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MOXONIDINE 400MICROGRAM TABLETS

Active substance(s): MOXONIDINE

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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

PHYSIOTENS® 400 microgram TABLETS/
MOXONIDINE 400 microgram TABLETS
(moxonidine)
Patient Information Leaflet

27mm

Your medicine is known by the above names but will be referred to as Physiotens in this leaflet. Other
strengths (200 micrograms and 300 micrograms) are also available.

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

1. What Physiotens is and what it is used for
Physiotens contains a medicine called moxonidine. This medicine belongs to a group of medicines called
“anti-hypertensives”.
Physiotens is used to treat high blood pressure (hypertension). It works by making your blood vessels relax
and widen. This helps to lower your blood pressure.
2. Before you take Physiotens
Do not take Physiotens if:
• you are allergic (hypersensitive) to moxonidine or any of the other ingredients of Physiotens (listed
in section 6)
• you have a slow heart rate caused by a heart problem called “sick sinus syndrome” or “2nd or 3rd
degree AV-block”
• you have heart failure
• you have serious kidney problems

WARNING!

Do not take Physiotens if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist
before taking Physiotens.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines obtained without a prescription, including herbal medicines. This is because Physiotens
can affect the way some other medicines work. Also some other medicines can affect the way Physiotens
works.

UK PIL DATED DECEMBER 2010

6464/1896D

07/01/13

Taking Physiotens with food and drink
• You can take the tablets with or without food
• Do not drink alcohol while you are taking Physiotens. This is because Physiotens may increase the
effects of alcohol.

CODE:

DT

DATE OF PROOF:

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Physiotens.

physiotens 400mcg tabs

ARTWORKER:

DATE:

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• other medicines to lower your blood pressure.
Physiotens may increase the effect of these medicines
• medicines for depression such as imipramine or amitriptyline
• tranquillisers, sedatives or sleeping tablets such as benzodiazepines
• beta-blockers (see “If you stop taking Physiotens” in section 3)
• Physiotens is removed from your body by your kidneys through a process called “tubular excretion”.
Other medicines removed from the kidneys in the same way could affect how Physiotens works.

Pregnancy and breast-feeding
• Tell your doctor if you are pregnant or might become pregnant. Your doctor will normally advise you
to stop taking Physiotens. Your doctor will advise you to take another medicine instead of
Physiotens.
• Tell your doctor if you are breast-feeding or about to start breast-feeding. Physiotens is not
recommended for mothers who are breast-feeding. Your doctor may advise you to take another
medicine if you want to breast-feed, or may ask you to stop breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
You may feel sleepy or dizzy while taking Physiotens. If this happens, talk to your doctor before driving or
using any tools or machines.
Important information about some of the ingredients of Physiotens
Physiotens contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or
digest some sugars, talk to your doctor before taking this medicine.
3. How to take Physiotens
Always take Physiotens exactly as your doctor has told you. You should check with your doctor or pharmacist
if you are not sure.
Taking this medicine
• Swallow the tablets whole with a full glass of water.
• Try to take your tablets around the same time each day. This will help you remember to take them.
How much to take
The usual starting dose is 200 micrograms a day.
• Your doctor may increase this dose to up to 600 micrograms a day
• If your doctor has told you to take 600 micrograms a day, this should be split in two (300
micrograms in the morning and 300 micrograms in the evening)
• Your doctor may tell you to take a lower dose if you have kidney problems.
Children and young people
Physiotens should not be given to children and young people under 18 years.

Colour
Swatch

Black

WARNING!

DATE:

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Physiotens.

PRODUCT:

05-0269
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

Take special care with Physiotens
Check with your doctor or pharmacist before taking your medicine if:
• you have a heart problem called “1st degree AV-block”
• you have severe heart problem such as angina or chest pain at rest
• you have kidney problems. Your doctor may need to adjust your dose.

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 Physiotens is and what it is used for
2. Before you take Physiotens
3. How to take Physiotens
4. Possible side effects
5. How to store Physiotens
6. Further information

PROOF HISTORY:
v.1 - waymade - 07/01/13

Leaflet Flat Size = 148 x 400

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or 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 becomes 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.

If you take more Physiotens than you should
If you take more Physiotens than you should, talk to a doctor or go to a hospital straight away. Take the
medicine pack with you. The following effects may happen: headache, feeling sleepy (somnolence,
sedation), fall in blood pressure (hypotension), slow heart rate (bradycardia), feeling dizzy (vertigo), being
sick (vomiting), feeling tired (fatigue), weakness and pain in your stomach (abdominal pain).
If you forget to take Physiotens
• If you forget to take a dose, take it as soon as your remember it. However, if it is nearly time for the
next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
How to stop taking Physiotens
• Keep taking your tablets until your doctor decides that you should stop.
• If you need to stop, your doctor will lower your dose slowly over a few weeks. If you are taking more
than one medicine for high blood pressure (such as beta-blockers), your doctor will tell you which
medicine to stop first. This is so that your body can adjust slowly to the change.

