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

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