ROTERCYSTI FILM-COATED TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rotercysti film-coated tablets

Dry extract of bearberry leaf

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read 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 these adverse effects are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after five days.

Contents of the leaflet

1. What Rotercysti film-coated tablets are and what they are used for
2. What you need to know before taking Rotercysti film-coated tablets
3. How to take Rotercysti film-coated tablets
4. Possible adverse effects
5. How to store Rotercysti film-coated tablets
6. Contents of the pack and other information

1. What Rotercysti Film-Coated Tablets Are and What They Are Used For

Rotercysti is a traditional herbal medicinal product used in adult women for the treatment of mild symptoms of 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.

The intended effect for the indications specified for this medicinal product is based solely on its traditional use.

2. What you need to know before starting to take Rotercysti film-coated tablets

Do not take Rotercysti film-coated tablets:

• If you are allergic to bearberry leaves or to any of the other components of this medicine (listed in section 6).
• If you have kidney disorders.

Warnings and precautions

• If you experience any disorders or symptoms such as fever, spasms, difficulty urinating, or blood in the urine while taking this medicine, you should consult a doctor, as these may be caused by another disease.
• Use in males is not recommended unless previously discussed with a doctor.
• The use of bearberry leaf may cause a brownish-green discoloration of the urine.

Children and adolescents

Use in children and adolescents under 18 years of age is not recommended unless previously discussed with a doctor.

Other medicines and Rotercysti film-coated tablets

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

Pregnancy and breastfeeding

This medicine should not be used during pregnancy and breastfeeding.

Driving and using machines

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

Rotercysti film-coated tablets contain lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Rotercysti film-coated tablets

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults: 2 tablets twice daily.

Maximum dose: 2 tablets four times daily.

Method of administration:

Swallow the tablets whole with water.

Duration of treatment:

This medicine contains arbutin and, like all medicines containing arbutin, Rotercysti must not be taken for longer than 5 consecutive days unless otherwise prescribed by a doctor. Medicines containing bearberry leaf extract must not be used for more than five episodes of 5 consecutive days per year.

If you take more Rotercysti film-coated tablets than you should

Cases of overdose have not been reported. Nevertheless, you must not take more Rotercysti film-coated tablets per day than the amount indicated in this leaflet or prescribed by your doctor.

If you forget to take Rotercysti film-coated tablets

Do not take a double dose to make up for forgotten doses. Continue taking the tablets as prescribed by your doctor or indicated in this leaflet.

If you stop taking Rotercysti film-coated tablets

Generally, stopping or ending treatment prematurely is harmless.

If you are unsure, consult your doctor or pharmacist.

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 may cause adverse effects, although not everyone will experience them.

The following adverse effects may occur: nausea, vomiting, and stomach pain. The frequency of these 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rotercysti film-coated tablets

Do not store above 25°C.

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

Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Rotercysti film-coated tablets

Each film-coated tablet contains approximately 500 mg of extract (as dry extract) from Arctostaphylos uva-ursi (L.), folium (bearberry leaf), equivalent to 105 mg of hydroquinone derivatives, calculated as anhydrous arbutin.

Extraction solvent: water.

The other components are maltodextrin, microcrystalline cellulose, lactose monohydrate, talc, sodium carboxymethyl potato starch, colloidal anhydrous silica, magnesium stearate, polyethylene glycol 3350, poly(vinyl alcohol), titanium dioxide E171, iron oxide red E172, iron oxide yellow E172, iron oxide black E172.

Appearance of the product and contents of the pack

Film-coated tablets, oblong, reddish-brown in colour.

Rotercysti film-coated tablets are available in packs containing 20, 30, 40 or 60 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Vemedia Manufacturing B.V.

Verrijn Stuartweg 60

NL-1112 AX Diemen

The Netherlands

Local representative:

Vemedia Pharma Hispania S.A.

Aragón, 182, 5th floor

08011 Barcelona

Tel. +34 93 453 62 19

Manufacturer:

Dragenopharm Apotheker Püschl GmbH

Göllstraße 1

84529 Tittmoning

Germany

or

VEMEDIA MANUFACTURING B.V.

Verrijn Stuartweg 60, P.O. Box 171 - Diemen, Noord-Holland - 1112 AX - The Netherlands

Marketing Authorization Number(s)

81744

This medicinal product is authorized in the European Economic Area Member States under the following names:

Netherlands: Roter CYSTIFLORA, filmomhulde tabletten

Belgium: RotierUva-Ursi, filmomhulde tabletten

Luxembourg: RotierUva-Ursi comprimés pelliculés

Italy: Roteruti, compresse rivestite con film

Portugal: RoterCysti comprimidos revestidos por película

Spain: Rotercysti comprimidos recubiertos con película

Date of the most recent revision of this leaflet: July 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es