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GENFURA 100MG TABLETS

Active substance(s): NITROFURANTOIN

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Product:

Genfura 50 mg &
100 mg Tablets

Printing Colours:

Non-Printing Colours:

Black

MA Holder:

Metwest

PL No.:

17521/0023 - 0024

Pack Size:

All

Dimensions:

Livery:

Metwest

Created By:

Manufacturer:

-

Profile

Final Preparation Date For Submission: 31/07/2014

Packing Site Technical Approval:

Market:

UK

Component:

Blister Leaflet

00/00/0000
148 x 297 mm

Artwork Code:

M0023-0024/O/PIL1-Br/M2

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
9 pt

Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
00/00/0000
00/00/0000

PACKAGE LEAFLET: INFORMATION FOR THE USER

GENFURA 50 mg &
100 mg TABLETS
(Nitrofurantoin)
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 become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS
1. What Genfura is for
2. Before you take Genfura
3. How to take Genfura
4. Possible side effects
5. How to store Genfura
6. Further information

1. WHAT GENFURA IS FOR
Genfura Tablets contain the active ingredient
nitrofurantoin which is an antibiotic. It can be used to
treat and prevent bacterial infections of the bladder,
kidney and other parts of the urinary tract.
If you are not sure why you have been prescribed
these tablets then please ask your doctor.

2. BEFORE YOU TAKE GENFURA
Do not take Genfura and tell your doctor if:
  2   * 
ingredients in the tablets (listed in section 6 of this
leaflet) or to other nitrofuran antibiotics. The signs
of an allergic reaction include a rash, itching or
shortness of breath
 + ' 
! 
infection). Your doctor will assess whether you may
take Genfura depending on how well your kidneys
are working.
 +
  '  
where you may have too many red blood cells
 + 787

 
!&89#
  "    

'
the red blood cells are broken down under stressful
conditions or due to taking medicines
 7
   ' &89
deficiency
      "
This medicine should not be given to infants under 3
months old.
Take special care with Genfura
Tell your doctor before you take this medicine if:
     &89
  
 + '  +*  +
system
 +  

 ++  
  * 
 +  !""   *  
sodium) imbalance
 '"
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking this
medicine.

Having tests
Your doctor will monitor you closely for any effects on
your liver, lungs, blood or nervous system, especially if
you are taking Genfura for long-term treatment.
If you are having urine tests, tell the doctor that you are
taking Genfura as it may interfere with the results.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, even medicines
bought without a prescription. This is because Genfura
can affect the way some other medicines work. Also,
some medicines can affect the way Genfura works.
In particular, tell your doctor or pharmacist if you are
taking any of the following:
  
       
as Quinolone antibiotics (e.g. Norfloxacin)
 
  
 
Sodium Bicarbonate
  

    
      
     
  
   

swelling of the joints (gout)
 
 
    !"" #
used for lots of different types of illness such as
eye, kidney, breathing or bowel problems
 $  
%   
!"" 
# 

pressure (glaucoma).
Genfura can make birth control pills less effective. An
additional form of contraception should be used.
Taking Genfura with food and drink
Genfura should be taken with food or milk. This lowers
the chance of getting an upset stomach.
Avoid alcohol whilst taking Genfura.
Pregnancy and breast-feeding
Do not take Genfura if you are pregnant, planning a
pregnancy or breast-feeding, unless your doctor has
told you to.
Driving and using machines
&   
' *
  
headaches. Do not drive or operate machinery if you
are affected in this way and avoid alcohol, as it can
make these effects worse.
Important information about some of the
ingredients of Genfura
This medicine contains lactose (a type of sugar). If
you know you have an intolerance to some sugars
contact your doctor before taking this medicine.

3. HOW TO TAKE GENFURA
Always take Genfura tablets exactly as your
doctor has told you.
Taking this medicine
 take this medicine by mouth with food or milk
   
      *' 
prescribed course.
The usual doses are given below. These may be
changed by your doctor:
Adults:
For treatment of infections: 50 mg or 100 mg four
times a day for seven days.
For prevention of further infections: 50 mg or
100 mg once a day, at night.
For prevention of infections during surgery: 50 mg
four times a day for the duration of the surgical
procedure and three days thereafter.

Elderly:
Same dosage as adults unless you suffer from kidney
problems. Follow your doctor’s advice.
Children over 3 months old:
Your doctor will work out the exact amount that your
child should take.
For treatment of infections: The usual dose is 3 mg
for each kilogram of the child’s body weight, divided
into four doses per day for seven days.
For prevention of further infections: The usual daily
dose is 1 mg for each kilogram of the child’s body
weight, given at night.
Children under 3 months old:
Not recommended.
If you take more Genfura than you should
$  
   
"
Take the package or container with you so the doctor
knows what you have taken. The symptoms of an
overdose may include nausea, vomiting or an upset
stomach.
If you forget to take Genfura
Don’t worry, just take your next scheduled dose at the
correct time. Do not take a double dose to make up for
the one you have missed.
If you stop taking Genfura
Keep taking this medicine until the course is finished,
unless you get any of the side effects listed in section 4
below. Keep taking the tablets even if you feel better
after a few days.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Genfura can cause side effects,
although not everybody gets them.
If you have an allergic reaction to Genfura see a
doctor straight away
An allergic reaction may include:
  
 *  *   

and raised lumps (hives)
    * *
 
 '  
 

 ' *   
chest or collapse
 +/ 
     +
   
tastes
       + 
in the stomach and back.
If you get any of the following side effects, STOP
TAKING Genfura and see your doctor as soon as
possible:
  '  *'   
difficulty in breathing, shortness of breath, chest
pain, chills, cough, general illness or fever
    



   
  
 +**   
*
unusual tiredness or weakness, unusual bleeding
and unexplained bruises. These may be a sign that
you have a blood disorder
 +
 "  
  
in pressure inside the head


 +*'   
weakness, tingling or numbness
 '  ' 
(jaundice) or inflammation of the liver (hepatitis),
which may cause tiredness, loss of appetite or
aching muscles and joints.

Tell your doctor if you get any of these side
effects:
   ! #
   !+  #
    


  

' 

   
 
 
 ' 
    +  
   
     
       * 

bacteria which are not sensitive to Genfura.
Reporting side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects

  +   ;' $
    
ww.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE GENFURA
Keep out of the sight and reach of children.
9 +=>?$"    
or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is
stated on the package or container. The expiry date
refers to the last day of that month.


 

+ ''
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

6. FURTHER INFORMATION
What Genfura tablets contain
The active ingredient in Genfura 50 mg and 100 mg
tablets is nitrofurantoin. The other ingredients are
 *    *  
    *
sodium starch glycollate and magnesium stearate.
What Genfura tablets look like and contents of the
pack
Genfura 50 mg tablets are round yellow tablets with
   =@     
 
    
engraved on the other.
Genfura 100 mg tablets are round yellow tablets with
   =C     
 
    
engraved on the other.
The tablets come in blister packs and containers of 28,
30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not
    
"
Marketing Authorisation Holder
'   J 
*
15 Runnelfield, Harrow on the Hill,


OPU@2;
Manufacturer
P  & P*
&
U@* >

 9 U=V*
12347 Berlin, Germany
For more information about this product, please
      P
"
This leaflet was last revised in 07/2014.
VV=@7VV=CXX%JU7X=

Product:

Genfura 50 mg &
100 mg Tablets

Printing Colours:

Non-Printing Colours:

Black

Profile

MA Holder:

Metwest

PL No.:

17521/0023 - 0024

Pack Size:

All

Dimensions:

Livery:

Metwest

Created By:

Manufacturer:

-

Artwork Code:

M0023-0024/O/PIL2-Br/M2

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
8.5 pt

Market:

UK

Component:

Pot Leaflet

Final Preparation Date For Submission: 31/07/2014

Packing Site Technical Approval:
00/00/0000
150 x 250 mm

Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
00/00/0000
00/00/0000

PACKAGE LEAFLET: INFORMATION FOR THE USER

GENFURA
50 mg & 100 mg TABLETS
(Nitrofurantoin)
Read all of this leaflet carefully before you start
taking this medicine.
7 Keep this leaflet.;  

  "
7If + _  *
 
  "
7This medicine has been prescribed for you.
9   "%   *+  
    "
7% 
    * 
notice any side effects not listed in this leaflet, please

   "

THIS LEAFLET CONTAINS
1. What Genfura is for
2. Before you take Genfura
3. How to take Genfura
4. Possible side effects
5. How to store Genfura
6. Further information

1. WHAT GENFURA IS FOR
Genfura Tablets contain the active ingredient nitrofurantoin
which is an antibiotic. It can be used to treat and prevent
bacterial infections of the bladder, kidney and other parts of
the urinary tract.
If you are not sure why you have been prescribed these
tablets then please ask your doctor.

