What condition is OTC tamsulosin used for?

Tamsulosin is used for the treatment of symptoms of benign prostatic hyperplasia (BPH) in males aged 45 to 75 years.

Symptoms include: Difficulty when starting urinating, urinating for longer or more frequently, needing to do so again within a short period of time, needing to get up to urinate several times at night.

Dose: A single 400 microgram capsule should be swallowed whole after the same meal each day.

Key Points

• You can make a 2 week initial supply to patients with BPH symptoms.
• If there has been an improvement in urinary symptoms, you can make a further 4 weeks  OTC supply of tamsulosin.
• If there are contraindications or symptoms are not relieved or are getting worse after the first 2 weeks then the patient must be referred to a doctor.
• Patients must be advised to see their doctor within 6 weeks of starting treatment for assessment of their symptoms and confirmation they can continue to take OTC tamsulosin.
• Pharmacists should ensure (by asking the patient) that a clinical assessment has taken place within 6 weeks of starting  OTC tamsulosin to enable further supply. Further supply after 6 weeks can be made if the patient confirms that the doctor has carried out a clinical assessment and agreed further supplies are suitable.
• Every 12 months the patient should see their doctor for a review.
  

What do I need to know before I supply tamsulosin?

• Ask the patient’s age (tamsulosin should only be supplied for men aged between 45 to 75 years)
• Ask about the patient’s symptoms (establish if patient has urinary symptoms of BPH – see box above).
• Check whether the patient’s symptoms have been present for a minimum of 3 months.
• Ask if the patient takes other medications or suffers from any medical conditions? 
• It is good practice to use the International Prostate Symptom Score to assess symptoms of BPH. For further information refer to Practice Guidance (RPSGB) or Clinical Knowledge Summaries

When should tamsulosin NOT be supplied?

Tamsulosin should not be supplied and referral should be considered when:

• Symptoms are less than 3 months duration
  The patient has had prostrate surgery.
• There is unstable or potentially undiagnosed diabetes (e.g. characterised by excessive thirst and tiredness)
• The patient has problems with their liver, kidney or heart
• The patient reports fainting, dizziness or weakness when standing (postural hypotension)
• Cataract surgery is planned
  The patient has recent blurred or cloudy vision that has not been examined by a GP or optician (as cataracts may be indicated)
• The patient has allergy or hypersensitivity to tamsulosin

Tamsulosim should not be supplied OTC if it or any other BPH treatment has been prescribed or if the patient takes any antihypertensive medicines with significant alpha₁ blocking activity e.g. doxazosin, indoramin, prazosin, terazosin, verapamil.

What other drugs does tamsulosin interact with?

There is a theoretical risk of an enhanced hypotensive effect when tamsulosin is given concurrently with drugs which may reduce blood pressure including anaesthetic agents and other alpha₁-blockers. See SPC for full list of drugs.

When should I refer the patient?

The patient should be referred if they have pain on urination in the last 3 months; fever that might be related to a urinary tract infection; bloody or cloudy urine in the last 3 months  or leaking of urine (incontinence) as this may indicate chronic urinary retention.

How does tamsulosin work?

Tamsulosin is an alpha blocker that relaxes smooth muscle in BPH producing an increase in urinary flow-rate and an improvement in obstructive symptoms.

Are there any side-effects from taking tamsulosin?

• Common side effects include dizziness,especially when first standing, the patient should be advised to sit or lie down until they feel better
• Less common, but possible, side effects include headache, palpitations, , rhinitis, constipation, diarrhoea, nausea, vomiting, rash, pruritus, urticaria, abnormal ejaculation, asthenia (weakness).
• As with other alpha-blockers, drowsiness, blurred vision, dry mouth or oedema can occur.No data is available on whether OTC tamsulosin affects the ability to drive or operate machines, but patients should be informed that drowsiness, blurred vision, dizziness and syncope (fainting) can occur.

How long should a patient take tamsulosin for? Is any follow up needed?

See key points above.

Can I provide any other support or advice to the patient?

Lifestyle changes can alleviate symptoms of BPH.  Avoiding drinking liquids 1-2 hours before going to bed, reducing consumption of alcohol or caffeine, regular exercise, increasing fruit and fibre in diet  (to avoid constipation which puts pressure on the bladder) and avoiding unnecessary use of cold and allergy medicines such as decongestants and antihistamines can all help reduce symptoms.

Should I keep records of tamsulosin supply?

You should consider keeping a record of the consultation confirming clinical assessment  by a GP took place within the 6 week timeframe in the patient medication record but you must obtain the patient’s permission before a record is made.

Can I supply tamsulosin to a third party eg, the patient’s wife?

It is good practice to make all sales of OTC tamsulosin directly to the patient. Supplies to third parties should normally only be carried out in exceptional circumstances (refer to the practice guidance on OTC Tamsulosin for further information).

Where to go for more information

Email: support@rpsgb.org

Telephone: 020 7572 2302

See full practice guidance: OTC tamsulosin for further information.

See NICE guidance on the management of lower urinary tract symptoms in men

It is very important that you review Boehringer Ingelheim’s Summary of Product Characteristics (SPC) and Patient Information Leaflet for Flomax ® Relief MR400 micrograms capsules before supplying this product.

Training materials for pharmacists and support staff are available from a range of sources including Boehringer Ingelheim (on Flomax Relief MR).

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