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ZINNAT SUSPENSION 250MG/5ML

Active substance(s): CEFUROXIME AXETIL

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Reason for update: Type IB GDS v 26 -RTQ – Response to outstanding points raised by MHRA assessor
Market: UK
Agency Approval Date:
Text Date: 05/10/2017
Text Issue and Draft No.: Issue 7, Draft 4

[GSK Logo]
Package Leaflet: Information for the user

Zinnat Suspension 250 mg/5 ml
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 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:

Reason for update: Type IB GDS v 26 -RTQ – Response to outstanding points raised by MHRA assessor
Market: UK
Agency Approval Date:
Text Date: 05/10/2017
Text Issue and Draft No.: Issue 7, Draft 4





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

Reason for update: Type IB GDS v 26 -RTQ – Response to outstanding points raised by MHRA assessor
Market: UK
Agency Approval Date:
Text Date: 05/10/2017
Text Issue and Draft No.: Issue 7, Draft 4

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.

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.
For step-by-step instructions on how to make up Zinnat sachets 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.

Reason for update: Type IB GDS v 26 -RTQ – Response to outstanding points raised by MHRA assessor
Market: UK
Agency Approval Date:
Text Date: 05/10/2017
Text Issue and Draft No.: Issue 7, Draft 4

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.

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).

Reason for update: Type IB GDS v 26 -RTQ – Response to outstanding points raised by MHRA assessor
Market: UK
Agency Approval Date:
Text Date: 05/10/2017
Text Issue and Draft No.: Issue 7, Draft 4

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)

Reason for update: Type IB GDS v 26 -RTQ – Response to outstanding points raised by MHRA assessor
Market: UK
Agency Approval Date:
Text Date: 05/10/2017
Text Issue and Draft No.: Issue 7, Draft 4





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.

6. Contents of the pack and other information
What Zinnat contains
• The active substance is 250 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 250 mg/5 ml is supplied in an amber, glass, multidose bottle. The
bottle contains either 50, 70 or 100 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. Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing Authorisation Holder: Glaxo Wellcome UK Limited, Stockley Park West,
Uxbridge, Middlesex UB11 1BT

Reason for update: Type IB GDS v 26 -RTQ – Response to outstanding points raised by MHRA assessor
Market: UK
Agency Approval Date:
Text Date: 05/10/2017
Text Issue and Draft No.: Issue 7, Draft 4

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:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Zinnat Suspension 250 mg/5 ml
Reference number 10949/0272
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.

Reason for update: Type IB GDS v 26 -RTQ – Response to outstanding points raised by MHRA assessor
Market: UK
Agency Approval Date:
Text Date: 05/10/2017
Text Issue and Draft No.: Issue 7, Draft 4

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.

Directions for making up suspension from sachets
1.
Empty granules from sachet into a glass.
2.
Add a small amount of cold water.
3.
Stir well and drink straight away.
 Do not mix the suspension or granules with hot liquids.

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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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