Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
ALPROSTADIL
Meda Health Sales Ireland Limited
G04BE01
ALPROSTADIL
250 Microgram
Stick/Urethral
Product subject to prescription which may not be renewed (A)
Drugs used in erectile dysfunction
Transfer Pending
2006-07-14
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MUSE ® 125, 250, 500 OR 1000 MICROGRAMS URETHRAL STICK (Alprostadil) 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, 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 MUSE is and what it is used for 2. What you need to know before you use MUSE 3. How to use MUSE 4. Possible side effects 5. How to store MUSE 6. Contents of the pack and other information 7. Commonly asked questions about MUSE 8. Helpful tips for improving your erection MUSE contains alprostadil in an applicator. Alprostadil is identical to a substance called prostaglandin E1 (PGE1) which occurs naturally in the body. The applicator is used to deliver alprostadil into your penis. It acts to widen blood vessels and increases blood flow. MUSE is used: • To help you get and maintain an erection when you have insufficient PGE 1. • By your doctor to test whether you suffer from impotence. MUSE is not for use by women and children. Do not use MUSE: • If you are allergic to alprostadil or any of the other ingredients of MUSE. These are listed in section 6. • If your penis is deformed, for example it is bent or severely curved. • If you have a disease of your penis, such as Peyronie's disease. • If you have any inflammation in your penis or urethra (pathway for urine to pass out of the penis). • If you have sickle cell anaemia or traits (abnormal red blood cells). • If you have leukaemia (cancer of blood cells). • If Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MUSE 250 microgram urethral stick. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each urethral stick contains 250 micrograms alprostadil. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Urethral Stick. MUSE is a sterile, single-use transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in polyethylene glycol and is formed into a urethral stick (1.4 mm in diameter by 6 mm in length) which is contained in the tip of the polypropylene applicator. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of erectile dysfunction of primarily organic etiology. Adjunct to other tests in the diagnosis and management of erectile dysfunction. MUSE is indicated in adults aged 18 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION USE IN ADULTS _Treatment of erectile dysfunction_ _Initiation of therapy:_ a medical professional should instruct each patient on the correct use of MUSE. The recommended starting dose is 500 micrograms. Dosage may be increased in a stepwise manner (to 1000 micrograms), or decreased (to 250 or 125 micrograms) under medical supervision until the patient achieves a satisfactory response. After an assessment of the patient's skill and competence with the procedure, the chosen dose may then be prescribed for home use. It is important for the patient to urinate before administration since a moist urethra makes administration of MUSE easier and is essential to dissolve the drug. To administer MUSE, remove the protective cover from the MUSE applicator, stretch the penis upward to its full length, and insert the applicator stem into the urethra. Depress the applicator button to release the medication from the applicator and remove the applicator from the urethra, (rocking the applicator gently prior to removal will ensure that the medication is separated from the applicator stem). Roll the penis between the hands for at least 10 seconds to ensure that the medication is Baca dokumen lengkapnya