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GENFURA 50MG TABLETS

Active substance(s): NITROFURANTOIN

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Genfura 50 mg &
100 mg Tablets

Black

Profile

Final Preparation Date For Submission: 13/07/2014

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.
- 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:
● you are allergic to Nitrofurantoin, any of the other
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
● 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 last month of your pregnancy.
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:
● any member of your family has G6PD deficiency
● you have problems with your liver, lungs or nervous
system
● you have anaemia or diabetes
● you have a vitamin B deficiency, especially folate
● you have an electrolyte (e.g. calcium, potassium or
sodium) imbalance
● you are weak or feeble.
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:
● Other medicines to treat bacterial infections such
as Quinolone antibiotics (e.g. Norfloxacin)
● Medicines to make your urine less acidic such as
Sodium Bicarbonate
● Antacids for indigestion or heartburn such as
Magnesium Trisilicate
● Barbiturates or Phenytoin for epilepsy
● Probenecid or Sulfinpyrazone to treat pain and
swelling of the joints (gout)
● Medicines called Anticholinergics (e.g. Atropine)
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).
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
Genfura may cause drowsiness, dizziness or
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
● as this medicine is an antibiotic, always finish the
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
Contact your doctor or go to a hospital immediately.
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:
● any kind of skin rash, flaking skin, itching or red
and raised lumps (hives)
● blistering of the skin, mouth, eyes and genitals
● swelling of the face or throat
● sudden wheezing, fluttering or tightness of the
chest or collapse
● fever or joint pain
● inflammation of the salivary glands causing unusual
tastes
● inflammation of the pancreas causing severe pain
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:
● problems with your lungs, which may cause
difficulty in breathing, shortness of breath, chest
pain, chills, cough, general illness or fever
● feeling confused or depressed
● changes of mood or mental state
● fever, sore throat, ulcers in the mouth and throat,
unusual tiredness or weakness, unusual bleeding
and unexplained bruises. These may be a sign that
you have a blood disorder
● severe headache. This may be due to an increase
in pressure inside the head
● disorder of the nerves, which may cause
weakness, tingling or numbness
● yellowing of the skin or whites of the eyes
(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:
● feeling sick (nausea)
● being sick (vomiting)
● stomach pain
● diarrhoea
● loss of appetite
● drowsiness
● dizziness or a feeling of spinning
● headache
● weakness
● uncontrollable eye movements
● 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.
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
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.
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.
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.

6. FURTHER 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
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
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 10/2014.
M0023-0024/O/PIL1-Br/M3

Genfura 50 mg &
100 mg Tablets

Black

Profile

Final Preparation Date For Submission: 13/10/2014

Packing Site Technical Approval:

15/10/2014
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:
● you are allergic to Nitrofurantoin, any of the other
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
● 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 last month of your pregnancy.
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:
● any member of your family has G6PD deficiency
● you have problems with your liver, lungs or nervous
system
● you have anaemia or diabetes
● you have a vitamin B deficiency, especially folate
● you have an electrolyte (e.g. calcium, potassium or
sodium) imbalance
● you are weak or feeble.
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:
● Other medicines to treat bacterial infections such as
Quinolone antibiotics (e.g. Norfloxacin)
● Medicines to make your urine less acidic such as
Sodium Bicarbonate
● Antacids for indigestion or heartburn such as
Magnesium Trisilicate
● Barbiturates or Phenytoin for epilepsy
● Probenecid or Sulfinpyrazone to treat pain and swelling
of the joints (gout)
● Medicines called Anticholinergics (e.g. Atropine) 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).
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
Genfura may cause drowsiness, dizziness or 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
● as this medicine is an antibiotic, always finish the
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
Contact your doctor or go to a hospital immediately. 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:
● any kind of skin rash, flaking skin, itching or red and
raised lumps (hives)
● blistering of the skin, mouth, eyes and genitals
● swelling of the face or throat
● sudden wheezing, fluttering or tightness of the chest or
collapse
● fever or joint pain
● inflammation of the salivary glands causing unusual
tastes
● inflammation of the pancreas causing severe pain 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:
● problems with your lungs, which may cause difficulty in
breathing, shortness of breath, chest pain, chills, cough,
general illness or fever
● feeling confused or depressed
● changes of mood or mental state
● fever, sore throat, ulcers in the mouth and throat,
unusual tiredness or weakness, unusual bleeding and
unexplained bruises. These may be a sign that you
have a blood disorder
● severe headache. This may be due to an increase in
pressure inside the head
● disorder of the nerves, which may cause weakness,
tingling or numbness
● yellowing of the skin or whites of the eyes (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:
● feeling sick (nausea)
● being sick (vomiting)
● stomach pain
● diarrhoea
● loss of appetite
● drowsiness
● dizziness or a feeling of spinning
● headache
● weakness
● uncontrollable eye movements
● 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.
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 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.
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.
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.

6. FURTHER 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
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
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 10/2014
M0023-0024/O/PIL2-Br/M3

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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