(amoxicillin trihydrate & potassium clavulanate) film-coated tablet
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before you take AmoxyClav generichealth 500/125 or AmoxyClav generichealth 875/125 tablets.
This leaflet answers some common questions about AmoxyClav generichealth 500/125 and AmoxyClav generichealth 875/125 tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the expected benefits of you taking AmoxyClav generichealth tablets against the risks this medicine could 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 AmoxyClav generichealth 500/125 & AmoxyClav generichealth 875/125 are used for
AmoxyClav generichealth tablets contain two active ingredients. One of these is a penicillin called amoxicillin and the other is clavulanic acid.
AmoxyClav generichealth tablets belong to the penicillin group of antibiotics.
AmoxyClav generichealth tablets are used for the short-term treatment of a wide range of infections caused by bacteria. These infections may affect the chest (eg. bronchitis or pneumonia), bladder (eg. cystitis), sinuses (eg. sinusitis), the ears (eg. otitis media) or the skin.
AmoxyClav generichealth tablets work by killing the bacteria that cause these infections. AmoxyClav generichealth tablets will not work against infections caused by viruses such as colds or the flu.
Your doctor may prescribe AmoxyClav generichealth tablets for another use. If you want more information, ask your doctor.
There is no evidence that AmoxyClav generichealth tablets are addictive.
Before you take generichealth 500/125 & AmoxyClav generichealth 875/125
When you must not take it
Do not take AmoxyClav generichealth tablets if:
- You have had an allergic reaction to penicillin or similar types of antibiotics (such as cephalosporins) or any of the ingredients contained in AmoxyClav generichealth 500/125 or AmoxyClav generichealth 875/125 tablets. The ingredients are listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty in breathing and swelling of the face or tongue.
- You have previously experienced liver problems after taking AmoxyClav generichealth tablets or any other medicines.
- The expiry date (EXP) printed on the pack has passed.
- The packaging is torn or shows signs of tampering.
Do not give this medicine to anyone else. Your doctor has prescribed it specifically for you and your condition.
If you are not sure whether you should start taking AmoxyClav generichealth tablets, talk to your doctor.
Before you start to take it
Tell your doctor if:
- You have ever had an allergic reaction (such as a rash) to antibiotics or other substances in the past.
- You are allergic to foods, dyes, preservatives or any other medicines.
- You have experienced liver problems after taking AmoxyClav tablets or any other medicines.
- You have glandular fever (mononucleosis) or leukaemia.
- You are pregnant or think you may be pregnant or are breast-feeding. Your doctor will discuss with you the possible risks and benefits of taking AmoxyClav generichealth tablets during pregnancy or while you are breastfeeding. AmoxyClav generichealth tablets can pass to your baby from breast milk.
- You have any kidney or liver problems. The dosage of AmoxyClav generichealth tablets may need to be changed or you may need to be given an alternative medicine.
- You have to test your urine for sugar. AmoxyClav generichealth tablets may affect the results of these tests.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. In particular, tell your doctor or pharmacist if you are taking any of the following:
- Warfarin or other medicines used to prevent blood clots.
- Mycophenolate.
- Medicines used to treat gout (eg. probenecid or allopurinol).
- Other antibiotics. These may interfere with the actions of AmoxyClav generichealth tablets.
- The contraceptive pill. As with other antibiotics, you may need to use extra birth control methods (eg. condoms) while taking AmoxyClav generichealth tablets.
Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when taking AmoxyClav generichealth tablets with other medicines.
How to take generichealth 500/125 & AmoxyClav generichealth 875/125
Follow the directions given to you by your doctor and pharmacist.
Their directions may differ from the information contained in this leaflet.
Please read the direction label carefully. If you have any concerns about how to take this medicine, talk to your doctor or pharmacist.
How much to take
Take as directed by your doctor or pharmacist.
The usual dose of AmoxyClav generichealth 500/125 and AmoxyClav generichealth 875/125 is one tablet twice a day.
How to take it
Swallow the AmoxyClav generichealth tablet with a full glass of water or other liquid.
When to take it
AmoxyClav generichealth tablets should be taken immediately before or with the first mouthful of food. AmoxyClav generichealth tablets work best when taken this way. It may also help to prevent stomach upsets. However, AmoxyClav generichealth tablets will still work if they are taken without food.
Space the doses as evenly as possible throughout the day. If you are taking AmoxyClav generichealth tablets twice a day, take a dose about every twelve hours.
How long to take it
Keep taking AmoxyClav generichealth tablets until the course is finished or for as long as your doctor tells you.
Do not stop taking AmoxyClav generichealth tablets just because you feel better as the infection can return.
