ROTERCYSTI 425.25 mg/519.75 mg Film-coated tablets

2. What You Need to Know Before Taking Rotercysti Film-Coated Tablets

Do not take Rotercysti film-coated tablets:

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

Warnings and Precautions

• If disorders or symptoms such as fever, spasms, urinary problems, or blood in the urine occur during the use of the medication, you should consult a doctor, as they may be caused by another illness.
• The use of this medication is not recommended in men, except after consulting a doctor.
• The use of bearberry leaf can cause a brownish-green discoloration of the urine.

Children and Adolescents

The use of this medication is not recommended in children and adolescents under 18 years of age, except after consulting a doctor.

Other Medications and Rotercysti Film-Coated Tablets

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

Pregnancy and Breastfeeding

This medication 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 medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Rotercysti Film-Coated Tablets

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.

Adults: 2 tablets twice a day.

Maximum dose: 2 tablets four times a day.

Method of Administration:

Take the tablets whole with water.

Duration of Treatment:

This medication contains arbutin, and like all medications containing arbutin, Rotercysti should not be taken for more than 5 consecutive days, except on medical prescription. Medications containing bearberry leaf extract should not be taken for more than five episodes of 5 consecutive days per year.

If You Take More Rotercysti Film-Coated Tablets Than You Should

No cases of overdose have been reported. Nevertheless, you should not take a higher dose of Rotercysti film-coated tablets per day than indicated in this package 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 as indicated in this package leaflet.

If You Stop Taking Rotercysti Film-Coated Tablets

Generally, stopping or terminating treatment early is harmless.

If you are unsure, consult your doctor or pharmacist.

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.

The following side effects may occur: nausea, vomiting, and stomach pain. The frequency of these is unknown.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Rotercysti Film-Coated Tablets

Do not store above 25°C.

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

Do not use this medication after the expiration date stated on the carton and blister. 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 any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Rotercysti Film-Coated Tablets

Each film-coated tablet contains approximately 500 mg of extract (as dry extract) of 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 potato starch glycolate, anhydrous colloidal silica, magnesium stearate, polyethylene glycol 3350, polyvinyl alcohol, titanium dioxide E171, red iron oxide E172, yellow iron oxide E172, black iron oxide E172.

Appearance and Package Contents

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

Rotercysti film-coated tablets are available in packages of 20, 30, 40, or 60 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Vemedia Manufacturing B.V.

Verrijn Stuartweg 60

NL-1112 AX Diemen

Netherlands

Local Representative:

Vemedia Pharma Hispania S.A.

c/ Aragón, 182 5th floor

08011 Barcelona

Phone: +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 - Netherlands

Marketing Authorization Number(s):

81744

This Medication is Authorized in the Member States of the European Economic Area 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 Last Revision of this Package Leaflet:July 2021

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