Consumer medicine information

Tamsulosin-WGR SR

Tamsulosin hydrochloride

BRAND INFORMATION

Brand name

Tamsulosin-WGR SR

Active ingredient

Tamsulosin hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Tamsulosin-WGR SR.

SUMMARY CMI

TAMSULOSIN-WGR SR

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I taking TAMSULOSIN-WGR SR?

TAMSULOSIN-WGR SR contains the active ingredient tamsulosin hydrochloride. TAMSULOSIN-WGR SR is used for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

For more information, see Section 1. Why am I taking TAMSULOSIN-WGR SR? in the full CMI.

2. What should I know before I take TAMSULOSIN-WGR SR?

Do not use if you have ever had an allergic reaction to TAMSULOSIN-WGR SR or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I take TAMSULOSIN-WGR SR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with TAMSULOSIN-WGR SR and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take TAMSULOSIN-WGR SR?

  • TAMSULOSIN-WGR SR is only to be taken by men.
  • The dose is one tablet taken each day.
  • Swallow the tablet whole, preferably with a glass of water. Do not crush, bite or chew TAMSULOSIN-WGR SR tablets.

More instructions can be found in Section 4. How do I take TAMSULOSIN-WGR SR? in the full CMI.

5. What should I know while taking TAMSULOSIN-WGR SR?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking TAMSULOSIN-WGR SR.
  • Before starting any new medicine, tell your doctor or pharmacist that you are taking TAMSULOSIN-WGR SR.
  • Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
  • If you are going to have eye surgery for cataracts or glaucoma, tell your surgeon that you are taking or have taking TAMSULOSIN-WGR SR tablets.
Things you should not do
  • Do not take TAMSULOSIN-WGR SR tablets to treat any other conditions unless your doctor tell you to.
  • Do not give TAMSULOSIN-WGR SR tablets to anyone else, even if they have the same condition as you.
  • Do not take this medicine if you have severe liver disease or severe kidney disease.
  • Do not take TAMSULOSIN-WGR SR if you have a history of orthostatic hypotension (you become dizzy or light-headed or have low blood pressure when you stand up, after sitting or lying down).
  • Do not take this medicine if you are also taking medications which relax the smooth muscle of blood vessels (such as Minipress, Prasig, Hytrin).
Driving or using machines
  • Be careful when driving or operating machinery until you know how TAMSULOSIN-WGR SR affects you.
  • TAMSULOSIN-WGR SR tablets may cause dizziness and may impair your reactions.
Looking after your medicine
  • Keep TAMSULOSIN-WGR SR tablets in the blister pack until it is time to take them.
  • Keep your tablets in a cool, dry place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while taking TAMSULOSIN-WGR SR? in the full CMI.

6. Are there any side effects?

Common side effects include: retrograde ejaculation (when ejaculation fluid is not squirted out, but back into the bladder); dizziness.

Serious side effects include: prolonged painful erection of the penis, unrelated to sexual activity; swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

TAMSULOSIN-WGR SR

Active ingredient: tamsulosin hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about taking TAMSULOSIN-WGR SR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking TAMSULOSIN-WGR SR.

Where to find information in this leaflet:

1. Why am I taking TAMSULOSIN-WGR SR?
2. What should I know before I take TAMSULOSIN-WGR SR?
3. What if I am taking other medicines?
4. How do I take TAMSULOSIN-WGR SR?
5. What should I know while taking TAMSULOSIN-WGR SR?
6. Are there any side effects?
7. Product details

1. Why am I taking TAMSULOSIN-WGR SR?

TAMSULOSIN-WGR SR contains the active ingredient tamsulosin hydrochloride. Tamsulosin hydrochloride belongs to a group of medicines called alpha-blockers.

