Consumer medicine information

DOUGLAS CEFACLOR-CD™ tablets

Cefaclor monohydrate 375 mg tablets


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about DOUGLAS CEFACLOR-CD. It does not contain all the available information.

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 DOUGLAS CEFACLOR-CD against the benefits this 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.

DOUGLAS CEFACLOR-CD tablets contain monohydrate as the active ingredient.

What DOUGLAS CEFACLOR-CD tablets are used for

DOUGLAS CEFACLOR-CD is an antibiotic used to treat infections in different parts of the body caused by bacteria.

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

DOUGLAS CEFACLOR-CD belongs to a group of antibiotics called cephalosporins (ke-fa-lo-spor-ins), which are closely related to penicillins.

DOUGLAS CEFACLOR-CD works by killing the bacteria causing your infection or by stopping its growth.

Your doctor may have prescribed DOUGLAS CEFACLOR-CD for another reason. Ask your doctor if you have any questions about what DOUGLAS CEFACLOR-CD has been prescribed for you.

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

There is no evidence that DOUGLAS CEFACLOR-CD is addictive.

Before you start using DOUGLAS CEFACLOR-CD tablets

When you must not take it

Do not take DOUGLAS CEFACLOR-CD tablets if:

  • You have an allergy to DOUGLAS CEFACLOR-CD, 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 DOUGLAS CEFACLOR-CD 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 DOUGLAS CEFACLOR-CD, talk to your doctor.

Before you take it

You must tell your doctor:

  1. If you have any type of allergic reaction to cephalosporin medicines, pencillin medicines or any other antibiotic medicines

You may have an increased chance of being allergic to DOUGLAS CEFACLOR-CD if you are allergic to cephalosporins or penicillins.

  1. If you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes
  2. If you have or have ever had any other health problems/medical conditions, including:
  • Kidney disease
  • Severe bowel conditions/disease
  • Liver disease
  1. If you are pregnant or intend to become pregnant

Your doctor will discuss the risks and benefits of using DOUGLAS CEFACLOR-CD during pregnancy.

  1. If you are breast-feeding or plan to breast-feed

Your doctor will discuss the risks and benefits of using DOUGLAS CEFACLOR-CD when breast-feeding.

If you have not told your doctor about any of the above, tell them before you start taking DOUGLAS CEFACLOR-CD.

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 DOUGLAS CEFACLOR-CD. 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 DOUGLAS CEFACLOR-CD, 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 DOUGLAS CEFACLOR-CD.

How DOUGLAS CEFACLOR-CD tablets are taken

How much to take

Your doctor will decide what does and how long you will receive DOUGLAS CEFACLOR-CD. This depends on your infection and other factors, such as your weight.

How to take it

Shallow the prescribed does of DOUGLAS CEFACLOR-CD tablets whose with a full glass of water. Do not cut, crush or chew the tablets.

Keep taking medicine for the full time of treatment, 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 take it

If it is almost time for you next dose, skip the does your 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 does, talk to your doctor or pharmacist.

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

If you have trouble remembering to take your medicine, ask you 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 DOUGLAS CEFACLOR-CD. 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 DOUGLAS CEFACLOR-CD tablets, you may have:

  • nausea
  • vomiting
  • heartburn
  • diarrhoea

While you are using DOUGLAS CEFACLOR-CD tablets

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 DOUGLAS CEFACLOR-CD 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 DOUGLAS CEFACLOR-CD, 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 DOUGLAS CEFACLOR-CD allows fungi to grow and the above symptoms to occur. DOUGLAS CEFACLOR-CD does not work against fungi.

If you become pregnant while you are taking DOUGLAS CEFACLOR-CD, tell your doctor.

If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking DOUGLAS CEFACLOR-CD.

If you have to have any blood or urine tests, tell your doctor you are taking DOUGLAS CEFACLOR-CD tablets. DOUGLAS CEFACLOR-CD 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 DOUGLAS CEFACLOR-CD.

Things you must not do

Do not give DOUGLAS CEFACLOR-CD to anyone else, even if they have the same condition as you.

Do not use DOUGLAS CEFACLOR-CD 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 DOUGLAS CEFACLOR-CD affects you.

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

Side affects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DOUGLAS CEFACLOR-CD. Like other medicines DOUGLAS CEFACLOR-CD 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 diarrhea

These are all serious side effects of DOUGLAS CEFACLOR-CD. You may need urgent medical attention.

If any of the following happen, stop using DOUGLAS CEFACLOR-CD 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 DOUGLAS CEFACLOR-CD. If you have them, you may have had a serious allergic reaction to DOUGLAS CEFACLOR-CD. 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 DOUGLAS CEFACLOR-CD:

  • 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. DOUGLAS CEFACLOR-CD 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 affect is rare.

Do not take any diarrhea 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 DOUGLAS CEFACLOR-CD tablets

Storage

At home, keep your DOUGLAS CEFACLOR-CD 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 DOUGLAS CEFACLOR-CD 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 like

DOUGLAS CEFACLOR-CD 375mg – blue tablets marked with Cefarclor DC 375mg in black.

DOUGLAS CEFACLOR-CD 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 C173015.

The printing ink contains: purified water, iron oxide, propylene glycol, hypromellose and isopropyl alcohol.

DOUGLAS CEFACLOR-CD does not contain gluten, sucrose, tartrazine or any other azo dyes.

DOUGLAS CEFACLOR-CD 375mg

AUSTR 77101

Sponsor & distributor

Genepharm Pty Ltd.
3/10 Inglewood Place
Norwest Business Park
Baulkham Hills NSW 2153

Date of most recent amendment: June 2008

Published by MIMS May 2009