Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DIPHENHYDRAMINE HYDROCHLORIDE; Bromhexine HCl; AMMONIUM CHLORIDE
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
DIPHENHYDRAMINE HYDROCHLORIDE; Bromhexine HCl; AMMONIUM CHLORIDE
100 ml
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ REXOM UNIZET SYRUP Diphenhydramine Hydrochloride/Bromhexine Hydrochloride/Ammonium Chloride (8mg/4mg/100mg per 5ml) 1 WHAT IS IN THIS LEAFLET 1. What REXOM UNIZET is used for 2. How REXOM UNIZET works 3. Before you use REXOM UNIZET 4. How to use REXOM UNIZET 5. While you are using REXOM UNIZET 6. Side effects 7. Storage and disposal of REXOM UNIZET 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT REXOM UNIZET IS USED FOR For productive cough and alleviation of nasal stuffiness, sneezing, lachrymation (flow of tears), mucolytic (to dissolve thick mucus and relieve respiratory difficulties) and bronchial congestion. HOW REXOM UNIZET WORKS Diphenhydramine is an antihistamine used to treat sneezing, runny nose, itching and other symptoms of allergies and the common cold. Bromhexine is a mucolytic agent which works by thinning the mucus in the airways, thus making the mucus less sticky and it facilitates the removal of the mucus. Ammonium chloride used as reflux expectorant. BEFORE YOU USE REXOM UNIZET _- When you must not use it _ Do not use it when you have: Hypersensitivity to any of the ingredients. Individual on monoamine oxidase inhibitor therapy within 14 days. Diphenhydramine should not be given to premature infants and neonates, they have increased susceptibility to antimuscarinic effect (eg: dry mouth, blurred vision, discomfort to the eyes, heart rhythm disorder, difficulty in urination, elevated body temperature and eye disease that may cause vision loss). Children below 2 years old. Pregnancy and lactation It is recommended that Rexom Unizet Syrup should not be used during pregnancy particularly as the safety of Rexom Unizet Syrup in human pregnancy is not established. It is recommended REXOM UNIZET SYRUP should not be used during lactation particularly as the safety of REXOM UNIZET SYRUP during lactation is not established. _-Before you start to use it_ When used for treatment of cou Läs hela dokumentet
REXOM UNIZET SYRUP NAME AND STRENGTH OF ACTIVE INGREDIENT(S) Each 5 ml contains: Diphenhydramine Hydrochloride …………………………….. 8 mg Bromhexine Hydrochloride ………………………..……….. 4 mg Ammonium Chloride …………………………………………. 100 mg Preservative: Sodium Benzoate ………………………………........................ 5 mg PRODUCT DESCRIPTION Red colour liquid with orange flavor. PHARMACODYNAMICS Diphenhydramine, an ethanolamine derivative is an antihistamine with antimuscarinic and pronounced central sedative properties. Bromhexine is a mucolytic agent used in the treatment of respiratory disorders associated with viscid or excessive mucus. Ammonium chloride used as reflux expectorant. PHARMACOKINETICS Diphenhydramine Hydrochloride is well absorbed from the gastrointestinal tract, although high first pass metabolism appears to affect systemic availability. Peak plasma concentrations are achieved about 1 to 4 hours after administration by mouth. Diphenhydramine is widely distributed throughout the body including the CNS. It crosses the placenta and has been detected in breast milk. It is highly bound to plasma protein. Bromohexine Hydrochloride is rapidly absorbed from the gastrointestinal tract and about 85 to 90% of the dose is excreted in the urine mainly as metabolites. Bromhexine is highly bound to plasma proteins. Ammonium Chloride is absorbed from the gastrointestinal tract. The ammonium ion is converted into urea in the liver, the anion thus liberated into the bloodstream and extracellular fluid causes a metabolic acidosis. INDICATIONS It is recommended for productive cough and alleviation of nasal stuffiness, sneezing, lachrymation, mucolytic and bronchial congestion. RECOMMENDED DOSE ADULTS: 10 ml (2 teaspoonfuls) of syrup 3 times a day, not to exceed 6 tsp in 24 hours. CHILDREN AGED 6-12 YEARS : 5 ml (1 teaspoonful) of syrup 3 times a day. Maximum daily dose: 15 ml syrup. Not to be used in children less than 2 years of age. To be used Läs hela dokumentet