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Flomax Relief MR capsules (pack of 28) for annoying pee problems in men |
Symptomatic Benign Prostatic Hyperplasia (BPH) is a common condition in middle aged and elderly men.
One in four men over the age of 40 suffers from what you may call annoying ‘pee’ problems, ranging from a frequent urge to pee (particularly at night) to difficulty getting started. New Flomax Relief MR is the first proven treatment to be made available without prescription in pharmacy for men aged between 45 and 75 years. Flomax provides relief from lower urinary tract symptoms (LUTS) caused by an enlarged prostate, otherwise known as benign prostatic hyperplasia (BPH).
BPH is a chronic disease which is characterised by the presence of several urinary symptoms that can be related to bladder emptying (voiding or obstructive symptoms) or filling (storage or irritative symptoms).
Typical voiding symptoms are slow stream, hesitancy and intermittency. Typical storage symptoms are increased daytime frequency, nocturia and urgency.
Nocturia, i. e.awakening one or more times at night for voiding, reduces the patient's quality of sleep and has a significant negative impact on how the patient feels the next day in terms of energy level/fatigue, concentration and mood and ultimately overall well-being and quality of life.
The great majority of BPH cases can be easily treated by taking simple oral medicines, and the most common are called alpha-blockers.
These work by relaxing muscles in the prostate, relieving pressure on the urethra, thus enabling urine to flow more freely and reducing pain.
Flomax Relief is a new, over-the-counter alpha-blocker treatment for the urinary symptoms of BPH. The main ingredient of Flomax is tamsulosin an established and generally well-tolerated treatment that was previously only available on prescription. Flomax binds selectively and competitively to relax the muscles surrounding the urethra, relieving pressure and allowing urine to flow more freely.
Flomax can help within a week.
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Each capsule contains as active ingredient tamsulosin hydrochloride 400 microgram, equivalent to 367 microgram tamsulosin.
Capsule modified release, hard (capsule). Orange/olive green coded with T0.4 and the company logo.
Treatment of functional symptoms of benign prostatic hyperplasia (BPH).
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Male 45 to 75 years.
One capsule daily, to be taken after the same meal each day.
The capsule should be swallowed whole and should not be crunched or chewed as this will interfere with the modified release of the active ingredient.
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Hypersensitivity to tamsulosin hydrochloride or any other component of the product; a history of orthostatic hypotension; severe hepatic insufficiency.
Special warnings and precautions for use
As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Flomax Relief, as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared.
The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. IFIS may lead to increased procedural complications during the operation. The initiation of therapy with tamsulosin in patients for whom cataract surgery is scheduled is not recommended.
Discontinuing tamsulosin 1 – 2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established.
During pre-operative assessment, cataract surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.
Additional warnings when supplied as a non-prescription medicine:
Flomax Relief should not be given to patients receiving antihypertensive medicines with significant alpha1-adrenoceptor antagonist activity (e.g. doxazosin, indoramin, prazosin, terazosin, verapamil) without first consulting a doctor.
Flomax Relief should not be given to a man who experiences postural hypotension.
Flomax Relief should not be supplied to any man with heart, renal, or liver disease, uncontrolled diabetes, urinary incontinence, or to a man who has had prostate surgery.
Flomax Relief should not be supplied to a man whose symptoms are of less than 3 months' duration.
Flomax Relief should not be given to any man who reports dysuria, haematuria, or cloudy urine, in the past 3 months, or who is suffering from a fever that might be related to a urinary tract infection.
Flomax Relief should not be used in those planning to have eye surgery for cataract, or who have recently experienced blurred or cloudy vision that has not been examined by a GP or Optician.
If urinary symptoms have not improved within 14 days of starting treatment with Flomax Relief, or are getting worse, the patient should stop taking Flomax Relief and be referred to the doctor.
Medical review is required for the diagnosis of BPH. Patients must see their doctor within 6 weeks of starting treatment, for assessment of their symptoms and confirmation that they can continue to take Flomax Relief from their Pharmacist.
Every 12 months, patients should be advised to consult a doctor for a clinical review.
Interaction with other medicinal products and other forms of interaction
No interactions have been seen when Flomax Relief was given concomitantly with either atenolol, enalapril , nifedipine or theophylline. Concomitant cimetidine brings about a rise in plasma levels of tamsulosin, and furosemide a fall, but as levels remain within the normal range posology need not be changed.
In vitro neither diazepam nor propranolol, trichlormethiazide, chlormadinon, amitryptyline, diclofenac, glibenclamide, simvastatin, and warfarin change the free fraction of tamsulosin in human plasma. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinon.
No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug metabolising enzyme system), involving amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of tamsulosin.
There is a theoretical risk of enhanced hypotensive effect when given concurrently with drugs which may reduce blood pressure including anaesthetic agents, other alpha1-adrenoceptor antagonists.
Pharmacodynamic properties
Pharmacotherapeutic group:
Alpha1-adrenoceptor antagonist.
Preparations for the exclusive treatment of prostatic disease.
Mechanism of action:
Tamsulosin binds selectively and competitively to postsynaptic alpha1-receptors, in particular to the subtype alpha1A, which bring about relaxation of the smooth muscle of the prostate, whereby tension is reduced.
Pharmacodynamic effects:
Flomax Relief increases maximum urinary flow rate by reducing smooth muscle tension in prostate and urethra and thereby relieving obstruction.
It also improves the complex of irritative and obstructive symptoms in which bladder instability and tension of the smooth muscles of the lower urinary tract play an important role. Alpha1-blockers can reduce blood pressure by lowering peripheral resistance. No reduction in blood pressure of any clinical significance was observed during studies with Flomax Relief.
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List of excipients
Flomax Relief modified release capsules contain the following excipients:
Content of capsule:
microcrystalline cellulose
methacrylic acid-ethyl acrylate copolymer
polysorbate 80
sodium laurilsulfate
triacetin
calcium stearate
talc
Capsule shell:
hard gelatin
indigotine E132
titanium dioxide E171
yellow iron oxide E172
red iron oxide E172
Printing ink:
shellac
propylene glycol
black iron oxide E172
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