TAMSULOSIN-WGR SR is for use by MEN only. TAMSULOSIN-WGR SR is used in men who have a medical condition called benign prostatic hyperplasia (also known as BPH). The prostate gland is at the outlet of the urinary bladder. In BPH, the prostate gland is bigger than normal, which may affect how well you are able to pass your urine. BPH is common in men over the age of 50 years and is NOT prostate cancer.

TAMSULOSIN-WGR SR is used to treat the symptoms of benign prostatic hyperplasia, including:

  • a slow urine flow, the urine stream may become a trickle, or it may stop and start.
  • a delay when you try to pass urine, or straining to do so.
  • inability to empty your bladder completely.
  • dribbling at the end of passing urine.
  • the need to pass urine often during the day.
  • the need to get up often during the night to pass urine.
  • a feeling of urgency to pass urine as soon as you first feel the need to do so.

2. What should I know before I take TAMSULOSIN-WGR SR?

Warnings

Do not take TAMSULOSIN-WGR SR if:

  • you are allergic to tamsulosin hydrochloride, or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
    Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.
  • you are a woman or a child. TAMSULOSIN-WGR SR is for use by MEN only. If you are not sure whether you should start taking TAMSULOSIN-WGR SR you should contact your doctor.
  • you have a history of orthostatic hypotension (where you become dizzy or light-headed or have low blood pressure when you stand up, after sitting or lying down).
  • you have severe kidney disease.
  • you have severe liver disease.
  • you are taking other medication which relaxes the smooth muscle of blood vessels (some of the trade names are Minipress, Prasig, Hytrin).

Do not take TAMSULOSIN-WGR SR if the expiry date (Exp.) printed on the pack has passed.

Do not take TAMSULOSIN-WGR SR if the packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • have prostate cancer. TAMSULOSIN-WGR SR does not treat prostate cancer. BPH and prostate cancer may have similar symptoms.
    A man can have prostate cancer and BPH at the same time. You should be checked for prostate cancer before you start taking TAMSULOSIN-WGR SR.
    It is recommended that men be checked for prostate cancer once a year, from 50 years of age onwards.
  • have allergies to a any other medicines, or any other substances, such as foods, preservatives or dyes, particularly to sulfa.
  • have angina (severe pain in the chest, usually on exertion) or have had a heart attack during the last six months.
  • have high, or low blood pressure, or your blood pressure is controlled by medication.
  • have had ejaculation problems.
  • you plan to have surgery, particularly eye surgery for cataracts or glaucoma. Your doctor will discuss the risks and benefits of using TAMSULOSIN-WGR SR.
  • have any other medical conditions.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with TAMSULOSIN-WGR SR and affect how it works. These include:

  • cimetidine, a medicine generally used to treat stomach ulcers or reflux.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect TAMSULOSIN-WGR SR.

Do not take TAMSULOSIN-WGR SR if you are taking other medication which relaxes the smooth muscle of blood vessels (some of the TAMSULOSIN-WGR SRs are Minipress, Prasig, Hytrin).

4. How do I take TAMSULOSIN-WGR SR?

How much to take

  • The dose is one tablet taken each day.
  • Patients with severe liver problems should not take these tablets.
  • Patients with severe kidney problems should not take these tablets.
  • Follow all directions given to you by your doctor and pharmacist carefully.

How to take TAMSULOSIN-WGR SR

  • Swallow the tablets whole, preferably with a glass of water.
  • Do not crush, bite or chew the tablet, as this changes how TAMSULOSIN-WGR SR tablets work.
  • TAMSULOSIN-WGR SR should be used regularly at the same time each day.

If you forget to take TAMSULOSIN-WGR SR

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you miss a whole day, just continue to take your normal daily dose the next day.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much TAMSULOSIN-WGR SR

If you think that you have used too much TAMSULOSIN-WGR SR, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor; or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too many TAMSULOSIN-WGR SR tablets, this may result in vomiting, diarrhoea and low blood pressure leading to dizziness or fainting.

If you experience any of these symptoms, seek urgent medical attention.

