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ROWACHOL

Information leaflet

                                                    Irish Medicines Board




                                   Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Rowachol Gastro-resistant Capsules, Soft

 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.

 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 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 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

 There are no known contraindications to the use of Rowachol Capsules.

 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).




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




 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 physician.

 4.7 Effects on ability to drive and use machines

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

 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

 Capsule Shell

 Gelatine
 Glycerol 85%
 Sodium Ethyl Parahydroxybenzoate (E215)
 Sodium Propyl Parahydroxybenzoate (E217)
 Sodium Copper Chlorophyllin (100% water soluble)




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




 6.2 Incompatibilities

 Not applicable.

 6.3 Shelf Life

 5 years.

 6.4 Special precautions for storage

 Do not store above 25°C. Keep the container tightly closed.

 6.5 Nature and contents of container

 Rowachol Capsules are packed in white, polypropylene tablet containers with polyethylene matt white circular caps.
 The caps have 'tear-strips' fully attached all around and a 'pull-off lip' above the 'tear-strip'.

 Rowachol Capsules are available in tablet containers of 50 and 500 capsules.

 Not all pack sizes may be marketed.

 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 74/8/1

 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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