Skip to Content

UK Edition. Click here for US version.

GENFURA 100MG TABLETS

Active substance(s): NITROFURANTOIN / NITROFURANTOIN / NITROFURANTOIN

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Product:

Genfura 50 mg &
100 mg Tablets

Printing Colours:

Non-Printing Colours:

Black

Profile

MA Holder:

Genethics Europe

PL No.:

42976/0017-0018

Pack Size:

All

Dimensions:

148 x 297 mm

Livery:

Genethics Europe

Created By:

DTawde

Manufacturer:

-

Artwork Code:

GE0017-0018/O/PIL1-Br/GE2

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
9 pt

Market:

UK

Component:

Blister Leaflet

Final Preparation Date For Submission: 11/01/2017

Packing Site Technical Approval:

00/00/0000
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, because it contains
important information for you.
- 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
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET
1. What Genfura Tablets is and what it
is used for
2. What you need to know before you
take Genfura Tablets
3. How to take Genfura Tablets
4. Possible side effects
5. How to store Genfura Tablets
6. Contents of the pack and other
information

1. WHAT GENFURA TABLETS IS AND
WHAT IT IS USED 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.
You must talk to a doctor if you do not feel better or if
you feel worse.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE GENFURA TABLETS
Do not take Genfura tablets and tell your doctor if:
 you are allergic to Nitrofurantoin or any of the other
ingredients of this medicine (listed in section 6) or
to other nitrofuran antibiotics. The signs of an
allergic reaction include a rash, itching or shortness
of breath
 you have problems with your kidneys (other than
infection). Your doctor will assess whether you
may take Genfura depending on how well your
kidneys are working.
 you have a blood problem known as porphyria
where you may have too many red blood cells
 you have glucose-6-phosphate dehydrogenase
(G6PD) deficiency. This is a genetic disorder where
the red blood cells are broken down under stressful
conditions or due to taking medicines
 you are breast-feeding an infant with G6PD
deficiency
 you are in the final stages of pregnancy (labour or
delivery) as there is a risk that it might affect the
baby.
This medicine should not be given to infants under 3
months old.
Warnings and precautions
Talk to your doctor or pharmacist before you take this
medicine if:
 you have diabetes
 you are suffering from any illness causing severe
weakness
 you have anaemia (a decrease in red blood cells
causing pale skin, weakness and breathlessness)
or a lack of vitamin B or abnormal levels of salts in
your blood (your doctor will be able to advise you)
 you have a history of allergic reactions.
The above conditions may increase the chance of
developing a side effect which results in damage to the

nerves, causes altered sense of feeling, like pins and
needles.
 you lack an enzyme (body chemical) called
glucose-6-phosphate dehydrogenase, which
causes your red blood cells to be more easily
damaged (this is more common in black people
and people of Mediterranean, Middle Eastern or
Asian origin. Your doctor will know)
 you have any disease of the lungs, liver or nervous
system. If you need to take Genfura Tablets for a
number of months, your doctor may want to
regularly check how your lungs and liver are working
 you have false positive results on testing your urine
for glucose
 your urine is dark yellow or brown coloured.
Children
Do not give Nitrofurantoin tablets to infants under 3
months of age
Other medicines and Nitrofurantoin tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
This is because Genfura can affect the way some
other medicines work. Also, some medicines can
affect the way Genfura works.
 Other medicines to treat bacterial infections such
as Quinolone antibiotics (e.g. Norfloxacin)
 Medicines to make your urine less acidic such as
potassium citrate mixture
 Antacids for indigestion or heartburn such as
Magnesium Trisilicate
 Probenecid or Sulfinpyrazone to treat pain and
swelling of the joints (gout)
 Medicines called Anticholinergics (e.g. Atropine,
hyoscine) used for lots of different types of illness
such as eye, kidney, breathing or bowel problems
 Carbonic Anhydrase Inhibitors (e.g. Acetazolamide)
to treat increased eyeball pressure (glaucoma).
 Oral contraceptives. Genfura can make birth
control pills less effective. An additional form of
contraception should be used.
 Typhoid vaccine, which is given for the prevention
of typhoid.
Genfura Tablets with food and drink and alcohol
Genfura should be taken at meal times with food or
milk. This lowers the chance of getting an upset
stomach and also helps absorption.
Avoid alcohol whilst taking Genfura.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
As far as it is known, Genfura Tablets may be used in
pregnancy. However, it should not be used during
labour or delivery because there is a possibility that
use at this stage may affect the baby. If you want to
breast feed, please consult your doctor first.
Driving and using machines
Genfura tablets may cause drowsiness, dizziness. Do
not drive or operate machinery if you are affected in
this way until such symptoms go away.
Genfura Tablets contains lactose
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 TABLETS
Always take Genfura tablets exactly as your doctor or
pharmacist has told you. Check with your doctor
before taking this medicine.
Taking this medicine
 take this medicine by mouth with food or milk
 as this medicine is an antibiotic, always finish the
prescribed course.
The recommended doses are given below. These may
be changed by your doctor:
The normal dosage depends on the type of infection
you have and instructions should be written on the
label provided by the pharmacist. Consult your
pharmacist or doctor if these instructions are not clear.

