OMNIC XL 400MICROGRAMS TABLETS

Active substance: TAMSULOSIN HYDROCHLORIDE

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27mm

FLOMAXTRA® XL 400 micrograms TABLETS
(Tamsulosin hydrochloride)
Patient Information Leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

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

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

WARNING!

Take special care with Flomaxtra XL (and speak to your doctor)
• If you have kidney problems
• If you are undergoing 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.

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.

DATE:
19/10/12
DATE OF PROOF:

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

UK PIL DATED SEPTEMBER 2012

06464/2776D

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.

CODE:

DT
ARTWORKER:
PRODUCT:

Flomaxtra XL 400mcg Tabs

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

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

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.

FREE CONFIDENTIAL PATIENT SUPPORT INFORMATION
Dear Patient,
Your doctor has prescribed Flomaxtra XL to help treat your prostate symptoms.
To help ensure you have the best possible information about your condition, you can request
patient support information.
This service is completely confidential and free of charge. No personal details will be kept.
Just fill in the form overleaf and send it to the address given or ring the Astellas
FREEPHONE NUMBER on 0800 068 8068.
May we take this opportunity of wishing you the very best of health.
Waymade Plc on behalf of Astellas Pharma Ltd.
This service is provided by Astellas and is not associated with Waymade Plc.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

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 alpha1- blockers. If you do
feel weak or dizzy make sure you sit or lie down straight away until the symptoms have
disappeared.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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

PROOF HISTORY:
v.1 - waymade - 19/10/12

Leaflet Flat Size = 148 x 400

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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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

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
As with other medicines of this type, drowsiness, blurred vision, dry mouth or swelling of the hands and feet
can occur.
Tell your doctor or pharmacist if any of the above symptoms become troublesome or last longer than a few
days, or if you notice any side effects not listed in this leaflet.

WARNING!

6. Further information
What Flomaxtra XL contains
Each film-coated, prolonged release tablet contains 400 micrograms tamsulosin hydrochloride, (equivalent to
367 micrograms of tamsulosin).

DATE:

CUSTOMER
APPROVED:



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

What Flomaxtra XL 400 micrograms tablets looks like and contents of the pack
These tablets are round, dark yellow, bi-convex, film-coated and engraved with ‘04’ on one side and plain on
the other.

13/02/13
DATE OF PROOF:

POM

PL No: 06464/2776

This product is manufactured by Astellas Pharma Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, The
Netherlands and is procured from within the EU and repackaged by theand 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.) 11.2.2013

UK PIL DATED SEPTEMBER 2012

06464/2776D

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

CODE:

DT

Product Licence Holder and Manufacturer

Flomaxtra XL 400mcg Tabs

ARTWORKER:

DATE:

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

PRODUCT:

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

Flomaxtra XL 400 micrograms tablets also contain the following inactive ingredients:
Tablet core: macrogol 7000000, macrogol 8000 and magnesium stearate.
Film-coat: Opadry yellow 03F22733 (which contains: hypromellose, macrogol 8000 and yellow iron oxide
(E172).

Send this form in an envelope to Astellas Pharma Ltd., PO Box 2097, Pulborough, RH20 2WP
or ring the Astellas free-of-charge number on 0800 068 8068.

Colour
Swatch

Your name
Black

Address

WARNING!







WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

The following side effects have also been reported:
Common (affects less than 1 in 10 people)
• dizziness
• abnormal ejaculation (i.e. less, or no noticeable, semen ejaculated)

PROOF HISTORY:
v.1 - waymade - 13/02/13

Leaflet Flat Size = 148 x 400

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).

27mm

OMNIC® XL 400 micrograms TABLETS
(Tamsulosin hydrochloride)
Patient Information Leaflet

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

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

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.

WARNING!

Take special care with Omnic XL (and speak to your doctor)
• If you have kidney problems
• If you are undergoing 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.

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.

DATE:
13/02/13
DATE OF PROOF:

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

UK PIL DATED SEPTEMBER 2012

06464/2776D

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.

CODE:

DT
ARTWORKER:
PRODUCT:

Omnic XL 400mcg Tabs

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

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

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.

FREE CONFIDENTIAL PATIENT SUPPORT INFORMATION
Dear Patient,
Your doctor has prescribed Omnic XL to help treat your prostate symptoms.
To help ensure you have the best possible information about your condition, you can request
patient support information.
This service is completely confidential and free of charge. No personal details will be kept.
Just fill in the form overleaf and send it to the address given or ring the Astellas
FREEPHONE NUMBER on 0800 068 8068.
May we take this opportunity of wishing you the very best of health.
Waymade Plc on behalf of Astellas Pharma Ltd.
This service is provided by Astellas and is not associated with Waymade Plc.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

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 alpha1- blockers. If you do
feel weak or dizzy make sure you sit or lie down straight away until the symptoms have
disappeared.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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

PROOF HISTORY:
v.1 - waymade - 13/02/13

Leaflet Flat Size = 148 x 400

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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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

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
As with other medicines of this type, drowsiness, blurred vision, dry mouth or swelling of the hands and feet
can occur.
Tell your doctor or pharmacist if any of the above symptoms become troublesome or last longer than a few
days, or if you notice any side effects not listed in this leaflet.

WARNING!

6. Further information
What Omnic XL contains
Each film-coated, prolonged release tablet contains 400 micrograms tamsulosin hydrochloride, (equivalent to
367 micrograms of tamsulosin).

DATE:

CUSTOMER
APPROVED:



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

What Omnic XL 400 micrograms tablets looks like and contents of the pack
These tablets are round, dark yellow, bi-convex, film-coated and engraved with ‘04’ on one side and plain on
the other.

13/02/13
DATE OF PROOF:

POM

PL No: 06464/2776

This product is manufactured by Astellas Pharma Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, 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.) 11.2.2013

UK PIL DATED SEPTEMBER 2012

06464/2776D

Omnic is a registered trademark of Astellas Pharma Europe B.V.

CODE:

DT

Product Licence Holder and Manufacturer

Omnic XL 400mcg Tabs

ARTWORKER:

DATE:

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

PRODUCT:

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

Omnic XL 400 micrograms tablets also contain the following inactive ingredients:
Tablet core: macrogol 7000000, macrogol 8000 and magnesium stearate.
Film-coat: Opadry yellow 03F22733 (which contains: hypromellose, macrogol 8000 and yellow iron oxide
(E172).

Send this form in an envelope to Astellas Pharma Ltd., PO Box 2097, Pulborough, RH20 2WP
or ring the Astellas free-of-charge number on 0800 068 8068.

Colour
Swatch

Your name
Black

Address

WARNING!







WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

The following side effects have also been reported:
Common (affects less than 1 in 10 people)
• dizziness
• abnormal ejaculation (i.e. less, or no noticeable, semen ejaculated)

PROOF HISTORY:
v.1 - waymade - 13/02/13

Leaflet Flat Size = 148 x 400

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).

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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