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

Stop taking Physiotens and see a doctor straight away if you notice any of the following serious side
effects - you may need urgent medical treatment:
• swelling of the face, lips or mouth (angioedema).
This is uncommon, affecting less than 1 in 100 people.
Other side effects include:
Very common (affects more than 1 in 10 people)
• dry mouth.

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





DATE:
07/01/13



6. Further information
Your medicine is called Physiotens 400 micrograms tablets/Moxonidine 400 micrograms tablets. Each tablet
contains 400 micrograms of the active ingredient, Moxonidine, in a dull red, round, tablet marked ‘0.4’ on one
side and plain on the reverse.

DATE OF PROOF:

Physiotens 400 microgram tablets/Moxonidine 400 microgram tablets also contain the following:
Lactose, hypromellose, magnesium stearate, crospovidone, povidone, ethyl cellulose, talc, macrogol 6000,
titanium dioxide (E171) and red iron oxide (E172).
Physiotens 400 microgram tablets/Moxonidine 400 microgram tablets are available in calendar blister
packs of 28 tablets.

UK PIL DATED DECEMBER 2010

6464/1896D

POM

CODE:

PRODUCT:

physiotens 400mcg tabs

ARTWORKER:

DT

Q.A.
APPROVED:
PRE-PRESS NO.:

05-0269



5. How to store Physiotens
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to
the last day of that month.
Physiotens 400 micrograms tablets/Moxonidine 400 micrograms tablets should not be stored above
25°C.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist.
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.

PL No: 6464/1896

This product is manufactured by Solvay Pharmaceuticals GmbH, D 31535 Neustadt a. Rbge, Germany 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.) 4.1.2013
Physiotens is a registered trademark of Solvay Pharmaceuticals GmbH.

Colour
Swatch

Black

000-0000D

WARNING!



CUSTOMER: Waymade

WARNING!

Uncommon (affects less than 1 in 100 people)
• neck pain
• feeling nervous
• fainting (syncope)
• swelling (oedema)
• ringing or noise in the ears (tinnitus)
• unusually slow heartbeat (bradycardia)
• low blood pressure, including low blood pressure when standing up.
DATE:

CUSTOMER
APPROVED:

Common (affects less than 1 in 10 people)
• back pain
• headache
• weakness (asthenia)
• feeling dizzy (vertigo)
• rash or itching (pruritus)
• difficulty sleeping (insomnia), feeling sleepy (somnolence)
• feeling sick (nausea), diarrhoea, being sick (vomiting), indigestion (dyspepsia).

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:

4. Possible side effects
Like all medicines Physiotens can cause side effects, although not everybody gets them. The following side
effects may happen with this medicine:

PROOF HISTORY:
v.1 - waymade - 07/01/13

Leaflet Flat Size = 148 x 400

If you have any further questions on the use of this product, ask 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.

000-0000D

MOXONIDINE 400 microgram TABLETS
Patient Information Leaflet
27mm

Your medicine is known by the above name but will be referred to as Moxonidine in this leaflet. Other
strengths (200 micrograms and 300 micrograms) are also available.

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

1. What Moxonidine is and what it is used for
Moxonidine contains a medicine called moxonidine. This medicine belongs to a group of medicines called
“anti-hypertensives”.
Moxonidine is used to treat high blood pressure (hypertension). It works by making your blood vessels relax
and widen. This helps to lower your blood pressure.
2. Before you take Moxonidine
Do not take Moxonidine if:
• you are allergic (hypersensitive) to moxonidine or any of the other ingredients of Moxonidine (listed
in section 6)
• you have a slow heart rate caused by a heart problem called “sick sinus syndrome” or “2nd or 3rd
degree AV-block”
• you have heart failure
• you have serious kidney problems
Do not take Moxonidine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist
before taking Moxonidine.

WARNING!

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Moxonidine.

UK PIL DATED DECEMBER 2010

Taking Moxonidine with food and drink
• You can take the tablets with or without food
• Do not drink alcohol while you are taking Moxonidine. This is because Moxonidine may increase the
effects of alcohol.
Pregnancy and breast-feeding
• Tell your doctor if you are pregnant or might become pregnant. Your doctor will normally advise you
to stop taking Moxonidine. Your doctor will advise you to take another medicine instead of
Moxonidine.
• Tell your doctor if you are breast-feeding or about to start breast-feeding. Moxonidine is not
recommended for mothers who are breast-feeding. Your doctor may advise you to take another
medicine if you want to breast-feed, or may ask you to stop breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
You may feel sleepy or dizzy while taking Moxonidine. If this happens, talk to your doctor before driving or
using any tools or machines.
Important information about some of the ingredients of Moxonidine
Moxonidine contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate
or digest some sugars, talk to your doctor before taking this medicine.
3. How to take Moxonidine
Always take Moxonidine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Taking this medicine
• Swallow the tablets whole with a full glass of water.
• Try to take your tablets around the same time each day. This will help you remember to take them.
How much to take
The usual starting dose is 200 micrograms a day.
• Your doctor may increase this dose to up to 600 micrograms a day
• If your doctor has told you to take 600 micrograms a day, this should be split in two (300
micrograms in the morning and 300 micrograms in the evening)
• Your doctor may tell you to take a lower dose if you have kidney problems.
Children and young people
Moxonidine should not be given to children and young people under 18 years.

