CYSTUROL COMPRESSED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cysturol Film-Coated Tablets

Extract of Arctostaphylos uva-ursi, Extract of Betula pendulaand/or Betula pubescens, Extract of Solidago gigantea

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 exactly.

• 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 it worsens or does not improve after 4 days.

Contents of the Package Leaflet

1. What Cysturol is and what it is used for
2. What you need to know before taking Cysturol
3. How to take Cysturol
4. Possible side effects
5. Storage of Cysturol
6. Package Contents and Additional Information

1. What Cysturol is and what it is used for

Cysturol contains extracts of bearberry leaf, birch leaf, and goldenrod. These extracts have a mild anti-inflammatory and disinfectant effect and stimulate urine production.

Cysturol is a traditional herbal medicinal product used in adult women for the treatment of symptoms of mild lower urinary tract infections (e.g., bladder infection), such as a burning sensation when 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 medicinal product for use in the specified indication, based solely on long-standing use.

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

Cysturol is indicated in adult women (from 18 years of age). The use of the medication is not recommended in men without a clinical assessment and recommendation by the doctor.

2. What you need to know before taking Cysturol

Do not take Cysturol

• if you are allergic to bearberry, birch, or goldenrod, birch pollen, or any of the other components of this medication (listed in section 6), as well as if you are allergic to plants of the Asteraceae (Compositae) family in general.
• if you have diseases in which increased fluid intake is contraindicated, such as certain heart or kidney diseases.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Cysturol.

Urinary tract infections can have serious consequences. If you have a chronic urinary tract infection or swollen legs (edema), you should only take Cysturol with the explicit consent of your doctor. The use of the medication is not recommended in men without a clinical assessment and recommendation by the doctor.

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

It may cause a harmless brownish-green discoloration of the urine.

Children and Adolescents

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

Other Medications and Cysturol

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

The simultaneous intake of synthetic diuretics is not recommended.

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.

Due to the lack of sufficient experience during pregnancy and breastfeeding, the use of Cysturol should be avoided.

Driving and Using Machines

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

3. How to Take Cysturol

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

Cysturol is 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 of Cysturol is enhanced by drinking plenty of fluids. Drink plenty of liquid (at least 1-2 liters per day) to achieve sufficient flushing of the urinary tract.

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

Use in Children and Adolescents

Since there is insufficient data, the use of Cysturol is not recommended in children and adolescents under 18 years of age.

If you take more Cysturol 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 Cysturol

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 further questions on 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.

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

The frequency of these side effects is unknown.

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 Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cysturol

No special storage conditions are required.

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

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

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

6. Package Contents and Additional Information

Composition of Cysturol

• 108-120 mg of dry extract of bearberry leaf (Arctostaphylos uva-ursi L. Spreng), equivalent to 432-600 mg of plant, which corresponds to 27 mg of hydroquinone derivatives calculated as anhydrous arbutin. Extraction solvent: water.

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

40 mg of dry extract of goldenrod aerial part (Solidago gigantea Ait.), equivalent to 160-240 mg of plant. Extraction solvent: 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 Package Contents

White-gray film-coated tablets with a smooth surface. Available in packs of 20, 40, and 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Deiters

C/ Riera de Montalegre, 49

08915 Badalona

Spain

Manufacturer:

DREHM Pharma GmbH

Grünbergstraße 15/3/3

AT-1120 Vienna

Austria

Date of the Last Revision of this Package Leaflet: July 2017

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