ROWATINEX

ROWATINEX soft capsules

Important notes (mandatory information)

Rowatinex capsules. Areas of application: For the treatment of urolithiasis (kidney stone disease, disease with the formation of kidney stones in the kidney and the urinary tract).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


Patient information: Information for the user
Rowatinex capsules
Enteric-coated soft capsules for oral use
Active ingredients: a-pinene, ß-pinene, camphene, borneol, anethole, fenchone, cineole

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Rowatinex capsules must be taken as directed to ensure the best possible treatment results.
- Keep the package leaflet. You may want to read it again later.
- Ask your pharmacist if you need more information or advice.
- If your symptoms worsen or do not improve, you must see a doctor.
- If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT ARE ROWATINEX CAPSULES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ROWATINEX CAPSULES?
3. HOW TO TAKE ROWATINEX CAPSULES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ROWATINEX CAPSULES BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE ROWATINEX CAPSULES AND WHAT ARE THEY USED FOR?

Rowatinex capsules are used to treat urolithiasis (kidney stone disease, disease with the formation of kidney stones in the kidney and the urinary tract).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ROWATINEX CAPSULES?

Rowatinex capsules must not be taken,
if you are hypersensitive (allergic) to any of the active ingredients a-pinene, ß-pinene, camphene, borneol, anethole, fenchone, cineole or any of the other ingredients of Rowatinex capsules (see section 2 "Important information about certain other ingredients of Rowatinex capsules" and section 6 "Further information").

Special care should be taken when taking Rowatinex capsules,
if you are taking blood-thinning medicines (anticoagulants) or are being treated with other medicines that are metabolised and excreted by the liver.

Taking Rowatinex capsules with other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines. Rowatinex capsules should only be used with caution in patients with anticoagulant therapy or when treated with medicines that are metabolised and excreted by the liver.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Rowatinex capsules should only be used during pregnancy and breast-feeding under the supervision of a doctor.

Driving and using machines
There is no evidence that Rowatinex capsules impair these functions.

Important information about certain other ingredients of Rowatinex capsules
The following other ingredients of Rowatinex capsules may cause allergic reactions: sodium methyl 4-hydroxybenzoate (E 215), sodium propyl 4-hydroxybenzoate (E 217) (possibly also HH after a delay) and yellow orange S 85% (E 110).

3. HOW TO TAKE ROWATINEX CAPSULES?

Always take Rowatinex capsules exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is

For adults: 1 capsule 4 to 5 times a day, unchewed, before meals.
For children aged 6 to 14: 1 to 2 capsules 2 times a day, unchewed, before meals.

If you have taken more Rowatinex capsules than you should
If you have taken more Rowatinex capsules than you should, please notify your doctor or pharmacist.

If you forget to take Rowatinex capsules
Do not take double the amount if you forget to take Rowatinex capsules. Take it as soon as you remember. Then continue with the next dose at the usual time.

If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Rowatinex capsules can have side effects, although not everybody gets them.

Please inform your doctor or pharmacist if you notice any side effects.

5. HOW SHOULD ROWATINEX CAPSULES BE STORED?

Keep medicines out of the reach of children.

Do not use the medicine after the expiry date which is stated on the carton and the container. The expiry date refers to the last day of the month.

Rowatinex capsules should not be stored above 25 °C.

Keep the container tightly closed.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

6. FURTHER INFORMATION

What Rowatinex capsules contain
The active ingredients in one enteric-coated soft capsule are
a-pinene 24.8 mg
ß-pinene 6.2 mg
camphene 15.0 mg
borneol 10.0 mg
anethole 4.0 mg
fenchone 4.0 mg
cineole 3.0 mg

The other ingredient is:
Olive oil.

The capsule shell contains:
Gelatine, glycerol 85%, sodium methyl 4-hydroxybenzoate (E 215), sodium propyl 4-hydroxybenzoate (E 217), yellow orange S 85% (E 110), quinoline yellow 70% (E 104).

What Rowatinex capsules look like and contents of the pack
Rowatinex capsules are yellow, spherical, enteric-coated soft gelatine capsules containing a pale yellow to greenish-yellow solution with a strong aromatic odour.
Original packs of 30, 50 and 100 capsules
Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer
ROWA WAGNER GmbH & Co. KG
Pharmaceutical factory
Frankenforster Strasse 77
D-51427 Bergisch Gladbach
Telephone: +49-2204-61081
Fax: +49-2204-61084
E-mail: info@rowakg.de

This package leaflet was last revised in October 2012.

Source: Information from the package leaflet
Status: 09/2015
Areas of application: For the treatment of urolithiasis (kidney stone disease, disease with the formation of kidney stones in the kidney and the urinary tract).