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Omnic Xl 400 Micrograms Tablets

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FLOMAXTRA® XL 400 micrograms TABLETS (Tamsulosin hydrochloride)

Patient Information Leaflet

This product is known as the above name, but will be referred to as Flomaxtra XL throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine. It contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Flomaxtra XL is and what it is used for

2.    Before you use Flomaxtra XL

3.    How to use Flomaxtra XL

4.    Possible side effects

5.    How to store Flomaxtra XL

6.    Further information

1. What Flomaxtra XL is and what it is used for

What is Flomaxtra XL

The active ingredient in Flomaxtra XL is tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and aids urination.

In the prostate gland, bladder and urethra there are specialised cells containing alpha1A- receptors that cause the muscles in the urethra to tighten. Flomaxtra XL is an alpha1A- adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water.

What Flomaxtra XL is used for

Flomaxtra XL is used to treat the symptoms associated with benign prostatic hyperplasia (BPH) which is enlargement of the prostate gland. These symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water.

2. Before you use Flomaxtra XL

Do not use Flomaxtra XL if you

•    are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Flomaxtra XL (see list in section 6 'Further information')

•    have a severe liver condition

•    have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking Flomaxtra XL, particularly if you are also taking other alpha!- blockers. If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared.

Take special care with Flomaxtra XL (and speak to your doctor)

•    If you have kidney problems

•    If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract).

Please inform your eye specialist that you have previously used, are using or are planning to use tamsulosin hydrochloride. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens.

Children

Do not give this medicine to children or adolescents under 18 years because it does not work in this population.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Flomaxtra XL can affect the way that some other medicines work and some other medicines can affect the way that Flomaxtra XL works.

In particular tell your doctor or pharmacist if you are taking:

•    Medicines to lower your blood pressure such as verapamil and diltiazem

•    Medicines to treat HIV such as ritonavir or indinavir.

•    Medicines to treat a fungal infection such as ketaconazole or itraconazole

•    Other alpha blockers such as doxazosin, indoramin, prazosin or alfuzosin

•    Erythromycin, an antibiotic used to treat infections

Please inform your doctor that you are on Flomaxtra XL before any operation or dental procedure as there is a potential that your medicine may interfere with the effects of the anaesthetic.

Pregnancy, breast-feeding and fertility

Flomaxtra XL is not indicated for use in women.

In men, abnormal ejaculation has been reported (ejaculation disorder).

This means that the semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

3. How to take Flomaxtra XL

Dosage

For adults and the elderly, the dose is one tablet each day. It can be taken with or without food. Swallow the tablet whole. Do not crunch or chew.

Your doctor may want to examine you from time to time whilst you are taking this medicine.

If you take more Flomaxtra XL than you should

If you have taken too many tablets, contact your doctor immediately or go to the nearest hospital casualty department taking any remaining medication and this patient information leaflet with you.

If you forget to take Flomaxtra XL

You may take your tablet later the same day if you have forgotten to take it earlier. If you have missed a day, just continue to take your daily tablet from the next day. Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flomaxtra XL may cause side effects, although not everybody gets them.

Stop taking this medicine and consult your doctor immediately if any of the following occur - you may need medical treatment.

Rare (affects less than 1 in 1000 people)

• Swelling of the face, throat or tongue with breathing problems linked to allergy

Very rare (affects less than 1 in 10,000 people)

•    Persistent painful erection usually unrelated to sexual activity.

•    Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).

•    Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea).

The following side effects have also been reported:

Common (affects less than 1 in 10 people)

•    dizziness

•    abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

Uncommon (affects less than 1 in 100 people)

•    weakness

•    headache

•    runny or blocked nose

•    dizziness as you sit or stand up

•    palpitations (rapid or irregular heart beat)

•    gastro-intestinal symptoms such as nausea and vomiting (feeling or being sick), diarrhoea or constipation

•    hypersensitivity reactions such as rash, itching, redness, local swelling and breathing problems

Rare (affects less than 1 in 1000 people)

•    fainting

Not known (frequency cannot be estimated from the available data):

•    blurred vision

•    impaired vision

•    nose bleeds (epistaxis)

•    serious skin rashes (erythema multiform, dermatitis exfoliative)

•    dry mouth

As with other medicines of this type, drowsiness, blurred vision or swelling of the hands and feet can occur. Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Flomaxtra XL

•    Store in the original package.

•    Keep out of the sight and reach of children.

•    Do not use Flomaxtra XL after the expiry date printed on the pack. The expiry date refers to the last day of that month.

•    If the tablets become discoloured or show any other signs of deterioration, you should consult your pharmacist who will advise you what to do.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Flomaxtra XL contains

Your medicine is called Flomaxtra XL 400 micrograms tablets.

Each film-coated, prolonged release tablet contains 400 micrograms of tamsulosin hydrochloride, equivalent to 367 micrograms of tamsulosin.

Flomaxtra XL 400 micrograms tablets also contain the following inactive ingredients: macrogol 7 000 000, macrogol 8 000, magnesium stearate (E470b), colloidal silica, butylated hydroxytoluene (E321), hypromellose (E464) and yellow iron oxide (E172).

What Flomaxtra XL looks like and contents of the pack

Each round, mustard yellow tablet is marked ‘04' on one side and plain on the reverse.

Flomaxtra XL 400 micrograms tablets are available as blister packs of 30 tablets.

POM    PL No: 6464/2733

This product is manufactured by Astellas Pharma Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, The Netherlands and/or Astellas Pharma Europe B.V., Sylviusweg 52, 2333 BE Leiden, The Netherlands and is procured from within the EU and repackaged by the Product Licence holder:

Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

Leaflet revision and issue date (Ref.) 12.03.2014

Flomaxtra is a registered trademark of ASTELLAS PHARMA EUROPE B.V.