5. What should I know while taking TAMSULOSIN-WGR SR?

Things you should do

Before starting any new medicine, tell your doctor or pharmacist that you are taking TAMSULOSIN-WGR SR tablets.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking TAMSULOSIN-WGR SR tablets.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise your doctor may think it is not working effectively and change your treatment unnecessarily.

If you are going to have eye surgery for cataracts or glaucoma, please tell your surgeon that you are taking or have taken TAMSULOSIN-WGR SR tablets.

Things you should not do

Do not use TAMSULOSIN-WGR SR tablets to treat any other conditions unless your doctor tell you to.

Do not give TAMSULOSIN-WGR SR tablets to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how TAMSULOSIN-WGR SR affects you.

TAMSULOSIN-WGR SR may cause dizziness or impair your reactions.

Looking after your medicine

Keep your tablets in the blister pack until it is time to take them.

Keep your tablets below 25°C.

Follow the instructions on the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink; or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Common:
  • "retrograde ejaculation". When this happens, the ejaculation fluid is not squirted out, most of it runs back into the bladder. Retrograde ejaculation is painless.
  • Dizziness
Uncommon:
  • headache
  • skin rash (red spots or patches), itching, hives
  • weakness
  • dizziness on standing
  • nausea, vomiting, diarrhoea, constipation
  • fast heart beats
  • blocked nose
  • burred or changes to vision
  • inflammation and blistering of the skin or mucous membranes of the lips, eyes, mouth, nasal passages or genitals, or nose bleeds.
Rare:
  • faintness
Speak to your doctor if you have any of these less serious side effects and they worry you.

TAMSULOSIN-WGR SR can occasionally cause people to feel faint and dizzy. You should get up slowly from the sitting or lying position to reduce the risk of dizziness or light-headedness. If you do feel faint on standing up, you should lie down for a short while. If the dizziness persists you should contact your doctor. You must not drive a car or operate machinery if you feel dizzy.

If you are having an operation on your eyes because of cataracts or glaucoma and are already taking or have taken TAMSULOSIN-WGR SR, the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during the procedure. This can be managed if your surgeon knows before carrying out the operation. If you are going to have eye surgery for cataracts or glaucoma, please tell your surgeon that you are taking or have taken TAMSULOSIN-WGR SR.

TAMSULOSIN-WGR SR may also occasionally cause blurred or reduced vision, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals, or nose bleeds.

Serious side effects

Serious side effectsWhat to do
  • prolonged painful erection of the penis, which is unrelated to sexual activity.
  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospitalifyou notice any of these seriousside effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

Each TAMSULOSIN-WGR SR tablet contains 400 micrograms of tamsulosin hydrochloride.

What TAMSULOSIN-WGR SR contains

Active ingredient
(main ingredient)		tamsulosin hydrochloride
Other ingredients
(inactive ingredients)		microcrystalline cellulose
polyethylene oxide
magnesium stearate

Do not take this medicine if you are allergic to any of these ingredients.

The tablets do not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

What TAMSULOSIN-WGR SR looks like

TAMSULOSIN-WGR SR tablets are white to off-white round tablets with a diameter of approximately 9 mm, debossed with “TSLN” on one side and “0.4” on the other side.

Each pack contains 30 tablets. (AUST R 433930).

Who distributes TAMSULOSIN-WGR SR

Wagner Pharmaceuticals Pty Ltd
6 Albert Street
Preston, Victoria, 3072
Tel: 1800 936 140

This leaflet was prepared in May 2024.

Published by MIMS November 2024

BRAND INFORMATION

Brand name

Tamsulosin-WGR SR

Active ingredient

Tamsulosin hydrochloride

Schedule

S4

 

Notes

Distributed by Wagner Pharmaceuticals Pty Ltd

1 Name of Medicine

Tamsulosin hydrochloride.

