Rowatinex

Patient Information Leaflet

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Rowatinex®
soft capsules
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.
• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 5 days, or if you feel worse, consult your doctor.

Table of contents:

1. What Rowatinex® is and what it is used for
2. What you need to know 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 Rowatinex® is and what it is used for

Rowatinex® is a medicine that has a diuretic effect and a mild spasmolytic action on the urinary tract, facilitating the elimination of small kidney stones.
Indications:
Adjunctive treatment in cases of small kidney stones (so-called "kidney sand").

2. Important information before using Rowatinex®

Do not use Rowatinex® if you have:

• hypersensitivity to any component of Rowatinex®,
• pregnancy,
• breastfeeding,
• acute or chronic kidney disorders.

Exercise special caution when using Rowatinex® if:
you experience pain symptoms, especially in the lumbar region, renal colic (characterized by
recurrent pain usually starting in the lumbar or kidney area), disturbances in urination, haematuria, etc.
If any of the above symptoms occur, consult a doctor.

Use of Rowatinex® in children
Rowatinex® must not be used in children.

Use of Rowatinex® with food and drink
The medicine should be taken 30 minutes before a meal.

Pregnancy
Do not use during pregnancy.

Breastfeeding
Do not use during breastfeeding.

Driving and operating machinery
No effects have been demonstrated so far.

Use with other medicines
No cases of interactions with other medicines have been reported to date. However, based on experimental data for essential oils, it may be assumed that taking the medicine could affect the metabolism of other drugs, resulting in reduced efficacy.

Inform your doctor about all medicines you have recently taken, including those available without a prescription.

Important information about certain ingredients of Rowatinex®
The medicine contains sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217), and sunset yellow (E 110), which may cause allergic reactions (delayed-type reactions possible).

3. How to use Rowatinex®

If not otherwise directed by a physician: 1 capsule, 3–4 times daily, 30 minutes before meals.
Method of administration
For oral use. It is recommended to increase fluid intake above normal levels during treatment with this medicinal product.
If you feel that the effect of Rowatinex® is too strong or too weak, consult your doctor.
If you take more Rowatinex® than you should
There have been no cases of overdose with Rowatinex® reported so far.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or pharmacist.
Treatment of poisoning:
If the medicinal product has been taken recently, empty the stomach by gastric lavage. The patient should be kept under continuous observation. If necessary, symptomatic treatment should be administered. Monitoring of cardiac function, respiratory capacity, and laboratory tests are recommended.
If you forget to take a dose
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicinal product, Rowatinex® may cause adverse reactions.
In a small number of patients, mild, transient gastrointestinal symptoms may occur, for example:
nausea. If vomiting occurs or other symptoms persist, the use of the medicinal product should be
discontinued.
In some individuals, other adverse reactions may occur during treatment with Rowatinex®.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your
doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

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 expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Translation of some abbreviations appearing on the blister pack:
Verw. bis - Expiry date
Ch - Batch number

6. Contents of the packaging and other information

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

What Rowatinex® looks like and contents of the pack
Aluminum blisters in a cardboard box.
Each package contains 30 or 50 soft capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Austria, 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 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw

Austrian marketing authorisation number (country of export): 13.342
Parallel import authorisation number: 277/18
Date of approval: 30.05.2023