The usual doses are:
Adults and Elderly:
Uncomplicated acute urinary tract infections:
50 mg (one 50 mg tablet) four times a day for seven
days.
Severe chronic recurrence:
100 mg (one 100 mg tablet/ two 50 mg tablets) four
times a day for seven days.
Long-term suppression:
100 mg (one 100 mg tablet/ two 50 mg tablets) once a
day.
Prophylaxis (prevention):
50 mg (one 50 mg tablet) four times a day for duration
of any surgical procedure and continue for 3 days
thereafter.
Use in Children
Children over 3 months old:
The dose depends on the weight of the child and will
be provided by your doctor. Follow your doctor’s
instructions exactly.
Children under 3 months old:
Children below 3 months of age should not take
Genfura tablets.
Medical Checks
Your doctor will watch carefully for any effects on the
liver, lungs, blood or nervous system. Nitrofurantoin
tablets may interference with the results of some tests
for glucose in the urine.
If you take more Genfura Tablets than you should
Contact your doctor or pharmacist immediately or go
to the emergency department of the nearest hospital.
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 Tablets
Don’t worry, just take your next scheduled dose at the
correct time. Do not take a double dose to make up for
a forgotten dose.
If you stop taking Genfura Tablets
Keep taking this medicine until the course is finished,
unless you get any of the side effects listed in section 4
below. Your doctor will tell you how long to take the
treatment. Do not stop earlier than you should.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Genfura can cause side effects,
although not everybody gets them.
Most of them are mild and disappear when you stop
taking Nitrofurantoin tablets.
If you notice any sudden wheeziness, difficulty in
breathing, swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body) STOP
TAKING your medicine and go to a doctor
immediately.
If you get any of the following side effects, STOP
TAKING Genfura and see your doctor as soon as
possible:
 problems with your lungs, your lungs may react to
Genfura tablets. This may develop quickly, within a
week of starting treatment or very slowly, especially
in elderly patients which may cause shortness of
breath, chest pain, chills, cough, general illness or
fever
 The nerves outside the spinal cord may be affected
causing changes to the sense of feeling and the
use of muscles. In addition, headache, extreme
changes of mood or mental state, confusion,
weakness, blurred vision may occur. These effects
may be severe and in some instances, permanent.
 severe headache. This may be due to an increase
in pressure inside the head
 yellowing of the skin or whites of the eyes
(jaundice) or inflammation of the liver (hepatitis).
Please note that while taking Nitrofurantoin Tablets
your urine may become dark yellow or brown coloured.
This is quite normal and not a reason to stop taking the
medicine.

Other side effects include:
 feeling sick (nausea)
 being sick (vomiting)
 stomach pain
 diarrhoea
 loss of appetite
 drowsiness
 dizziness or a feeling of spinning
 headache
 weakness
 temporary hair loss
 changes in the colour of your urine
 infections of the genitals or urinary tract, caused by
bacteria which are not sensitive to Genfura.
 Blood cells have been affected in some patients.
This may result in bruising, delayed clotting of the
blood, sore throat, fever, anaemia, and a
susceptibility to colds or persistent cold.
 A variety of skin rashes or reactions have occurred
in some patients. These may appear as flaking
skin, a red rash or fever accompanied by rapid
heart rate and severe rash with blistering. Other
reactions may include inflammation of salivary
glands (causing facial pains), inflammation of the
pancreas gland (causing severe abdominal pain)
and joint pains.
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
directly via the Yellow Card Scheme at
www.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 TABLETS
Keep this medicine out of the sight and reach of
children.
Do not store above 25°C. Store in the original package
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.
Do not throw away any medicines via wastewater. Ask
your pharmacist how to throw away medicines you no
longer use. These measures will help to protect the
environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Genfura tablets contain
The active ingredient in Genfura 50 mg and 100 mg
tablets is nitrofurantoin. The other ingredients are
lactose, maize starch, pregelatinised maize starch,
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
the marking MP23 on one side and a break line
engraved on the other.
Genfura 100 mg tablets are round yellow tablets with
the marking MP24 on one side and a break line
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
all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited,
41-43 Klimentos Tower, Nicosia 1061, Cyprus.
Manufacturer
Haupt Pharma Berlin GmbH,
Moosrosenstrasse 7, 12347 Berlin, Germany
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last revised in 01/2017