2 Qualitative and Quantitative Composition

Tamsulosin-WGR SR modified release tablets contain the active ingredient tamsulosin hydrochloride.
Each Tamsulosin-WGR SR modified release tablet contains 400 microgram of tamsulosin hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tamsulosin-WGR SR 400 microgram tablets are white to off-white round tablets with a diameter of approximately 9 mm, debossed with "TSLN" on one side and "0.4" on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

For the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

4.2 Dose and Method of Administration

One tablet daily.
The tablet must be swallowed whole and not be broken, crunched or chewed, as this compromises the modified release properties of the tablet for the active ingredient.
Tamsulosin-WGR SR can be taken on an empty stomach, or before, with or after food.

4.3 Contraindications

Hypersensitivity, including drug-induced angioedema, to tamsulosin hydrochloride or any other component of the product.
A history of orthostatic hypotension.
Severe hepatic impairment (Child-Pugh scores > 9).
Severe renal impairment with creatinine clearance of less than 10 mL/min.
Concurrent use of another α1-adrenoceptor inhibitor.

4.4 Special Warnings and Precautions for Use

Syncope and postural hypotension.

Patients beginning treatment with tamsulosin tablets should be cautioned to avoid situations where injury could result should syncope occur. Postural hypotension can occur during treatment with tamsulosin tablets, but rarely results in syncope. However, the patient should be warned of this possibility and advised to sit or lie down if symptoms of hypotension should occur.

Exclusion of prostatic carcinoma and other urological conditions.

Carcinoma of the prostate and other conditions which can cause the same symptoms as benign prostatic hyperplasia should be excluded before starting therapy with tamsulosin tablets. Digital rectal examination and, as considered appropriate, determination of prostate specific antigen should be performed before treatment and at regular intervals afterwards.

Myocardial ischaemia.

Patients with myocardial infarction or angina pectoris within the preceding six months were excluded from the Phase III clinical studies. As a result, the safety of tamsulosin tablets in these patients has not been formally assessed.

Dizziness.

As tamsulosin tablets may cause dizziness, patients should be warned to take care whilst operating machinery or driving.

Intra-operative floppy iris syndrome.

Intra-operative Floppy Iris Syndrome (IFIS) has been observed during cataract and glaucoma surgery in some patients taking or who have previously been treated with α1-adrenoceptor antagonists, including tamsulosin. This variant of small pupil syndrome is characterised by the combination of a flaccid iris that billows in response to intra-operative irrigation currents, progressive intra-operative miosis despite pre-operative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phaco-emulsification incisions.
During pre-operative assessment, ophthalmologists and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being, or have been, treated with α1-adrenoceptor antagonists in order to ensure that appropriate measures will be in place to manage IFIS during surgery if it occurs. The patient's ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilisation of iris hooks, iris dilator rings, or visco-elastic substances. The benefit of stopping α1-adrenoceptor antagonist therapy prior to cataract or glaucoma surgery has not been established.

Sulfa allergy.

Cases of allergic reaction to tamsulosin in patients with a past history of sulphonamide allergy have been reported. If a patient reports a sulfa allergy, caution is warranted when administering tamsulosin tablets.

Use in hepatic impairment.

In a study of patients with moderate hepatic impairment, free tamsulosin levels remained unchanged after treatment with 400 microgram tamsulosin hydrochloride in a modified release capsule formulation when compared to normal subjects. Since the type of formulation will not affect the disposition of tamsulosin no dose adjustment for tamsulosin tablets is expected in patients with mild to moderate hepatic impairment.
Severe hepatic impairment (Child-Pugh scores > 9) is a contraindication, see Section 4.3 Contraindications.

Use in renal impairment.

Severe renal impairment, with creatinine clearance of less than 10 mL/min is a contraindication, as these patients have not been studied, see Section 4.3 Contraindications.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

Tamsulosin-WGR SR is not indicated for use in children.

Other populations.

Tamsulosin-WGR SR is not indicated for use in women.

Effects on laboratory tests.

