País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
ITRACONAZOLE
LTT Pharma Limited
J02AC02
ITRACONAZOLE
100 Milligram
Capsule
Product subject to prescription which may be renewed (B)
itraconazole
Authorised
2012-07-06
SPORANOX 100MG 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: What Sporanox capsules are and what they are used for What you need to know before you use Sporanox capsules How to use Sporanox capsules Possible side effects How to store Sporanox capsules Contents of the pack and other information 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 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. WHAT YOU NEED TO KNOW BEFORE YOU USE SPORANOX CAPSULES DO NOT USE SPORANOX CAPSULES IF: * You are allergic to itraconazole or any of the other ingredients of this medicine (listed in section 6) * You are pregnant or could become pregnant unless your doctor has told you to (see ‘Pregnancy and breast-feeding’ below) * You have a serious heart condit Llegiu el document complet
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: contains sucrose. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Capsule, hard. _Product imported from the UK:_ Capsules (size 0): opaque blue cap and pink transparent body containing coated beads. 4 CLINICAL PARTICULARS As per PA0748/009/002 5 PHARMACOLOGICAL PROPERTIES As per PA0748/009/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sugar spheres Hypromellose 2910 5mPa.s Macrogol 20 000 _Capsule shell_ Gelatin Titanium dioxide (E171) Indigotin disulphonate sodium (E132) Erythrosine (E127) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store the capsules in their carton to protect from light. Do not store above 30°C HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 25/11/2016_ _CRN 2185007_ _page number: 1_ 6.5 NATURE AND CONTENTS OF CONTAINER Tristar Blister-Plastic foil consisting of three layers. Polyvinylchloride on the outside, low density polyethylene in the middle, and polyvinylidene chloride on the inside. Aluminium foil (thickness 20µm) coated on the inner side with colourless heatseal lacquer PVC mixed polymers with acrylates 6 g/m2. or: PVC blister consisting of – Polyvinylchloride 'genotherm' glass clear, thickness 250 µm; Aluminium foil (thickness 20µm) coated on the inner side with a colourless heat-seal Lacquer: PVC mixed polymers with acrylates, 6g/m². Pack size Llegiu el document complet