Cefaclor (as monohydrate)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Cefaclor Sandoz. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Cefaclor Sandoz against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Cefaclor Sandoz is used for
The name of your medicine is Cefaclor Sandoz. It contains the active ingredient cefaclor monohydrate.
Cefaclor Sandoz is an antibiotic used to treat infections in different parts of the body caused by bacteria.
Cefaclor Sandoz belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection.
Cefaclor Sandoz will not work against infections caused by viruses such as colds or the flu.
Your doctor may have prescribed Cefaclor Sandoz for another reason. Ask your doctor if you have any questions about why Cefaclor Sandoz has been prescribed for you.
This medicine is available only with a doctor's prescription.
Cefaclor Sandoz is not addictive.
Before you take Cefaclor Sandoz
When you must not take it
Do not take Cefaclor Sandoz if:
1.you have an allergy to cefaclor, any other cephalosporins or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include wheezing, shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, skin rash, itching or hives.
2.you have had a serious allergic reaction to any penicillins.
You may be more likely to have an allergic reaction to Cefaclor Sandoz if you are allergic to penicillin medicines.
Do not give Cefaclor Sandoz to a premature baby or to a baby less than one month old. The safety and effectiveness of Cefaclor Sandoz have not been established in this age group.
Do not use Cefaclor Sandoz if the packaging is torn or shows signs of tampering or if the medicine does not look quite right.
Do not use Cefaclor Sandoz after the expiry date printed on the pack has passed.
If you are not sure whether you should start taking Cefaclor Sandoz, contact your doctor.
Before you start to take it
Tell your doctor if:
1.you have had any type of allergic reaction to any penicillin medicines.
You may have an increased chance of being allergic to Cefaclor Sandoz if you are allergic to penicillins.
2.you have any allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes
3.you are pregnant, or intend to become pregnant.
Cefaclor Sandoz may affect your developing baby if you take it during pregnancy. Your doctor will discuss the risks and benefits of using Cefaclor Sandoz during pregnancy.
4.you are breast-feeding or intend to breast-feed.
Cefaclor Sandoz passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of using Cefaclor Sandoz when breast-feeding.
5.if you have or have had any medical conditions, including:
- kidney problems
- stomach or bowel problems
- liver problems
If you have not told your doctor about any of the above, tell them before you take Cefaclor Sandoz.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with Cefaclor Sandoz. These include:
probenecid, a medicine used to treat gout
These medicines may be affected by Cefaclor Sandoz, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Talk to your doctor about the need for an additional method of contraception while taking Cefaclor Sandoz. Some antibiotics may decrease the effectiveness of some birth control pills.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Cefaclor Sandoz.
How to take Cefaclor Sandoz
Follow all directions given to you by your doctor or pharmacist carefully. These directions may differ from the information contained in this leaflet.
If you do not understand the instructions on the container, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how much Cefaclor Sandoz you need to take. This will depend on the type of infection you have.
The usual dose of Cefaclor Sandoz is 250 mg every 8 to 12 hours. This dose may vary depending on your condition.
The dose for children varies according to the age of the child, their weight and the type of infection.
Your doctor and pharmacist will tell you the right amount to give your child.
How to take it
Always shake the bottle before measuring the correct volume to be taken using a metric medicine measure.
When to take it
Cefaclor Sandoz can be taken with or without food.
How long to take it
Continue taking this medicine until you finish the bottle or for as long as your doctor tells you. Keep taking this medicine for the full course of treatment, even if you begin to feel better after a few days. If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.
If you forget to take it
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, and then go back to taking your suspension as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are not sure what to do ask your doctor or pharmacist.
If you have trouble remembering to take your suspension, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Cefaclor Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you have taken too much Cefaclor Sandoz you may experience symptoms such as feeling sick in the stomach, vomiting or diarrhoea.
While you are using Cefaclor Sandoz
Things you must 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 severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after Cefaclor Sandoz has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.
If you get a sore white mouth or tongue while taking or soon after stopping Cefaclor Sandoz, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of Cefaclor Sandoz allows fungi to grow and the above symptoms to occur. Cefaclor Sandoz does not work against fungi.