GE0017-0018/O/PIL1-Br/GE2

Product:

Genfura 50 mg &
100 mg Tablets

Printing Colours:

Non-Printing Colours:

Black

Profile

MA Holder:

Genethics Europe

PL No.:

42976/0017-0018

Pack Size:

All

Dimensions:

150 x 250 mm

Livery:

Genethics Europe

Created By:

DTawde

Manufacturer:

-

Artwork Code:

GE0017-0018/O/PIL2-Br/GE2

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
8 pt

Market:

UK

Component:

Pot Leaflet

Final Preparation Date For Submission: 11/01/2017

Packing Site Technical Approval:

00/00/0000
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, because it contains important information
for you.
- 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 only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET
1. What Genfura Tablets is and what it is used
for
2. What you need to know before you take
Genfura Tablets
3. How to take Genfura Tablets
4. Possible side effects
5. How to store Genfura Tablets
6. Contents of the pack and other information

1. WHAT GENFURA TABLETS IS AND
WHAT IT IS USED 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.
You must talk to a doctor if you do not feel better or if you feel
worse.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE GENFURA TABLETS
Do not take Genfura tablets and tell your doctor if:
 you are allergic to Nitrofurantoin or any of the other
ingredients of this medicine (listed in section 6) or to other
nitrofuran antibiotics. The signs of an allergic reaction
include a rash, itching or shortness of breath
 you have problems with your kidneys (other than infection).
Your doctor will assess whether you may take Genfura
depending on how well your kidneys are working.
 you have a blood problem known as porphyria where you
may have too many red blood cells
 you have glucose-6-phosphate dehydrogenase (G6PD)
deficiency. This is a genetic disorder where the red blood
cells are broken down under stressful conditions or due to
taking medicines
 you are breast-feeding an infant with G6PD deficiency
 you are in the final stages of pregnancy (labour or delivery)
as there is a risk that it might affect the baby.
This medicine should not be given to infants under 3 months
old.
Warnings and precautions
Talk to your doctor or pharmacist before you take this medicine if:
 you have diabetes
 you are suffering from any illness causing severe weakness
 you have anaemia (a decrease in red blood cells causing
pale skin, weakness and breathlessness) or a lack of
vitamin B or abnormal levels of salts in your blood (your
doctor will be able to advise you)
 you have a history of allergic reactions.
The above conditions may increase the chance of developing a
side effect which results in damage to the nerves, causes
altered sense of feeling, like pins and needles.
 you lack an enzyme (body chemical) called
glucose-6-phosphate dehydrogenase, which causes your

red blood cells to be more easily damaged (this is more
common in black people and people of Mediterranean,
Middle Eastern or Asian origin. Your doctor will know)
 you have any disease of the lungs, liver or nervous system.
If you need to take Genfura Tablets for a number of
months, your doctor may want to regularly check how your
lungs and liver are working
 you have false positive results on testing your urine for
glucose
 your urine is dark yellow or brown coloured.
Children
Do not give Nitrofurantoin tablets to infants under 3 months of
age
Other medicines and Nitrofurantoin tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription. This is because Genfura can
affect the way some other medicines work. Also, some
medicines can affect the way Genfura works.
 Other medicines to treat bacterial infections such as
Quinolone antibiotics (e.g. Norfloxacin)
 Medicines to make your urine less acidic such as potassium
citrate mixture
 Antacids for indigestion or heartburn such as Magnesium
Trisilicate
 Probenecid or Sulfinpyrazone to treat pain and swelling of
the joints (gout)
 Medicines called Anticholinergics (e.g. Atropine, hyoscine)
used for lots of different types of illness such as eye,
kidney, breathing or bowel problems
 Carbonic Anhydrase Inhibitors (e.g. Acetazolamide) to treat
increased eyeball pressure (glaucoma).
 Oral contraceptives. Genfura can make birth control pills
less effective. An additional form of contraception should be
used.
 Typhoid vaccine, which is given for the prevention of
typhoid.
Genfura Tablets with food and drink and alcohol
Genfura should be taken at meal times with food or milk. This
lowers the chance of getting an upset stomach and also helps
absorption.
Avoid alcohol whilst taking Genfura.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
As far as it is known, Genfura Tablets may be used in
pregnancy. However, it should not be used during labour or
delivery because there is a possibility that use at this stage may
affect the baby. If you want to breast feed, please consult your
doctor first.
Driving and using machines
Genfura tablets may cause drowsiness, dizziness. Do not drive
or operate machinery if you are affected in this way until such
symptoms go away.
Genfura Tablets contains lactose
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 TABLETS
Always take Genfura tablets exactly as your doctor or
pharmacist has told you. Check with your doctor before taking
this medicine.
Taking this medicine
 take this medicine by mouth with food or milk
 as this medicine is an antibiotic, always finish the
prescribed course.
The recommended doses are given below. These may be
changed by your doctor:
The normal dosage depends on the type of infection you have
and instructions should be written on the label provided by the
pharmacist. Consult your pharmacist or doctor if these
instructions are not clear.

