Leaflet: information for the user

RoterCysti coated tablets

Dried extract of gayuba leaf

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

Follow exactly the administration instructions contained 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.
• You should consult a doctor if you get worse or do not improve after five days.

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

The expected effect in the specified indications for this medication is based exclusively on its traditional use.

Do not take Rotercysti coated tablets:

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

Warnings and precautions

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

Children and adolescents

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

Other medications and Rotercysti coated tablets

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

Pregnancy and breastfeeding

This medication should not be used during pregnancy and breastfeeding.

Driving and operating machines

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

Rotercysti 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.

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.

Adults: 2 tablets twice a day.

Maximum dose: 2 tablets four times a day.

Administration form:

Take the tablets whole with water.

Treatment duration:

This medication contains arbutin and, like all medications that contain arbutin, Rotercysti should not be taken for more than 5 consecutive days, unless prescribed by a doctor. Medications containing gayuba leaf extract should not be taken for more than five episodes of 5 consecutive days per year.

If you take more Rotercysti coated tablets than you should

No cases of overdose have been reported. However, do not take a higher dose of Rotercysti coated tablets each day than indicated in this leaflet or prescribed by your doctor.

If you forgot to take Rotercysti coated tablets

Do not take a double dose to compensate for the missed doses, continue taking the tablets as prescribed by your doctor or indicated in this leaflet.

If you interrupt the treatment with Rotercysti coated tablets

Generally, interrupting or prematurely ending treatment is harmless.

If unsure, consult your doctor or pharmacist.

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.

The following adverse effects may occur: nausea, vomiting, and stomach pain. The frequency of these 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: www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Do not store above 25°C.

Keep this medication out of sight and reach of children.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of the 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 of Rotercysti coated tablets

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

Extraction solvent: water.

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

Appearance of the product and contents of the package

Coated tablets, oblong, brown-red in color.

RoterCysti coated tablets are available in packages of 20, 30, 40 or 60 coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

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

Tel.+34 93 453 62 19

Responsible for manufacturing:

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 medicinal product is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet:July 2021

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