If you become pregnant while you are taking Cefaclor Sandoz tell your doctor immediately.
If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Cefaclor Sandoz.
If you have to test your urine for sugar while you are being given Cefaclor Sandoz, make sure your doctor knows which type of test you use. Cefaclor Sandoz may affect the results of some of these tests.
If you have to have any blood tests tell your doctor you are taking Cefaclor Sandoz. Cefaclor Sandoz may affect the results of some blood tests.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Cefaclor Sandoz.
Things you must not do
Do not stop taking your Cefaclor Sandoz because you are feeling better, unless advised by your doctor. If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.
Do not give Cefaclor Sandoz to anyone else, even if they have the same condition as you.
Do not use Cefaclor Sandoz to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how Cefaclor Sandoz affects you. Cefaclor Sandoz may cause drowsiness and dizziness in some people. Make sure you know how you react to Cefaclor Sandoz before you drive a car, operate machinery or do anything else that may be dangerous if you are affected.
Children should be careful when riding bicycles or climbing trees.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Cefaclor Sandoz. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
While taking Cefaclor Sandoz
Tell your doctor if you notice any of the following and they worry you:
oral thrush - white, furry, sore tongue and mouth
vaginal thrush - sore and itchy vagina and/or discharge
feeling sick, vomiting
inability to sleep
These side effects are usually mild.
If any of the following happen, stop taking Cefaclor Sandoz and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
severe abdominal cramps or stomach cramps
watery and severe diarrhoea, which may also be bloody or contain mucus
rash, itching, severe body rash with pinkish, itchy swellings of the skin (hives), blistering or peeling of the skin
signs of frequent infections such as fever, chills, sore throat or mouth ulcers
pain or swelling of the joints
yellowing of the skin or eyes
shortness of breath, wheezing or difficulty in breathing
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
severe blisters and bleeding of the lips, eyes, mouth, nose and genitals
unusual muscle stiffness causing poor control of movement
kidney pain, blood in the urine, passing more or less urine than is normal for you
These are very serious side effects. You may need urgent medical attention or hospitalisation. Serious side effects are rare.
After taking Cefaclor Sandoz
Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with Cefaclor Sandoz:
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
These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention. However, this side effect is rare.
Do not take any diarrhoea medicine without first checking with your doctor.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using Cefaclor Sandoz
Keep Cefaclor Sandoz where children cannot reach it.
Keep your suspension refrigerated (do not freeze) until it is time to take your dose. If you keep the suspension out of the refrigerator, it will not keep well.
The bottle should be shaken well before use and discarded 14 days after the date on which it was prepared. Keep the bottle tightly closed.
If your doctor tells you to stop taking Cefaclor Sandoz or you find that the medicine has passed the expiry date, ask your pharmacist what to do with any medicine that is left over.
What it looks like
Cefaclor Sandoz Suspension is a yellowish to orange-yellow liquid and has a strawberry taste.
Each bottle of Cefaclor Sandoz 125mg/5mL contains 100 mL of liquid.
Each bottle of Cefaclor Sandoz 250mg/5mL contains 75 mL of liquid.
Cefaclor Sandoz contains 125mg/5mL or 250mg/5mL cefaclor (as monohydrate) as the active ingredient.
It also contains the following ingredients:
sodium lauryl sulfate
iron oxide yellow (CI 77492)
Sandoz Pty Ltd
Level 4, 100 Harris Street
Pyrmont NSW 2009
Tel: 1800 634 500 1800 634 500
Australian Registration Numbers:
125mg/5mL: AUST R 76048
250mg/5mL: AUST R 76049
This leaflet was prepared in July 2007
Published by MIMS/myDr April 2008
Consumers should be aware that the information provided by the Consumer Medicines Information (“CMI”) search (“CMI Search”) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. UBM Medica Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. “Published by MIMS/myDr January 2007”), the CMI provided was complete to the best of UBM Medica Australia’s knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. UBM Medica Australia, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from