Rowatinex

Read the entire leaflet carefully, as it contains important information for the patient.

• This medicine is available without a prescription so that certain conditions can be treated without medical assistance. However, to achieve a good treatment outcome, Rowatinex® should be used carefully and in accordance with the information provided in this leaflet.
• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you need advice or further information.
• If symptoms worsen or do not improve within 5 days, consult a doctor.

Rowatinex®
Oral drops
Each 100 g of drops contains:
α-pinene 24.8 g
β-pinene 6.2 g
Camphor 15.0 g
Cineole 3.0 g
Fenchone 4.0 g
Borneol 10.0 g
Anethole 4.0 g
Excipients:
Olive oil 33.0 g

Available pack sizes:
1 pack contains 10 ml or 20 ml of oral drops.

Marketing Authorisation Holder:
Rowa-Wagner GmbH & Co KG,
Arzneimittelfabrik,
Frankenforster Strasse 77,
D-51427 Bergisch Gladbach,
Germany

Leaflet contents:

1. What Rowatinex® is and what it is used for
2. Before you use Rowatinex®
3. How to use Rowatinex®
4. Possible side effects
5. How to store Rowatinex®
6. Further information about Rowatinex®

1. What Rowatinex® is and what it is used for

Rowatinex® is a medicine with diuretic and mild antispasmodic effects on the urinary tract, facilitating the elimination of small kidney stone deposits.
Indications:
Adjuvant treatment in cases of diagnosed small kidney stone deposits (so-called "kidney sand").

2. Before using Rowatinex®

Do not use Rowatinex® if you have:

• hypersensitivity to any of the components of Rowatinex®,
• pregnancy,
• breastfeeding,
• acute or chronic kidney diseases.

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 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 to date.

Use with other medicines:
No cases of interactions with other medicines 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 medicines you have recently taken, including those available without a prescription.

3. How to use Rowatinex®

Unless otherwise directed by a physician, the dose is 3–5 drops (0.115–0.192 ml) at a time, administered 4–5 times daily, 30 minutes before meals.
Use the dropper provided to measure the dose accurately.
Method of administration:
Oral use. Administer the drops on a sugar cube or teaspoon of sugar.
It is recommended to drink increased amounts of fluids than usual during treatment with this medicinal product.
If you feel that the effect of Rowatinex® is too strong or too weak, consult your doctor.

In case of overdose:
No cases of overdose with Rowatinex® have been reported to date.
If you take more than the 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 a dose is missed:
Do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, Rowatinex® may cause adverse reactions.
Mild, transient gastrointestinal symptoms, such as nausea, may occur in a small number of patients. If vomiting occurs or other symptoms persist, discontinue use of the medicine.
Other adverse reactions may occur in some individuals during treatment with Rowatinex®.
If any adverse reactions not listed in this leaflet occur, inform your doctor about them.

5. Storage of the medicinal product Rowatinex®

The medicine should be stored in a place inaccessible and not visible to children.
Store below 25°C.
Do not use the medicine after the expiry date stated on the packaging.

6. Other information
For more detailed information, please contact the representative of the marketing authorization holder.

VITAMED PHARMACEUTICALS Sp. z o.o.
Ostrowskiego 24, 97-213 Smardzewice
tel. +48 44 710 86 99
Date of leaflet preparation: