Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Fexofenadine hydrochloride
SYNERRV SDN BHD
Fexofenadine hydrochloride
5 x 10 Tablets; 1 x 10 Tablets; 3 X 10 Tablets
IND-SWIFT LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SYNERRV FEXOFENADINE 120MG (FEXOFENADINE HYDROCHLORIDE 120MG TABLETS USP) SYNERRV FEXOFENADINE 180MG (FEXOFENADINE HYDROCHLORIDE 180MG TABLETS USP) Fexofenadine hydrochloride (120mg & 180mg) 1 WHAT IS IN THIS LEAFLET 1. What SYNERRV FEXOFENADINE is used for 2. How SYNERRV FEXOFENADINE works 3. Before you use SYNERRV FEXOFENADINE 4. How to use SYNERRV FEXOFENADINE 5. While you are using it 6. Side effects 7. Storage and Disposal of SYNERRV FEXOFENADINE 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS SYNERRV FEXOFENADINE USED FOR SYNERRV FEXOFENADINE (120mg & 180mg) is used in adult and adolescents of 12 years and older to relieve the symptoms that occur with hay fever (seasonal allergic rhinitis) such as sneezing, itchy, watery or red eyes, and itchy or runny nose. Additionally, SYNERRV FEXOFENADINE (180mg only) is also used to relieve the symptoms of long-term hives (chronic idiopathic urticaria – a raised, itchy rash of unknown cause) HOW SYNERRV FEXOFENADINE WORKS SYNERRV FEXOFENADINE contains Fexofenadine hydrochloride, which is an antihistamine. It works by blocking the action of histamine in order to treat allergy symptoms. BEFORE YOU USE SYNERRV FEXOFENADINE _-When you must not use it _ Do not take SYNERRV FEXOFENADINE if you are allergic (hypersensitive) to Fexofenadine or any of the other ingredients of this medicine listed at the end of this leaflet. _-Before you start to use it _ Check with your doctor before taking SYNERRV FEXOFENADINE if: • You have problems with your liver or kidneys. • You are an elderly. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. _Pregnancy and breastfeeding: _ Tell your doctor before taking this medicine if you: • Are pregnant or plan to get pregnant. • Are breastfeeding or plan to start breastfeeding. Fexofenadine hydrochloride should be used during pregnancy and breastfeeding o Lue koko asiakirja
DIMENSION: 130 X 250MM PAPER SHOULD BE MAPLITHO (60 GSM) BLACK COMPOSITION: Synerrv Fexofenadine 120 (Fexofenadine Hydrochloride 120 mg Tablets USP) Each film coated tablet contains: Fexofenadine hydrochloride USP … 120 mg Excipients: Lactose spray dried, Pregelatinized starch, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate, Povidone and Opadry pink 03B54819 Colours: Iron Oxide Red, Iron Oxide Yellow and Titanium Dioxide Synerrv Fexofenadine 180 (Fexofenadine Hydrochloride 180 mg Tablets USP) Each film coated tablet contains: Fexofenadine hydrochloride USP … 180 mg Excipients: Lactose spray dried, Pregelatinized starch, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate, Povidone and Opadry pink 03B54819 Colours: Iron Oxide Red, Iron Oxide Yellow and Titanium Dioxide DESCRIPTION: _For 120mg: _Peach coloured, oblong shaped, biconvex film coated tablets with both sides plain. The tablets are approximately 15.5 mm in length and 7 mm in breadth. _For 180mg:_ Peach coloured, oblong shaped, biconvex film coated tablets with both sides plain. The tablets are approximately 18 mm in length and 8 mm in breadth. DOSAGE FORM: Film Coated Tablets PRESENTATION: 10's, 30's and 50's Tablets (1 x 10's, 3 x 10's & 5 x 10's Alu/PVC/PVdC Blister Strips) PROPERTIES: Fexofenadine, a pharmacologically active metabolite of Terfenadine, is a non-sedating antihistamine with selective peripheral H1 receptor antagonist with the chemical name (±)-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-, -dimethyl benzeneacetic acid hydrochloride. The molecular formula is C H NO HCL and its molecular weight is 538.13. 32 39 4 STRUCTURAL FORMULA: CLINICAL PHARMACOLOGY: PHARMACODYNAMICS: Pharmacotherapeutic group: Antihistamines for systemic use, ATC Code: R06AX26 Mechanism of Action Fexofenadine hydrochloride is a non-sedating H antihistamine. Fexofenadine is a pharmacologically active metabolite of Terfenadine. 1 Efficacy and Safety Single and twice daily doses of Fexofenadine hydrochlori Lue koko asiakirja