Rowachol Gastro-resistant Capsules, Soft

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Menthol; Menthone; Alpha pinene; Borneol; Cineole; Camphene; Beta pinene

Available from:

Rowa Pharmaceuticals Limited

INN (International Name):

Menthol; Menthone; Alpha pinene; Borneol; Cineole; Camphene; Beta pinene

Dosage:

percent volume/volume

Pharmaceutical form:

Gastro-resistant capsule, soft

Prescription type:

Product not subject to medical prescription

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROWACHOL
®
GASTRO-RESISTANT CAPSULES, SOFT
Α-PINENE, Β -PINENE, MENTHOL, MENTHONE, CAMPHENE, BORNEOL, CINEOLE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1. What Rowachol® is and what it is used for
2. What you need to know before you take Rowachol®
3. How to take Rowachol®
4. Possible side effects
5. How to store Rowachol®
6. Contents of the pack and other information
1. WHAT ROWACHOL® IS AND WHAT IT IS USED FOR
Rowachol® is intended for use in the breaking up (dissolving or
disintegrating) or passage
(expulsion) of gallstones. Rowachol® increases bile production and
relaxes the bile ducts.
This helps reduce painful spasms of bile ducts. It also makes it
easier for any gallstones
present to be passed out (expelled) with the bile.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROWACHOL®
DO NOT TAKE ROWACHOL®:
-
if you are allergic to α-pinene, β-pinene, borneol, menthol,
menthone, camphene,
cineole or any of the other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR FIRST BEFORE YOU TAKE ROWACHOL®
DO NOT TAKE ROWACHOL UNLESS YOUR DOCTOR HAS CONFIRMED A DIAGNOSIS OF
GALLSTONES ESPECIALLY IN THE CASE OF CHILDREN.
Talk to your doctor or pharmacist before taking Rowachol® if you are
taking medicines to
thin your blood or medicines that are broken down by the liver.
OTHER MEDICINES AND ROWACHOL®
Tell your doctor or pharmacist if you are taking, have recently taken
or might tak

Summary of Product characteristics

Health Products Regulatory Authority
17 February 2020
CRN009LV8
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rowachol Gastro-resistant Capsules, Soft
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
α-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 the 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
odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management and dissolution of radiolucent gallstones in the
functioning gall bladder WHERE A DEFINITE DIAGNOSIS HAS
BEEN MADE BY A DOCTOR ESPECIALLY IN THE CASE OF CHILDREN.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Method of administration: Oral.
Adults: 1 to 2 capsules three times daily before meals.
_Paediatric Population:_
Children aged 0 to 6 years: No data are available.
Children aged 6 to 14 years: 1 capsule twice daily before meals.
Adolescents aged 14 to 18 years: 1 to 2 capsules three times 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 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.
Health Products Regulatory Authority
17 February 2020
CRN009LV8
Page 2 of 4
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 s