Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Bromhexine HCl
SUNWARD PHARMACEUTICAL SDN. BHD.
Bromhexine HCl
100 x10 Tablets; 50 Tablets; 1000 Tablets; 10x10 Tablets; 50 x10 Tablets
SUNWARD PHARMACEUTICAL SDN. BHD.
SW BROMHEXINE TABLET Bromhexine Hydrochloride (8mg) 1 _ Consumer Medication Information Leaflet (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What SW Bromhexine Tablet is used for 2. How SW Bromhexine Tablet works 3. Before you use SW Bromhexine Tablet 4. How to SW Bromhexine Tablet 5. While you are using it 6. Side effects 7. Storage and disposal of SW Bromhexine Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT SW BROMHEXINE TABLET IS USED FOR It is indicated for nasal (inflammation of the mucous membrane in the bronchial tubes) and other respiratory condition as aid to support the body clearing the muccus expectoration. HOW SW BROMHEXINE TABLET WORKS The active ingredient in this medicine is bromhexine hydrochloride. Bromhexine hydrochloride is a synthetic derivative of the herbal active ingredient vasicine. It enhance mucus transport by reducing viscosity and by activating the ciliated epithelium (mucociliary clearance). The ambroxol is a metabolite of bromhexine, hence it is highly bound to plasma protein BEFORE YOU USE SW BROMHEXINE TABLET _- When you must not use it _ Do not take this medicine if you are hypersensitive to bromhexine hydrocholoride or any of the other ingredients listed at the end of the leaflet. _ _ _Pregnancy and breastfeeding _ You should check with your doctor if you are or think you may be pregnant, planning to become pregnant or if you are breastfeeding. It is not recommended for pregnant women and nursing mothers unless the expected benefit outweighs any potential risks. _- Before you start to use it _ Tell your doctor before taking this medicine if you have: Peptic/Gastirc ulser _- Taking other medicines _ There are a few medicines which may inter- act with SW Bromhexine Tablet. It is important to tell your doctor or pharmacist about all the medicines that you are taking, including those obtained without doctor’s prescription. You should talk to your doctor or pharmacist if you are taking:- Erythromycin or Cephalexin antibiotic HO Przeczytaj cały dokument
PKG NO Product Name Revision Code Colour Dimension _Regulatory Department_ _Artwork_ _ Information_ : : : : : SW BROMHEXINE ELIXIR/ TABLET LEAFLET CL305A-R12 BLACK LETTERING 72MM (W) X 108MM (H) BROMHEXINE ELIXIR/TABLET Bromhexine HCl Preservative: Methyl Paraben Bromhexine Elixir 4 mg / 5ml 10 mg / 5ml Bromhexine Tablet 8 mg / Tablet - PHARMACOLOGY: Bromhexine is a synthetic derivative of the herbal active ingredient vasicine. Preclinically, it has been shown to increase the proportion of serous bronchial secretion. Bromhexine enhances mucous transport by reducing mucous viscosity and by activating the ciliated epithelium (mucociliary clearance). In clinical studies, bromhexine showed a secretolytic and secretomotor effect in the bronchial tract area, which facilitates expectoration and eases cough. Bromhexine hydrochloride is rapidly absorbed from the gastro-intestinal tract and about 85 to 90% of a dose is excreted in the urine mainly as metabolites. Ambroxol is a metabolite of bromhexine. Bromhexine is highly bound to plasma proteins. Administration of bromhexine HCl by mouth to healthy subjects produced peak plasma concentrations after about 1 hour. Only small amounts were excreted unchanged in the urine with a half-life of about 6.5 hours. INDICATIONS: It is indicated in bronchitis and other respiratory conditions as an aid to expectoration. CONTRAINDICATIONS: It is contraindicated in patients who is hypersensitive to it and should be given cautiously to patients with gastric ulceration. SIDE EFFECTS/ADVERSE REACTIONS: Gastro-intestinal side effects may occur occasionally and a transient rise in serum amino-transferase values has been reported. Immune System Disorders Frequency not known: Anaphylactic reactions including anaphylactic shock. Skin and Subcutaneous Skin Disorders Frequency not known: Severe skin reactions (including Stevens Johnson syndrome, Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM) and Acute Generalized Exanthematous Pustulosis (AGEP). PRECAUTIONS/WARNINGS: Bromhexine should Przeczytaj cały dokument