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    Summary of Product Characteristics: Rowachol Capsules

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    The document summarizes the characteristics of Rowachol Capsules, an herbal supplement used as an adjuvant treatment for gallstones and liver disease. It contains several terpenes and is administered orally. Common side effects include belching and minty taste. The supplement should be used cautiously with other medications and during pregnancy/lactation.

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    Summary of Product Characteristics: Rowachol Capsules

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    asdwasd
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    The document summarizes the characteristics of Rowachol Capsules, an herbal supplement used as an adjuvant treatment for gallstones and liver disease. It contains several terpenes and is administered orally. Common side effects include belching and minty taste. The supplement should be used cautiously with other medications and during pregnancy/lactation.

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    The document summarizes the characteristics of Rowachol Capsules, an herbal supplement used as an adjuvant treatment for gallstones and liver disease. It contains several terpenes and is administered orally. Common side effects include belching and minty taste. The supplement should be used cautiously with other medications and during pregnancy/lactation.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    38 views3 pages

    Summary of Product Characteristics: Rowachol Capsules

    Uploaded by

    asdwasd
    The document summarizes the characteristics of Rowachol Capsules, an herbal supplement used as an adjuvant treatment for gallstones and liver disease. It contains several terpenes and is administered orally. Common side effects include belching and minty taste. The supplement should be used cautiously with other medications and during pregnancy/lactation.

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    © All Rights Reserved
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    of 3

    Summary of Product Characteristics

    1 NAME OF THE MEDICINAL PRODUCT

    Rowachol Capsules

    2 QUALITATIVE AND QUANTITATIVE COMPOSITION

    Each capsule contains:


    α-Pinene 13.6 mg, ß-Pinene 3.4 mg, L-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 and Sodium Propyl
    Parahydroxybenzoate.

    For a full list of excipients, see section 6.1

    3 PHARMACEUTICAL FORM

    Gastro-resistant Capsules, soft

    Spherical, green, soft gelatin, gastro-resistant capsules containing a greenish yellow


    oral solution with a strong aromatic odour.

    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

    Known hypersensitivity to any of the active ingredients or to any of the inactive ingredients in
    the formulation.

    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).
    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

    In rare cases, symptoms of belching and mint taste in the mouth have been reported, after
    meals. These symptoms can be reduced by taking medication on an empty stomach 30
    minutes before a meal.
    A small number of patients reported appearance of pain and ulcers in the mouth. This
    phenomenon is reversible and disappeared soon after stopping treatment.

    Reporting suspected adverse reactions after authorisation of the medicinal product is


    important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
    Any suspected adverse events should be reported to the Ministry of Health according to the
    National Regulation by using an online form
    (http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic
    @moh.gov.il ).

    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, Sodium Propyl
    Parahydroxybenzoate, Sodium Copper Chlorophyllin (100% water soluble).

    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 100 capsules. Not all pack

    sizes may be marketed.

    6.6 Special precautions for disposal

    No special requirements.

    7. LICENSE HOLDER

    Megapharm Ltd., P.O.Box 519 Hod Hasharon, 4510501

    8. MANUFACTURER

    Rowa Pharmaceut. LTD.


    Newtown, Bantry Co. Cork, Ireland

    9 ISRAEL LICENSE NUMBER


    107-68-20688

    The format of this leaflet was determined by the ministry of health and its content was checked
    and approved in January 2016.

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