ROWACHOL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BORNEOL; CAMPHENE; CINEOLE; MENTHOL; MENTHONE; PINENE; PINENE

Available from:

MEGAPHARM LTD

ATC code:

N/A

Pharmaceutical form:

CAPSULES

Composition:

MENTHOL 32 MG; MENTHONE 6 MG; PINENE 3.4 MG; BORNEOL 5 MG; CAMPHENE 5 MG; CINEOLE 2 MG; PINENE 13.6 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

ROWA PHARMACEUT. LTD.,IRELAND

Therapeutic indications:

An adjuvant in the treatment of gall-bladder stones and liver diseases.

Authorization date:

2015-08-25

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied without physician’s prescription
_ _
ROWACHOL
®
CAPSULES
_ _
ACTIVE INGREDIENTS:
L-Menthol 32 mg
Menthone 6 mg
Pinene beta 3.4 mg
Pinene alfa 13.6 mg
Borneol 5 mg
Camphene 5 mg
Cineole 2 mg
_ _
For the list of inactive ingredients – see section "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains essential information
about this medicine. If you have any further questions, refer to the
physician or to the pharmacist.
Refer to the physician if the signs of the illness (symptoms) get
worse or do not improve.
WHAT IS THIS MEDICINE INTENDED FOR?
ROWACHOL is used as a supplement for the treatment of gallstones and
liver diseases.
ROWACHOL acts by dissolving, breaking up and expelling gallstones by
increasing the secretion of bile. In addition,
ROWACHOL inhibits the formation of substances contributing to the
generation of sediments and formation of stones.
ROWACHOL relaxes the bile ducts, thus reducing pain and facilitating
expulsion of gallstones.
BEFORE USING THIS MEDICINE
_ _
_ _
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
BEFORE THE TREATMENT WITH ROWACHOL, TELL YOUR PHYSICIAN IF:

you are taking anticoagulants to thin the blood or medicines that are
broken down by the liver.
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICINES, INCLUDING
NON-PRESCRIPTION MEDICINES AND NUTRITIONAL
SUPPLEMENTS, INFORM YOUR PHYSICIAN OR PHARMACIST. In particular if you
are taking:

Medicines to thin the blood (anticoagulants such as Warfarin)

Medicines that are broken down in the liver.
_ _
USING THE MEDICINE AND FOOD
ROWACHOL should be taken before meals.
A low cholesterol diet is recommended.
PREGNANCY AND BREASTFEEDING
There is no information on the use of ROWACHOL during human pregnancy,
and there is no evidence of a teratogenic
effect in animals. Some of the ingredients may pass through the
placenta to the fetus, and

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ROWACHOL Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
α-Pinene
13.6 mg, ß-Pinene 3.4 mg, L-Menthol 32.0 mg, Menthone 6.0 mg, Borneol
5.0 mg, Camphene 5.0 mg, Cineole 2.0 mg.
Each capsule also contains Sodium Ethyl Parahydroxybenzoate and Sodium
Propyl
Parahydroxybenzoate.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Gastro-resistant Capsules, soft
Spherical, green, soft gelatin, gastro-resistant capsules containing a
greenish yellow
oral solution with a strong
aromatic odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
An adjuvant in the treatment of gall-bladder stones and liver
diseases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Oral.
Recommended Dosage Schedule:
_Adults:_ The usual dosage is 1 to 2 capsules three times daily before
meals.
_Children aged 6 to 14 years_: The usual dosage is 1 capsule twice
daily before meals.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any of the active ingredients or to any of
the inactive ingredients in
the formulation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The product should only be used with caution in patients on
anti-coagulants or drugs
dependent on the liver for
metabolism and excretion.
The following ingredients of Rowachol capsules may cause allergic
reactions: Sodium Ethyl
Parahydroxybenzoate
(E215), Sodium Propyl Parahydroxybenzoate (E217) (possibly
delayed).
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Rowachol Capsules should only be used with caution in patients on
anti-coagulants or drugs
dependent on the liver for
metabolism and excretion.
4.6
FERTILITY, PREGNANCY AND LACTATION
There is no information on experience of use during human pregnancy.
There is no evidence
of a teratogenic effect in
animals. However, some at least of the ingredients can cross the
placenta. The product should therefore only be used
during pregnancy or lactation if
considered essential by the p