Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
ACRIVASTINE
McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom
R06AX18
ACRIVASTINE 8 mg
CAPSULE
ACRIVASTINE 8 mg
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Withdrawn
2006-08-10
lef t margin 14 mm right margin 12 mm 6 mm 6 mm spot = 12 x 2 centered in the margin of 14 mm Distance between cutted line/middel of the spot = 83.6 MM IIFF YYO OU U AARREE P PRREEGGN NAAN NTT O ORR B BRREEAASSTT--FFEEEED DIIN NGG I Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding. SSP PEECCIIAALL W WAARRN NIIN NGGSS AAB BO OU UTT TTH HIISS M MEED DIICCIIN NEE I Do not drink GGRRAAP PEEFFRRU UIITT JJU UIICCEE while taking Benadryl Allergy Relief. I In most people this product does not cause drowsiness. However, there are rare exceptions and you should take care when you use this product for the first time. If this product makes you feel drowsy, do not drive or operate machinery. I As with all antihistamines, it is advisable to avoid excessive alcohol consumption when taking this medicine. SSO OM MEE O OFF TTH HEE IIN NGGRREED DIIEEN NTTSS CCAAN N CCAAU USSEE P PRRO OB BLLEEM MSS I This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3 3 H HO OW W TTO O TTAAKKEE TTH HIISS M MEED DIICCIIN NEE C CH HEECCKK TTH HEE TTAAB BLLEE O OVVEERR TTH HEE P PAAGGEE TTO O SSEEEE H HO OW W M MU UCCH H M MEED DIICCIIN NEE TTO O TTAAKKEE.. I For oral use only. I Do not take more than the stated dose shown in the table. C CH HIILLD DRREEN N U UN ND DEERR 1 12 2 YYEEAARRSS O OLLD D This medicine is not recommended for children aged under 12 years. I This medicine is used to relieve the symptoms of hay fever and other allergic conditions such as pet allergies, dust allergies and skin reactions. I This medicine is for use by adults and children aged 12 – 65 years. I D DO O N NO OTT TTAAKKEE TTH HIISS M MEED DIICCIIN NEE:: I There are some people who should not use this medicine. To find out if you are one of them _See Section 2_ c I If Διαβάστε το πλήρες έγγραφο
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1. NAME OF THE MEDICINAL PRODUCT Benadryl Allergy Relief 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Benadryl Allergy Relief contains 8 mg Acrivastine per capsule. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Benadryl Allergy Relief is indicated for the symptomatic relief of allergic rhinitis, including hay fever. Benadryl Allergy Relief is also indicated for chronic idiopathic urticaria. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS AND CHILDREN 12 -65 YEARS: One 8 mg capsule, as necessary up to three times a day. USE IN THE ELDERLY (OVER 65 YEARS) As yet, no specific studies have been carried out in the elderly. Until further information is available, Benadryl Allergy Relief should not be given to elderly patients. METHOD OF ADMINISTRATION For oral use. 4.3. CONTRAINDICATIONS Benadryl Allergy Relief is contraindicated in individuals with known hypersensitivity to acrivastine, triprolidine or to any of the excipients listed in section 6.1. Renal excretion is the principal route of elimination of acrivastine. Until specific studies have been carried out Benadryl Allergy Relief should not be given to patients with significant renal impairment. Page 2 of 5 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE The following statements will appear on the pack: Do not store above 30°C. Store in the original package. Keep out of the reach and sight of children. 4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION It is usual to advise patients not to undertake tasks requiring mental alertness whilst under the influence of alcohol and other CNS depressants. Concomitant administration of acrivastine may, in some individuals, produce additional impairment. There are no data to demonstrate an interaction between acrivastine and ketoconazole, erythromycin or grapefruit juice. However, due to known interactions between these compounds and other Διαβάστε το πλήρες έγγραφο