מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LORATADINE
SUNWARD PHARMACEUTICAL SDN. BHD.
LORATADINE
60 ml; 100 ml; 120 ml; 1000 ml; 100 ml mL; 120 ml mL; 60 ml mL
SUNWARD PHARMACEUTICAL SDN. BHD.
SUNADINE TABLET 10MG / SUNADINE SYRUP 5MG/5ML Loratadine (10mg, 5mg/5ml) 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Sunadine Tablet/Syrup is used for 2. How Sunadine Tablet/Syrup works 3. Before you use Sunadine Tablet/Syrup 4. How to use Sunadine Tablet/Syrup 5. While you are using it 6. Side effects 7. Storage and Disposal of Sunadine Tablet/ Syrup 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SUNADINE TABLET/SYRUP IS USED FOR It is used to relieve symptoms associated with; seasonal allergic rhinitis (such as sneezing, stuffy nose, and throat itchy due to inflam- mation of the mucous membrane inside the nose and throat). long term hives (associated with skin swelling, redness, itchiness, patches). other skin allergic disorders due to certain allergens. HOW SUNADINE TABLET/SYRUP WORKS The active ingredient in the medicine is Loratadine. Loratadine is anti-histamine which work by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. BEFORE YOU USE SUNADINE TABLET/SYRUP _- When you must not use it _ Do not take Sunadine Tablet/Syrup if you are hypersensitivity to Loratadine or any ingredients listed at the end of this leaflet. _- Before you start to use it _ Talk to your doctor before taking Sunadine Tablet/Syrup, if you have: liver problem kidney problem glaucoma (increased pressure inside the eye). difficulty in urination due to enlargement of prostate gland. epilepsy (fits). _Pregnancy and breastfeeding _ You should check with your doctor if you are pregnant or think you may be pregnant, planning to become pregnant or if you are breastfeeding. Loratadine have been detected in breast milk. It is not recommended for pregnant women and nursing mothers unless the expected benefit outweighs any potential risks. _Children _ Use with caution and on doctor's/pharmacist's advice in children younger than 2 years of age Safety and effectiveness in childre קרא את המסמך השלם
SUNADINE TABLET 10MG/ SUNADINE SYRUP 5MG/5ML Tablet : Loratadine 10mg / tablet Syrup : Loratadine 5mg / 5ml FURTHER INFORMATION CONCERNING THIS DRUG CAN BE OBTAINED FROM YOUR FAMILY PHYSICIAN / LOCAL GENERAL PRACTITIONER / PHARMACIST. Manufacturer & Product Registration Holder: SUNWARD PHARMACEUTICAL SDN. BHD. No. 9, 11 & 17, Jalan Kempas 4, Taman Perindustrian Tampoi Indah, 81200 Johor Bahru, Johor, Malaysia. CL673A-R10 Revision Date: 21/10/2022 Children 2-6 years of age: Body weight > 30kg Body weight ≤ 30kg Category Adults and children 12 years of age and over: Two 5ml spoonful (10mg) syrup once daily. One 5ml spoonful (5mg) syrup once daily. One tablet (10mg)/Two 5ml spoonful (10mg) syrup once daily. Half a tablet (5mg)/One 5ml spoonful (5mg) syrup once daily. One tablet (10mg)/Two 5ml spoonful (10mg) syrup once daily. Dose Children 6-12 years of age: Body weight > 30kg Body weight ≤ 30kg PRODUCT DESCRIPTION: Tablet : Oval, white, convex, film-coated tablet with single score on one side only. Syrup : A clear, colourless syrup with peach flavour. PHARMACODYNAMICS: Antihistamines (loratadine) diminish or abolish the main actions of histamine in the body by competitive, reversible blockade of histamine receptor sites on tissues. Histamines H 1 -receptors are responsible for vasodilatation, increased capillary permeability, flare and itch reactions in the skin, and to some extent for contraction of smooth muscle in the bronchi and gastrointestinal tract. Loratadine is a long-acting tricyclic antihistamine with selective peripheral histamine H 1 -receptor antagonistic activity. Studies have been shown that neither loratadine nor its metabolites readily cross the blood-brain barrier. It has higher affinity for the peripheral rather than the central nervous system H 1 -receptors. Hence, less problem of daytime sedation for those who have to drive or operate machinery. PHARMACOKINETICS: It is rapidly absorbed from the gastrointestinal tract after oral administration. The peak plasma concentration is being attai קרא את המסמך השלם