ROTERUTI
ItalyIt is used by women to treat the symptoms of mild lower urinary tract infections (such as bladder infections), such as a burning sensation during urination or the need to urinate frequently.
Frequently asked questions
How should Roteruti be taken?
Adults should take 2 tablets twice daily, without exceeding the maximum dosage of 2 tablets four times daily. The tablets should be swallowed whole with water.
How long can this medicine be taken?
It must not be taken for more than 5 consecutive days, unless otherwise directed by a doctor. Furthermore, five episodes of 5 consecutive days per year should not be exceeded.
When should Roteruti not be taken?
It must not be taken if you are allergic to bearberry leaves or any of its components, if you suffer from kidney disorders, or if you are pregnant or breastfeeding. Use in men and children under 18 years of age is recommended only under medical advice.
What are the possible side effects of Roteruti?
Nausea, vomiting, and stomach ache may occur.
What should I do if I notice changes in my urine?
The use of bearberry leaf may cause a brownish-green discoloration of the urine. However, if blood appears in the urine or if there are urination problems, it is necessary to consult a doctor.
What should I do if no improvement is felt?
If no improvement is noted after five days or if symptoms worsen, it is necessary to consult a doctor.
Instructions for use
Package leaflet: Information for the user
Roteruti, film-coated tablets
Dry extract of bearberry leaves
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more advice or information, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after five days.
Contents of this leaflet:
- What Roteruti is and what it is used for
- What you need to know before taking Roteruti
- How to take Roteruti
- Possible side effects
- How to store Roteruti
- Contents of the pack and other information
1. What Roteruti is and what it is used for
Roteruti is a traditional herbal medicinal product used in women for the treatment of symptoms of mild infections of the lower urinary tract (e.g. bladder infections), such as a burning sensation during urination and/or frequent urination.
The use of this traditional herbal medicinal product for the specified therapeutic indications is based solely on long-standing, traditional use.
2. What you need to know before taking Roteruti
Do not take Roteruti
- if you are allergic to bearberry leaves or to any of the other ingredients of this medicine (listed in section 6);
- if you have kidney disorders.
Warnings and precautions
- If, during the use of this medicine, you experience any disorders or symptoms such as fever, spasms, problems with urination, or blood in the urine, you must consult a doctor, as these may be caused by another medical condition.
- Use in males is not recommended unless directed by a doctor.
- If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
- The use of bearberry leaf may cause a brownish-greenish discoloration of the urine.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended, unless directed by a doctor.
Other medicines and Roteruti
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
This medicine must not be used during pregnancy or while breastfeeding.
Driving and using machines
No studies have been conducted regarding the effect on the ability to drive vehicles or operate machinery.
3. How to take Roteruti
Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults: 2 tablets twice daily.
Maximum dosage: 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, Roteruti should not be taken for more than 5 consecutive days unless otherwise prescribed by a doctor. Medicines containing bearberry leaf extract should not be used for more than five episodes of 5 consecutive days per year.
If you take more Roteruti than you should
Cases of overdose have not been reported. However, you must not take a daily amount of Roteruti exceeding that stated in this leaflet or prescribed by your doctor.
If you forget to take Roteruti
Do not take a double dose to make up for the forgotten tablet. Continue taking the medicine as prescribed by your doctor or as indicated in this leaflet.
If you stop taking Roteruti
Stopping or prematurely ending treatment is generally harmless.
If you are unsure, consult your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur: nausea, vomiting and stomach ache; the frequency of these is unknown.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Roteruti
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 which is stated on the carton after “Exp.” and on the blister after “EXP.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Roteruti contains
Each film-coated tablet contains approximately 500 mg of extract (as dry extract) from Arctostaphylos uva-ursi (L.), folium (bearberry leaf), corresponding to 105 mg of hydroquinone derivatives, calculated as anhydrous arbutin.
Extraction solvent: water.
The other ingredients are maltodextrin, microcrystalline cellulose, monohydrate lactose, talc, sodium polycarboxymethyl starch, anhydrous colloidal silicon dioxide, magnesium stearate, macrogol 3350, polyvinyl alcohol, titanium dioxide E171, red iron oxide E172, yellow iron oxide E172 and black iron oxide E172.
Description of the appearance of Roteruti and contents of the pack
Oblong, brownish-red film-coated tablets.
Roteruti is available in packs of 20, 30, 40 or 60 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen
The Netherlands
Manufacturer
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany
Marketing Authorization Holder for sale
Vemedia Pharma S.r.l – Parma
Marketing Authorization Number
044222014 - "Film-coated Tablets" 20 Tablets in PVC/PE/PVDC/Al Blister
044222026 - "Film-coated Tablets" 30 Tablets in PVC/PE/PVDC/Al Blister
044222038 - "Film-coated Tablets" 40 Tablets in PVC/PE/PVDC/Al Blister
044222040 - "Film-coated Tablets" 60 Tablets in PVC/PE/PVDC/Al Blister
This medicinal product is authorized in the European Economic Area countries under the following names:
The 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
This leaflet was last updated on.
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The original data is available in the language of the country of manufacture.
Data source: Italian Medicines Agency (AIFA)
Data last verified: September 21, 2026