Consumer medicine information

FLOMAXTRA

Tamsulosin hydrochloride

BRAND INFORMATION

Brand name

Flomaxtra

Active ingredient

Tamsulosin hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using FLOMAXTRA.

SUMMARY CMI

FLOMAXTRA™

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 using FLOMAXTRA™?

FLOMAXTRA™ is used in men who have a medical condition called benign prostatic hyperplasia (also known as BPH). In BPH the prostate gland is bigger than normal. BPH is NOT prostate cancer.

FLOMAXTRA™ belongs to a group of medicines called alpha-blockers.

For more information, see Section 1. Why am I using FLOMAXTRA™? in the full CMI.

2. What should I know before I use FLOMAXTRA™?

FLOMAXTRA™ is for use by MEN only. If you are a woman or a child, do not take FLOMAXTRA™. If you are not sure whether you should start taking FLOMAXTRA™ you should contact your doctor.

There are a number of circumstances in which a person should not use this medicine or may need to use caution. It is important to understand if these apply to you before taking FLOMAXTRA™ (see Section 2. What should I know before I use FLOMAXTRA™? in the full CMI for more details).

3. What if I am taking other medicines?

Some medicines may interfere with FLOMAXTRA™ 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 use FLOMAXTRA™?

The usual dose is one tablet a day.

The tablet should be swallowed whole, preferably with a glass of water. Do not crunch, bite or chew the tablet.

More instructions can be found in Section 4. How do I use FLOMAXTRA™? in the full CMI.

5. What should I know while using FLOMAXTRA™?

Things you should do
  • If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking FLOMAXTRA™.
  • If you are going to have eye surgery for cataracts or glaucoma, please tell your surgeon that you are taking or have taken FLOMAXTRA™.
Things you should not do
  • Do not give FLOMAXTRA™ to anyone else, even if they have the same condition as you.
  • Do not take FLOMAXTRA™ for any other complaints unless your doctor tells you to.
Driving or using machines
  • Be careful when driving or operating machinery until you know how FLOMAXTRA™ affects you.
    FLOMAXTRA™ may cause dizziness and may impair your reactions.
Drinking alcohol
  • Tell your doctor if you drink alcohol.
Looking after your medicine
  • Keep FLOMAXTRA™ 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 using FLOMAXTRA™? in the full CMI.

6. Are there any side effects?

There are a number of side effects associated with this medicine. It is important to be aware of them so that you can identify any symptoms if they occur (see the full CMI for more details). Some serious side effects may include 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.

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

FLOMAXTRA™ Prolonged release tablets

Active ingredient(s): tamsulosin (tam-su-lo-sin)

Consumer Medicine Information (CMI)

This leaflet answers some common questions about FLOMAXTRA™.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you having FLOMAXTRA™ against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor, nurse or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

Where to find information in this leaflet:

1. Why am I using FLOMAXTRA™?
2. What should I know before I use FLOMAXTRA™?
3. What if I am taking other medicines?
4. How do I use FLOMAXTRA™?
5. What should I know while using FLOMAXTRA™?
6. Are there any side effects?
7. Product details

1. Why am I using FLOMAXTRA™?

FLOMAXTRA™ is a medicine for use by MEN only.

FLOMAXTRA™ is used in men who have a medical condition called benign prostatic hyperplasia (also known as BPH). In BPH the prostate gland is bigger than normal. BPH is NOT prostate cancer.

FLOMAXTRA™ belongs to a group of medicines called alpha-blockers.

Your doctor has prescribed FLOMAXTRA™ for you because you have symptoms caused by an enlarged prostate gland. BPH occurs only in men. It is common in men over the age of 50 years.

