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ROWACHOL

Information leaflet

                                                   Irish Medicines Board




                                  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 a 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.

 4.2 Posology and method of administration

 Route of Administration: Oral.

 Recommended Dosage Schedule:

 Adults: The usual dosage is 3 to 5 oral drops three times daily before meals.

 Children aged 6 to 14 years: The usual dosage is 1 to 2 oral drops three times daily before meals.

 4.3 Contraindications

 There are no known contraindications to the use of Rowachol Oral Drops.

 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.

 4.5 Interaction with other medicinal products and other forms of interaction

 Rowachol Oral Drops 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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Date Printed 01/03/2011                               CRN 2096490                                         page number: 1
                                                    Irish Medicines Board




 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 physician.

 4.7 Effects on ability to drive and use machines

 There is no evidence of impairment of these functions in patients taking Rowachol oral drops.

 4.8 Undesirable effects

 A slight taste of peppermint may occur initially. No case of side effects has been reported.

 4.9 Overdose

 No case of overdose has been reported.

 5 PHARMACOLOGICAL PROPERTIES

 5.1 Pharmacodynamic properties

 The several ingredients are well absorbed, metabolised in the liver and excreted in bile and urine.

 5.2 Pharmacokinetic properties

 Not applicable.

 5.3 Preclinical safety data

 Not applicable.

 6 PHARMACEUTICAL PARTICULARS

 6.1 List of excipients

 Virgin Olive Oil

 6.2 Incompatibilities

 Not applicable.

 6.3 Shelf Life

 5 years.

 6.4 Special precautions for storage

 Do not store above 25ºC. Keep the bottle tightly closed.




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Date Printed 01/03/2011                               CRN 2096490                                         page number: 2
                                                    Irish Medicines Board




 6.5 Nature and contents of container

 Rowachol Oral Drops is packed in 10 ml amber, round glass bottles.
 The bottles have black circular caps with clear plastic dropper interiors.

 Rowachol Oral Drops is available in bottles of 10 ml.

 6.6 Special precautions for disposal

 No special requirements.

 7 MARKETING AUTHORISATION HOLDER

 Rowa Pharmaceuticals Ltd
 Newtown
 Bantry
 Co Cork
 Ireland

 8 MARKETING AUTHORISATION NUMBER

 PA 74/8/2

 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 Date of first authorisation: 1st April 1983

 Date of last renewal: 1st April 2008

 10 DATE OF REVISION OF THE TEXT

 February 2011




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Date Printed 01/03/2011                               CRN 2096490                                         page number: 3
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