Country: New Zealand
Lingwa: Ingliż
Sors: Medsafe (Medicines Safety Authority)
Tamsulosin hydrochloride 400ug;
Seqirus (NZ) Ltd
Tamsulosin hydrochloride 400 µg
400 mcg
Modified release tablet
Active: Tamsulosin hydrochloride 400ug Excipient: Hypromellose Macrogol 7,000,000 (incl. 0.2mg butylated hydroxytoluene; 6.0mg collodial anhydrous silica) Iron oxide yellow Macrogol 8000 Magnesium stearate
Blister pack, Al/Al, 10 tablets
Prescription
Prescription
Astellas Pharma Tech Co Limited
Package - Contents - Shelf Life: Blister pack, Al/Al - 10 tablets - 3 years from date of manufacture stored at or below 25°C - Blister pack, Al/Al - 30 tablets - 3 years from date of manufacture stored at or below 25°C
2005-05-13
1 FLOMAXTRA ® PROLONGED RELEASE TABLETS tamsulosin _(TAM-SU-LO-SIN)_ CONSUMER MEDICINE INFORMATION_ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FLOMAXTRA ® . It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you having FLOMAXTRA ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FLOMAXTRA ® IS USED FOR FLOMAXTRA ® is a medicine for use by MEN only. FLOMAXTRA ® is used in men who have a medical condition called benign prostatic hyperplasia (also known as BPH). In BPH the prostate gland is bigger than normal. BPH is NOT prostate cancer. FLOMAXTRA ® belongs to a group of medicines called alpha-blockers. Your doctor has prescribed FLOMAXTRA ® for you because you have symptoms caused by an enlarged prostate gland. BPH occurs only in men. It is common in men over the age of 50 years. The prostate gland is at the outlet of your urinary bladder. Because your prostate has become bigger than it should be, it is affecting how well you are able to pass your urine. This causes some, or all of the following symptoms; they usually start gradually and increase in severity: • Urine flow is slow. • The urine stream may become a trickle, or it may stop and start. • You find a delay when you try to pass urine, and you have to strain to do so. • You feel that you cannot empty your bladder completely. • You may dribble at th Aqra d-dokument sħiħ
1 DATA SHEET FLOMAXTRA ® AUST R 115534 NAME OF MEDICINE Tamsulosin hydrochloride The chemical structure of tamsulosin hydrochloride is: CH 2 NHCH 2 CH 2 O H 2 NO 2 S CH 3 H CH 3 O CH 3 CH 2 O The chemical name is (R)-5-[2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2- methoxybenzenesulfonamide, monohydrochloride. The molecular weight is 444.98. The CAS registry number is CAS-106463-17-6 (hydrochloride). DESCRIPTION FLOMAXTRA ® is a film-coated, prolonged release tablet containing 400 µg tamsulosin hydrochloride, an α 1 - adrenoceptor blocking agent. It has a high affinity for the α 1A -receptor subtype predominantly present in the human prostate. FLOMAXTRA ® also contains macrogol 7,000,000, macrogol 8,000, magnesium stearate, butylated hydroxytoluene, colloidal silica anhydrous, hypromellose, iron oxide yellow. None of the excipients is derived from animal sources. Tamsulosin hydrochloride is sparingly soluble in water (1:85) and slightly soluble in alcohol. It is stable in an acid environment. PHARMACOLOGY The tone of the human prostate smooth muscle is maintained primarily by noradrenaline released from adrenergic nerves and stimulating post-junctional α 1 -adrenoceptors. This provides the rationale for the use of α 1 -adrenoceptor antagonists for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). PHARMACOLOGICAL ACTIONS Pharmacological studies have established that tamsulosin is a selective, potent and competitive α 1 - adrenoceptor antagonist and that it has a greater affinity for the α 1A -receptor subtype, predominantly present in the human prostate. α1-adrenoceptor antagonists generally can reduce blood pressure by lowering peripheral resistance. However, no reduction in blood pressure of any clinical significance was Aqra d-dokument sħiħ