Cysturol film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Cysturol film-coated tablets
Extract of Arctostaphylos uva-ursi, Extract of Betula pendula and/or Betula pubescens, Extract of Solidago gigantea
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for taking this medicine as described 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 more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You must consult a doctor if you worsen or do not improve after 4 days.
Contents of this leaflet
- What Cysturol is and what it is used for
- What you need to know before taking Cysturol
- How to take Cysturol
- Possible adverse effects
- How to store Cysturol
- Contents of the pack and other 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 antiseptic 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 a 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 traditional use.
You should consult a doctor if symptoms worsen or do not improve after 4 days.
Cysturol is indicated for adult women (aged 18 years and over). Use of the medicine in men is not recommended unless their clinical condition has been assessed and use is advised by a doctor.
2. What you need to know before starting to take Cysturol
Do not take Cysturol
- if you are allergic to bearberry, birch or goldenrod, birch pollen or any of the other components of this medicine (listed in section 6), as well as if you are allergic to plants of the Asteraceae (Compositae) family in general.
- if you suffer from conditions where 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 suffer from chronic urinary tract infections or have swollen legs (edema), you should only take Cysturol with the explicit consent of your doctor. Use of this medicine in men is not recommended unless their clinical condition has been evaluated and use is advised by a physician.
Consult your doctor if you develop fever, difficulty urinating, cramps or blood in the urine, or flank, lower back or stomach pain while using this medicine.
It may cause a harmless brownish-green discoloration of the urine.
Children and adolescents
Due to lack of sufficient experience and information, use of this medicine is not recommended in children and adolescents under 18 years of age.
Other medicines and Cysturol
Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or might need to take/use any other medicines.
Concomitant use of synthetic diuretics is not recommended.
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.
Due to insufficient experience during pregnancy and breastfeeding, Cysturol should not be taken.
Driving and use of machines
No studies on the effects on the ability to drive and use machines have been conducted.
3. How to take Cysturol
Follow exactly the dosage instructions for this medicine as stated in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult 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 ample liquids (a minimum of 1–2 litres per day) to achieve adequate flushing of the urinary tract.
This medicine contains arbutin and should not be taken for more than 5 consecutive days unless otherwise advised by a doctor. Medicines containing bearberry leaf extract should not be used 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 sufficient data are not available, the use of Cysturol is not recommended in children and adolescents under 18 years of age.
If you take more Cysturol than you should
Cases of overdose have not been reported.
In the event 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 Cysturol
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 can cause adverse effects, although not everyone will experience them.
Hypersensitivity to the active substances contained in this medicine has been reported, including allergic rhinitis and skin allergic reactions with itching, rash, and urticaria, as well as gastrointestinal discomfort with nausea, vomiting, abdominal pain, and diarrhea.
The frequency of these adverse effects is unknown.
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 through 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 Cysturol
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cysturol
- 108-120 mg of dry leaf extract of bearberry (Arctostaphylos uva-ursi L. Spreng), equivalent to 432-600 mg of plant, corresponding to 27 mg of hydroquinone derivatives calculated as anhydrous arbutin. Extraction solvent: water.
46.25 mg of dry leaf extract of birch (Betula pendula Roth and/or Betula pubescens Ehrh.), equivalent to 185-277.5 mg of plant. Extraction solvent: water.
40 mg of dry aerial part extract of goldenrod (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 contents of the pack
Film-coated tablets, greyish-white in colour with a smooth surface. Available in packs of 20, 40 and 60 tablets.
Only some 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 most recent review of this leaflet: July 2017
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es