Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
BENZOIC ACID, CINNAMIC ACID, BISMUTH OXIDE, ZINC OXIDE, LIDOCAINE HYDROCHLORIDE
Boston Healthcare Limited Unit 6, Navigation Court, Calder Park, Wakefield, West Yorkshire WF2 7JB, United Kingdom
D04AX
BENZOIC ACID 0.4 % (W/W) CINNAMIC ACID 0.45 % (W/W) BISMUTH OXIDE 2 % (W/W) ZINC OXIDE 10 % (W/W) LIDOCAINE HYDROCHLORIDE 0.65 % (W/W)
CREAM
BENZOIC ACID 0.4 % (W/W) CINNAMIC ACID 0.45 % (W/W) BISMUTH OXIDE 2 % (W/W) ZINC OXIDE 10 % (W/W) LIDOCAINE HYDROCHLORIDE 0.65 % (W/W)
OTC
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Withdrawn
2006-04-19
GIRAFFE CREATIVE TECHNOLOGY LTD., 35 REDSANDS DRIVE, FULWOOD, PRESTON, LANCASHIRE PR2 6GG UNITED KINGDOM TEL: 01772 655900 - FAX: 01772 700750 EMAIL: INFO@GIRAFFELTD.COM _Colours_ _(Printed)_ _Title:_ _Ref:_ _Date:_ _Size:_ _Client:_ _Artwork:_ _Modified:_ _Program:_ Hemocane Cream PIL HMO/BOST/25g 06/08/11 135(W) x 180(H) Boston Healthcare David Gore 20/06/12 Adobe Illustrator CS4 Black _Colours_ _(Non printed)_ TRIM This leaflet is provided to give you information about Hemocane Cream and what you should know to use it correctly. PLEASE READ CAREFULLY WHAT IS HEMOCANE CREAM? The name of your medicine is Hemocane Cream. It is used to treat pain and discomfort caused by haemorrhoids (piles), or anal fissures (crack or tear). WHAT DOES HEMOCANE CREAM CONTAIN? Hemocane Cream contains five active ingredients (w/w) Lidocaine Hydrochloride Ph Eur 0.65%, Zinc Oxide Ph Eur 10%, Bismuth Oxide 2%, Cinnamic Acid BP 0.45%, Benzoic Acid Ph Eur 0.4%. Lidocaine has local anaesthetic properties, Zinc oxide and bismuth oxide, when applied locally, have mild astringent (shrink) actions and provide a soothing, protective action on mucous membranes and raw surfaces. Benzoic Acid and Cinnamic Acid have mild antiseptic properties. Also contains Propylene Glycol, Glycerol, Cetostearyl Alcohol, Polawax EM3354, Arlacel 83 and Polysorbate 80. One of the active ingredients in this medicine is Lidocaine Hydrochloride. This is the new name for Lignocaine Hydrochloride. The ingredient itself has not changed. MARKETING AUTHORISATION HOLDER: MANUFACTURED BY: Boston Healthcare Ltd., 6 Navigation Court, Calder Park, Wakefield WF2 7BJ BEFORE YOU USE HEMOCANE CREAM Do not use Hemocane Cream if you have a known history of allergy toward Lidocaine and any of other components of the product actives and ingredients. Not recommended for children. PREGNANCY A Soma hati kamili
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Hemocane Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lidocaine Hydrochloride Ph Eur 0.65 %w/w Zinc Oxide Ph Eur 10.0 %w/w Bismuth Oxide 2.0 %w/w Cinnamic Acid BP 0.45 %w/w Benzoic Acid Ph Eur 0.4 %w/w 3. PHARMACEUTICAL FORM Cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Effective treatment for the symptoms of haemorrhoids and allied ano-rectal conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults - apply morning and night and after bowel movements until the condition are controlled. Not recommended for children. Cream is inserted into the rectum (via an applicator) and/or externally in the anal region. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist or worsen, or if an allergic reaction occurs, discontinue use immediately and consult your doctor. Persons who suffer from haemorrhoids are advised to consult their doctor. Keep out of reach of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 FERTILITY, PREGNANCY AND LACTATION No ill effects are expected when used according to the dosage recommendations. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. Page 2 of 3 4.8 UNDESIRABLE EFFECTS None. 4.9 OVERDOSE Overdosage is unlikely to occur with the cream. Symptoms would be associated with high plasma levels of lidocaine hydrochloride. 5. PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Lidocaine has local anaesthetic properties. Zinc oxide and bismuth oxide, when applied l Soma hati kamili