Rowachol Oral Drops, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Rowa Pharmaceuticals Limited

INN (International Name):

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

Dosage:

percent volume/volume

Pharmaceutical form:

Oral drops, solution

Prescription type:

Product not subject to medical prescription

Authorization status:

Not marketed

Authorization date:

1983-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROWACHOL®
ORAL DROPS, SOLUTION
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 take any other
me

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rowachol Oral Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 g of oral drop solution contains:
-Pinene 13.6 g, ß-Pinene 3.4 g Menthol 32.0 g, Menthone 6.0 g,
Borneol 5.0 g, Camphene 5.0 g, Cineole 2.0g.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Drops, Solution
Pale yellow to greenish-yellow oral drop 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: 3 to 5 oral drops three times daily before meals.
_Paediatric Population:_
Children 0-6 years: No data are available
Children aged 6 to 14 years: 1 to 2 oral drops three times daily
before meals.
Adolescents aged 14-18 years: 3 to 5 oral drops 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.
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