Flomaxtra XL

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Flomaxtra XL on Prescriptsy

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Flomaxtra XL is a prescription-only medicine containing tamsulosin hydrochloride 0.4 mg in a modified-release formulation.

It is used to treat the urinary symptoms associated with benign prostatic hyperplasia (BPH), commonly known as an enlarged prostate.

Tamsulosin is a selective alpha-1A adrenoceptor blocker that relaxes the smooth muscle in the prostate gland and bladder neck, improving urine flow and reducing the bothersome lower urinary tract symptoms (LUTS) that affect millions of men in the United Kingdom.

Flomaxtra XL is manufactured by Astellas Pharma and is also available as generic tamsulosin MR capsules.

Benign prostatic hyperplasia is one of the most common conditions affecting older men.

The prostate gland naturally enlarges with age under the influence of dihydrotestosterone (DHT), and by the age of 60, more than half of men have histological evidence of BPH.

By age 80, up to 80% of men are affected.

As the prostate grows, it compresses the urethra (the tube through which urine passes), causing a range of urinary symptoms collectively known as lower urinary tract symptoms.

These include hesitancy (difficulty starting to urinate), a weak or intermittent urine stream, straining, terminal dribbling, incomplete bladder emptying, increased frequency (including nocturia, the need to urinate at night), urgency, and urge incontinence.

LUTS can significantly impair quality of life, disrupt sleep, and cause anxiety and social embarrassment.

This page provides a comprehensive clinical overview of Flomaxtra XL, including how it works, dosing, side effects, safety warnings, and how to obtain a prescription in the UK.

Important safety information about Flomaxtra XL

• Flomaxtra XL is a prescription-only medicine (POM) for adult males only.
• Swallow the capsule whole after the same meal each day. Do not crush, chew, or open it.
• Tell your ophthalmologist you take or have taken tamsulosin before any cataract surgery.
• Rise slowly from sitting or lying positions, as dizziness may occur, especially when starting treatment.
• Flomaxtra XL treats urinary symptoms only; it does not shrink the prostate or prevent prostate cancer.

Understanding benign prostatic hyperplasia

The prostate is a walnut-sized gland located below the bladder and surrounding the upper portion of the urethra.

Its primary function is to produce fluid that nourishes and transports sperm.

From around the age of 40, the prostate begins to enlarge in most men, a process driven by the conversion of testosterone to dihydrotestosterone (DHT) by the enzyme 5-alpha reductase within prostate tissue.

This growth is not cancerous and is termed benign prostatic hyperplasia.

BPH causes urinary symptoms through two mechanisms. The static component arises from the physical bulk of the enlarged gland compressing the urethra.

The dynamic component results from increased smooth muscle tone in the prostate and bladder neck, mediated by alpha-1A adrenoceptors.

Tamsulosin and other alpha-1 blockers target the dynamic component, while 5-alpha reductase inhibitors (finasteride, dutasteride) address the static component by shrinking the prostate over several months.

In some men, combination therapy with both drug classes is used.

NICE guideline CG97 (lower urinary tract symptoms in men) recommends alpha-1 blockers as first-line pharmacological treatment for moderate to severe LUTS secondary to BPH.

How Flomaxtra XL works: mechanism of action

Alpha-1 adrenoceptors are G-protein-coupled receptors present on smooth muscle cells throughout the body.

Three subtypes exist: alpha-1A (predominant in prostate, prostatic urethra, and bladder neck), alpha-1B (predominant in vascular smooth muscle), and alpha-1D (found in the detrusor muscle, spinal cord, and sacral parasympathetic nerves).

The smooth muscle tone in the prostate and bladder neck is maintained by noradrenaline acting on alpha-1A receptors.

Tamsulosin has a 10 to 20-fold greater affinity for alpha-1A receptors than for alpha-1B receptors.

By selectively blocking alpha-1A receptors, it relaxes the smooth muscle in the prostate, prostatic capsule, prostatic urethra, and bladder neck, reducing the dynamic component of urethral obstruction and improving urine flow.

Because it has relatively little effect on alpha-1B receptors in blood vessels, tamsulosin causes less vascular smooth muscle relaxation and therefore less orthostatic hypotension than non-selective alpha-1 blockers such as doxazosin.

The modified-release (XL) formulation of Flomaxtra uses an osmotic push-pull system (OROS) to deliver tamsulosin at a controlled rate over 24 hours.

