Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
BORNEOL; CAMPHENE; CINEOLE; MENTHOL; MENTHONE; PINENE; PINENE
MEGAPHARM LTD
N/A
CAPSULES
MENTHOL 32 MG; MENTHONE 6 MG; PINENE 3.4 MG; BORNEOL 5 MG; CAMPHENE 5 MG; CINEOLE 2 MG; PINENE 13.6 MG
PER OS
Not required
ROWA PHARMACEUT. LTD.,IRELAND
An adjuvant in the treatment of gall-bladder stones and liver diseases.
2022-09-30
Page 1 of 3 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a physician's prescription ROWACHOL CAPSULES ACTIVE INGREDIENTS : Menthol 32 mg Menthone 6 mg β – Pinene 3.4 mg Borneol 5 mg Camphene 5 mg Cineole 2 mg α -Pinene 13.6 mg For a list of the inactive and allergenic ingredients in the preparation, see Chapter 2 under the heading “Important information about some of this medicine’s ingredients” and Chapter 6, “Additional information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, consult your physician or pharmacist. Take the medicine in accordance with the instructions in Chapter 3 “ How to use this medicine? ”. Consult with a pharmacist if you require more information. Consult with a physician if the symptoms of the illness get worse or do not improve after 14 days. The duration of treatment may vary depending on the size of the stones and the physician’s diagnosis. 1. WHAT IS THIS MEDICINE INTENDED FOR? ROWACHOL is used as an adjuvant in the treatment of gallbladder stones and liver diseases. ROWACHOL acts to dissolve, disintegrate and remove gallstones by increasing bile secretion. ROWACHOL also inhibits the formation of substances that contribute to deposit build-up and stone formation. ROWACHOL relaxes the bile ducts, thus reducing pain and helping to remove the stones. 2. BEFORE USING THE MEDICINE SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: Do not take Rowachol unless your physician has confirmed a diagnosis of gallstones, especially in the case of children. BEFORE TREATMENT WITH ROWACHOL, TELL YOUR PHYSICIAN IF: • You are taking blood-thinning medicines or medicines that are broken down in the liver. DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to α - pinene, β -pinene, borneol, menthol, menthone, camphene, cineole, or any of the additional ingredients in this Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rowachol 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. Excipient(s) with known effect 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 odor. 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 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 A 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. 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 such as obstructive jaundice, ascending cholangitis, sepsis, acute pancreatitis. The physician should be aware of the necessity of being properly informed [particularly in the case of elderly patients] so that appropriate measures can be taken. The following ingredients of Rowachol capsules may cause allergic reactions: Sodium Ethyl Parahydroxybenzoate (E215), Sodium Propyl Parahydroxyben Olvassa el a teljes dokumentumot