SUMMARY CMI

ZINNAT tablets

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using ZINNAT tablets?

ZINNAT tablets contains the active ingredient cefuroxime axetil. ZINNAT tablets is used to treat bacterial infections in your body including infections of ear, nose and throat, lungs or chest, urinary tract, skin and soft tissues. It is also used to treat sexually transmitted infections (urethritis and cervictis).

For more information, see Section 1. Why am I using ZINNAT tablets? in the full CMI.

2. What should I know before I use ZINNAT tablets?

Do not use if you have ever had an allergic reaction to ZINNAT or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use ZINNAT tablets? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ZINNAT tablets and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ZINNAT tablets?

• The usual dose of ZINNAT is one 250 mg tablet twice a day for 7 to 10 days.
• Take your complete course of ZINNAT tablets as directed by your doctor or pharmacist.

More instructions can be found in Section 4. How do I use ZINNAT tablets? in the full CMI.

5. What should I know while using ZINNAT tablets?

For more information, see Section 5. What should I know while using ZINNAT tablets? in the full CMI.

6. Are there any side effects?

Common side effects include headache, abdominal pain, dizziness, nausea or vomiting, mild diarrhoea, indigestion or wind, or dry mouth.

Serious side effects include skin rash, a widespread rash with blisters and skin peeling on much of the body surface, persistent diarrhoea, overgrowth of yeast in the body, or allergic reactions.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

ZINNAT tablets

Active ingredient: cefuroxime axetil

Consumer Medicine Information (CMI)

This leaflet provides important information about using ZINNAT tablets. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ZINNAT tablets.

Where to find information in this leaflet:

1. Why am I using ZINNAT tablets?
2. What should I know before I use ZINNAT tablets?
3. What if I am taking other medicines?
4. How do I use ZINNAT tablets?
5. What should I know while using ZINNAT tablets?
6. Are there any side effects?
7. Product details

1. Why am I using ZINNAT tablets?

ZINNAT tablets contains the active ingredient cefuroxime axetil. ZINNAT belongs to a group of medicines called cephalosporin antibiotics.

ZINNAT works by killing bacteria (germs) that cause infections such as infections of:

• ear, nose and throat
• lungs or chest
• urinary tract
• skin and soft tissues

ZINNAT is also used to treat sexually transmitted infections (urethritis and cervictis).

ZINNAT is not addictive.

2. What should I know before I use ZINNAT tablets?

Warnings

Do not use ZINNAT tablets if:

• you have ever had an allergic reaction to cefuroxime, penicillin, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• the expiry date (EXP) printed on the pack has passed.
• the packaging is torn or shows signs of tampering.

Check with your doctor if you:

• are allergic to foods, dyes, preservatives or any other medicines.
• have had to stop taking another medicine for your infection.
• test your urine for sugar. ZINNAT may interfere with some urine tests.
• have kidney problems.
• are taking any other medicines, including medicines you buy without a prescription.
• need a blood test. ZINNAT can affect the results of a test for blood sugar levels, or a blood screen called the Coombs test.
• are taking the contraceptive pill. ZINNAT may reduce how well the contraceptive pill works.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with ZINNAT tablets and affect how it works. This include:

• Combined oral contraceptives
• Ranitidine (histamine-2 blocker)

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ZINNAT tablets.

4. How do I use ZINNAT tablets?

How much to take

• Take your complete course of ZINNAT tablets as directed by your doctor or pharmacist.
  Do not stop just because you feel better, as the medicine may not have killed all the germs and you may start feeling unwell again.
• The usual dose of ZINNAT is one 250 mg tablet twice a day for 7 to 10 days. Your doctor may have prescribed a different dosage regimen.

How to take ZINNAT tablets

• Swallow the whole tablet with a drink of water.
• ZINNAT tablets work better when taken after food.

If you forget to use ZINNAT tablets

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

If you use too much ZINNAT tablets

If you think that you have used too much ZINNAT tablets, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using ZINNAT tablets?

Things you should do

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Remind any doctor or pharmacist you visit that you are taking ZINNAT tablets.

Things you should not do

• Do not give this medicine to anyone else, even if they have the same condition as you.
• Do not use ZINNAT tablets to treat any other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ZINNAT tablets affects you.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store it a cool, dry place where it stays below 30°C. Do not store it:

• in the bathroom, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Keep your ZINNAT in its pack until it is time to take it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What ZINNAT tablets contains

Do not take this medicine if you are allergic to any of these ingredients.

What ZINNAT tablets looks like

Zinnat Tablets 125 mg: White, film coated, capsule shaped, biconvex tablets engraved "GXES5" on one face and blank on the other. Available in blister packs (AUST R 47620) of 2, 10, 14 and 50.