This produces a smooth plasma concentration profile with lower peak levels than immediate-release formulations, further reducing the risk of first-dose hypotension and allowing once-daily dosing without dose titration.

Clinical evidence supporting tamsulosin

Tamsulosin has been extensively studied in large randomised controlled trials.

Pivotal phase III trials demonstrated statistically significant improvements in the International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), and quality of life compared with placebo.

Improvements in symptom scores were apparent within 1 to 2 weeks and sustained over years of follow-up.

The CombAT (Combination of Avodart and Tamsulosin) trial compared tamsulosin alone, dutasteride alone, and the combination in men with moderate to severe LUTS and prostatic enlargement.

The combination provided greater symptom improvement and reduced the risk of acute urinary retention and BPH-related surgery compared with either monotherapy.

This evidence supports the use of combination therapy in men with large prostates (over 30 to 40 mL) or high PSA levels indicating significant prostatic enlargement.

The MTOPS (Medical Therapy of Prostatic Symptoms) trial similarly showed that combining an alpha-1 blocker with finasteride reduced the risk of overall clinical progression of BPH compared with either drug alone.

Tamsulosin is the most widely prescribed alpha-1 blocker for BPH worldwide and has an established long-term safety profile.

UK prescribing guidance

NICE CG97 (lower urinary tract symptoms in men, 2010, updated 2015) recommends that men with moderate to severe LUTS affecting quality of life should be offered an alpha-1 blocker as first-line drug treatment.

Tamsulosin, alfuzosin, and doxazosin are all suitable options. Tamsulosin and alfuzosin are preferred in patients taking antihypertensive therapy, as they cause less orthostatic hypotension than doxazosin.

For men with prostates estimated to be larger than 30 mL (or PSA above 1.4 ng/mL as a surrogate marker of prostate volume), a 5-alpha reductase inhibitor (finasteride or dutasteride) may be added to reduce the risk of disease progression.

Referral to urology is recommended for men with recurrent urinary retention, renal impairment due to BPH, suspected bladder stones, haematuria, or symptoms not responding to medical therapy.

Surgical options include transurethral resection of the prostate (TURP), laser prostatectomy, and minimally invasive techniques.

The BNF lists tamsulosin MR 0.4 mg once daily as the standard dose with no titration required.

This fixed-dose approach, combined with the low incidence of first-dose hypotension, makes tamsulosin one of the most convenient alpha-1 blockers to initiate in primary care.

Tamsulosin compared with other alpha-1 blockers

Several alpha-1 blockers are available for BPH in the UK.

Doxazosin is non-selective, blocking all three alpha-1 receptor subtypes, and requires dose titration from 1 mg to 8 mg.

It is effective but carries a higher risk of orthostatic hypotension and is also licensed for hypertension.

Alfuzosin MR 10 mg has intermediate uroselective properties and is given once daily.

Tamsulosin 0.4 mg MR is the most uroselective option, with the lowest incidence of cardiovascular side effects.

Silodosin 8 mg is the newest and most alpha-1A-selective agent but has a higher incidence of retrograde ejaculation (approximately 28%).

The choice between these agents depends on the patient's comorbidities, concurrent medications, tolerance of side effects, and preference regarding ejaculatory function.

Dosage and administration

The dose of Flomaxtra XL is one capsule (0.4 mg) taken once daily, approximately 30 minutes after the same meal each day.

Taking it after food ensures consistent absorption from the modified-release formulation. Swallow the capsule whole with water; do not crush, chew, break, or open it.

No dose titration is required. No dose adjustment is needed for elderly patients or those with mild to moderate renal or hepatic impairment.

Tamsulosin is not recommended in severe hepatic impairment.

Treatment with Flomaxtra XL is usually long-term. BPH is a progressive condition, and stopping tamsulosin will typically result in the return of urinary symptoms.

Your GP will review your treatment periodically to assess symptom control and to determine whether additional treatments (such as a 5-alpha reductase inhibitor) are warranted.

Side effects of Flomaxtra XL

Common side effects

Dizziness is the most frequently reported side effect and is usually mild and transient.

It results from alpha-1 adrenoceptor blockade in blood vessels and is most likely during the first few days of treatment.

Rise slowly from sitting or lying positions to reduce the risk. Abnormal ejaculation (most commonly retrograde ejaculation) occurs in up to 1 in 10 men.

