Consumer medicine information

CEFACLOR SUN


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 CEFACLOR SUN?

CEFACLOR SUN contains the active ingredient cefaclor monohydrate. CEFACLOR SUN is used to treat infections caused by bacteria in different parts of the body. For more information, see Section 1. Why am I using CEFACLOR SUN? in the full CMI.

2. What should I know before I use CEFACLOR SUN?

Do not use if you have ever had an allergic reaction to CEFACLOR SUN 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 CEFACLOR SUN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CEFACLOR SUN 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 CEFACLOR SUN?

  • Your doctor will tell you how much CEFACLOR SUN you need to take.
  • This will depend on the type of infection you have.

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

5. What should I know while using CEFACLOR SUN?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using CEFACLOR SUN.
  • Tell your doctor if the symptoms of your infection do not improve within a few days, or if they become worse.
  • If you become pregnant while you are taking CEFACLOR SUN, tell your doctor immediately.
Things you should not do
  • Do not give CEFACLOR SUN to anyone else, even if they have the same condition as you.
  • Do not use CEFACLOR SUN to treat any other complaints unless your doctor tells you to.
  • Do not stop taking your medicine or change the dosage without checking with your doctor.
Driving or using machines
  • Be careful driving or operating machinery until you know how CEFACLOR SUN affects you.
Looking after your medicine CEFACLOR SUN suspension: Store in a refrigerator (2-8°C. Refrigerate. Do not freeze). Discard unused suspension after 14 days.

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

6. Are there any side effects?

Common side effects include oral thrush-white, furry, sore tongue; vaginal thrush-sore and itchy vagina and/or abnormal discharge; itchy rash; diarrhea. Serious side effects include nausea; vomiting; drowsiness; headache; hyperactivity, nervousness, insomnia, confusion, dizziness, hallucinations; severe muscles stiffness; swelling of the joints or pain in the joints with or without fever; itching or swelling of the skin; yellowing of the skin or eyes; frequent infections such as fever, severe chills, sore throat or mouth ulcers; bleeding or bruising more easily than normal; difficulty in swallowing or breathing.

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.

CEFACLOR SUN

Active ingredient(s): cefaclor monohydrate


Consumer Medicine Information (CMI)

This leaflet provides important information about using CEFACLOR SUN. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CEFACLOR SUN against the benefits it is expected to have for you. 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 CEFACLOR SUN. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.ebs.tga.gov.au. Those updates may contain important information about the medicine and its use of which you should be aware.

Where to find information in this leaflet:

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

1. Why am I using CEFACLOR SUN?

CEFACLOR SUN contains the active ingredient cefaclor monohydrate. CEFACLOR SUN is in a class of medications called cephalosporin antibiotics which are closely related to penicillins.

CEFACLOR SUN is an antibiotic used to treat infections caused by bacteria in different parts of the body including infections of the:

  • ears, nose, throat and tonsils (upper respiratory tract);
  • chest and lungs (lower respiratory tract);
  • bladder and kidneys (lower urinary tract);
  • skin

CEFACLOR SUN works by killing the bacteria causing your infection or by stopping its growth.

CEFACLOR SUN will not work against infections caused by viruses such as colds or the flu.

Your doctor may have prescribed CEFACLOR SUN for another reason. Ask your doctor if you have any questions about why CEFACLOR SUN has been prescribed for you.

This medicine is not addictive.

2. What should I know before I use CEFACLOR SUN?

Warnings

Do not use CEFACLOR SUN if:

  • You are allergic to cefaclor monohydrate, or any of the ingredients listed at the end of this leaflet.
    Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
  • Always check the ingredients to make sure you can use this medicine.
  • You have had a serious allergic reaction to penicillins
  • The packaging is torn or shows signs of tampering
  • The expiry date on the pack has passed
    If you take this medicine after the expiry date has passed, it may not work as well (or it may make you feel sick).

Do not give CEFACLOR SUN to a child under the age of 12 years.

The safety and efficacy of this product in children has not been established.

Check with your doctor if you:

  • If you have any type of allergic reaction to cephalosporin medicines, penicillin medicines or any other antibiotic medicines.
    You may have an increased chance of being allergic to CEFACLOR SUN if you are allergic to cephalosporins or pencillins.
  • If you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
  • If you have or have ever had any other health problems/medical conditions, including:
    – kidney disease;
    – severe bowel conditions/disease;
    – liver disease.

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.

Your doctor will discuss the risks and benefits of using CEFACLOR SUN during pregnancy.

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

Your doctor will discuss the risks and benefits of using CEFACLOR SUN when breastfeeding.

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 CEFACLOR SUN. These include:

Antacids: If you need to take an antacid, do not take it within 1 hour of taking CEFACLOR SUN.

Probenecid (eg. Pro-Cid).

These medicines may be affected by CEFACLOR SUN, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking CEFACLOR SUN.

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

4. How do I use CEFACLOR SUN?

How much to take / use

  • Your doctor will tell you how much CEFACLOR SUN you need to take.
    This depends on type of infection you have.
  • Follow the instructions provided when CEFACLOR SUN was prescribed, including the number of days it should be taken.

