Cefaclor monohydrate 375mg tablets
Modified release tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about CEFACLOR-GA 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-GA against the benefits the medicine is expected to 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-GA tablets are used for
CEFACLOR-GA is an antibiotic used to treat infections in different parts of the body caused by bacteria.
CEFACLOR-GA will not work against infections caused by viruses such as colds or the flu.
CEFACLOR-GA belongs to a group of antibiotics called cephalosporins (ke-fa-lo-spor-ins), which are closely related to penicillins.
CEFACLOR-GA works by killing the bacteria causing your infection or by stopping its growth.
Your doctor may have prescribed CEFACLOR-GA for another reason. Ask your doctor if you have any questions about why CEFACLOR-GA has been prescribed for you.
This medicine is available only with a doctor’s prescription.
There is no evidence that CEFACLOR-GA is addictive
Before you start using CEFACLOR-GA tablets
When you must not take it
Do not take CEFACLOR-GA tablets if:
- You have an allergy to CEFACLOR-GA, cefaclor, other cephalosporins or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty breathing, swelling of the face, lips or tongue.
- You have had a serious allergic reaction to penicillins
- The package 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-GA to children. The safety and efficacy of this product in children has not been established.
If you are not sure whether you should start using CEFACLOR-GA, talk to your doctor.
Before you start to take it
You must tell your doctor:
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-GA if you are allergic to cephalosporins or penicillins.
- 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
- If you are pregnant or intend to become pregnant
Your doctor will discuss the risks and benefits of using CEFACLOR-GA during pregnancy.
- If you are breast-feeding or plan to breast-feed
Your doctor will discuss the risks and benefits of using CEFACLOR-GA when breast-feeding.
If you have not told your doctor about any of the above, tell them before you start taking CEFACLOR-GA.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket of health food shop. Some medicines may interfere with CEFACLOR-GA. These include:
- probenecid a medicine used to treat gout or to prolong the action of certain antibiotics.
- magnesium or aluminium containing antacids, medicines used to treat stomach upsets or stomach ulcers.
These medicines may be affected by CEFACLOR-GA, 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-GA.
How CEFACLOR-GA tablets are taken
How much to take
Your doctor will decide what dose and how long you will receive CEFACLOR-GA. This depends on your infection and other factors, such as your weight.
How to take it
Swallow the prescribed dose of CEFACLOR-GA tablets whole with a full glass of water. Do not cut, crush or chew the tablets.
If you forget to take it
If it is almost time for you 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 it as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your medicine, 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 casualty at your nearest hospital if you think that you or anyone else may have taken too much CEFACLOR-GA. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers of these places/services handy.
If you take too many CEFACLOR-GA tablets, you may have:
- nausea
- vomiting
- heartburn
- diarrhoea
While you are using CEFACLOR-GA
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, pharmacist or nurse immediately. Do this even if it occurs several weeks after CEFACLOR-GA 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-GA, 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-GA allows fungi to grow and the above symptoms to occur. CEFACLOR-GA does not work against fungi.
If you become pregnant while you are taking CEFACLOR-GA, tell your doctor.
If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking CEFACLOR-GA.
If you have to have any blood or urine tests, tell your doctor you are taking CEFACLOR-GA tablets. CEFACLOR-GA may affect the results of some blood and urine tests.
Tell all the doctors, dentists and pharmacists who are treating you that you are receiving CEFACLOR-GA.
Things you must not do
Do not give CEFACLOR-GA to anyone else, even if they have the same condition as you.
Do not use CEFACLOR-GA 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-GA affects you. CEFACLOR-GA generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines CEFACLOR-GA may cause dizziness or tiredness in some people.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking CEFACLOR-GA. Like other medicines CEFACLOR-GA can cause some side effects. If they occur, most are likely to be minor and temporary. However some may be serious and need medical attention.
Ask your doctor or pharmacist to answer any questions you may have.
While taking it
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
- Mild stomach upsets, such as feeling sick
- Diarrhoea
Tell your doctor immediately to go to casualty at your nearest hospital if you notice any of the following:
- Fever
- Skin rashes which may be itchy
- Vomiting
- Severe diarrhoea
These are all serious side effects of CEFACLOR-GA. You may need urgent medical attention.
If any of the following happen, stop using CEFACLOR-GA and tell your doctor immediately or go to casualty at your nearest hospital:
- life threatening allergic reactions which may include skin rash, itching, difficulty breathing, swelling of the face, lips or tongue
- skin rash with joint pain and fever
- decrease in urine volume.
These are all very serious side effects of CEFACLOR-GA. If you have them, you may have had a serious allergic reaction to CEFACLOR-GA. You may need urgent medical attention or hospitalisation.
After finishing it
Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with CEFACLOR-GA:
- 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. CEFACLOR-GA can cause bacteria which are normally present in the bowel and are normally harmless to multiply and thereby cause the above symptoms. 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 any other effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using CEFACLOR-GA tablets
Storage
At home, keep your CEFACLOR-GA tablets in their original packs until it is time to use them. If you take the tablets out of the pack, they may not keep well.
Keep it in a cool, dry place where the temperature stays below 25° C.
Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking CEFACLOR-GA or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.
Product Description
What it looks it
CEFACLOR-GA 375mg, modified release tablets – blue tablets marked with CEFACLOR-GA 375 mg in black.
CEFACLOR-GA tablets are available in a pack of 10 tablets.
Ingredients
Active ingredients
Cefaclor monohydrate
Other ingredients (excipients)
Hypromellose, hydroxypropyl cellulose, lactose, magnesium stearate, purified talc and colloidal anhydrous silica.
The film coating contains: hypromellose, titanium dioxide, polyethylene glycol, indigo carmine CI73015.
The printing ink contains: purified water, iron oxide, propylene glycol, hypromellose and isopropyl alcohol.
CEFACLOR-GA does not contain gluten, sucrose, tartrazine or any other azo dyes.
Supplier
www.ascentpharma.com.au
Ascent Pharma Pty Ltd
151-153 Clarendon St
South Melbourne Vic. 3205
For further information call 1800 554 414
AUST R 77101
This leaflet was prepared in June 2010
Published by MIMS January 2011