البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Itraconazole
PCO Manufacturing Ltd.
J02AC; J02AC02
Itraconazole
100 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
Triazole derivatives; itraconazole
Authorised
2014-08-22
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER SPORANOX ® 100 MG CAPSULES itraconazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sporanox capsules are and what they are used for 2. What you need to know before you use Sporanox capsules 3. How to use Sporanox capsules 4. Possible side effects 5. How to store Sporanox capsules 6. Contents of the pack and other information 1. WHAT SPORANOX CAPSULES ARE AND WHAT THEY ARE USED FOR The name of your medicine is Sporanox 100 mg capsules. It is called ‘Sporanox capsules’ in this leaflet. Sporanox capsules contain a medicine called itraconazole. This belongs to a group of medicines called ‘antifungals’. Sporanox capsules are used in adults for infections caused by fungi or yeasts. They are used for: • Infections of the mouth or vagina causing ‘thrush’ • Skin infections • Infections affecting other parts of the body Patches of skin may take a few weeks to completely clear up after you have finished your treatment with Sporanox capsules. Finger and toe nails may take several months to completely clear up. This is because your skin or nail will only look normal after new skin or nail has grown, even though the medicine has killed the fungus that caused the infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX CAPSULES DO NOT USE SPORANOX CAPSULES: • IF YOU ARE ALLERGIC (hypersensitive) to any of the ingredients in SPORANOX CAPSULES (listed in section 6) • IF YOU ARE PREGNANT, THINK YOU MIGHT BE PREGNANT OR COULD BECO اقرأ الوثيقة كاملة
Health Products Regulatory Authority 30 January 2024 CRN00F1JC Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sporanox 100 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains itraconazole 100 mg. Excipient(s) with known effect: sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard _Product imported from Greece and Poland:_ Capsule (size 0): opaque blue cap and pink transparent body containing coated beads. 4 CLINICAL PARTICULARS As per PA22612/012/002 5 PHARMACOLOGICAL PROPERTIES As per PA22612/012/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Product imported from Greece:_ _ _ Sugar spheres Hypromellose Macrogol _Capsule shell:_ Gelatin Titanium dioxide (E171) Indigotin disulphonate sodium (E132) Erythrosine (E127) _Product imported from Poland:_ Sugar spheres (consisting of corn starch, hydrolyzed starch syrup and sucrose) Hypromellose Macrogol _Capsule shell:_ Gelatin Titanium dioxide (E171) Indigotin disulphonate sodium salt (E 132) Erythrosine sodium (E 127) Health Products Regulatory Authority 30 January 2024 CRN00F1JC Page 2 of 2 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 °C. Store in the original package in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Blister strips each containing 5 or 14 capsules in an outer cardboard carton. Pack sizes: 14, 15 or 28 capsules. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/400/001 9 DATE OF FIRST AUTHORISATION/RENEWAL اقرأ الوثيقة كاملة