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XISMOX 60 XL PROLONGED RELEASE TABLETS

Active substance(s): ISOSORBIDE MONONITRATE

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Patient Information Leaflet

Tardisc® XL 60 Prolonged Release Tablets
(Isosorbide Mononitrate)
Please read all of this leaflet carefully before
you start taking Tardisc XL 60 because it
contains important information for you.
This medicine is available without prescription.
However, you still need to use TARDISC XL 60
Prolonged Release Tablets carefully to get the
best results from it.
 
     
again.
 
  
 
information or advice.
   
 
 
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Tardisc XL 60 is and what it is used for
2. What you need to know before you take
Tardisc XL 60
3. How to take Tardisc XL 60
4. Possible side effects
5. How to store Tardisc XL 60
6. Contact of the pack and other information
1. WHAT TARDISC XL 60 IS AND WHAT IT
IS USED FOR
The name of your medicine is TARDISC XL 60
Prolonged Release Tablets (referred to as
TARDISC XL 60) throughout this leaflet.
TARDISC XL 60 contains the active ingredient
Isosorbide Mononitrate, which belongs to a group
of medicines called nitrates. It is used to
prevent an attack of angina pectoris (chest
pain) from happening. Angina is a crushing pain
or tightness in the chest, although the pain may

      

when the muscle in the heart does not receive
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improving the supply
of blood and oxygen to the heart muscle. The
tablets will release your medicine slowly and will
treat your condition throughout the day.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE TARDISC XL 60
DO NOT use these tablets to treat sudden
chest pain (acute agina). Instead seek
immediate medical attention. These tablets
!
!  
   

prevent symptoms of angina from happening.
Do not take TARDISC XL 60 if:
    -

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mononitrate or any of the other ingredients of
Tardisc XL 60 (listed in Section 6: Further
information).
  //  

  // ! 


  /
/   
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'cardiomyopathy' or 'pericarditis' or you have
narrow heart valves.
    
 
   

called Phosphodiesterase Type 5 inhibitors,
(used for male impotence). See the section
3    
3
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WARNINGS AND PRECAUTIONS
Take special care with TARDISC XL 60
   /  -
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with your doctor as treatment may be started
with a 30mg dose.
  
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   /  - ! /  
your blood, due to lung disease for example).
  
   -


include shivering, abnormal drowsiness,
confusion)
  
     
  
  
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If any of the above apply to you, or you are not

   
 
   
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Children
This medicine is not suitable for children.
Other medicines and Tardisc XL 60
Please tell your doctor or pharmacist if you are
   /   
medicines, including medicines obtained without
a prescription and herbal medicines. This is
because Tardisc XL 60 can affect the way some
  
! 
  
  /
an effect on Tardisc XL 60. You should not take
Viagra (sildenafil) or other medicines from
this group such as Cialis (tadalafil) or Levitra
(vardenafil), drugs used for erectile
dysfunction (impotence in men), whilst on
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preparations such as TARDISC XL 60 as well can
cause a severe and possible dangerous fall in
blood pressure. This could result in fainting, or
even worse, in a heart attack.
The following medicines may interfere with the
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sharp and severe drop in blood pressure)
   -

   
eye during cataract surgery and other types of
eye surgery)
 
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in some medical conditions)
 

   


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vasodilators, angiotensin II receptor
antagonists, ACE inhibitors).
Taking TARDISC XL 60 with alcohol
Avoid drinking alcohol!   "#$%
&'*+

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may be worse than normal and you may feel
dizzy or faint.
Pregnancy and breast-feeding
TARDISC XL 60 should not be used during
 !
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advice from your doctor if you become pregnant
!   
  
Driving and using machines
Do not drive or operate machinery until you
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you are confident that it won't affect your driving.
If you experience headache or dizziness following
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your doctor before you start driving or using
machines.
TARDISC XL 60 contains lactose and sucrose
If you have been told by your doctor that you
have an intolerance to one or more sugars,
    
   
product.

3. HOW TO TAKE TARDISC XL 60
This medicine has been prescribed for you and

    

 

 ! 
pharmacist if you are not sure. It is important
that you take this medicine only once a day
and at the same time each day. This is
important to reduce the risk of your body
becoming less sensitive to the effects of
TARDISC XL 60.
TARDISC XL 60 tablets should be swallowed with
half a glass of water and must not be crushed or
chewed.
The recommended dose is:
Adults: one TARDISC XL 60 tablet once daily in
the morning.
  /
  

according to your symptoms, age and other
   

      
(30 mg) up to 2 tablets (120 mg) a day, both to be
   
Use in Children
This medicine is not recommended for children.
Use in Elderly
If you are an elderly person, your dosage should
be the same as above, unless you suffer from low
 

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disorder – in any case you should follow your
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TARDISC XL 60 or existing treatment (see
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You must not take Tardisc XL 60 for a sudden
attack of angina. If you have a sudden attack,
take a glycerol trinitrate tablet (follow the
instructions given on the label).
Very occasionally, some people see the remains
of the tablet in their bowel motions. This is quite
normal and does not mean that the medicine has
not been released.
If you take more TARDISC XL 60 than you
should
     




      
nearest hospital casualty department or tell your
doctor immediately.
"   ! 
!
doctor:
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! 

   
Symptoms of an overdose can include:
pounding headache, excitation, cold sweat,
nausea (feeling sick), vomiting (being sick),
vertigo (a feeling of dizziness or "spinning"),
fainting, racing pulse.
If you forget to take TARDISC XL 60
    
  



you remember. However, if it is almost time for

 


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Do not take a double dose to make up for a
forgotten dose.
If you stop taking TARDISC XL 60
Do not suddenly stop taking TARDISC XL 60
tablets, as this could make your angina
worse. If your treatment is to be stopped this
should be done gradually. Be sure to follow your
=
 
 


pharmacist any further questions you may have.
4. POSSIBLE SIDE EFFECTS
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side effects, although not everybody gets them.
Serious side effects:
If you suffer from any of the following signs, tell
your doctor immediately:
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Other side effects:
 
 
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mononitrate, particularly when treatment begins.
Common (may affect up to 1 in 10 people)
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it usually disappears in time on continued use
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up from a lying or sitting position, but this
usually disappear in time on continued use.
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Uncommon (may affect up to 1 in 100 people)
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Very rare (may affect up to 1 in 10,000 people)
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If you develop any of these side effects and they
are severe, or they get worse, or last for more
than a few days, contact your doctor or
pharmacist. If you have any other unexpected
 
!
  
   
or pharmacist immediately.
5. HOW TO STORE TARDISC XL 60

   
   
children. These tablets should not be stored
above 25°C. Do not transfer them to another
container. Do not use TARDISC XL 60 after the
expiry date which is stated on the blister and
   =W=   

the last day of that month. Medicines should not
be disposed of via wastewater or household
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!

 
medicines no longer required or past their expiry
date. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What TARDISC XL 60 contains
   /

 


   
(60 mg).
   
     

silica, hypromellose 2208, lactose
 - 
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(composed of sucrose and maltodextrin),
magnesium stearate, iron oxide yellow E172.
What TARDISC XL 60 looks like and contents
of the pack
TARDISC XL 60 tablets are light yellow, biconvex,
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tablets); 30 tablets in foil blister strips (3 blister
 
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Marketing Authorisation Holder and
Manufacturer:
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This leaflet was last revised in January 2014.

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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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