Interactions with laboratory tests have not been established.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Drugs known to interact with tamsulosin.

Concomitant cimetidine leads to a rise in plasma levels of tamsulosin, while furosemide leads to a fall (about 12% following a single 20 mg intravenous dose). However, as levels remain within the normal range, dosage need not be adjusted.
Concurrent administration of tamsulosin with other α1-adrenoceptor antagonists is contraindicated because of the potential for hypotensive effects, see Section 4.3 Contraindications.

Drugs which may interact with tamsulosin.

Tamsulosin binds extensively to plasma proteins and may displace other protein-bound drugs. Clinical trial data are not available.
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.

Drugs which do not interact significantly with tamsulosin.

Tamsulosin did not affect the pharmacokinetics of a single intravenous dose of digoxin 0.5 mg.
No interactions have been seen when tamsulosin hydrochloride was given concomitantly with either atenolol, enalapril, nifedipine or theophylline.

General.

Tamsulosin is metabolised in the liver and may be expected to interact with other hepatically-metabolised drugs. Pharmacokinetic studies in healthy volunteers revealed that concomitant administration with strong inhibitors of CYP3A4 or CYP2D6 may lead to increased exposure to tamsulosin. Concomitant administration with ketoconazole (a known CYP3A4 inhibitor) resulted in an increased Cmax and AUC of tamsulosin. Tamsulosin 400 microgram should not be used in combination with strong inhibitors of CYP3A4 in patients known to be CYP2D6 poor metabolizers. Concomitant administration with paroxetine (a known CYP2D6 inhibitor) resulted in an increased Cmax and AUC of tamsulosin. Tamsulosin should therefore be used with caution in patients who are taking other drugs, particularly those which undergo hepatic metabolism.

Other in vitro findings.

In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinone, amitriptyline, 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 chlormadinone.
An in vitro study using human liver microsomal fractions showed no effect of amitriptyline, salbutamol, glibenclamide and finasteride on the rate of disappearance of tamsulosin. The clinical relevance of these findings is uncertain.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

α-adrenoceptor antagonists are known to reduce male fertility by affecting penile erection, emission and/or ejaculation. In male rats, a severe reduction in male copulation rate and fertility was observed after a single dose or after repeated oral doses of tamsulosin. Spermatogenesis was not affected in the rat studies, and the effect on fertility was reversible. The no effect dose on male rat fertility was associated with plasma tamsulosin levels (AUC) at least 50% of those expected in human males treated with tamsulosin.
Treatment of female rats with tamsulosin caused disruption of the oestrus cycle and a severe reduction in fertility, due to interference of fertilisation with the ova. These effects were shown to be reversible.
(Category B2)
Tamsulosin is intended for use only in males.
Tamsulosin, at oral doses causing maternal toxicity, was not embryotoxic or teratogenic when administered during gestation in rats (doses up to 300 mg/kg/day) or rabbits (doses up to 50 mg/kg/day). However, administration of tamsulosin during the peri-/post-natal period was associated with a higher incidence of stillbirths and reduced pup weight gain after birth. No adverse effects on development or reproductive performance were observed on surviving pups, however, there is some evidence for impairment of offspring reproductive capacity when maternal treatment with tamsulosin is started before pregnancy.
 Tamsulosin is intended for use only in males.
In female rats, tamsulosin and/or its metabolites were shown to pass into milk after oral administration of the drug during lactation. The effect on the newborn is not known.

4.7 Effects on Ability to Drive and Use Machines

As tamsulosin tablets may cause dizziness, patients should be warned to take care whilst operating machinery or driving.

4.8 Adverse Effects (Undesirable Effects)

Priapism.

Rarely, tamsulosin, like other alpha-1 antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction.

Abnormal ejaculation.

Patients should be advised on the potential for abnormal ejaculation to occur upon commencement of tamsulosin treatment. Retrograde ejaculation is the most commonly reported abnormal ejaculation event associated with the use of tamsulosin tablets (see Table 1).

