Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Rupatadine fumarate 12.8mg Equivalent to 10 mg rupatadine free base
iNova Pharmaceuticals (New Zealand) Limited
Rupatadine fumarate 12.8 mg (Equivalent to 10 mg rupatadine free base)
10 mg
Tablet
Active: Rupatadine fumarate 12.8mg Equivalent to 10 mg rupatadine free base Excipient: Iron oxide red Iron oxide yellow Lactose Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch
Blister pack, PVC/PVDC//Alu, 3 tablets (sample pack), 3 tablets
Prescription
Prescription
Urquima SA
RUPATAL tablets are indicated for symptomatic treatment of seasonal allergic rhinitis (SAR) in adults and adolescents (over 12 years of age).
Package - Contents - Shelf Life: Blister pack, PVC/PVDC//Alu, 3 tablets (sample pack) - 3 tablets - 3 years from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC//Alu, 20 tablets - 20 tablets - 3 years from date of manufacture stored at or below 25°C protect from light
2009-10-30
RUPATAL ® 10 MG TABLETS Rupatadine (as fumarate) 10 mg CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RUPATAL tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking RUPATAL against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT RUPATAL IS USED FOR RUPATAL is an antihistamine. RUPATAL_ _relieves symptoms of allergic rhinitis such as sneezing, runny nose, itching in the eyes and nose. RUPATAL is also used to relieve symptoms associated with chronic idiopathic urticaria (an allergic skin rash) such as itching and hives (localised skin redness and swelling). THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR’S PRESCRIPTION. Your doctor, however, may prescribe RUPATAL_ _for another purpose. Ask your doctor if you have any questions about why RUPATAL has been prescribed for you. BEFORE YOU TAKE/GIVE RUPATAL_ _ _ _ _WHEN YOU MUST NOT _ _TAKE/GIVE IT _ DO NOT TAKE RUPATAL IF YOU HAVE AN TO RUPATADINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, difficulty in breathing or faintness. DO NOT TAKE RUPATAL IF YOU HAVE, OR HAVE HAD LIVER OR KIDNEY DISEASE. DO NOT TAKE RUPATAL WITH GRAPEFRUIT JUICE, AS THIS MAY INCREASE THE LEVEL OF RUPATAL IN YOUR BODY. THERE IS CURRENTLY NOT ENOUGH INFORMATION AVAILABLE TO RECOMMEND RUPATAL_ _FOR USE IN CHILDREN UNDER 12 YEARS OF AGE. DO NOT TAKE RUPATAL_ _AFTER THE EXPIRY DATE (EXP) PRINTED ON Pročitajte cijeli dokument
DATA SHEET RUPATAL ® _ _ _RUPATADINE (AS FUMARATE) 10 MG TABLETS _ PRESENTATION RUPATAL tablets are round, light salmon pink in colour and with no markings. Each tablet contains 10 mg of rupatadine (as fumarate). USES _ACTIONS _ Rupatadine is a non-sedating antiallergic compound which displays strong antagonist activity towards both histamine H1 receptors and Platelet- Activating Factor (PAF) receptors. PAF and histamine are known to complement and promote secretion of each other. PAF induces vasodilatation and an increase in vascular permeability, which may be responsible for the appearance of rhinorrhoea and nasal congestion. PAF may have a major role in the late phase allergic reaction. Rupatadine’s PAF antagonistic activity represents the likely mechanism behind the inhibition of eosinophil migration which has been suggested to be beneficial in the treatment of chronic urticaria. In addition, rupatadine is an antiallergic drug with other benefits such as inhibition of mast cell degranulation, neutrophil and eosinophil migration and cytokine release. Rupatadine shows high H1 receptor affinity and little or no activity on other CNS receptors. Rupatadine also has a very long side chain and little liposolubility, therefore, there is little or no crossing of the blood-brain barrier. These properties account for the observed lack of sedation. _PHARMACOKINETICS _ ABSORPTION AND BIOAVAILABILITY Rupatadine is rapidly absorbed after oral administration, with a t max of approximately 0.75 hours after intake. The mean C max was 2.6 ng/mL after a single oral dose of 10 mg and 4.6 ng/mL after a single oral dose of 20 mg. Pharmacokinetics of rupatadine was linear for a dose between 10 and 40 mg. After a dose of 10 mg/day for 7 days, the mean C max was 3.8 ng/mL. The plasma concentration followed a bi-exponential drop-off with a mean Rupatal-DS-NZ-S4-05Aug11D_25°C 1 elimination half-life of 5.9 hours. The binding Pročitajte cijeli dokument