ZINNAT SUSPENSION 125MG/5ML
Active substance(s): CEFUROXIME AXETIL
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3
10000000146746
Package Leaflet: Information for the user
cefuroxime axetil
Suspension 125 mg/5 ml
10000000146746
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR
Zinnat
N/A
JMF223
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 or nurse.
• 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 or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Zinnat is and what it is used for
2. What you need to know before you take
Zinnat
3. How to take Zinnat
4. Possible side effects
5. How to store Zinnat
6. Contents of the pack and other information
1. What Zinnat is and what it is used for
Zinnat is an antibiotic used in adults and
children. It works by killing bacteria that cause
infections. It belongs to a group of medicines
called cephalosporins.
Zinnat is used to treat infections of:
• the throat
• sinus
• middle ear
• the lungs or chest
• the urinary tract
• the skin and soft tissues.
Zinnat can also be used:
• to treat Lyme disease (an infection spread by
parasites called ticks).
Your doctor may test the type of bacteria causing
your infection and monitor whether the bacteria
are sensitive to Zinnat during your treatment.
2. What you need to know before you take
Zinnat
Do not take Zinnat:
• if you are allergic to cefuroxime axetil or any
cephalosporin antibiotics or any of the other
ingredients of Zinnat (listed in section 6).
• if you have ever had a severe allergic
(hypersensitive) reaction to any other type of
betalactam antibiotic (penicillins,
monobactams and carbapenems).
➔ If you think this applies to you, don’t take
Zinnat until you have checked with your
doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Zinnat.
Children
Zinnat is not recommended for children aged
under 3 months, as the safety and effectiveness
are not known in this age group.
You must look out for certain symptoms, such as
allergic reactions, fungal infections (such as
candida) and severe diarrhoea
(pseudomembranous colitis) while you are taking
Zinnat. This will reduce the risk of any problems.
See ‘Conditions you need to look out for’ in
Section 4.
If you need a blood test
Zinnat can affect the results of a test for blood
sugar levels, or a blood screen called the Coombs
test. If you need a blood test:
➔ Tell the person taking the sample that you
are taking Zinnat.
Other medicines and Zinnat
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Medicines used to reduce the amount of acid in
your stomach (e.g. antacids used to treat
heartburn) can affect how Zinnat works.
Probenecid
Oral anticoagulants
➔ Tell your doctor or pharmacist if you are
taking any medicine like this.
Contraceptive pills
Zinnat may reduce the effectiveness of the
contraceptive pill. If you are taking the
contraceptive pill while you are being treated
with Zinnat you also need to use a barrier
method of contraception (such as condoms).
Ask your doctor for advice.
Pregnancy and breast-feeding and fertility
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.
Driving and using machines
Zinnat can make you dizzy and have other side
effects that make you less alert.
➔ Don’t drive or use machines if you do not feel
well.
Important information about some of the
ingredients of Zinnat
Zinnat suspension contains sugar (sucrose). If you
are diabetic you need to take this into account
for your diet.
Zinnat suspension also contains aspartame,
which is a source of phenylalanine. If you have
an intolerance to aspartame or have a condition
called phenylketonuria (PKU):
➔ Check with your doctor that Zinnat is suitable
for you.
N/A
N/A
1
K
0
0
3. How to take Zinnat
Always take this medicine exactly as your doctor
or pharmacist has told you to. Check with your
doctor or pharmacist if you are not sure.
Take Zinnat after food. This will help to make
the treatment more effective.
Shake the bottle before use.
Zinnat suspension can be diluted in cold fruit
juices, or milk drinks but should be taken
immediately.
Don’t mix Zinnat with hot liquids.
For step-by-step instructions on how to make up
Zinnat suspension see Instructions for
reconstitution at the end of this leaflet.
The recommended dose
Adults
The recommended dose of Zinnat is 250 mg to
500 mg twice daily depending on the severity
and type of infection.
Children
The recommended dose of Zinnat is 10 mg/kg
(to a maximum of 125 mg) to 15 mg/kg (to a
maximum of 250 mg) twice daily depending on:
• the severity and type of infection
• the weight and age of the child, up to a
maximum of 500 mg per day.
