FLOMAX RELIEF MR CAPSULES 28 CAPS

Flomax Relief MR
Tamsulosin hydrochloride 400 microgram
Pack Quantity: 28 Caps

Flomax Relief MR is an over-the-counter, once-daily treatment for the lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in men between 45 - 75 years

For more information

Flomax Consumer Careline = 0800 731 9070
www.flomaxrelief.co.uk
www.1in4men.com

Therapeutic indications
Treatment of functional symptoms of benign prostatic hyperplasia (BPH).

Posology and method of administration
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.

Contraindications
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.

Pregnancy and lactation
Not applicable as Flomax Relief is intended for male patients only

Effects on ability to drive and use machines
No data is available on whether Flomax Relief adversely affects the ability to drive or operate machines. However, in this respect patients should be aware of the fact that drowsiness, blurred vision, dizziness and syncope can occur.

Adverse Effects include:
Common: dizziness.
Uncommon: headache, palpitations, postural hypotension, rhinitis, constipation, diarrhoea, nausea, vomiting, rash, pruritus, urticaria, abnormal ejaculation, asthenia.
Rare: syncope, angioedema.
Very rare: priapism. Drowsiness, blurred vision, dry mouth or oedema can occur. IFIS (intraoperative floppy iris syndrome) has occurred in some patients during cataract surgery.