ROWATINEX

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Rowatinex (Роватинекс)
enteric soft capsules
Rowatinex and Роватинекс are the same brand names of the same medicinal product written in Polish and Bulgarian.
Please read this leaflet carefully before taking 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 side effects, including any that are not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 5 days, 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 with diuretic and mild spasmolytic effects on the urinary tract, facilitating the elimination of small kidney stone deposits.
Indications:
Used as an adjunctive treatment in cases of small kidney stone deposits (so-called "renal sand").

2. Important information before using Rowatinex

Do not use Rowatinex if you have:

• hypersensitivity to any component of the medicine Rowatinex,
• pregnancy,
• breastfeeding period,
• 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 of occurrence of the above symptoms, consult a doctor.

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 a meal.

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 administration of the medicine could affect the metabolism of other drugs, resulting in reduced efficacy.

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

The medicine contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.
The medicine may cause allergic reactions (including delayed-type reactions).

The medicine contains Sunset Yellow FCF (E 110).
The medicine may cause allergic 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:
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:
Cases of overdose with Rowatinex have not been reported to date.
If you take more than the recommended dose, seek immediate 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 under continuous medical 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 forgotten dose.

4. Possible adverse reactions

Like all medicines, Rowatinex may cause adverse reactions.
In a small number of patients, mild, transient gastrointestinal symptoms may occur,
e.g.: nausea. If vomiting occurs or other symptoms persist,
the use of the medicine should be discontinued.
In some individuals, other adverse reactions may occur during treatment with Rowatinex.
If any other adverse reactions not listed in this leaflet occur,
they should be reported to a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist, or nurse.
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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions helps to collect further information on the safety of the medicine.

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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Rowatinex contains
One enteric soft capsule contains:
α-pinen (α-Pinenum) 24.8 mg
β-pinen (β-Pinenum) 6.2 mg
Camphene (Camphenum) 15.0 mg
Cineole (Cineolum) 3.0 mg
Fenchone (Fenchonum) 4.0 mg
Borneol (Borneolum) 10.0 mg
Anethole (Anetholum) 4.0 mg

Excipients:
Olive oil 33.0 mg
Capsule shell: gelatin, glycerol 85%, sodium parahydroxybenzoate ethyl, sodium parahydroxybenzoate propyl, orange-yellow FCF 85% (E 110), quinoline yellow WS 70% (E 104).

Pack sizes available:
One package (bottle) contains 30 enteric soft capsules.

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

Marketing authorisation holder in Bulgaria, 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
and
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35/37
87-100 Toruń
Poland

Marketing authorisation number in Bulgaria, country of export: 9700086
Parallel import authorisation number: 124/23