Zinnat is not recommended for children aged
under 3 months, as the safety and effectiveness
are not known in this age group.
Depending on the illness or how you or your
child responds to treatment, the initial dose may
be changed or more than one course of
treatment may be needed.
Patients with kidney problems
If you have a kidney problem, your doctor may
change your dose.
➔ Talk to your doctor if this applies to you.
If you take more Zinnat than you should
If you take too much Zinnat you may have
neurological disorders, in particular you may be
more likely to have fits (seizures).
➔ Don’t delay. Contact your doctor or your
nearest hospital emergency department
immediately. If possible, show them the
Zinnat pack.
If you forget to take Zinnat
Do not take a double dose to make up for a
forgotten dose. Just take your next dose at the
usual time.
If you stop taking Zinnat
Don’t stop Zinnat without advice
It is important that you take the full course of
Zinnat. Don’t stop unless your doctor advises you
to – even if you are feeling better. If you don’t
complete the full course of treatment, the
infection may come back.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
8.2 pt
8.8 pt
100%
8.2 pt
No
Page 1 of 2
3
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Conditions you need to look out for
A small number of people taking Zinnat get an
allergic reaction or potentially serious skin
reaction. Symptoms of these reactions include:
• severe allergic reaction. Signs include raised
and itchy rash, swelling, sometimes of the
face or mouth causing difficulty in breathing.
• skin rash, which may blister, and looks like
small targets (central dark spot surrounded
by a paler area, with a dark ring around the
edge).
• a widespread rash with blisters and peeling
skin. (These may be signs of Stevens-Johnson
syndrome or toxic epidermal necrolysis).
Other conditions you need to look out for while
taking Zinnat include:
• fungal infections. Medicines like Zinnat can
cause an overgrowth of yeast (Candida) in the
body which can lead to fungal infections
(such as thrush). This side effect is more likely
if you take Zinnat for a long time.
• severe diarrhoea (Pseudomembranous
colitis). Medicines like Zinnat can cause
inflammation of the colon (large intestine),
causing severe diarrhoea, usually with blood
and mucus, stomach pain, fever.
• Jarisch-Herxheimer reaction. Some patients
may get a high temperature (fever), chills,
headache, muscle pain and skin rash while
being treated with Zinnat for Lyme disease.
This is known as the Jarisch-Herxheimer
reaction. Symptoms usually last a few hours
or up to one day.
➔ Contact a doctor or nurse immediately if you
get any of these symptoms.
Common side effects
These may affect up to 1 in 10 people:
• fungal infections (such as Candida)
• headache
• dizziness
• diarrhoea
• feeling sick
• stomach pain.
Common side effects that may show up in blood
tests:
• an increase in a type of white blood cell
(eosinophilia)
• an increase in liver enzymes.
Uncommon side effects
These may affect up to 1 in 100 people:
• being sick
• skin rashes.
Uncommon side effects that may show up in
blood tests:
• a decrease in the number of blood platelets
(cells that help blood to clot)
• a decrease in the number of white blood cells
• positive Coomb’s test.
Other side effects
Other side effects have occurred in a very small
number of people, but their exact frequency is
unknown:
• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• inflammation of the liver (hepatitis).
Side effects that may show up in blood tests:
• red blood cells destroyed too quickly
(haemolytic anaemia).
Reporting of 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 or by searching for
MHRA Yellow Card in the Google Play or Apple
App Store. By reporting side effects you can help
provide more information on the safety of this
medicine.
5. How to store Zinnat
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the pack after EXP. The expiry
date refers to the last day of that month.
The suspension should be stored in a fridge at all
times when not taking the medicine. Do not
allow it to freeze. It can be kept in the fridge for
up to 10 days.
Do not use Zinnat if it shows any sign of
deterioration.
Don’t throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.
10000000146746
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR
Zinnat
N/A
JMF223
6. Contents of the pack and other
information
What Zinnat contains
• The active substance is 125 mg per 5 ml of
cefuroxime (present as cefuroxime axetil).
• The other ingredients are aspartame (E951),
xanthan gum, acesulfame potassium,
Povidone K30, stearic acid, sucrose, tutti
fruitti flavour and purified water.
• See section 2 for further important
information about some of the ingredients of
Zinnat.