It is not harmful and resolves when the medication is stopped. Headache, rhinitis (nasal congestion or stuffiness), and gastrointestinal symptoms (nausea, diarrhoea, constipation) may also occur.

Uncommon and rare side effects

Postural hypotension may cause light-headedness or, rarely, syncope (fainting). Palpitations, tachycardia, and asthenia (general weakness) are uncommon. Skin reactions including rash, pruritus, and urticaria occur infrequently.

Intraoperative floppy iris syndrome is a rare but clinically important effect relevant to cataract surgery.

Very rarely, priapism (a painful erection lasting more than 4 hours) has been reported; this requires emergency medical treatment. Angioedema and Stevens-Johnson syndrome are extremely rare allergic reactions.

When to seek urgent help

Seek emergency medical attention (call 999 or go to A&E) if you experience a sudden inability to pass urine (acute urinary retention), a persistent painful erection lasting more than 4 hours, severe allergic reaction (swelling of face, lips, tongue, or throat; difficulty breathing), or fainting.

Call NHS 111 if you experience persistent dizziness, significant worsening of urinary symptoms, or troublesome side effects.

Report suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Before starting treatment

A proper clinical assessment must be performed before starting tamsulosin to confirm that symptoms are due to BPH and to exclude prostate cancer, urinary tract infection, neurogenic bladder, bladder stones, and urethral stricture.

This typically involves a symptom questionnaire (IPSS), digital rectal examination, urine dipstick, PSA test, flow rate measurement, and sometimes a post-void residual volume ultrasound.

Tamsulosin treats symptoms only and does not reduce the risk of prostate cancer.

Cataract surgery

Tamsulosin is the alpha-1 blocker most strongly associated with intraoperative floppy iris syndrome.

Patients must inform their ophthalmologist if they are currently taking or have ever taken tamsulosin, even if it was discontinued years ago.

The surgeon can take precautions, such as pre-operative atropine drops, iris retractors, or modifying the surgical technique, to minimise the risk of iris prolapse and other complications.

Ideally, tamsulosin should not be initiated in patients with planned cataract surgery.

Drug interactions

Potent CYP3A4 inhibitors (ketoconazole) and CYP2D6 inhibitors (paroxetine) increase tamsulosin plasma levels; caution is required.

Do not combine tamsulosin with other alpha-1 blockers, as this leads to additive hypotension.

PDE5 inhibitors (sildenafil, tadalafil, vardenafil) may potentiate the hypotensive effect; advise patients to be aware of symptoms of low blood pressure.

Diuretics and other antihypertensives may enhance orthostatic effects; blood pressure monitoring is recommended when initiating combination treatment.

Special populations

Flomaxtra XL is for adult males only. It is not licensed or indicated for women or children. In the context of renal stones, off-label use in both sexes has been reported, but this falls outside the licensed indication.

How to get Flomaxtra XL in the UK

Flomaxtra XL is a prescription-only medicine.

Your GP can prescribe it following a clinical assessment of your urinary symptoms, including digital rectal examination, PSA test, and urine analysis to exclude infection or haematuria.

Authorised online prescribers registered with the General Pharmaceutical Council (GPhC) can also prescribe tamsulosin after a suitable clinical consultation.

The NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Generic tamsulosin MR capsules are available at lower cost and are equally effective.

Living with BPH: lifestyle advice alongside tamsulosin

Several lifestyle measures can help manage BPH symptoms alongside medication. Reducing caffeine and alcohol intake, particularly in the evening, can decrease urinary frequency and nocturia.

Practising bladder training (gradually increasing the time between voiding) may improve bladder capacity.

Avoiding excessive fluid intake before bedtime, double voiding (waiting a moment after finishing urination and then trying again), and avoiding constipation (which can worsen urinary symptoms by pressing on the prostate) are all helpful strategies.

If nocturia significantly disrupts sleep, your GP may consider desmopressin or review your fluid intake patterns.

Regular prostate reviews, including repeat PSA testing and symptom assessment, are recommended to monitor for disease progression.

Sources

• Flomaxtra XL 0.4 mg, Summary of Product Characteristics (EMC)
• Tamsulosin hydrochloride, British National Formulary (BNF)
• NICE CG97: Lower urinary tract symptoms in men: management
• Benign prostate enlargement, NHS
• MHRA Yellow Card Scheme