ZINNAT TABLETS 500MG

Reason for update: Article 61(3) MAH name correction, layout & dimensions changes, GSK Logo (NOT
MARKETED)
Market: UK
Agency Approval Date:
Text Date: 15/12/2016
Text Issue and Draft No.: issue5draft2

[GlaxoSmithKline Logo]
Package Leaflet: Information for the Patient

Zinnat® Tablets 500 mg
cefuroxime axetil
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 Zinnat:

500 mg presentation – not marketed

Reason for update: Article 61(3) MAH name correction, layout & dimensions changes, GSK Logo (NOT
MARKETED)
Market: UK
Agency Approval Date:
Text Date: 15/12/2016
Text Issue and Draft No.: issue5draft2





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.
500 mg presentation – not marketed

Reason for update: Article 61(3) MAH name correction, layout & dimensions changes, GSK Logo (NOT
MARKETED)
Market: UK
Agency Approval Date:
Text Date: 15/12/2016
Text Issue and Draft No.: issue5draft2

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
500 mg presentation – not marketed

Reason for update: Article 61(3) MAH name correction, layout & dimensions changes, GSK Logo (NOT
MARKETED)
Market: UK
Agency Approval Date:
Text Date: 15/12/2016
Text Issue and Draft No.: issue5draft2

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.

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

500 mg presentation – not marketed

Reason for update: Article 61(3) MAH name correction, layout & dimensions changes, GSK Logo (NOT
MARKETED)
Market: UK
Agency Approval Date:
Text Date: 15/12/2016
Text Issue and Draft No.: issue5draft2

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.

500 mg presentation – not marketed

Reason for update: Article 61(3) MAH name correction, layout & dimensions changes, GSK Logo (NOT
MARKETED)
Market: UK
Agency Approval Date:
Text Date: 15/12/2016
Text Issue and Draft No.: issue5draft2

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 500 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 500 mg are white, film-coated, capsule-shaped tablets plain on one
side and engraved with ‘GXEG2’ on the other. They are packaged in aluminium foil
blister packs, enclosed in a carton. Each pack contains 2, 4, 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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0800 198 5000 (UK Only)
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Product name
Zinnat Tablets 500 mg
Reference number 10949/0119
500 mg presentation – not marketed

Reason for update: Article 61(3) MAH name correction, layout & dimensions changes, GSK Logo (NOT
MARKETED)
Market: UK
Agency Approval Date:
Text Date: 15/12/2016
Text Issue and Draft No.: issue5draft2

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
[GlaxoSmithKline Logo]

500 mg presentation – not marketed