What Zinnat looks like and contents of the pack
Zinnat Suspension 125 mg/5 ml is supplied in an
amber, glass, multidose bottle. The bottle
contains 70 ml of suspension. Your pharmacist
will have made this up with water using the
original granules that were supplied in the
bottle. The bottle is contained within a carton.
Marketing authorisation holder and
manufacturer
Marketing Authorisation Holder:
Glaxo Wellcome UK Limited, Stockley Park West,
Uxbridge, Middlesex UB11 1BT
Manufacturer: Glaxo Operations UK Ltd,
Harmire Road, Barnard Castle,
Co. Durham DL12 8DT
Other formats
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:
N/A
N/A
1
K
0
0
0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name
Zinnat Suspension
125 mg/5 ml
Reference number
10949/0094
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in October 2017.
Trade marks are owned by or licensed to the GSK
group of companies.
© 2017 GSK group of companies or its licensor.
Instructions for reconstitution
Directions for making up the suspension
Shake the bottle to loosen the
content. All the granules should
be free-flowing in the bottle.
Remove the cap and the heat-seal
membrane. If the latter is
damaged or not present, the
product should be returned to
the pharmacist.
Add the total amount of cold
water as stated on the label or
up to the volume line on the cup
provided (if supplied). If the
water was previously boiled it
must be allowed to cool to room
temperature before adding. Do
not mix Zinnat granules for oral
suspension with hot or warm
liquids. Cold water must be used
to prevent the suspension
becoming too thick.
Pour the total amount of cold
water into the bottle. Replace
the cap. Allow the bottle to
stand to allow the water to fully
soak through the granules; this
should take about 1 minute.
Invert the bottle and shake well
(for at least 15 seconds) until all
the granules have mixed with
the water.
Turn the bottle into an upright
position and shake well for at
least 1 minute until all the
granules have blended with the
water. Store the Zinnat suspension
immediately at between 2 and 8°C
(do not freeze) and let it rest for
at least one hour before taking
the first dose.
8.2 pt
8.8 pt
100%
8.2 pt
No
10000000146746
Page 2 of 2
10000000146746
Package Leaflet: Information for the user
cefuroxime axetil
Suspension 125 mg/5 ml
10000000146746
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR
Zinnat
N/A
JMF223
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 or nurse.
• 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 or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Zinnat is and what it is used for
2. What you need to know before you take
Zinnat
3. How to take Zinnat
4. Possible side effects
5. How to store Zinnat
6. Contents of the pack and other information
1. What Zinnat is and what it is used for
Zinnat is an antibiotic used in adults and
children. It works by killing bacteria that cause
infections. It belongs to a group of medicines
called cephalosporins.
Zinnat is used to treat infections of:
• the throat
• sinus
• middle ear
• the lungs or chest
• the urinary tract
• the skin and soft tissues.
Zinnat can also be used:
• to treat Lyme disease (an infection spread by
parasites called ticks).
Your doctor may test the type of bacteria causing
your infection and monitor whether the bacteria
are sensitive to Zinnat during your treatment.
2. What you need to know before you take
Zinnat
Do not take Zinnat:
• if you are allergic to cefuroxime axetil or any
cephalosporin antibiotics or any of the other
ingredients of Zinnat (listed in section 6).
• if you have ever had a severe allergic
(hypersensitive) reaction to any other type of
betalactam antibiotic (penicillins,
monobactams and carbapenems).
➔ If you think this applies to you, don’t take
Zinnat until you have checked with your
doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Zinnat.
Children
Zinnat is not recommended for children aged
under 3 months, as the safety and effectiveness
are not known in this age group.
You must look out for certain symptoms, such as
allergic reactions, fungal infections (such as
candida) and severe diarrhoea
(pseudomembranous colitis) while you are taking
Zinnat. This will reduce the risk of any problems.
See ‘Conditions you need to look out for’ in
Section 4.
If you need a blood test
Zinnat can affect the results of a test for blood
sugar levels, or a blood screen called the Coombs
test. If you need a blood test:
➔ Tell the person taking the sample that you
are taking Zinnat.
