Rovatinex

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Rowatinex (Роватинекс)

Enteric soft capsules
Rowatinex and Роватинекс are the same trade names for the same drug, written in Polish and Bulgarian.

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 a 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 the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist or nurse. See section 4.
• If there is no improvement after 5 days or the patient feels worse, they should contact their 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. Package contents 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:
as an auxiliary agent in cases of small kidney stone deposits (so-called "kidney sand").

2. Important information before using Rowatinex

Do not use Rowatinex in the following cases:

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

Use Rowatinex with caution if:

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

No effects have been shown so far.

Using 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.
You should inform your doctor about all medicines you have taken recently, even those that are available without a prescription.

The medicine contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late-type reactions).

The medicine contains orange yellow FCF (E 110)

The medicine may cause allergic reactions.

3. How to use Rowatinex

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

Method of use:

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, you should consult your doctor.

In case of overdose:

No cases of Rowatinex overdose have been reported so far.
If you have taken 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 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 function, and perform laboratory tests.

In case of a missed dose:

Do 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 taking the medicine.
In some people, other side effects may occur while taking 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 any possible side effects not listed in the leaflet, you should tell your doctor or 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
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Rowatinex

The medicine should be stored out of sight and 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 refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Rowatinex contains

One enteric soft capsule contains:
α-pinene (α-Pinenum)
24.8 mg
β-pinene (β-Pinenum)
6.2 mg
Camphor (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 ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, orange yellow FCF 85% (E 110), quinoline yellow WS 70% (E 104).
Available packages:
1 package (bottle) contains 30 enteric soft capsules.
To obtain more detailed information, you should contact the marketing authorization holder or 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:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35/37
87-100 Toruń
Marketing authorization number in Bulgaria, the country of export:9700086

Parallel import authorization number: 124/23

Date of leaflet approval: 29.06.2023

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