Rovatinex

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Rowatinex®

Soft capsules

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days or if you feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Rowatinex® and what is it used for
• 2. Important information before taking Rowatinex®
• 3. How to take Rowatinex®
• 4. Possible side effects
• 5. How to store Rowatinex®
• 6. Contents of the pack and other information

1. What is Rowatinex® and what is it used for

Rowatinex® is a medicine that acts as a diuretic and has a mild spasmolytic effect on the urinary tract, facilitating the elimination of small kidney stone deposits.

Indications:

As an auxiliary treatment in cases of small kidney stone deposits (so-called "kidney sand").

2. Important information before taking Rowatinex®

Do not take Rowatinex® if you:

• are allergic to any of the ingredients of Rowatinex®,
• are pregnant,
• are breastfeeding,
• have acute or chronic kidney diseases.

Be cautious when taking Rowatinex® if you:

experience pain symptoms, especially in the lumbar region, renal colic (characterized by recurring pain usually starting in the lumbar region or kidney area), urinary disorders, hematuria, etc. If you experience any of these symptoms, contact your doctor.

Taking Rowatinex® in children

Do not give this medicine to children.

Taking Rowatinex® with food and drink

Take the medicine 30 minutes before a meal.

Pregnancy

Do not take during pregnancy.

Breastfeeding

Do not take during breastfeeding.

Driving and using machines

No effects have been reported so far.

Taking other medicines

No interactions with other medicines have been reported, but based on experimental data for essential oils, it can be assumed that taking the medicine may affect the metabolism of other medicines, resulting in a weakening of their effect. Inform your doctor about all medicines you have taken recently, including those available without a prescription.

Important information about some ingredients of Rowatinex®

The medicine contains sodium ethyl para-hydroxybenzoate, sodium propyl para-hydroxybenzoate (E 217), and orange yellow (E 110), which may cause allergic reactions (possible late-type reactions).

3. How to take Rowatinex®

Unless otherwise directed by your doctor, take 1 capsule, 3-4 times a day, 30 minutes before meals.

Method of administration

Oral administration. It is recommended to drink more fluids than usual while taking the medicine. If you feel that the effect of Rowatinex® is too strong or too weak, consult your doctor.

In case of overdose

No cases of overdose have been reported so far. If you have taken more than the recommended dose, contact your doctor or pharmacist immediately. Treatment of poisoning:If the medicine was taken recently, the stomach should be emptied by gastric lavage. The patient should be under constant observation. If necessary, symptomatic treatment should be applied. It is recommended to monitor heart function, respiratory efficiency, and perform laboratory tests.

In case of missed dose

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Rowatinex® can cause side effects. In a small number of patients, mild, transient gastrointestinal symptoms may occur, such as nausea. If vomiting occurs or other symptoms persist, discontinue the use of the medicine. In some individuals, other side effects may occur while taking Rowatinex®.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 (22) 49 21 301, fax: +48 (22) 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Rowatinex®

Keep the medicine out of the reach and sight of children. Store in the original packaging to protect from light. Do not use the medicine after the expiration date stated on the packaging. The expiration date is the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

Translation of some abbreviations on the blister pack:

Verw. bis

• Expiration date Ch
• Batch number

6. Contents of the pack and other information

What Rowatinex® contains

One soft capsule contains: α-pineneand β-pinene, Camphor, Cineole, Fenchone, 31.0 mg, 15.0 mg, 3.0 mg, 4.0 mg, Borneol, Anethole, 10.0 mg, 4.0 mg, Excipients:Olive oil, 33.0 mg, Capsule shell: gelatin, glycerol 85%, sodium ethyl para-hydroxybenzoate, sodium propyl para-hydroxybenzoate (E 217), orange yellow (E 110), quinoline yellow (E 104).

What Rowatinex® looks like and what the pack contains

Aluminum blisters in a cardboard box. Each pack contains 30 or 50 soft capsules. For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Austria, the country of export:

WABOSAN Arzneimittelvertriebs GmbH, Anton Anderer Platz 6/1, A-1210 Vienna, Austria

Manufacturer

Pharmazeutische Fabrik Montavit Ges.m.b.H., Salzbergstraße 96, 6067 Absam, Austria, Lupuca Pharma GmbH, Gewerbering 4, 3484 Grafenwörth, Austria

Parallel importer:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, Laboratorium Galenowe Olsztyn Sp. z o.o., ul. Spółdzielcza 25A, 11-001 Dywity, Olsztyn, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa, CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź, IVA Pharm Sp. z o.o., ul. Drawska 14/1, 02-202 Warszawa, Pharma Innovations Sp. z o. o., ul. Jagiellońska 76, 03-301 Warszawa, Marketing authorization number in Austria, the country of export: 13.342, Parallel import authorization number: 277/18

Date of leaflet approval:

[Information about the trademark] Approved: 30.05.2023