Other medicines and Zinnat
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Medicines used to reduce the amount of acid in
your stomach (e.g. antacids used to treat
heartburn) can affect how Zinnat works.
Probenecid
Oral anticoagulants
➔ Tell your doctor or pharmacist if you are
taking any medicine like this.
Contraceptive pills
Zinnat may reduce the effectiveness of the
contraceptive pill. If you are taking the
contraceptive pill while you are being treated
with Zinnat you also need to use a barrier
method of contraception (such as condoms).
Ask your doctor for advice.
Pregnancy and breast-feeding and fertility
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.
Driving and using machines
Zinnat can make you dizzy and have other side
effects that make you less alert.
➔ Don’t drive or use machines if you do not feel
well.
Important information about some of the
ingredients of Zinnat
Zinnat suspension contains sugar (sucrose). If you
are diabetic you need to take this into account
for your diet.
Zinnat suspension also contains aspartame,
which is a source of phenylalanine. If you have
an intolerance to aspartame or have a condition
called phenylketonuria (PKU):
➔ Check with your doctor that Zinnat is suitable
for you.
N/A
N/A
1
K
0
0
3. How to take Zinnat
Always take this medicine exactly as your doctor
or pharmacist has told you to. Check with your
doctor or pharmacist if you are not sure.
Take Zinnat after food. This will help to make
the treatment more effective.
Shake the bottle before use.
Zinnat suspension can be diluted in cold fruit
juices, or milk drinks but should be taken
immediately.
Don’t mix Zinnat with hot liquids.
For step-by-step instructions on how to make up
Zinnat suspension see Instructions for
reconstitution at the end of this leaflet.
The recommended dose
Adults
The recommended dose of Zinnat is 250 mg to
500 mg twice daily depending on the severity
and type of infection.
Children
The recommended dose of Zinnat is 10 mg/kg
(to a maximum of 125 mg) to 15 mg/kg (to a
maximum of 250 mg) twice daily depending on:
• the severity and type of infection
• the weight and age of the child, up to a
maximum of 500 mg per day.
Zinnat is not recommended for children aged
under 3 months, as the safety and effectiveness
are not known in this age group.
Depending on the illness or how you or your
child responds to treatment, the initial dose may
be changed or more than one course of
treatment may be needed.
Patients with kidney problems
If you have a kidney problem, your doctor may
change your dose.
➔ Talk to your doctor if this applies to you.
If you take more Zinnat than you should
If you take too much Zinnat you may have
neurological disorders, in particular you may be
more likely to have fits (seizures).
➔ Don’t delay. Contact your doctor or your
nearest hospital emergency department
immediately. If possible, show them the
Zinnat pack.
If you forget to take Zinnat
Do not take a double dose to make up for a
forgotten dose. Just take your next dose at the
usual time.
If you stop taking Zinnat
Don’t stop Zinnat without advice
It is important that you take the full course of
Zinnat. Don’t stop unless your doctor advises you
to – even if you are feeling better. If you don’t
complete the full course of treatment, the
infection may come back.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
8.2 pt
8.8 pt
100%
8.2 pt
No
Page 1 of 2
3
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Conditions you need to look out for
A small number of people taking Zinnat get an
allergic reaction or potentially serious skin
reaction. Symptoms of these reactions include:
• severe allergic reaction. Signs include raised
and itchy rash, swelling, sometimes of the
face or mouth causing difficulty in breathing.
• skin rash, which may blister, and looks like
small targets (central dark spot surrounded
by a paler area, with a dark ring around the
edge).
• a widespread rash with blisters and peeling
skin. (These may be signs of Stevens-Johnson
syndrome or toxic epidermal necrolysis).
Other conditions you need to look out for while
taking Zinnat include:
• fungal infections. Medicines like Zinnat can
cause an overgrowth of yeast (Candida) in the
body which can lead to fungal infections
(such as thrush). This side effect is more likely
if you take Zinnat for a long time.
• severe diarrhoea (Pseudomembranous
colitis). Medicines like Zinnat can cause
inflammation of the colon (large intestine),
causing severe diarrhoea, usually with blood
and mucus, stomach pain, fever.
• Jarisch-Herxheimer reaction. Some patients
may get a high temperature (fever), chills,
headache, muscle pain and skin rash while
being treated with Zinnat for Lyme disease.