Clinical trials.

Table 1 shows the incidence of undesirable effects following 400 microgram tamsulosin tablet treatment. This data is based on a phase 3 clinical study in which there were no relevant differences between the treatment and placebo groups in the percentage of patients reporting at least 1 Treatment Emergent Adverse Event (TEAE). Most TEAEs were of mild or moderate intensity.
The most frequent TEAEs were ejaculation disorders. These are TEAEs that are often associated with α1-AR antagonists.
The following treatment-related adverse events were reported from clinical trials, where Common is ≥ 1% and < 10%; Uncommon is ≥ 0.1% and < 1%; Rare is ≥ 0.01% and < 0.1%; and Very rare is < 0.01%.

Cardiac disorders.

Uncommon: palpitations.

Gastro-intestinal disorders.

Uncommon: constipation, diarrhoea, nausea, vomiting.

General disorders.

Uncommon: asthenia.

Nervous system disorders.

Common: dizziness (1.3%), insomnia. Uncommon: headache. Rare: syncope.

Reproductive system disorders.

Common: ejaculation disorder. Very rare: priapism.

Respiratory, thoracic and mediastinal disorders.

Uncommon: rhinitis.

Skin and subcutaneous tissue disorders.

Uncommon: rash, pruritus, urticaria. Rare: angioedema.

Vascular disorders.

Uncommon: postural hypotension.

Post-marketing experience.

The following events have also been reported during the post-marketing period. These events are reported voluntarily from a population of uncertain size; therefore, it is not possible to reliably estimate their frequency.

General disorders.

Chest discomfort that could be caused or associated with other medical conditions such as respiratory conditions or cardiac disease.

Vision disorders.

Blurred vision, vision impairment.
During cataract and glaucoma surgery, a variant of small pupil syndrome known as Intra-operative Floppy Iris Syndrome (IFIS) has been reported in association with α1-adrenoceptor antagonist therapy, see Section 4.4 Special Warnings and Precautions for Use, Intra-operative floppy iris syndrome.

Skin and subcutaneous tissue disorders.

Skin desquamation, dermatitis exfoliative, erythema multiforme, Stevens-Johnson syndrome, photosensitivity reaction.

Respiratory, thoracic and mediastinal disorders.

Epistaxis.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Acute overdose with 5 mg tamsulosin hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mmHg), vomiting and diarrhoea were observed, which were treated with fluid replacement and the patient could be discharged the same day.
If acute hypotension occurs after overdosage, cardiovascular support should be given and maintained. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this is insufficient then volume expanders and, when necessary, vasopressors could be administered. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins.
Tamsulosin tablet is a modified release formulation. The signs and symptoms of overdose may be delayed or modified from the time of ingestion.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The tone of the human prostate smooth muscle is maintained primarily by noradrenaline released from adrenergic nerves and stimulating post-junctional α1-adrenoceptors. This provides the rationale for the use of α1-adrenoceptor antagonists for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
Pharmacological studies have established that tamsulosin is a selective, potent and competitive α1-adrenoceptor antagonist and that it has a greater affinity for the α1A-receptor subtype, predominantly present in the human prostate.
α1-adrenoceptor antagonists generally can reduce blood pressure by lowering peripheral resistance. However, no reduction in blood pressure of any clinical significance was observed during studies with tamsulosin.
The binding of tamsulosin to α1-adrenoceptors in the prostate results in relaxation of prostate smooth muscle followed by improvements in urodynamics. Thus, tamsulosin increases maximum urinary flow rate by reducing smooth muscle tension in the prostate and urethra and thereby relieving obstruction.
It also improves the symptoms related to bladder instability and tension of the smooth muscle of the lower urinary tract.
These effects on urinary storage and voiding symptoms are maintained during long-term therapy.
The need for surgery or catheterisation is significantly delayed.

Clinical trials.

