Rovatinex

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

Rowatinex

soft capsules

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including all possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Rowatinex and what is it used for
• 2. Important information before using Rowatinex
• 3. How to use Rowatinex
• 4. Possible side effects
• 5. How to store Rowatinex
• 6. Contents of the packaging 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 excretion of small kidney stone deposits.
Indications for use:
Assistance in the case of small kidney stone deposits (so-called "kidney sand").

2. Important information before using Rowatinex

Do not use Rowatinex in the case of:

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

Use Rowatinex with special caution if:

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

Using Rowatinex in children:

The medicine should not be used in children.

Using 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 using machines:

No effects have been shown so far.

Using other medicines:

No interactions with other medicines have been found, 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.
You should inform your doctor about all medicines you have taken recently, even those that are available without a prescription.

Important information about some components of Rowatinex:

• Rowatinex containsorange yellow FCF 85% (E 110). The medicine may cause allergic reactions.
• Rowatinex containssodium ethyl parahydroxybenzoate (E 215) and sodium propyl parahydroxybenzoate (E 217). The medicine may cause allergic reactions (possible late-type reactions).

3. How to use Rowatinex

If your doctor does not recommend otherwise, 1 capsule, 3-4 times a day, 30 minutes before meals.

Method of use:

Orally. 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, you should consult your doctor.

In case of taking a larger dose of Rowatinex than recommended:

No cases of overdose have been reported so far.
In case of taking a larger dose than recommended, you should immediately consult your doctor or pharmacist.
Treatment of poisoning:
If the medicine was taken recently, the stomach should be emptied using 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 missing a dose of Rowatinex:

You should not take a double dose to make up for the 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, you should stop using the medicine.
In some people, other side effects may occur during the use of Rowatinex.
If you experience other side effects not listed in this leaflet, you should inform your doctor.

Reporting side effects

If you experience any side effects, including all possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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,
Aleje Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 492 13 01
fax: +48 22 492 13 09
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

The medicine should be stored out of sight and out of reach of children.
Store in a temperature below 25°C.
Do not use the medicine after the expiration date stated on the packaging. The expiration date means the last day of the given month.
Medicines should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

One capsule contains:
α-Pinene
ß-Pinene
Camphor
Cineole
Fenchone
Borneol
Anethole
24.8 mg
6.2 mg
15.0 mg
3.0 mg
4.0 mg
10.0 mg
4.0 mg
Excipients:
olive oil
33.0 mg
Capsule shell: gelatin, glycerol 85%, sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217), orange yellow FCF 85% (E 110), quinoline yellow WS 70% (E 104).
Available packaging:
Bottle made of colorless glass with a screw cap, in a cardboard box, containing 30 yellow soft capsules.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export: 9700086
Parallel import authorization number: 194/20

Date of leaflet approval: 30.05.2025

[Information about the trademark]