This is known as the Jarisch-Herxheimer
reaction. Symptoms usually last a few hours
or up to one day.
➔ Contact a doctor or nurse immediately if you
get any of these symptoms.
Common side effects
These may affect up to 1 in 10 people:
• fungal infections (such as Candida)
• headache
• dizziness
• diarrhoea
• feeling sick
• stomach pain.
Common side effects that may show up in blood
tests:
• an increase in a type of white blood cell
(eosinophilia)
• an increase in liver enzymes.
Uncommon side effects
These may affect up to 1 in 100 people:
• being sick
• skin rashes.
Uncommon side effects that may show up in
blood tests:
• a decrease in the number of blood platelets
(cells that help blood to clot)
• a decrease in the number of white blood cells
• positive Coomb’s test.
Other side effects
Other side effects have occurred in a very small
number of people, but their exact frequency is
unknown:
• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• inflammation of the liver (hepatitis).
Side effects that may show up in blood tests:
• red blood cells destroyed too quickly
(haemolytic anaemia).
Reporting of 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 or by searching for
MHRA Yellow Card in the Google Play or Apple
App Store. By reporting side effects you can help
provide more information on the safety of this
medicine.
5. How to store Zinnat
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the pack after EXP. The expiry
date refers to the last day of that month.
The suspension should be stored in a fridge at all
times when not taking the medicine. Do not
allow it to freeze. It can be kept in the fridge for
up to 10 days.
Do not use Zinnat if it shows any sign of
deterioration.
Don’t throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.
10000000146746
GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR
Zinnat
N/A
JMF223
6. Contents of the pack and other
information
What Zinnat contains
• The active substance is 125 mg per 5 ml of
cefuroxime (present as cefuroxime axetil).
• The other ingredients are aspartame (E951),
xanthan gum, acesulfame potassium,
Povidone K30, stearic acid, sucrose, tutti
fruitti flavour and purified water.
• See section 2 for further important
information about some of the ingredients of
Zinnat.
What Zinnat looks like and contents of the pack
Zinnat Suspension 125 mg/5 ml is supplied in an
amber, glass, multidose bottle. The bottle
contains 70 ml of suspension. Your pharmacist
will have made this up with water using the
original granules that were supplied in the
bottle. The bottle is contained within a carton.
Marketing authorisation holder and
manufacturer
Marketing Authorisation Holder:
Glaxo Wellcome UK Limited, Stockley Park West,
Uxbridge, Middlesex UB11 1BT
Manufacturer: Glaxo Operations UK Ltd,
Harmire Road, Barnard Castle,
Co. Durham DL12 8DT
Other formats
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:
N/A
N/A
1
K
0
0
0800 198 5000 (UK Only)
Please be ready to give the following
information:
Product name
Zinnat Suspension
125 mg/5 ml
Reference number
10949/0094
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in October 2017.
Trade marks are owned by or licensed to the GSK
group of companies.
© 2017 GSK group of companies or its licensor.
Instructions for reconstitution
Directions for making up the suspension
Shake the bottle to loosen the
content. All the granules should
be free-flowing in the bottle.
Remove the cap and the heat-seal
membrane. If the latter is
damaged or not present, the
product should be returned to
the pharmacist.
Add the total amount of cold
water as stated on the label or
up to the volume line on the cup
provided (if supplied). If the
water was previously boiled it
must be allowed to cool to room
temperature before adding. Do
not mix Zinnat granules for oral
suspension with hot or warm
liquids. Cold water must be used
to prevent the suspension
becoming too thick.
Pour the total amount of cold
water into the bottle. Replace
the cap. Allow the bottle to
stand to allow the water to fully
soak through the granules; this
should take about 1 minute.
Invert the bottle and shake well
(for at least 15 seconds) until all
the granules have mixed with
the water.
Turn the bottle into an upright
position and shake well for at
least 1 minute until all the
granules have blended with the
water. Store the Zinnat suspension
immediately at between 2 and 8°C
(do not freeze) and let it rest for
at least one hour before taking
the first dose.
8.2 pt
8.8 pt
100%
8.2 pt
No
10000000146746
Page 2 of 2
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.