The efficacy of tamsulosin tablets has been evaluated in 2 randomised, placebo-controlled studies: the phase 2 dose-response study 617-CL-303 and the phase 3 study 617-CL-307. A total of 2962 patients were studied, of which 560 were treated with 0.4 mg of tamsulosin tablets and 564 were treated with placebo. The remaining subjects were treated with 0.4 mg (capsules), 0.8 mg and 1.2 mg (tablets) doses of tamsulosin hydrochloride.
Inclusion criteria. In both studies the inclusion criteria were male patients aged ≥ 45 years, diagnosed as having lower urinary tract symptoms (LUTS) suggestive of BPH, with voiding/obstructive symptoms (including incomplete emptying of the bladder, intermittency, poor stream or hesitancy), and/or storage/irritative/filling symptoms (including daytime frequency, urgency or nocturia).
These patients had a total International Prostate Symptom Score (I-PSS) of ≥ 13, both at enrolment (Visit 1) and at baseline after the 2-week placebo run-in period (Visit 2). At enrolment, they also had to have a maximum flow rate (Qmax) of ≥ 4.0 mL/s and ≤ 12.0 mL/s, with a voided volume ≥ 120 mL during free flow.
Patients with cardiac ischaemia were excluded from participation in these trials. Safety in such patients has not been formally assessed.

Study 617-CL-303.

Study 617-CL-303 was a multi-center, double-blind, randomised, placebo-controlled, parallel group, dose-response study. In this study, 211 patients received placebo, and 203 patients received 400 microgram of tamsulosin tablets once daily for 12 weeks of the double-blind randomised treatment. The results of study 617-CL-303 are summarised in Table 2.

Study 617-CL-307.

Study 617-CL-307 was a multi-center, double-blind, randomised, placebo and active-controlled, parallel group study. In this study, 353 patients received placebo, and 357 patients received 400 microgram of tamsulosin tablets once daily for 12 weeks of the double-blind randomised treatment. The results of study 617-CL-307 are summarised in Table 3.
The primary efficacy parameter in both studies following 400 microgram tamsulosin treatment was the change from baseline to endpoint in total I-PSS scores. The secondary efficacy analyses contained the changes from baseline in voiding and storage I-PSS sub-scores, and I-PSS Quality of Life scores.
The I-PSS questionnaire was developed and validated by the American Urological Association (I-PSS previously called the AUA Symptom Index) and consisted of 7 questions evaluating the frequency of 7 urinary symptoms. These included 4 voiding symptoms (poor stream, hesitancy, intermittency and incomplete bladder emptying) and 3 storage symptoms (daytime frequency, nocturia and urgency). The patient rated each of the 7 symptoms on a scale of 0-5 of increasing symptom severity. The total score could therefore range from 0-35, the voiding sub-score from 0-20 and the storage sub-score from 0-15. The questionnaire was adopted by the World Health Organization, who added a further question assessing the impact of the urinary symptoms on the Quality of Life. The Quality of Life question asked how the patient would feel about his current level of symptoms for the rest of his life, ranging from 1 (delighted) to 6 (terrible).

5.2 Pharmacokinetic Properties

Absorption.

Tamsulosin is a modified release tablet of the non-ionic gel matrix type. The tamsulosin formulation provides consistent slow release of tamsulosin, which is maintained over the whole pH range encountered in the gastro-intestinal tract, resulting in an adequate exposure, with little fluctuation, over 24 hours.
Tamsulosin administered is absorbed from the intestine. Of the administered dose, approximately 55 to 59% is estimated to be absorbed. The rate and extent of absorption of tamsulosin hydrochloride administered as tamsulosin tablets are only slightly affected by food, but this is unlikely to be clinically significant.
Tamsulosin hydrochloride administered as tamsulosin tablets exhibits near linear pharmacokinetics (plasma concentrations Cmax and AUC vs dose) over the dosage range 0.4 mg through 0.8 mg to 1.2 mg once daily. Steady state is reached by day 4 of multiple dosing. The pharmacokinetics of a 400 microgram once daily dose of tamsulosin hydrochloride as tamsulosin tablets as a single dose under fasted conditions, and steady state under fed and fasted conditions, are shown in Table 4.
As a result of the modified release characteristic of tamsulosin, the trough concentrations - at steady state, of tamsulosin hydrochloride in plasma amount to approximately 40% of the peak plasma concentrations, under fasted and fed conditions.
There is a considerable inter-patient variation in the plasma concentrations of tamsulosin hydrochloride, after both single and multiple dosing.