2. BEFORE YOU TAKE GENFURA
Do not take Genfura and tell your doctor if:
  2   * 
ingredients in the tablets (listed in section 6 of this leaflet)
or to other nitrofuran antibiotics. The signs of an allergic
reaction include a rash, itching or shortness of breath
 + ' 
! 
   #";
 ' ' 
Genfura depending on how well your kidneys are
working.
 +
  '  '
 +  

 
 + 787

 !&89#
deficiency. This is a genetic disorder where the red
blood cells are broken down under stressful conditions

  

 7
   ' &89
  
      "
  
 
 not be given to infants under 3
 
"
Take special care with Genfura
Tell your doctor before   
 Z
     &89
  
 + '  +*  +

 +  

 ++  
  * 
 +  !""   *  

 #  
 '"
If you are not sure if any of the above apply to you, talk to

      
"

Having tests
;
 '       
 +* *
 + *  
 &  7   "
If you are having urine tests, tell the doctor that you are
 &    ' "
Taking other medicines
 
            +
recently taken any 
*+  

without a prescription. This is because Genfura can affect
'  
'"*  

can affect the way Genfura works.
%  *
     
 ' Z
  
       
[      !""2O #
 
  
 

   
  

    
      
     
  
   
' 
of the joints (gout)
 
 
    !"" #

for lots of different types of illness such as eye, kidney,
 ' 
 $  
%   !"" 
#
 
!  #"
&              +"  


        

"
Taking Genfura with food and drink
& 
 ' 
 " '
     "
Avoid alcohol whilst taking Genfura.
Pregnancy and breast-feeding
9   &       *   
  7
* 
 

you to.
Driving and using machines
&   
' *
 
 "
9 
 +     
  
'
+
 *     '"
Important information about some of the ingredients of
Genfura
  
    lactose (a type of sugar). If you
 '+       

    
"

3. HOW TO TAKE GENFURA
Always take Genfura tablets exactly as your doctor has
told you.
Taking this medicine
   
 ' 
 
   
      *' 
prescribed course.

 + '"   


 Z
Adults:
For treatment of infections: >V UVV  
day for seven days.
For prevention of further infections:>V UVV 
once a day, at night.
For prevention of infections during surgery: >V 
 

    


three days thereafter.

Elderly:
 
  
       

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 ]
+ "
Children over 3 months old:
;
 ' 'O     

should take.
For treatment of infections: 
 @ 
     
]
' *
+

 
doses per day for seven days.
For prevention of further infections: The usual daily dose
U      
]
' * + 
night.
Children under 3 months old:
2  

"
If you take more Genfura than you should
$  
   
"
the package or container with you so the doctor knows what
+ "   +
  

*+     "
If you forget to take Genfura
9 ] '* /   O  


  
  "9 

 
 + 
"
If you stop taking Genfura
^     
        
*
unless you get any of the side effects listed in section 4
below. Keep taking the tablets even if you feel better after a
few days.

4. POSSIBLE SIDE EFFECTS
J   
* &     
  *
 +
 "
If you have an allergic reaction to Genfura see a doctor
straight away
       
Z
  
 *  *   


 
 ! +#
    * *
 
 '  
 

 ' *    
collapse
 +/ 
     +
   
tastes
       +  
  
 "
If you get any of the following side effects, STOP
TAKING Genfura and see your doctor as soon as
possible:
  '  *'   
  
breathing, shortness of breath, chest pain, chills, cough,
general illness or fever
    



   
  
 +**   
*
unusual tiredness or weakness, unusual bleeding and
 O 
 "   
have a blood disorder
 +
 "  
   
pressure inside the head


 +*'   ' *
     
 '  ' !/
#
    +!  #*'   
 
*     
/ "

Tell your doctor if you get any of these side effects:
   ! #
   !+  #
    


  

' 

   
 
 
 ' 
    +  
   
     
       * 

bacteria which are not sensitive to Genfura.
Reporting side effects
% 
 *
   "
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
;'$
  ''" "+"X' 
"
   
       +
 
      
"

5. HOW TO STORE GENFURA
Keep out of the sight and reach of children.
9 +=>?$"    
container and keep the container tightly closed.
9       O 
* '  

     "O 


  "

 
  

  +  '' 

'"  '


  _ 
" ' 
  +   "

6. FURTHER INFORMATION
What Genfura tablets contain
  + 
  & >V 
UVV 
   " 
  *  
 *  
    * 
   
 
    "
What Genfura tablets look like and contents of the pack
& >V 
'' 
 =@  

  +
 
the other.
& UVV 
'' 
 =C  

  +
 
the other.
     
   =`*@V*
>V*>8*8V*`C*UVV*=>V*>VV
UVVV"2 
   
"
Marketing Authorisation Holder
'   J 
*
U>z  
*P' P *


OPU@2;
Manufacturer
P  & P*
&
U@* >

 9 U=V*
U=@C{ *&  
\      
 *   
    P
"
This leaflet was last revised in 07/2014
VV=@7VV=CXX%J=7X=

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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