OMNIC® XL 400 micrograms TABLETS (Tamsulosin hydrochloride)

Patient Information Leaflet

This product is known as the above name, but will be referred to as Omnic XL throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine. It contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Omnic XL is and what it is used for

2.    Before you use Omnic XL

3.    How to use Omnic XL

4.    Possible side effects

5.    How to store Omnic XL

6.    Further information

1. What Omnic XL is and what it is used for

What is Omnic XL

The active ingredient in Omnic XL is tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and aids urination.

In the prostate gland, bladder and urethra there are specialised cells containing alpha1A- receptors that cause the muscles in the urethra to tighten. Omnic XL is an alpha1A- adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water.

What Omnic XL is used for

Omnic XL is used to treat the symptoms associated with benign prostatic hyperplasia (BPH) which is enlargement of the prostate gland. These symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water.

2. Before you use Omnic XL

Do not use Omnic XL if you

•    are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Omnic XL (see list in section 6 'Further information')

•    have a severe liver condition

•    have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking Omnic XL, particularly if you are also taking other alpha!- blockers. If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared.

Take special care with Omnic XL (and speak to your doctor)

•    If you have kidney problems

•    If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract).

Please inform your eye specialist that you have previously used, are using or are planning to use tamsulosin hydrochloride. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens.

Children

Do not give this medicine to children or adolescents under 18 years because it does not work in this population.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Omnic XL can affect the way that some other medicines work and some other medicines can affect the way that Omnic XL works.

In particular tell your doctor or pharmacist if you are taking:

•    Medicines to lower your blood pressure such as verapamil and diltiazem

•    Medicines to treat HIV such as ritonavir or indinavir.

•    Medicines to treat a fungal infection such as ketaconazole or itraconazole

•    Other alpha blockers such as doxazosin, indoramin, prazosin or alfuzosin

•    Erythromycin, an antibiotic used to treat infections

Please inform your doctor that you are on Omnic XL before any operation or dental procedure as there is a potential that your medicine may interfere with the effects of the anaesthetic.

Pregnancy, breast-feeding and fertility

Omnic XL is not indicated for use in women.

In men, abnormal ejaculation has been reported (ejaculation disorder).

This means that the semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

3. How to take Omnic XL

Dosage

For adults and the elderly, the dose is one tablet each day. It can be taken with or without food. Swallow the tablet whole. Do not crunch or chew.

Your doctor may want to examine you from time to time whilst you are taking this medicine.

If you take more Omnic XL than you should

If you have taken too many tablets, contact your doctor immediately or go to the nearest hospital casualty department taking any remaining medication and this patient information leaflet with you.

If you forget to take Omnic XL

You may take your tablet later the same day if you have forgotten to take it earlier. If you have missed a day, just continue to take your daily tablet from the next day. Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Omnic XL may cause side effects, although not everybody gets them.

Stop taking this medicine and consult your doctor immediately if any of the following occur - you may need medical treatment.

Rare (affects less than 1 in 1000 people)

• Swelling of the face, throat or tongue with breathing problems linked to allergy

Very rare (affects less than 1 in 10,000 people)

•    Persistent painful erection usually unrelated to sexual activity.

•    Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).

•    Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea).

The following side effects have also been reported:

Common (affects less than 1 in 10 people)

•    dizziness

•    abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

Uncommon (affects less than 1 in 100 people)

•    weakness

•    headache

•    runny or blocked nose

•    dizziness as you sit or stand up

•    palpitations (rapid or irregular heart beat)

•    gastro-intestinal symptoms such as nausea and vomiting (feeling or being sick), diarrhoea or constipation

•    hypersensitivity reactions such as rash, itching, redness, local swelling and breathing problems

Rare (affects less than 1 in 1000 people)

•    fainting

Not known (frequency cannot be estimated from the available data):

•    blurred vision

•    impaired vision

•    nose bleeds (epistaxis)

•    serious skin rashes (erythema multiform, dermatitis exfoliative)

•    dry mouth

As with other medicines of this type, drowsiness, blurred vision or swelling of the hands and feet can occur. Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Omnic XL

•    Store in the original package.

•    Keep out of the sight and reach of children.

•    Do not use Omnic XL after the expiry date printed on the pack. The expiry date refers to the last day of that month.

•    If the tablets become discoloured or show any other signs of deterioration, you should consult your pharmacist who will advise you what to do.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Omnic XL contains

Your medicine is called Omnic XL 400 micrograms tablets.

Each film-coated, prolonged release tablet contains 400 micrograms tamsulosin hydrochloride, (equivalent to 367 micrograms of tamsulosin).

Omnic XL 400 micrograms tablets also contain the following inactive ingredients:

macrogol 7 000 000, macrogol 8 000, magnesium stearate (E470b), colloidal silica, butylated hydroxytoluene (E321), hypromellose (E464) and yellow iron oxide (E172).

What Omnic XL looks like and contents of the pack

Each round, mustard yellow tablet is marked ‘04' on one side and plain on the reverse.

Omnic XL 400 micrograms tablets are available as blister packs of 30 tablets.

POM    PL No: 06464/2733

This product is manufactured by Astellas Pharma Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, The Netherlands and/or Astellas Pharma Europe B.V., Sylviusweg 52, 2333 BE Leiden, The Netherlands and is procured from within the EU and repackaged by the Product Licence holder:

Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

Leaflet revision and issue date (Ref.) 12.03.2014

Omnic is a registered trademark of Astellas Pharma Europe Ltd.

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