Colour
Swatch

Black

WARNING!

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• other medicines to lower your blood pressure.
Moxonidine may increase the effect of these medicines
• medicines for depression such as imipramine or amitriptyline
• tranquillisers, sedatives or sleeping tablets such as benzodiazepines
• beta-blockers (see “If you stop taking Moxonidine” in section 3)
• Moxonidine is removed from your body by your kidneys through a process called “tubular excretion”.
Other medicines removed from the kidneys in the same way could affect how Moxonidine works.

6464/1896D

07/01/13
DATE OF PROOF:

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines obtained without a prescription, including herbal medicines. This is because Moxonidine
can affect the way some other medicines work. Also some other medicines can affect the way Moxonidine
works.

CODE:

DATE:

DT
ARTWORKER:
PRODUCT:

Moxonidine 400mcg tabs

Q.A.
APPROVED:
CUSTOMER: Waymade

05-0269

DATE:

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Moxonidine.

PRE-PRESS NO.:

CUSTOMER
APPROVED:

Take special care with Moxonidine
Check with your doctor or pharmacist before taking your medicine if:
• you have a heart problem called “1st degree AV-block”
• you have severe heart problem such as angina or chest pain at rest
• you have kidney problems. Your doctor may need to adjust your dose.

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 Moxonidine is and what it is used for
2. Before you take Moxonidine
3. How to take Moxonidine
4. Possible side effects
5. How to store Moxonidine
6. Further information

PROOF HISTORY:
v.1 - waymade - 07/01/13

Leaflet Flat Size = 148 x 400

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or 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 becomes 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.

If you take more Moxonidine than you should
If you take more Moxonidine than you should, talk to a doctor or go to a hospital straight away. Take the
medicine pack with you. The following effects may happen: headache, feeling sleepy (somnolence,
sedation), fall in blood pressure (hypotension), slow heart rate (bradycardia), feeling dizzy (vertigo), being
sick (vomiting), feeling tired (fatigue), weakness and pain in your stomach (abdominal pain).
If you forget to take Moxonidine
• If you forget to take a dose, take it as soon as your remember it. However, if it is nearly time for the
next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
How to stop taking Moxonidine
• Keep taking your tablets until your doctor decides that you should stop.
• If you need to stop, your doctor will lower your dose slowly over a few weeks. If you are taking more
than one medicine for high blood pressure (such as beta-blockers), your doctor will tell you which
medicine to stop first. This is so that your body can adjust slowly to the change.

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

Stop taking Moxonidine and see a doctor straight away if you notice any of the following serious side
effects - you may need urgent medical treatment:
• swelling of the face, lips or mouth (angioedema).
This is uncommon, affecting less than 1 in 100 people.
Other side effects include:
Very common (affects more than 1 in 10 people)
• dry mouth.

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






UK PIL DATED DECEMBER 2010

POM

6464/1896D

07/01/13

Moxonidine 400 microgram tablets are available in calendar blister strips in blister packs of 28 tablets.

CODE:

DATE:

DT

DATE OF PROOF:

Moxonidine 400 micrograms tablets also contain the following:
Lactose, hypromellose, magnesium stearate, crospovidone, povidone, ethyl cellulose, talc, macrogol 6000,
titanium dioxide (E171) and red iron oxide (E172).

Moxonidine 400mcg tabs

ARTWORKER:

6. Further information
Your medicine is called Moxonidine 400 microgram tablets. Each tablet contains 400 micrograms of the
active ingredient, Moxonidine, in a dull red, round tablet marked ‘0.4’ on one side and plain on the reverse.

PRODUCT:

Q.A.
APPROVED:
05-0269
PRE-PRESS NO.:



5. How to store Moxonidine
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to
the last day of that month.
Moxonidine 400 microgram tablets should not be stored above 25°C.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist.
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.

PL No: 6464/1896

This product is manufactured by Solvay Pharmaceuticals GmbH, D 31535 Neustadt a. Rbge, Germany 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.) 4.1.2013

Colour
Swatch

Black

000-0000D

WARNING!



CUSTOMER: Waymade

WARNING!

Uncommon (affects less than 1 in 100 people)
• neck pain
• feeling nervous
• fainting (syncope)
• swelling (oedema)
• ringing or noise in the ears (tinnitus)
• unusually slow heartbeat (bradycardia)
• low blood pressure, including low blood pressure when standing up.
DATE:

CUSTOMER
APPROVED:

Common (affects less than 1 in 10 people)
• back pain
• headache
• weakness (asthenia)
• feeling dizzy (vertigo)
• rash or itching (pruritus)
• difficulty sleeping (insomnia), feeling sleepy (somnolence)
• feeling sick (nausea), diarrhoea, being sick (vomiting), indigestion (dyspepsia).

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:

4. Possible side effects
Like all medicines Moxonidine can cause side effects, although not everybody gets them. The following side
effects may happen with this medicine:

PROOF HISTORY:
v.1 - waymade - 07/01/13

Leaflet Flat Size = 148 x 400

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

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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