Patient leaflet - Zinnat 125 mg / 5 ml granules for oral suspension

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 have ever developed a severe skin rash or skin
peeling, blistering and/or mouth sores after treatment with cefuroxime or any other cephalosporin antibiotics. If you think this applies to you, don’t take Zinnat until you have checked with your doctor.

Take special care with Zinnat:

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with cefuroxime treatment. Seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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.

It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Zinnat suspension also contains benzyl alcohol (E1519) which may cause allergic reactions.

This medicine contains 0.021 g aspartame in each 5 ml dose This medicine contains 3 g of sucrose in each 5 ml dose The medicine contains 6 mg of propylene glycol (E1520) in each 5 ml dose

This medicine contains 4.5 mg benzyl alcohol (E1519) in each 5 ml dose

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 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.

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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.
widespread rash, high body temperature and
enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
chest pain in the context of allergic reactions,
which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)
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. 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. 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.

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 125 mg per 5 ml of cefuroxime (present as cefuroxime axetil).

The other ingredients are aspartame (E951), xanthan gum, acesulfame potassium (E950), Povidone K30, stearic acid, sucrose, tutti frutti flavour (contains propylene glycol (E1520)), benzyl alcohol (E1519) 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 40 ml, 50 ml, 60 ml, 70 ml 80 ml or 100 ml of the 125 mg/5 ml suspension. This medicine must be made 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: Sandoz Pharmaceuticals d.d., Verovškova ulica 57, 1000 Ljubljana, Slovenia

Manufacturer:

Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, Co. Durham DL12 8DT

Lek farmacevtska družba d.d.

Verovškova ulica 57

Ljubljana, 1526 Slovenia

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

D24 YK11

Ireland

Sandoz GmbH, Kundl (AICO FDF Kundl), Biochemiestraße 10, 6250 Kundl

This leaflet was last revised in October 2024.

Trade marks are owned by or licensed to the Sandoz group of companies.

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.

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Signature

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Quality

V054 – Grouped quality changes including BRS change 006.0

18/10/2024

Futura CEEF

151 x 364 mm

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