without a clinical evaluation and a doctor's recommendation.

Do not takeCysturol

-if you are allergic to saponin, birch, or goldenseal, to birch pollen or to any of the other ingredients of this medicine (including those listed in section 6), as well as if you are allergic to plants of the familyAsteraceae(Compositae) in general.

-if you have diseases in which it is contraindicated to increase fluid intake, such as certain heart or kidney diseases.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeCysturol.

Urinary tract infections can have serious consequences. If you have a chronic urinary tract infection or have swollen legs (edema), you should only takeCysturolwith the explicit consent of your doctor. It is not recommended to use the medication in men without a clinical evaluation and a recommendation from your doctor.

Consult your doctor if you experience the onset of fever, difficulty urinating, cramps or blood in the urine, chest, lumbar or stomach pain during use of the medication.

It may cause an innocuous brownish-green discoloration of the urine.

Children and adolescents

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

Other medications andCysturol

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

It is not recommended to take the medication simultaneously with synthetic diuretics.

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.

Due to the lack of sufficient experience during pregnancy and breastfeeding, you should refrain from takingCysturol.

Driving and operating machines

No studies have been conducted on the effects on the ability to drive and operate machines.

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

Cysturolis administered orally.

The recommended dose is:

Adult women

Take 2 tablets 2 or 3 times a day. The tablets should be swallowed whole with a glass of water or other liquid.

The effect ofCysturolis potentiated by drinking abundantly. Drink plenty of liquid (at least 1-2 liters per day) to achieve sufficient urinary tract flushing.

This medication contains arbutin and should not be taken for more than 5 consecutive days, unless recommended by a doctor. Medications containing extract of gayuba leaf should not be taken for more than five episodes of 5 consecutive days per year.The continuous use ofCysturolshould not exceed 14 days.

Use in children and adolescents

Since there is not enough data, the use ofCysturolis not recommended in children and adolescents under 18 years old.

If you take moreCysturolthan 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 takeCysturol

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.

Hypersensitivity to the active principles contained in this medication, including allergic rhinitis and skin allergic reactions with itching, rash, and urticaria, as well as gastrointestinal discomfort with nausea, vomiting, abdominal pain, and diarrhea, have been described.

The frequency of these adverse effects is unknown.

Reporting 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 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.

This product does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the blister pack and on the box. The expiration date is the last day of the month indicated.

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

Composition ofCysturol

-108-120 mg of dried leaf extract of bearberry (Arctostaphylos uva-ursiL. Spreng), equivalent to 432-600 mg of plant, corresponding to 27 mg of hydroquinone derivatives calculated as anhydrous arbutin. Solvent of extraction: water.

46.25 mg of dried birch leaf extract (Betula pendula Roth and/or Betula pubescens Ehrh.), equivalent to 185-277.5 mg of plant. Solvent of extraction: water.

40 mg of dried aerial part of goldenrod (Solidago giganteaAit.) extract, equivalent to 160-240 mg of plant. Solvent of extraction: ethanol (57.9% V/V).

-The other components are: maltodextrin, simethicone, microcrystalline cellulose, povidone, colloidal silica, talc, sodium croscarmellose, magnesium stearate, macrogol 400, hypromellose, and titanium dioxide (E171).

Appearance of the product and contents of the packaging

Coated tablets with a white-grayish film and a smooth surface. Available in packaging of 20, 40, and 60 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Deiters

C/ Riera de Montalegre, 49

08915 Badalona

Spain

Responsible for manufacturing:

DREHM Pharma GmbH

Grünbergstraße 15/3/3

AT-1120 Vienna

Austria

Last review date of this leaflet: July 2017

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