Zinnat Tablets 250 mg: White, film coated, capsule shaped, biconvex tablets engraved "GXES7" on one face and blank on the other. Available in blister packs (AUST R 47621) of 2, 10, 14, 20 and 50.

Not all strengths/pack sizes are distributed in Australia.

Who distributes ZINNAT tablets

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards, NSW 2065
Australia

This leaflet was revised in January 2024.

Published by MIMS March 2024

1 Name of Medicine

Cefuroxime axetil.

2 Qualitative and Quantitative Composition

Zinnat tablets 125 mg.

Zinnat tablets 250 mg.

3 Pharmaceutical Form

Zinnat 125 mg and 250 mg tablets are present in blister packs.

Zinnat tablets 125 mg.

Zinnat tablets 250 mg.

4 Clinical Particulars

4.1 Therapeutic Indications

Cefuroxime is indicated for the treatment of the following mild to moderately severe infections in adults caused by sensitive bacteria.
Acute upper respiratory infections: otitis media, sinusitis, tonsillitis and pharyngitis.
Acute exacerbations of chronic bronchitis, or acute bronchitis.
Skin and skin structure infections for example, furunculosis, pyoderma and impetigo.
Acute uncomplicated gonococcal urethritis, and cervicitis due to non-penicillinase producing gonococci.

4.2 Dose and Method of Administration

The usual course of therapy with Zinnat tablets is 5 to 7 days for treatment of bronchitis, and 7 to 10 days for other infections.
Cefuroxime axetil should be taken after a light meal for optimum absorption.

Adults.

Acute exacerbations of chronic bronchitis.

Acute bronchitis.

Uncomplicated gonococcal urethritis or cervicitis.

Other infections.

Renal impairment.

4.3 Contraindications

Patients with known hypersensitivity to cephalosporin antibiotics or who have experienced a major allergy to penicillin (anaphylaxis, angioneurotic oedema, urticaria).

4.4 Special Warnings and Precautions for Use

Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions have been reported in patients on penicillin/cephalosporin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins/cephalosporins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin/cephalosporin hypersensitivity who have experienced severe reactions when treated with a penicillin/cephalosporins. Past history of a severe allergic reaction to penicillin/cephalosporin is a contraindication to the use of cefuroxime axetil. Before initiating therapy with any penicillin/cephalosporin careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see Section 4.8 Adverse Effects (Undesirable Effects)). If an allergic reaction occurs, cefuroxime axetil should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.
Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.
As with other antibiotics, use of cefuroxime axetil may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of other non-susceptible organisms (e.g. Enterococci and Clostridium), which may require interruption of treatment.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefuroxime axetil. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further. Mild cases usually respond to drug discontinuation alone although cholestyramine may help by binding the toxin in the colonic lumen. However, in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.

Severe cutaneous adverse reactions.

Neurotoxicity.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Drugs such as ranitidine may result in a lower bioavailability of cefuroxime axetil compared with that of the fasting state.
In common with other antibiotics, cefuroxime axetil may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

As this medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions to cefuroxime axetil have been generally mild and transient in nature. The drug was discontinued in 2.1% of cases, mainly due to diarrhoea/nausea.
The following adverse reactions to cefuroxime axetil have been reported in clinical trials. However, the possibility of the occurrence of other adverse reactions, seen with the cephalosporin class of antibiotics, should be borne in mind.

Cardiac disorders.

Gastrointestinal.

Hepatic.

CNS.

Haemopoietic.

Hypersensitivity.

Infections and infestations.

Skin and other subcutaneous tissue disorders.

Others.

Cephalosporin-class adverse reactions.

Reporting suspected adverse effects.

4.9 Overdose

Overdosage of cephalosporins can cause cerebral irritation leading to convulsions.
Serum levels of cefuroxime can be reduced by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Aerobes gram-negative.

Aerobes gram-positive.

Susceptibility tests.

Diffusion techniques.

Dilution techniques.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Preclinical safety data were either not assessed or not identified as part of the registration of this medicine.

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Zinnat tablets also contain microcrystalline cellulose, croscarmellose sodium, hypromellose, methyl hydoxybenzoate, Opaspray White M-1-7120, propylene glycol, propyl hydroxybenzoate, colloidal anhydrous silica, sodium lauryl sulphate and hydrogenated vegetable oil.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Each 125 mg tablet is available in foil blisters of 2, 10, 14 and 50.
Each 250 mg tablet is available in foil blisters of 2, 10, 14, 20 and 50.
Not all strengths/pack sizes are distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes