Rowatinex

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Rowatinex
soft capsules
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your 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 or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 5 days, you should consult your doctor.

Table of contents:

1. What Rowatinex is and what it is 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 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 stone deposits.
Indications:
As an adjunct in cases of small kidney stone deposits (so-called "kidney sand").

2. Important information before using Rowatinex

Do not use Rowatinex if you have:

• hypersensitivity to any of the ingredients of Rowatinex,
• pregnancy,
• breastfeeding,
• acute or chronic kidney disorders.

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

Use of Rowatinex in children:
Rowatinex should not be used in children.

Use of Rowatinex with food and drink:
The medicine should be taken 30 minutes before meals.

Pregnancy:
Do not use during pregnancy.

Breastfeeding:
Do not use during breastfeeding.

Driving and operating machinery:
No influence has been demonstrated so far.

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

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

Important information about some ingredients of Rowatinex:

• Rowatinex contains Sunset Yellow FCF 85% (E 110). This medicine may cause allergic reactions.
• Rowatinex contains sodium ethylparahydroxybenzoate (E 215) and sodium propylparahydroxybenzoate (E 217). This medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Rowatinex

Unless otherwise directed by a physician: 1 capsule, 3–4 times daily, 30 minutes before meals.
Method of administration:
Orally. It is recommended to increase fluid intake above normal levels during treatment with this medicine.
If you feel that the effect of Rowatinex is too strong or too weak, consult your doctor.
In case of taking more Rowatinex than recommended:
There have been no cases of overdose with Rowatinex reported to date.
If you have taken more than the recommended dose, seek immediate advice from a doctor or pharmacist.
Treatment of poisoning:
If the medicine 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 miss a dose:
Do not take a double dose to make up for the 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, treatment with the medicine should be discontinued.
In some individuals, other adverse reactions may occur during treatment with Rowatinex.
If any adverse reactions not listed in this leaflet occur, inform your doctor about them.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
telephone: +48 22 492 13 01
fax: +48 22 492 13 09
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables more information on the safety of the medicine to be collected.

5. How to store Rowatinex

Keep the medicine out of the sight and reach of children.
Store below 25°C.
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 in use. This will help protect the environment.

6. Contents of the package and other information

One capsule contains:
α-Pinene 24.8 mg
ß-Pinene 6.2 mg
Camphene 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 ethylparaben (E 215), sodium propylparaben (E 217), orange yellow FCF 85% (E 110), quinoline yellow WS 70% (E 104).

Available packaging:
A bottle made of colorless glass with a screw cap, in a cardboard box, containing 30 soft, yellow capsules.

For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Bulgaria, the country of export:
Rowa-Wagner GmbH & Co KG
Arzneimittelfabrik
Frankenforster strasse 77
D-51427 Bergisch Gladbach
Germany

Manufacturer:
Rowa-Wagner GmbH & Co KG
Arzneimittelfabrik
Frankenforster strasse 77
D-51427 Bergisch Gladbach
Germany

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation number in Bulgaria, the country of export: 9700086
Parallel import licence number: 194/20