Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PSEUDOEPHEDRINE HYDROCHLORIDE; CETIRIZINE HYDROCHLORIDE
PAHANG PHARMACY SDN. BHD.
PSEUDOEPHEDRINE HYDROCHLORIDE; CETIRIZINE HYDROCHLORIDE
100Tablet Tablets
Sun Pharmaceutical Industries Limited
_Consumer Medication Information Leaflet (RiMUP) _ CETRIZET D TABLET Cetirizine hydrochloride/Pseudoephedrine hydrochloride (5mg/120mg) 1 WHAT IS IN THIS LEAFLET 1. What _Cetrizet D_ is used for 2. How _Cetrizet D_ works 3. Before you use _Cetrizet D_ 4. How to use _Cetrizet D_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Cetrizet D_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _CETRIZET D_ IS USED FOR _Cetrizet D_ should be administered when both the antiallergic properties of cetirizine HCl and the nasal decongestant activity of pseudoephedrine HCl are desired. _Cetrizet D_ is used in the treatment of symptoms associated with seasonal allergy or hay fever, perennial (throughout the year) allergic rhinitis (inflammation of the mucous membrane inside the nose) and common cold e.g., nasal congestion, sneezing, rhinorrhea (runny nose), nasal and ocular pruritus (itchy eyes). HOW _CETRIZET D_ WORKS Cetirizine is an antihistamine that helps to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced in the body during an allergic reaction. Pseudoephedrine is a decongestant what works by reducing swelling of the blood vessels inside your nose. This helps to open up your nasal airway, making breathing easier. BEFORE YOU USE _CETRIZET D_ _ _ _When you must not use it _ Do not use Cetrizet D if you have any of the following: A history of hypersensitivity to any of the constituents, to ephedrine or to any piperazines. Previous intolerance to pseudoephedrine. Breast Feeding Have severe high blood pressure or severe coronary artery disease (heart disease). Taking or have taken monoamine oxidase inhibitors (for depression) within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure. Kidney insufficiency, uncontrolled hyperthyroidism (overactive thyroid), severe arrhythmia (abnormal heart rhythm), in Read the complete document
165 mm Front side Size: 165x200 mm COMPOSITION: Each film coated tablet of CETRIZET D contains: Cetirizine Hydrochloride BP 5 mg Pseudoephedrine Hydrochloride BP 120 mg (As extended release) PRODUCT DESCRIPTION: A yellow coloured, circular, film coated tablet with break line marked on one side and plain on the other side. DESCRIPTION: Combination of antihistamine and decongestant used to relieve allergic rhinitis. ACTION AND MODE OR MECHANISMS OF ACTION: PHARMACODYNAMIC: Cetirizine is a potent antihistamine with a low potential for drowsiness at pharmacologically active doses and with additional anti-allergic properties. It is selective H -antagonist with negligible effects on other receptors and so is virtually free from anti- 1 cholinergic and anti-serotonin effects. At pharmacologically active doses, it induces neither sedation nor behaviour changes. This may be explained by the fact that cetirizine does not cross the blood-brain barrier. It was shown in human pharmacology studies that cetirizine inhibits certain effects produced by exogenous histamine. This activity appears rapidly. Cetirizine also inhibits the effects produced by endogenous histamine released in vivo by any agent. It also inhibits the cutaneous reaction induced by VIP (Vasoactive Intestinal Polypeptide) and substance P, neuropeptides, which are believed to take part in the allergic reaction. Cetirizine inhibits the histamine-mediated 'early' phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the 'late' allergic response. Cetirizine markedly reduces bronchial hyper-reactivity to histamine in the asthmatic patient. It also reduces the allergic reaction induced by specific allergens. These effects are obtained without any central effects being demonstrated either by psychometric tests or by quantified EEG. Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory tract decongestant. Pseudoephedrine is substantially l Read the complete document