ROTERCYSTI FILM-COATED TABLETS
Ask a doctor about a prescription for ROTERCYSTI FILM-COATED TABLETS
How to use ROTERCYSTI FILM-COATED TABLETS
Introduction
Package Leaflet: Information for the User
Rotercysti Film-Coated Tablets
Dry Extract of Bearberry Leaf
Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.
Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.
- Keep this package leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after five days.
Contents of the Package Leaflet
- What Rotercysti film-coated tablets are and what they are used for
- What you need to know before taking Rotercysti film-coated tablets
- How to take Rotercysti film-coated tablets
- Possible side effects
- Storage of Rotercysti film-coated tablets
- Package contents and additional 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 symptoms of mild lower urinary tract infections (e.g., bladder infection), such as burning sensation when urinating and/or frequent need to urinate, provided that 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.
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
- Country of registration
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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