Distribution.

In man, tamsulosin is about 99% bound to plasma proteins. The volume of distribution is small (about 0.2 L/kg).

Metabolism.

Tamsulosin 400 microgram modified release tablet contains tamsulosin as the R(-) isomer. In humans, there is no in vivo conversion to the less active S(+) isomer. Tamsulosin has a low first pass effect, being metabolised slowly. Most tamsulosin is present in plasma in the form of unchanged drug. Tamsulosin is metabolised in the liver. In vitro results suggest that CYP3A4 and also CYP2D6 are involved in metabolism, with possible minor contributions to tamsulosin metabolism by other CYP isozymes. Inhibition of hepatic drug metabolising enzymes may lead to increased exposure to tamsulosin, see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions. In rats, tamsulosin was seen to cause minimal induction of microsomal liver enzymes. No dose adjustment is warranted in hepatic insufficiency, see Section 4.3 Contraindications.
None of the metabolites is more active than the original precursor compound.

Excretion.

Tamsulosin and its metabolites are mainly excreted in the urine. The amount excreted as unchanged drug is estimated to be about 4 - 6% of the dose administered as tamsulosin.
No dose adjustment is warranted in renal impairment, see Section 4.3 Contraindications.

5.3 Preclinical Safety Data

Genotoxicity.

In vivo and in vitro genotoxicity studies have been conducted.
Tamsulosin HCI produced no evidence of genotoxic potential in assays for gene mutation (Ames reverse mutation test and mouse lymphoma thymidine kinase assay), chromosomal damage (Chinese hamster ovary cells and mouse micronucleus assay) and other genotoxic effects (unscheduled DNA repair synthesis and in vivo sister chromatid exchange).

Carcinogenicity.

Reproduction toxicity studies in rats and carcinogenicity studies in mice and rats have been conducted.
Oral (dietary) administration of tamsulosin for up to 2 years in rats and mice was associated with an increased incidence of pituitary adenoma, mammary gland hyperplasia, mammary gland fibroadenoma and (in mice only) mammary gland adenocarcinoma. These effects occurred at plasma tamsulosin concentrations (AUC) up to 10 times lower than those expected in men undergoing treatment with tamsulosin, but they were observed only in female animals and are probably due to the hyperprolactinaemic effect of tamsulosin. It is not known if tamsulosin elevates prolactin during modified administration in humans. The relevance for human risk of the findings of prolactin-mediated endocrine tumours in female rodents is unknown.

6 Pharmaceutical Particulars

6.1 List of Excipients

Tamsulosin-WGR SR 400 microgram modified release tablets contain the following inactive ingredients: microcrystalline cellulose, polyethylene oxide and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Tamsulosin-WGR SR 400 microgram modified release tablets should be stored below 25°C and protect from light.

6.5 Nature and Contents of Container

Tamsulosin-WGR SR is available in OPA/Al/PVC blister packs of 30 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Tamsulosin hydrochloride is sparingly soluble in water (1:85) and slightly soluble in alcohol. It is stable in an acid environment.

Chemical structure.


Chemical name: 5-[(2R)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxybenzenesulfonamide hydrochloride.
Molecular formula: C20H29ClN2O5S.
Molecular weight: 445.0.

CAS number.

106463-17-6.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes