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Tamsulosin hydrochloride oral modified release


Oral formulations of tamsulosin hydrochloride.

Drugs List

  • CONTIFLO XL 400microgram capsules
  • COSITAM XL 400microgram prolonged release tablet
  • FARAMSIL 400microgram prolonged release tablet
  • FARAMSIL 400microgram prolonged release tablet
  • FLOMAX RELIEF MR 400microgram modified release capsules
  • FLOMAXTRA XL 400microgram modified release tablet
  • OMSULA 400microgram modified release capsules
  • PAMSVAX XL 400microgram capsules
  • TABPHYN MR 400microgram capsules
  • TAMFREX XL 400microgram modified release capsules
  • tamsulosin 400microgram modified release capsules
  • tamsulosin 400microgram modified release tablet
  • TAMSUMAC 400microgram prolonged release capsules
  • Therapeutic Indications


    Benign prostatic hyperplasia

    Treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).

    Unlicensed Uses

    Dysfunctional voiding of urine

    Treatment of dysfunctional voiding in children.



    400 micrograms once daily.

    The 'Pharmacy' product is licensed for men aged 45 to 75.


    Dysfunctional voiding (unlicensed)
    Children aged 12 to 18 years
    400 micrograms once daily.

    Additional Dosage Information

    Tamsulosin hydrochloride should not be used in combination with strong inhibitors of CPY3A4 in patients with poor metaboliser CYP2D6 phenotype.


    Micturition syncope
    History of postural hypotension
    Peri-operative period in ocular surgery
    Severe hepatic impairment

    Precautions and Warnings

    Glucose-galactose malabsorption syndrome
    Renal impairment - creatinine clearance below 10ml/minute

    Advise ability to drive/operate machinery may be affected by side effects
    Advise hypotension/syncope may affect ability to drive/operate machinery
    Not all available brands are licensed for all age groups
    Some brands contain Carmoisine (E122) - can trigger allergic reactions
    Some brands contain Quinoline Yellow (E104) : May cause allergic reactions
    Some formulations contain lactose
    Some formulations contain Ponceau 4R (E124)-may cause allergic reactions
    Some formulations contain sunset yellow (E110); may cause allergic reaction
    Perform digital rectal examination & PSA prior to and following treatment
    Advise patient to sit or lie down at first signs of orthostatic hypotension
    Intraoperative Floppy Iris Syndrome has been reported in cataract surgery
    Intraoperative Floppy Iris Syndrome has been reported in glaucoma surgery
    Discontinue 1 to 2 weeks prior to cataract surgery
    Discontinue 1 to 2 weeks prior to glaucoma surgery
    Discontinue if angioedema occurs
    May have additive effects with antihypertensives
    Advise patient grapefruit products may increase plasma level

    Patients undergoing cataract or glaucoma surgery who are taking tamsulosin hydrochloride or have received this drug previously may develop Intraoperative Floppy Iris Syndrome (IFIS), which is a variant of small pupil syndrome. IFIS may cause complications during surgery. Tamsulosin therapy should not be initiated in patients who are scheduled to undergo ocular surgery.
    During the pre-operative assessment prior to ocular surgery, surgeons must ascertain whether the patient has ever received tamsulosin hydrochloride. If they have, appropriate measures should be in place to manage any occurrence of IFIS during the procedure.

    Additional warnings for the 'Pharmacy' product

    Tamsulosin is not suitable for self-medication in men with the following conditions:

    Postural hypotension
    Cardiac disease
    Renal impairment
    Hepatic impairment
    Uncontrolled diabetes
    History of prostate surgery
    Urinary incontinence
    Symptoms suggestive of urinary tract infection (dysuria, haematuria, cloudy urine, fever) or urinary tract infection in the last 3 months.

    Tamsulosin should not be self-prescribed by men where symptoms of BPH have been present for less than 3 months.

    Pregnancy and Lactation


    Not indicated for use in women.


    Not indicated for use in women.


    Advise patients that capsules and tablets should be swallowed whole (not chewed, crushed or broken).

    For the 'Pharmacy' product advise patients that if symptoms have not improved within 14 days of starting treatment, or have become worse, the patient should stop treatment and consult a doctor. Advise the patient to see a doctor within 6 weeks of starting treatment to assess for symptoms of BPH. Every 12 months patients should be advised to consult a doctor for a clinical review.

    Advise patient grapefruit products may increase plasma levels of tamsulosin.

    Patients should be aware that dizziness, drowsiness, blurred vision and syncope can occur which may effect the ability to drive or operate machinery.

    Side Effects

    Atrial fibrillation
    Blurred vision
    Dry mouth
    Ejaculation disorders
    Erythema multiforme
    Exfoliative dermatitis
    Failure of ejaculation
    Hypersensitivity reactions
    Intraoperative floppy iris syndrome
    Postural hypotension
    Retrograde ejaculation
    Stevens-Johnson syndrome
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: January 2020

    Reference Sources

    Summary of Product Characteristics: Contiflo XL 400 microgram prolonged-release capsules. Ranbaxy (UK) Ltd. Revised October 2019.

    Summary of Product Characteristics: Cositam XL 400 microgram prolonged-release tablets. Consilient Health Ltd. Revised December 2013.

    Summary of Product Characteristics: Faramsil 400 microgram prolonged-release tablets. Sandoz Ltd. Revised December 2017.

    Summary of Product Characteristics: Flectone XL 400 microgram prolonged release tablets. Teva UK Ltd. Revised March 2014.

    Summary of Product Characteristics: Flomax Relief MR. Sanofi. Revised July 2018.

    Summary of Product Characteristics: Flomaxtra XL 400 micrograms film-coated prolonged release tablet. Astellas Pharma Ltd. Revised November 2019.

    Summary of Product Characteristics: Losinate MR 400 microgram modified-release capsules. Synthon BV. Revised September 2015.

    Summary of Product Characteristics: Omsula 0.4mg prolonged-release capsules, hard. Gedeon Richter (UK) Ltd. Revised January 2021.

    Summary of Product Characteristics: Pamsvax XL 400 micrograms capsules. Accord-UK Ltd. November 2019.

    Summary of Product Characteristics: Pinexel PR 400 micrograms prolonged-release hard capsules. Wockhardt UK Ltd. Revised January 2017.

    Summary of Product Characteristics: Prosurin XL 400 micrograms capsules. Generics UK T/A Mylan. Revised May 2016.

    Summary of Product Characteristics: Tabphyn MR 400 microgram. Genus Pharmaceuticals Ltd. Revised January 2015.

    Summary of Product Characteristics: Tamfrex XL 400 microgram capsules. Aurobindo Pharma-Milpharm Ltd. Revised February 2019.

    Summary of Product Characteristics: Tamsumac 0.4mg prolonged release capsules, hard. Macleods Pharma UK Limited. Revised June 2016.

    NICE Evidence Services Available at: Last accessed: 16 March 2021

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