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MOXONIDINE TABLETS 200 MICROGRAMS

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S1603 LEAFLET Physiotens 20120719

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

PHYSIOTENS TABLETS 200 micrograms
MOXONIDINE TABLETS 200 micrograms
(moxonidine)



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)



PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

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





You can take the tablets with or without food.

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





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

Do not drink alcohol while you are taking Physiotens. This is
because Physiotens may increase the effects of alcohol.

Pregnancy and breast-feeding



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.



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

Always take Physiotens exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

Do not take Physiotens if:

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 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

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.

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.
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 above 25°C.



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



Do not take the tablets after the expiry date printed on the
packet.



Take any tablets you haven’t used to a 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.

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.
4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION
What Physiotens contains


Each tablet contains 200 micrograms of moxonidine.



Physiotens also contains the following inactive ingredients:
lactose, crospovidone, povidone, magnesium stearate,
hydroxypropylmethylcellulose, ethylcellulose, talc, polyethylene
glycol 6000, E171 and E172.

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:


swelling of the face, lips or mouth (angioedema). This is
uncommon, affecting less than 1 in 100 people.

What Physiotens looks like and contents of the pack


Physiotens are round, pale pink and are marked 0.2.



Physiotens is available in calendar blister packs of 28.

Other side effects include:

Product Licence holder

Very 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 more than 1 in 10 people)
 dry mouth.
Common
(affects less than 1 in 10 people)

Manufacturer
Physiotens are manufactured by Solvay Pharmaceuticals, 01400
Chatillon-sur- Chalaronne, France.



back pain



headache



weakness (asthenia)



feeling dizzy (vertigo)



rash or itching (pruritus)

Leaflet revision date: 19 July 2012



difficulty sleeping (insomnia), feeling sleepy (somnolence)



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

Physiotens is a registered trade mark of Solvay Pharmaceuticals
GmbH, Germany.

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.

POM

PL No. 19488/1603

S1603 LEAFLET Physiotens 20120719

S1603 LEAFLET Moxonidine Tablets 20120719

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

MOXONIDINE TABLETS 200 micrograms
(moxonidine)
Your medicine is called Moxonidine Tablets 200 micrograms but will
be referred to as Moxonidine Tablets throughout the remainder of
the leaflet.



other medicines to lower your blood pressure. Moxonidine
Tablets may increase the effect of these medicines



medicines for depression such as imipramine or amitriptyline



tranquillisers, sedatives or sleeping tablets such as
benzodiazepines



PACKAGE LEAFLET: INFORMATION FOR THE USER

beta-blockers (see “If you stop taking Moxonidine Tablets” in
Section 3)



Moxonidine Tablets are 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 Tablets work.

Information for other strengths of Moxonidine Tablets also may be
present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine.

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



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

Taking Moxonidine Tablets with food and drink



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



You can take the tablets with or without food.



Do not drink alcohol while you are taking Moxonidine Tablets.
This is because Moxonidine Tablets may increase the effects of
alcohol.



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.

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
Tablets. Your doctor will advise you to take another medicine
instead of Moxonidine Tablets.



Tell your doctor if you are breast-feeding or about to start
breast-feeding. Moxonidine Tablets are 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 Tablets are and what they are used for
2. Before you take Moxonidine Tablets
3. How to take Moxonidine Tablets
4. Possible side effects
5. How to store Moxonidine Tablets
6. Further information

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

1. WHAT MOXONIDINE TABLETS ARE AND WHAT THEY ARE
USED FOR
Moxonidine Tablets contain a medicine called moxonidine. This
medicine belongs to a group of medicines called “antihypertensives”.
Moxonidine Tablets are 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 TABLETS
Do not take Moxonidine Tablets if:


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

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



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





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

Children and young people



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

Moxonidine Tablets should not be given to children and young
people under 18 years.

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

If you take more Moxonidine Tablets than you should
If you take more Moxonidine Tablets 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 Tablets

5. HOW TO STORE MOXONIDINE TABLETS



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 above 25°C.



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



Do not take the tablets after the expiry date printed on the
packet.



Take any tablets you haven’t used to a 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.

How to stop taking Moxonidine Tablets


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.
4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION
What Moxonidine Tablets contain


Each tablet contains 200 micrograms of moxonidine.



Moxonidine Tablets also contain the following inactive
ingredients: lactose, crospovidone, povidone, magnesium
stearate, hydroxypropylmethylcellulose, ethylcellulose, talc,
polyethylene glycol 6000, E171 and E172.

Like all medicines, Moxonidine Tablets can cause side effects,
although not everybody gets them. The following side effects may
happen with this medicine:
Stop taking Moxonidine Tablets 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.
Common

What Moxonidine Tablets look like and contents of the pack


Moxonidine Tablets are round, pale pink and are marked 0.2.



Moxonidine Tablets are available in calendar blister packs of
28.

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.

(affects less than 1 in 10 people)

Manufacturer



back pain



headache

Moxonidine Tablets are manufactured by Solvay Pharmaceuticals,
01400 Chatillon-sur- Chalaronne, France.



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.

POM

PL No. 19488/1603

Leaflet revision date: 19 July 2012
S1603 LEAFLET Moxonidine Tablets 20120719

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