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PHYSIOTENS 200 MICROGRAMS FILM-COATED TABLETS

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S1162 LEAFLET Physiotens 20121015

PACKAGE LEAFLET: INFORMATION FOR THE USER

PHYSIOTENS 200 micrograms FILM-COATED TABLETS
(moxonidine)

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)

Your medicine is called Physiotens 200 micrograms Film-Coated
Tablets but will be referred to as Physiotens throughout the
remainder of the leaflet.



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.

Information for other strengths of Physiotens also may be present in
this leaflet.

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

Read all of this leaflet carefully before you start taking this
medicine.

Taking Physiotens with food and drink



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.



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.

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.

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

Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
Driving and using machines

6. Further information

You may feel sleepy or dizzy while taking Physiotens. If this
happens, talk to your doctor before driving or using any tools or
machines.

1. WHAT PHYSIOTENS IS AND WHAT IT IS USED FOR

Important information about some of the ingredients of
Physiotens

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.

Physiotens contains lactose (a type of sugar). If you have been told
by your doctor that you cannot tolerate or digest certain sugars, talk
to your doctor before taking this medicine.
3. HOW TO TAKE PHYSIOTENS

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)

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.



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.

How much to take



you have serious kidney problems

The usual starting dose is 200 micrograms a day.

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.
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 a severe heart problem such as angina or chest pain
at rest



you have kidney problems. Your doctor may need to adjust your
dose.

If any of the above apply to you (or 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.



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.
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

5. HOW TO STORE PHYSIOTENS



If you forget to take a dose, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the missed
dose.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store the above 25°C.



Do not take a double dose to make up for a forgotten dose.



Do not use after the expiry date printed on the carton or blister
label.



This medicine is for your use only. It can only be prescribed by
a doctor. Never give it to anyone else. It may harm them even if
their symptoms are the same as yours.



If the tablets becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.

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

6. FURTHER INFORMATION
What Physiotens contains


Each film-coated tablet contains 200 micrograms of
moxonidine.



Physiotens also contains the following inactive ingredients:
lactose monohydrate, povidone K25, crospovidone, magnesium
stearate, hypromellose, ethylcellulose, macrogol 6000, talc, red
ferric oxide E171 and titanium dioxide E172.

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:
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:

What Physiotens looks like and contents of the pack





Physiotens are small round light pink tablets marked ‘0.2’ on
one side and plain on the other.



Physiotens are available in calendar packs of 28 and 56 tablets.

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)

Product Licence holder

 dry mouth.
Common

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

(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).

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.

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.

Manufacturer
Physiotens are manufactured by Abbott Healthcare SAS, Route de
Belleville, Lieu-dit -Maillard-, 01400 Chatillon sur Chalaronne,
France.
POM

PL No. 19488/1162

Leaflet revision date: 15 October 2012
Physiotens is a registered trade mark of Solvay Pharmaceuticals
GmbH, Germany.
S1162 LEAFLET Physiotens 20121015

S1162 LEAFLET Moxonidine 20121015

PACKAGE LEAFLET: INFORMATION FOR THE USER

MOXONIDINE 200 micrograms FILM-COATED TABLETS
Your medicine is called Moxonidine 200 micrograms Film-Coated
Tablets but will be referred to as Moxonidine Tablet throughout the
remainder of the leaflet.
Information for other strengths of Moxonidine Tablet also may be
present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine.

In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:


other medicines to lower your blood pressure. Moxonidine
Tablet 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 Tablet” in
Section 3)



Moxonidine Tablet 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 Tablet works.



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

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



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

Taking Moxonidine Tablet with food and drink



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.



You can take the tablets with or without food.





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.

Do not drink alcohol while you are taking Moxonidine Tablet.
This is because Moxonidine Tablet 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
Tablet. Your doctor will advise you to take another medicine
instead of Moxonidine Tablet.



