Medication Guide App

ZINNAT SUSPENSION 250MG/5ML

Active substance: CEFUROXIME AXETIL

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Reason for MHRA Submission: Implementation of Article 30
Text Date: May 2013
Date of MHRA Submission:
Date of MHRA Approval:
Issue 3, draft 1

[GlaxoSmithKline Logo]
Package Leaflet: Information for the Patient

Zinnat® Suspension 250 mg/5 ml
cefuroxime
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.
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:
x
the throat
x
sinus
x
middle ear
x
the lungs or chest
x
the urinary tract
x
the skin and soft tissues.
Zinnat can also be used:
x
to treat Lyme disease (an infection spread by parasites called ticks).

2. What you need to know before you take Zinnat
Don’t take Zinnat:
x
x

if you are allergic (hypersensitive) to any cephalosporin antibiotics or any of
the other ingredients of Zinnat.
if you have ever had a severe allergic (hypersensitive) reaction to any other type
of betalactam antibiotic (penicillins, monobactams and carbapenems).

Reason for MHRA Submission: Implementation of Article 30
Text Date: May 2013
Date of MHRA Submission:
Date of MHRA Approval:
Issue 3, draft 1

Î

If you think this applies to you, don’t take Zinnat until you have checked with
your doctor.

Take special care with Zinnat
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:
Î Tell the person taking the sample that you are taking Zinnat.
Other medicines and Zinnat
Tell your doctor or pharmacist if you are taking any other medicines, if you’ve started
taking any recently or you start taking new ones. This includes medicines you can
obtain without a prescription.
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
Î 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
Tell your doctor before you take Zinnat:
x
if you are pregnant, think you might be pregnant or are planning to become
pregnant
x
if you are breastfeeding.
Your doctor will consider the benefit of treating you with Zinnat against the risk to your
baby.
Driving and using machines

Reason for MHRA Submission: Implementation of Article 30
Text Date: May 2013
Date of MHRA Submission:
Date of MHRA Approval:
Issue 3, draft 1

Zinnat can make you dizzy and have other side effects that make you less alert.
Î 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):
Î

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.
The usual dose
Adults
The usual dose of Zinnat is 250 mg to 500 mg twice daily depending on the severity
and type of infection.
Children
The usual 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:
x
the severity and type of infection
x
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.

Reason for MHRA Submission: Implementation of Article 30
Text Date: May 2013
Date of MHRA Submission:
Date of MHRA Approval:
Issue 3, draft 1

Patients with kidney problems
If you have a kidney problem, your doctor may change your dose.
Î Talk to your doctor if this applies to you.
If you take too much Zinnat
If you take too much Zinnat you may have neurological disorders, in particular you may
be more likely to have fits (seizures).
Î 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
Don't take an extra dose to make up for a missed dose. Just take your next dose at
the usual time.
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.

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:
x

severe allergic reaction. Signs include raised and itchy rash, swelling,
sometimes of the face or mouth causing difficulty in breathing.

x

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).

x

a widespread rash with blisters and peeling skin. (These may be signs of
Stevens-Johnson syndrome or toxic epidermal necrolysis).

x

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.

Reason for MHRA Submission: Implementation of Article 30
Text Date: May 2013
Date of MHRA Submission:
Date of MHRA Approval:
Issue 3, draft 1

x

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

x

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.
Î 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:
x
x
x
x
x
x

fungal infections (such as Candida)
headache
dizziness
diarrhoea
feeling sick
stomach pain.

Common side effects that may show up in blood tests:
x
x

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:
x
x

being sick
skin rashes.

Uncommon side effects that may show up in blood tests:
x
x
x

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:
x
x
x
x
x
x

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).

Reason for MHRA Submission: Implementation of Article 30
Text Date: May 2013
Date of MHRA Submission:
Date of MHRA Approval:
Issue 3, draft 1

Side effects that may show up in blood tests:
x

red blood cells destroyed too quickly (haemolytic anaemia).

If you get any side effects
Î Tell your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet.

5. How to store Zinnat
Keep this medicine out of the sight and reach of children.
Do not use this medince 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
x The active substance is 250 mg per 5 ml of cefuroxime (present as cefuroxime
axetil).
x The other ingredients are aspartame (E951), xanthan gum, acesulfame potassium,
Povidone K30, stearic acid, sucrose, tutti fruitti flavour and purified water.
x 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: GlaxoSmithKline UK, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer: Glaxo Wellcome Operations, 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:

Reason for MHRA Submission: Implementation of Article 30
Text Date: May 2013
Date of MHRA Submission:
Date of MHRA Approval:
Issue 3, draft 1

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.
Leaflet date: June 2013
Zinnat is a registered trademark of the GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of companies. All rights reserved
[GlaxoSmithKline Logo]

Reason for MHRA Submission: Implementation of Article 30
Text Date: May 2013
Date of MHRA Submission:
Date of MHRA Approval:
Issue 3, draft 1

Instructions for reconstitution
Directions for making up the suspension
1.
Shake the bottle to loosen the granules and remove the cap
2.
Add the amount of water stated on the bottle label, or as stated on the cup (if
supplied), and replace the cap.
3.
Turn the bottle upside down and rock vigorously for at least 15 seconds.
4.
Turn the bottle the right way up and shake vigorously.
5.
Zinnat suspension, must be stored in the fridge between 2°C and 8°C.
6.
If using a dosing syringe, allow the reconstituted suspension to stand for at least
one hour before taking the first dose.
For children who can’t take Zinnat using a spoon, a dosing syringe with a 5 mL
graduation is supplied. Use the oral dosing syringe supplied with the pack to measure
your dose accurately:
1.
2.
3.
4.
5.
6.
7.

Remove the bottle cap. Keep it safely.
Hold the bottle firmly. Push the plastic adapter into the neck of the bottle.
Insert the syringe firmly into the adapter.
Turn the bottle upside down.
Pull out syringe plunger until the syringe contains the first part of your full dose.
Turn the bottle the correct way up. Remove the syringe from the adapter.
Put the syringe into your mouth, placing the tip of the syringe against the inside
of your cheek. Slowly push the plunger in, allowing time to swallow. Don’t push
too hard and squirt the liquid into the back of your throat or you may choke.
8.
Repeat steps 3 to 7 in the same way until you have taken your whole dose.
9.
Take the syringe out of the bottle and wash it thoroughly in clean water. Let it
dry completely before you use it again.
10. Close the bottle tightly with the cap, leaving the adaptor in place.

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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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