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:

2022-09-30

Patient Information leaflet

Page 1 of 3
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS)
- 1986
This medicine is dispensed without a physician's prescription
ROWACHOL
CAPSULES
ACTIVE INGREDIENTS
:
Menthol
32 mg
Menthone
6 mg
β –
Pinene
3.4 mg
Borneol
5 mg
Camphene
5 mg
Cineole
2 mg
α
-Pinene
13.6 mg
For a list of the inactive and allergenic ingredients in the
preparation, see Chapter 2
under the heading “Important information about some of
this
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 to use this
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?
ROWACHOL is used as an adjuvant in the treatment of gallbladder stones
and liver diseases.
ROWACHOL acts to dissolve, disintegrate and remove gallstones by
increasing bile secretion.
ROWACHOL also inhibits the formation of substances that contribute to
deposit build-up and
stone formation. ROWACHOL relaxes the bile ducts, thus reducing pain
and helping to remove
the stones.
2.
BEFORE USING THE MEDICINE
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: Do not take
Rowachol unless your
physician has confirmed a diagnosis of gallstones, especially in the
case of children.
BEFORE TREATMENT WITH ROWACHOL, TELL YOUR PHYSICIAN IF:
•
You are taking blood-thinning medicines or medicines that are broken
down in the
liver.
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to α
-
pinene, β
-pinene, borneol, menthol, menthone, camphene, cineole,
or any of the additional ingredients in this

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rowachol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:

-Pinene
13.6 mg, ß-Pinene 3.4 mg, Menthol 32.0 mg, Menthone 6.0 mg, Borneol
5.0 mg, Camphene 5.0 mg, Cineole
2.0 mg.
Excipient(s) with known effect
Each capsule also contains Sodium Ethyl Parahydroxybenzoate (E215) and
Sodium Propyl Parahydroxybenzoate
(E217).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant Capsules,
Soft spherical, green, soft gelatine, gastro-resistant capsules
containing a greenish yellow oral solution with a strong
aromatic odor.
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
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
A definite diagnosis of radiolucent gallstones 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 cholelithiasis should be initiated
with the awareness that stones can give rise to
serious clinical complications, especially if the stones obstruct the
common bile duct such as obstructive jaundice,
ascending cholangitis, sepsis, acute pancreatitis. The physician
should be aware of the necessity of being properly
informed [particularly in the case of elderly patients] so that
appropriate measures can be taken.
The following ingredients of Rowachol capsules may cause allergic
reactions: Sodium Ethyl Parahydroxybenzoate
(E215), Sodium Propyl Parahydroxyben