ROWATINEX

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ANETHOLE; BORNEOL; CAMPHENE; CINEOLE; FENCHONE; PINENE ALFA; PINENE BETA

متاح من:

MEGAPHARM LTD

ATC رمز:

G04BC

الشكل الصيدلاني:

CAPSULES

تركيب:

CAMPHENE 15 MG; CINEOLE 3 MG; FENCHONE 4 MG; BORNEOL 10 MG; ANETHOLE 4 MG; PINENE BETA 6.2 MG; PINENE ALFA 24.8 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

ROWA PHARMACEUT. LTD.,IRELAND

المجموعة العلاجية:

URINARY CONCREMENT SOLVENTS

الخصائص العلاجية:

As an adjuvant in infections of kidenys and urinary tract.

تاريخ الترخيص:

2022-10-31

نشرة المعلومات

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS_ _(PREPARATIONS) - 1986
This medicine is dispensed without a physician's prescription
Rowatinex
Capsules
Active ingredients:
_Camphene_
15 mg
_Cineole_
3 mg
_Fenchone_
4 mg_ _
_Borneol_
10 mg _ _
_Anethole_
4 mg_ _
_Pinene_ _beta_
6.2 mg_ _
_Pinene_ _alfa_
24.8 mg
_ _
For a list of inactive and allergenic ingredients in the preparation,
see chapter 2
Section “Important information about some of the medicine’s
ingredients” and chapter
6 “Additional information”.
_ _
Read this leaflet carefully in its entirety before using the
medicine._ _This leaflet contains
concise information about the medicine._ _If you have further
questions, consult your physician
or pharmacist.
Take the medicine in accordance with the instructions in chapter 3
“How should you use the
medicine?”._ _Consult with a pharmacist if you require more
information._ _Consult with a
physician if the symptoms of the illness get worse or do not improve
after 14 days.
The duration of treatment may vary depending on the size of the stones
and the physician’s
diagnosis.
_ _
1.
What is this medicine intended for? _ _
Rowatinex is an adjuvant in infections of kidneys and urinary tract.
Rowatinex helps to dissolve, break down and remove kidney and urinary
tract stones._ _
Rowatinex relaxes muscles in the area, increases blood flow and
reduces inflammation, thus
reducing pain and helping to remove the stones._ _
Rowatinex reduces the formation of stones by
increasing the solubility of calcium salts, which
are the main component of kidney and urinary tract stones._ _
_ _
2.
Before using the medicine_ _
_ _
Do not use this medicine if:
You are sensitive (allergic) to any of the active ingredients,
Camphene, Cineole,
Fenchone, Borneol, Anethole, Pinene beta, Pinene alfa, or to any of
the additional
ingredients contained in the medicine (please see chapter 6
“Additional information”).
Special warnings regarding the use of the medicine:
Before treatment with Rowatinex, te

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rowatinex
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
−
Pinene
24.8 mg,
β
−
Pinene 6.2 mg, Camphene 15.0 mg, Borneol 10.0 mg, Anethol 4.0 mg,
Fenchone
4.0 mg, Cineole 3.0 mg.
Excipient(s) with known effect:
Each capsule also contains Sodium Ethyl Parahydroxybenzoate (E215),
Sodium Propyl
Parahydroxybenzoate (E217) and Sunset Yellow FCF 85% (E110).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant Capsules,
Soft yellow, spherical, soft gelatine gastro-resistant capsules
containing a pale yellow to greenish-yellow
oral solution with a strong aromatic odor.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an adjuvant in infections of kidneys and urinary tract.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Oral.
Recommended Dosage Schedule:
Adults: The usual dosage is 1-2 capsule 3 times daily before meals
Children aged 6 to 14 years: The usual dosage is 1 capsule twice daily
before meals.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
DEFINITE DIAGNOSIS OF UROLITHIASIS AND NEPHROLITHIASIS MUST BE MADE
BEFORE TAKING THIS PRODUCT TO RULE
OUT OTHER POSSIBLE CONDITIONS.
The product should only be used with caution in patients on
anti-coagulants or drugs dependent on the
liver for
metabolism and excretion.
Conservative medical management of uro- and nephrolithiasis should be
initiated with the awareness that
stones can give rise to serious clinical complications such as
obstruction of the urinary system, sepsis. The
physician should be aware of the necessity of being properly informed
so that appropriate measures can be
taken.
Rowatinex capsules contain sodium ethyl parahydroxybenzoate (E215),
sodium propyl
parahydroxybenzoate (E217) which may cause allergic reactions
(possibly delayed).
Rowatinex also contains sunset yellow FCF 85% (E110) which may c