When to take / use CEFACLOR SUN

  • CEFACLOR SUN should be used at about the same time each day. This will have the best effect. It will also help you remember when to take this medicine.

How to take CEFACLOR SUN

Continue taking your medicine for as long as your doctor tells you.

It is important to complete the full course prescribed by your doctor, even if you begin to feel better after a few days.

If you do not complete the full course of treatment prescribed by your doctor, the infection may not clear completely or your symptoms may return.

If you forget to use CEFACLOR SUN

CEFACLOR SUN should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember and then go back to taking it as you would do normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

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

  • If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
  • If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you use too much CEFACLOR SUN

If you think that you have used too much CEFACLOR SUN, 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.

If you take too much CEFACLOR SUN, you may have:

  • sick;
  • vomiting;
  • upset stomach;
  • diarrhea.

5. What should I know while using CEFACLOR SUN?

Things you should do

  • If the symptoms of your infection do not improve within a few days, or if they become worse tell your doctor.
  • If you get a sore white mouth or tongue while taking or soon after stopping CEFACLOR SUN, tell your doctor. Also tell your doctor if your get vaginal itching or discharge.
    This may mean you have a fungal infection called thrush. Sometimes the use of CEFACLOR SUN allows fungi to grow and the above symptoms to occur. CEFACLOR SUN does not work against fungi.
  • If you become pregnant while you are taking CEFACLOR SUN, tell your doctor.
  • If you are about to start taking any new medicine, tell your doctor or pharmacist that you are taking CEFACLOR SUN
  • If you have to have any blood or urine tests, tell your doctor you are taking CEFACLOR SUN. CEFACLOR SUN may affect the results of some blood and urine tests.
    Keep all of your doctor’s appointments so that your progress can be checked.
    Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
    If you are diabetic, check with your doctor or pharmacist before using urine sugar tests.
    CEFACLOR SUN may cause false test results with some urine sugar tests.

Things you should not do

  • Do not stop using CEFACLOR SUN or change the dosage without checking with your doctor.
  • Do not give CEFACLOR SUN to anyone else, even if they have same condition as you.
  • Do not use CEFACLOR SUN 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 CEFACLOR SUN affects you.

CEFACLOR SUN generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, CEFACLOR SUN may cause dizziness or tiredness in some people.

Looking after your medicine

Keep CEFACLOR SUN suspension in your refrigerator at 2°C to 8°C. Do not freeze. Discard unused suspension after 14 days.

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

Less serious side effects What to do
  • oral thrush – white furry, sore tongue and mouth;
  • vaginal thrush – sore and itchy vagina and/or discharge;
  • itchy rash;
  • diarrhea.
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects What to do
  • nausea;
  • vomiting;
  • drowsiness;
  • headache;
  • hyperactivity, nervousness, insomnia, confusion, dizziness, hallucinations;
  • severe muscle stiffness;
  • swelling of the joints with or without fever;
  • pain in the joints with or without fever;
  • itching or swelling of the skin;
  • yellowing of the skin or eyes;
  • frequent infections such as fever, severe chills, sore throat or mouth ulcers;
  • bleeding or bruising more easily than normal;
  • difficulty in swallowing or breathing.
Speak to your doctor as soon as possible if you notice any of the following and they worry you:
  • severe abdominal cramps or stomach cramps;
  • watery and severe diarrhoea which may also be bloody;
  • fever, in combination with one or both of the above.

Do not take any diarrhoea medicine without first checking with your doctor.
You may have a serious condition affecting your bowel, requiring urgent medical attention.

Tell your doctor immediately if you notice any of the following, particularly if they occur several weeks after stopping treatment with CEFACLOR SUN
  • sudden signs of allergy such as rash, itching or hives on the skin with swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

These is a very serious side effect. You may need urgent medical attention or hospitalisation. This side effect is very rare.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 CEFACLOR SUN contains

Active ingredient
(main ingredient)
cefaclor monohydrate
Other ingredients
(inactive ingredients)
  • xanthan gum
  • sodium benzoate
  • sucrose
  • colloidal anhydrous silica
  • allura red AC
  • strawberry flavouring (PI)
  • sodium citrate
  • anhydrous citric acid
  • simethicone emulsion (PI)
Potential allergens Sugars and benzoates

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

What CEFACLOR SUN looks like

Your pharmacist will make up the medicine in bottle before dispensing it to you. The resulting suspension is pink and has a strawberry taste.

It is available in two different strengths:

  • 125 mg/5mL (AUST R 226400)
  • 250 mg/5mL (AUST R 226401)

Who distributes CEFACLOR SUN

Sun Pharma ANZ Pty Ltd
12 Waterloo Road
Macquarie Park
Sydney NSW 2113
Australia
Email: customerservice.aus@sunpharma.com
Telephone: 1800 726 229

This leaflet was prepared in August 2017

Published by MIMS October 2023