The prostate gland is at the outlet of your urinary bladder. Because your prostate has become bigger than it should be, it is affecting how well you are able to pass your urine. This causes some, or all of the following symptoms; they usually start gradually and increase in severity:

  • Urine flow is slow.
  • The urine stream may become a trickle, or it may stop and start.
  • You find a delay when you try to pass urine, and you have to strain to do so.
  • You feel that you cannot empty your bladder completely.
  • You may dribble at the end of passing urine.
  • You need to pass urine often during the day.
  • You need to get up often during the night to pass urine.
  • You feel an urgency to pass urine as soon as you first feel the need to do so.

Ask your doctor if you have any questions about why FLOMAXTRA™ has been prescribed for you.

2. What should I know before I use FLOMAXTRA™?

Warnings

FLOMAXTRA™ is for use by MEN only. If you are a woman or a child, do not take FLOMAXTRA™. If you are not sure whether you should start taking FLOMAXTRA™ you should contact your doctor.

Do not use FLOMAXTRA™ if:

  • you are allergic to any of the ingredients in the tablet (see "Product Description"). Signs of allergic reaction may include a skin rash, itching, shortness of breath or swelling of the face, lips or tongue
  • you become dizzy or light-headed or have low blood pressure when you stand up, after sitting or lying down.
    This is called orthostatic hypotension.
  • you have serious liver problems.
  • you have serious kidney function problems.
  • you are taking other medication which relaxes the smooth muscle of blood vessels (some of the tradenames are Minipress, Prasig, Hytrin).

Do not take FLOMAXTRA™ if the packaging is torn or shows signs of tampering or the tablets do not look quite right.

Do not take FLOMAXTRA™ if the expiry date on the pack has passed.

Use FLOMAXTRA™ only if your doctor has prescribed it for you.

All medicines have benefits and risks. In deciding to prescribe FLOMAXTRA™ for you, your doctor has weighed the risk of taking FLOMAXTRA™ against the benefit it is expected to have for you.

Your doctor has prescribed FLOMAXTRA™ for BPH. FLOMAXTRA™ 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 FLOMAXTRA™. It is recommended that men be checked for prostate cancer once a year, from 50 years of age onwards. These checks should continue while you are on FLOMAXTRA™.

Check with your doctor if you:

  • are allergic to FLOMAXTRA™ or any of its ingredients (see Section 7. Product Details).
  • 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.
  • are suffering from any other illness.
  • have any allergies to sulfa or any other medications.

If you are going to have eye surgery for cataracts or glaucoma, please tell your surgeon that you are taking or have taken FLOMAXTRA™. (see Section 6. Are there side effects?).

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

Your doctor will discuss the risks and benefits of using FLOMAXTRA™.

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 and FLOMAXTRA™ may interfere with each other. These medicines include:

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

Taking these medicines with FLOMAXTRA™ may increase the risk of possible side effects (see Section 6. Are there side effects?).

Other medications can also interfere with FLOMAXTRA™ and make you feel drowsy. Ask your doctor or pharmacist for more information.

4. How do I use FLOMAXTRA™?

Your doctor will tell you how much you should take, when and how often. It is important that you take this medicine as directed by your doctor.

Do not take FLOMAXTRA™ if the packaging is torn or shows signs of tampering, or if the tablets show visible signs of deterioration.

If you are unsure ask your doctor or pharmacist.

How much to take

  • The dose is one tablet a day.
  • Patients with severe liver problems should not take these tablets.
  • Patients with severe kidney problems should not take these tablets.
  • Carefully follow all directions given to you by your doctor and pharmacist.
  • These directions may differ from the information in this leaflet

How to take it

  • The FLOMAXTRA™ tablet should be swallowed whole, preferably with a glass of water.
  • Do not crunch, bite or chew the tablet, as this changes how FLOMAXTRA™ works.
  • Crunching, biting or chewing the tablet will release the medicine quickly and side effects may then occur

If you forget to take it

  • 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 it as soon as you remember, and then go back to taking FLOMAXTRA™ as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
  • If you miss a whole day, just continue to take your normal daily dose the next day.

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

If you take too much (overdose)

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.

You may need urgent medical attention.

If you take too many FLOMAXTRA™ 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 using FLOMAXTRA™?

Things you should do

Be sure to keep all of your doctor's appointments so that your progress can be checked.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking FLOMAXTRA™.

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 FLOMAXTRA™ (see Section 6. Are there any side effects?).

Things you should not do

Do not give FLOMAXTRA™ to anyone else, even if they have the same condition as you.

Do not take FLOMAXTRA™ for any other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how FLOMAXTRA™ affects you.

FLOMAXTRA™ may cause dizziness and may impair your reactions.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

  • Keep FLOMAXTRA™ 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.
  • Do not store FLOMAXTRA™ in the bathroom or near a sink.
  • Do not leave them in a car or on a window sill. Heat and dampness can destroy some medicines.
  • Keep FLOMAXTRA™ tablets where children cannot reach them.
    A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
    Note the expiry date on the pack. Do not use after this expiry date.

Getting rid of any unwanted medicine

If your doctor tells you to stop taking FLOMAXTRA™ or the expiry date has passed, ask your pharmacist what to do with any tablets that are left over.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking FLOMAXTRA™.

Like all medicines, FLOMAXTRA™ can cause some unwanted side effects in some people. Sometimes they are serious, most of the time they are not. Side effects not listed in this leaflet may occur in some patients. You may need to get medical attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

If you notice any unwanted effects not mentioned in this leaflet, please inform your doctor, or pharmacist.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Less serious side effects

Less serious side effectsWhat to do
  • "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
  • headache
  • skin rash (red spots or patches), itching, hives
  • weakness
  • dizziness on standing
  • nausea, vomiting, diarrhoea, constipation
  • fast heart beats
  • blocked nose
  • faintness
  • chest discomfort, could be caused or associated with other medical conditions such as respiratory conditions or cardiac disease

FLOMAXTRA™ 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 FLOMAXTRA™, 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 FLOMAXTRA™.
FLOMAXTRA™ 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.

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • extremely rarely, medications similar to FLOMAXTRA™ have caused prolonged painful erection of the penis, which is unrelated to sexual activity. If you have a prolonged erection, call your doctor or go to the Emergency Room as soon as possible.
  • swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
If any of the following happen, tell your doctor or go to accident and emergency at your nearest hospital immediately. These are very serious side effects. If you have them, you may have had a serious allergic reaction to FLOMAXTRA™. You may need urgent medical attention or hospitalisation.

This is not a complete listing. Other unwanted effects may occur in some men. Tell your doctor if you notice any other effects or if the unwanted effects are particularly bothersome.

You should always tell your doctor about any problems you have whilst taking FLOMAXTRA™.

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.

What FLOMAXTRA™ contains

Active ingredient
(main ingredient)		FLOMAXTRA™ tablets - each tablet contains 400 µg tamsulosin hydrochloride.
Other ingredients
(inactive ingredients)
  • macrogol 7,000,000
  • macrogol 8,000
  • magnesium stearate
  • butylhydroxytoluene
  • colloidal silica anhydrous
  • hypromellose
  • iron oxide yellow.
None of the excipients are derived from animal sources and therefore, where appropriate, FLOMAXTRA™ tablets are suitable medication for vegetarian, vegan and concerned religious patients.

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

The FLOMAXTRA™ tablet is specially designed to gradually release tamsulosin into the body.

What FLOMAXTRA™ looks like

FLOMAXTRA™ tablets (AUST R 115534) are approximately 9 mm, round, bi-convex, yellow, and engraved with the code '04'.

FLOMAXTRA™ tablets are supplied in boxes of 10 and 30 tablets.

FLOMAXTRA™ tablets are sealed in a blister pack.

Who distributes FLOMAXTRA™

FLOMAXTRA™ is supplied in Australia by:

Astellas Pharma Australia Pty Ltd
Suite 2.01, 2 Banfield Road
Macquarie Park NSW 2113

Medical Information:
1800 751 755

This leaflet was prepared in July 2023.

Published by MIMS October 2023

BRAND INFORMATION

Brand name

Flomaxtra

Active ingredient

Tamsulosin hydrochloride

Schedule

S4

 

1 Name of Medicine

Tamsulosin hydrochloride.

2 Qualitative and Quantitative Composition

Flomaxtra is a film-coated, prolonged release tablet containing 400 microgram tamsulosin hydrochloride, an α1-adrenoceptor blocking agent, equivalent to 367 microgram of tamsulosin per tablet.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Flomaxtra is a film-coated, prolonged release tablet.
Flomaxtra tablets are yellow, approximately 9 mm, round, bi-convex, film-coated and debossed with the code '04' on one 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 prolonged release properties of the tablet for the active ingredient.
Flomaxtra 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 Flomaxtra tablets should be cautioned to avoid situations where injury could result should syncope occur. Postural hypotension can occur during treatment with Flomaxtra, 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 Flomaxtra. 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 3 clinical studies. As a result, the safety of Flomaxtra in these patients has not been formally assessed.

Dizziness.

As Flomaxtra 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 viscoelastic 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 Flomaxtra.

Use in hepatic impairment.

In a study of patients with moderate hepatic impairment, free tamsulosin levels remained unchanged after treatment with Flomax (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 Flomaxtra 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.

Flomaxtra is not indicated for use in children.

Other populations.

Flomaxtra is not indicated for use in women.

Effects on laboratory tests.

No data available.

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 Flomaxtra 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.

Flomaxtra 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 Flomaxtra.
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)
Flomaxtra 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.
 Flomaxtra 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 Flomaxtra 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 Flomaxtra treatment. Retrograde ejaculation is the most commonly reported abnormal ejaculation event associated with the use of Flomaxtra (see Table 1).

Clinical trials.

Table 1 shows the incidence of undesirable effects following 400 microgram Flomaxtra 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 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.
Flomaxtra is a sustained release formulation. The signs and symptoms of overdose may be delayed or prolonged from the time of ingestion.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (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 Flomaxtra.
The binding of tamsulosin to α1-adrenoceptors in the prostate results in relaxation of prostate smooth muscle followed by improvements in urodynamics. Thus, Flomaxtra 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 Flomaxtra 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 Flomaxtra 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 Flomaxtra 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 Flomaxtra 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 Flomaxtra 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.

Flomaxtra is a prolonged release tablet of the non-ionic gel matrix type. The Flomaxtra 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 as Flomaxtra 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 Flomaxtra tablets are only slightly affected by food, but this is unlikely to be clinically significant.
Tamsulosin hydrochloride administered as Flomaxtra 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 Flomaxtra 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 prolonged release characteristic of Flomaxtra, 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.

Flomaxtra 400 microgram 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 4.5 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 are 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 Flomaxtra.
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 HCl 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 Flomaxtra, but they were observed only in female animals and are probably due to the hyperprolactinaemic effect of tamsulosin. It is not known if Flomaxtra elevates prolactin during prolonged 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

Flomaxtra also contains macrogol 7,000,000, macrogol 8,000, magnesium stearate, butylated hydroxytoluene, colloidal silica anhydrous, hypromellose, iron oxide yellow. None of the excipients is derived from animal sources.

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

Flomaxtra should be stored below 25°C.

6.5 Nature and Contents of Container

Flomaxtra is available in packs of 10 or 30 tablets supplied in aluminium foil blister strips, each of which contains 10 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.

The chemical structure of tamsulosin hydrochloride is:
The chemical name is (R)-5-[2-[[2-(2-ethoxyphenoxy) ethyl]amino]propyl]-2- methoxybenzenesulfonamide, monohydrochloride. The molecular weight is 444.98.

CAS number.

CAS-106463-17-6 (hydrochloride).

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes