Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Dutasteride
PCO Manufacturing Ltd.
G04CB; G04CB02
Dutasteride
0.5 milligram(s)
Capsule, soft
Product subject to prescription which may not be renewed (A)
Testosterone-5-alpha reductase inhibitors; dutasteride
Authorised
2008-06-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AVODART ® 0.5 MG SOFT CAPSULES dutasteride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or nurse. – 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Avodart is and what it is used for 2. What you need to know before you take Avodart 3. How to take Avodart 4. Possible side effects 5. How to store Avodart 6. Contents of the pack and other information 1. WHAT AVODART IS AND WHAT IT IS USED FOR AVODART IS USED TO TREAT MEN WITH AN ENLARGED PROSTATE (_benign prostatic hyperplasia_) – a non-cancerous growth of the prostate gland, caused by producing too much of a hormone called dihydrotestosterone. The active ingredient is dutasteride. It belongs to a group of medicines called 5-alpha reductase inhibitors. As the prostate grows, it can lead to urinary problems, such as difficulty in passing urine and a need to go to the toilet frequently. It can also cause the flow of the urine to be slower and less forceful. If left untreated, there is a risk that your urine flow will be completely blocked (_acute urinary retention_). This requires immediate medical treatment. In some situations surgery is necessary to remove or reduce the size of the prostate gland. Avodart lowers the production of dihydrotestosterone, which helps to shrink the prostate and relieve the symptoms. This will reduce the risk of acute urinary retention and the need for surgery. Avodart may also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate). 2. WHAT YOU NEED TO KNOW BEFOR Izlasiet visu dokumentu
Health Products Regulatory Authority 08 June 2022 CRN00CZ1Q Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Avodart 0.5mg soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.5 mg dutasteride. Excipient(s) with known effect Each capsule contains lecithin (which may contain soya oil). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft. _Product imported from Greece, France, Spain, Italy and Bulgaria:_ The capsules are opaque, yellow, oblong soft gelatin capsules marked with 'GX CE2' on one side in red ink. 4 CLINICAL PARTICULARS As per PA1077/104/001 5 PHARMACOLOGICAL PROPERTIES As per PA1077/104/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Capsule contents:_ mono- and diglycerides of caprylic/capric acid butylhydroxytoluene (E321). _Capsule shell:_ gelatin glycerol titanium dioxide (E171) iron oxide yellow (E172) triglycerides, medium chain lecithin (may contain soya oil). Red printing ink containing iron oxide red (E172) as the colourant, polyvinyl acetate phthalate, propylene glycol and Macrogol 400. 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 08 June 2022 CRN00CZ1Q Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs containing 30 soft capsules 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING Dutasteride is absorbed through the skin, therefore contact with leaking capsules must be avoided. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water (see section 4.4). Any unused product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Izlasiet visu dokumentu