Tell your doctor if you are breast-feeding or about to start
breast-feeding. Moxonidine Tablet 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.

In this leaflet:
1. What Moxonidine Tablet is and what it is used for
2. Before you take Moxonidine Tablet
3. How to take Moxonidine Tablet
4. Possible side effects
5. How to store Moxonidine Tablet
6. Further information

Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.

1. WHAT MOXONIDINE TABLET IS AND WHAT IT IS USED FOR

Driving and using machines

Moxonidine Tablet contains a medicine called moxonidine. This
medicine belongs to a group of medicines called “antihypertensives”.

You may feel sleepy or dizzy while taking Moxonidine Tablet. If this
happens, talk to your doctor before driving or using any tools or
machines.
Important information about some of the ingredients of
Moxonidine Tablet

Moxonidine Tablet 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 TABLET
Do not take Moxonidine Tablet if:


you are allergic (hypersensitive) to moxonidine or any of the
other ingredients of Moxonidine Tablet (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 Tablet if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking
Moxonidine Tablet.
Take special care with Moxonidine Tablet
Check with your doctor or pharmacist before taking your medicine
if:


you have a heart problem called “1st degree AV-block”



you have a severe heart problem such as angina or chest pain
at rest



you have kidney problems. Your doctor may need to adjust your
dose.

If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking Moxonidine Tablet.
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 Tablet can affect the way some other
medicines work. Also some other medicines can affect the way
Moxonidine Tablet works.

Moxonidine Tablet contains lactose (a type of sugar). If you have
been told by your doctor that you cannot tolerate or digest certain
sugars, talk to your doctor before taking this medicine.
3. HOW TO TAKE MOXONIDINE TABLET
Always take Moxonidine Tablet 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 Tablet should not be given to children and young
people under 18 years.
If you take more Moxonidine Tablet than you should
If you take more Moxonidine Tablet 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 Tablet

5. HOW TO STORE MOXONIDINE TABLET



If you forget to take a dose, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the missed
dose.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store the above 25°C.



Do not take a double dose to make up for a forgotten dose.



Do not use after the expiry date printed on the carton or blister
label.



This medicine is for your use only. It can only be prescribed by
a doctor. Never give it to anyone else. It may harm them even if
their symptoms are the same as yours.



If the tablets becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

How to stop taking Moxonidine Tablet


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.

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

6. FURTHER INFORMATION
What Moxonidine Tablet contains


Each film-coated tablet contains 200 micrograms of
moxonidine.



Moxonidine Tablet also contains the following inactive
ingredients: lactose monohydrate, povidone K25, crospovidone,
magnesium stearate, hypromellose, ethylcellulose, macrogol
6000, talc, red ferric oxide E171 and titanium dioxide E172.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Moxonidine Tablet can cause side effects,
although not everybody gets them. The following side effects may
happen with this medicine:
Stop taking Moxonidine Tablet and see a doctor straight away
if you notice any of the following serious side effects – you
may need urgent medical treatment:

What Moxonidine Tablet looks like and contents of the pack





Moxonidine Tablet is small round light pink tablets marked ‘0.2’
on one side and plain on the other.



Moxonidine Tablet is available in calendar packs of 28 and 56
tablets.

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.
Common
(affects less than 1 in 10 people)

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



back pain



headache

Manufacturer



weakness (asthenia)



feeling dizzy (vertigo)



rash or itching (pruritus)

Moxonidine Tablet is manufactured by Abbott Healthcare SAS,
Route de Belleville, Lieu-dit -Maillard-, 01400 Chatillon sur
Chalaronne, France.



difficulty sleeping (insomnia), feeling sleepy (somnolence)



feeling sick (nausea), diarrhoea, being sick (vomiting),
indigestion (dyspepsia).

Uncommon

POM

PL No. 19488/1162

Leaflet revision date: 15 October 2012

(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.

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.

S1162 LEAFLET Moxonidine 20121015

Expand Transcript

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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