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ZINNAT TABLETS 250MG

Active substance(s): CEFUROXIME AXETIL

PDF Transcript

Pharma code Ref. No. 7830

1
Package Leaflet: Information for the Patient
®

cefuroxime axetil

10000000143152
GSK-GBR-Barnard Castle-UKBAR

Tablets 125 mg and 250 mg

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 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 diahorrea (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.

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.
Swallow Zinnat tablets whole with some water.
Don’t chew, crush or split the tablets — this may
make the treatment less effective.
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
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.

United Kingdom-GBR

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. By reporting
side effects you can help provide more
information on the safety of this medicine.

Zinnat
N/A
JMF231

N/A
N/A
1
K

0

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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.
Store in the original pack in a dry place at or
below 30°C.
Do not use Zinnat if the tablets are chipped or
there are other visible signs 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.

6. Contents of the pack and other
information
What Zinnat contains
• The active substance in each tablet is 125 mg or
250 mg cefuroxime (present as cefuroxime
axetil).
• The other ingredients are microcrystalline
cellulose, croscarmellose sodium type A,
sodium lauryl sulphate, hydrogenated
vegetable oil, silica colloidal anhydrous,
methylhydroxypropyl cellulose, propylene
glycol, methyl parahydroxybenzoate, propyl
parahydroxybenzoate and Opaspray white
M-1-7120J [containing titanium dioxide
(E171) and sodium benzoate (E211)].
What Zinnat looks like and contents of the pack
Zinnat Tablets 125 mg are white, film-coated,
capsule-shaped tablets plain on one side and
engraved with ‘GXES5’ on the other. They are
packaged in aluminium foil blister packs, enclosed
in a carton. Each pack contains 14 tablets.
Zinnat Tablets 250 mg are white, film-coated,
capsule-shaped tablets plain on one side and
engraved with ‘GXES7’ on the other. They are
packaged in aluminium foil blister packs, enclosed
in a carton. Each pack contains 14 and 50 tablets.
Marketing authorisation holder and manufacturer
Marketing Authorisation Holder: Glaxo Wellcome
UK Limited, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer: Glaxo Wellcome Operations,
Harmire Road, Barnard Castle, Co. Durham DL12 8DT
Other formats
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charge:

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Product name
Zinnat Tablets 125 mg

Zinnat Tablets 250 mg
Reference number
10949/0095
This is a service provided by the Royal National
Institute of Blind People.
This leaflet was last revised in September 2016.
Zinnat is a registered trade mark of the GSK group
of companies
© 2016 GSK group of companies. All rights reserved

10000000143152

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