The usual doses are:
Adults and Elderly:
Uncomplicated acute urinary tract infections:
50 mg (one 50 mg tablet) four times a day for seven days.
Severe chronic recurrence:
100 mg (one 100 mg tablet/ two 50 mg tablets) four times a day
for seven days.
Long-term suppression:
100 mg (one 100 mg tablet/ two 50 mg tablets) once a day.
Prophylaxis (prevention):
50 mg (one 50 mg tablet) four times a day for duration of any
surgical procedure and continue for 3 days thereafter.
Use in Children
Children over 3 months old:
The dose depends on the weight of the child and will be
provided by your doctor. Follow your doctor’s instructions
exactly.
Children under 3 months old:
Children below 3 months of age should not take Genfura
tablets.
Medical Checks
Your doctor will watch carefully for any effects on the liver,
lungs, blood or nervous system. Nitrofurantoin tablets may
interference with the results of some tests for glucose in the
urine.
If you take more Genfura Tablets than you should
Contact your doctor or pharmacist immediately or go to the
emergency department of the nearest hospital. 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 Tablets
Don’t worry, just take your next scheduled dose at the correct
time. Do not take a double dose to make up for a forgotten
dose.
If you stop taking Genfura Tablets
Keep taking this medicine until the course is finished, unless
you get any of the side effects listed in section 4 below. Your
doctor will tell you how long to take the treatment. Do not stop
earlier than you should.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Genfura can cause side effects, although
not everybody gets them.
Most of them are mild and disappear when you stop taking
Nitrofurantoin tablets.
If you notice any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or itching (especially
affecting your whole body) STOP TAKING your medicine and
go to a doctor immediately.
If you get any of the following side effects, STOP TAKING
Genfura and see your doctor as soon as possible:
 problems with your lungs, your lungs may react to Genfura
tablets. This may develop quickly, within a week of starting
treatment or very slowly, especially in elderly patients which
may cause shortness of breath, chest pain, chills, cough,
general illness or fever
 The nerves outside the spinal cord may be affected causing
changes to the sense of feeling and the use of muscles. In
addition, headache, extreme changes of mood or mental
state, confusion, weakness, blurred vision may occur.
These effects may be severe and in some instances,
permanent.
 severe headache. This may be due to an increase in
pressure inside the head
 yellowing of the skin or whites of the eyes (jaundice) or
inflammation of the liver (hepatitis).
Please note that while taking Nitrofurantoin Tablets your urine
may become dark yellow or brown coloured. This is quite
normal and not a reason to stop taking the medicine.

Other side effects include:
 feeling sick (nausea)
 being sick (vomiting)
 stomach pain
 diarrhoea
 loss of appetite
 drowsiness
 dizziness or a feeling of spinning
 headache
 weakness
 temporary hair loss
 changes in the colour of your urine
 infections of the genitals or urinary tract, caused by bacteria
which are not sensitive to Genfura.
 Blood cells have been affected in some patients. This may
result in bruising, delayed clotting of the blood, sore throat,
fever, anaemia, and a susceptibility to colds or persistent
cold.
 A variety of skin rashes or reactions have occurred in some
patients. These may appear as flaking skin, a red rash or
fever accompanied by rapid heart rate and severe rash with
blistering. Other reactions may include inflammation of
salivary glands (causing facial pains), inflammation of the
pancreas gland (causing severe abdominal pain) and joint
pains.
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 directly via the Yellow Card
Scheme at www.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 TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package 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.
Do not throw away any medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Genfura tablets contain
The active ingredient in Genfura 50 mg and 100 mg tablets is
nitrofurantoin. The other ingredients are lactose, maize starch,
pregelatinised maize starch, 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 the
marking MP23 on one side and a break line engraved on the
other.
Genfura 100 mg tablets are round yellow tablets with the
marking MP24 on one side and a break line 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 all pack sizes
may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited,
41-43 Klimentos Tower, Nicosia 1061, Cyprus.
Manufacturer
Haupt Pharma Berlin GmbH,
Moosrosenstrasse 7, 12347 Berlin, Germany
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last revised in 01/2017

GE0017-0018/O/PIL2-Br/GE2

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.

Hide