Do not stop taking AmoxyClav generichealth tablets, or change the dose, without first checking with your doctor.
If you forget to take it
If your next dose is due within six hours, skip the dose you missed and take your next dose at the normal time. Otherwise, take the missed dose as soon as you remember and then go back to taking your tablets as directed by your doctor.
Do not take a double dose to make up for the dose that you have missed. Taking more than the prescribed dose can increase the chance of unwanted side- effects.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice if you think you or anyone else may have taken too much, even if there are no signs of discomfort or poisoning.
Symptoms of overdose include mild to severe nausea, vomiting, cramps and diarrhoea.
If you are not sure what to do, contact your doctor, pharmacist or nearest hospital. Be sure to show the doctor the AmoxyClav generichealth 500/125 or AmoxyClav generichealth 875/125 pack.
While you are taking generichealth 500/125 & AmoxyClav generichealth 875/125
Things you must do
Take AmoxyClav generichealth tablets exactly as your doctor has prescribed.
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 working as it should and change your treatment unnecessarily.
Tell your doctor, dentist or pharmacist you are taking AmoxyClav generichealth tablets before starting any other medicines. Some medicines may affect the way other medicines work.
Tell your doctor if the symptoms of your infection become worse, or do not improve within a few days of starting AmoxyClav generichealth tablets.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use to treat any other complaints unless your doctor says to.
Things to be careful of
Alcohol should be avoided during and for several days after treatment with AmoxyClav generichealth tablets. Some people who drink alcohol while taking antibiotics similar to AmoxyClav generichealth tablets have experienced adverse effects.
Be careful driving or operating machinery until you know how AmoxyClav generichealth tablets affect you. Generally, these tablets do not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, AmoxyClav generichealth tablets may cause dizziness or tiredness in some people.
If you develop severe diarrhoea either when taking AmoxyClav generichealth tablets or within several weeks after treatment, tell your doctor as soon as possible. Do not take any medication to stop the diarrhoea (eg. Lomotil® or Imodium®).
Side effects
Check with your doctor as soon as possible if you think you are experiencing any side-effects or allergic reactions due to taking AmoxyClav generichealth tablets, even if the problem is not listed below.
Like other medicines, AmoxyClav generichealth tablets can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention. Tell your doctor about any effect which is troublesome or ongoing.
Mild effects
Tell your doctor if you notice any of the following that are troublesome or ongoing:
- diarrhoea (several loose bowel movements per day), indigestion, pain in the stomach, feeling sick or being sick;
- white, furry, sore tongue and mouth (oral thrush), abnormal taste;
- soreness or itching of the vagina or vaginal discharge (vaginal thrush);
- aseptic meningitis, headache, dizziness, tiredness, hot flushes;
- tooth discolouration;
- unusually active (hyperactivity).
More serious effects
Tell your doctor immediately if you notice any of the following during or after taking AmoxyClav generichealth tablets:
- itching, rash;
- dark urine or pale stools;
- yellowing of the skin or eyes (jaundice);
- severe stomach cramps;
- severe watery or bloody diarrhoea;
- unusual bleeding or bruising.
These may be symptoms of rare but serious side-effects and require urgent medical attention.
Stop taking AmoxyClav generichealth tablets and immediately contact your doctor or go to the emergency department of your nearest hospital if any of the following happens:
- wheezing;
- hives;
- severe skin reaction;
- fainting;
- swelling of limbs, face, lips, mouth or throat;
- difficulty swallowing or breathing;
- joint discomfort or swelling;
- swollen lymph glands;
- nausea and vomiting;
- fever.
These may be signs of an allergic reaction or other reaction to AmoxyClav generichealth tablets. Allergy to these antibiotics is rare.
- Fits/seizures.
Rare events that have been reported with AmoxyClav generichealth tablets include:
- inflammation of the bowel (colitis);
- inflammation of the liver (hepatitis);
- inflammation of the kidney (nephritis);
- blood disorders;
- crystals in the urine (crystalluria).
Remember, you should tell your doctor or pharmacist as soon as possible if any of these, or any other unusual events or problems, occur during or after treatment with AmoxyClav generichealth tablets.
This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor or pharmacist if you notice any side effects from your medicine which are not mentioned here.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After taking generichealth 500/125 & AmoxyClav generichealth 875/125
Storage
Keep your tablets in the original pack until it is time to take them. If you take the tablets out of the pack, they may not keep well.
Keep the pack in a cool dry place. Do not leave it in the car on a hot day. Do not store medicine in the bathroom or near a sink. Heat and dampness can destroy AmoxyClav generichealth tablets.
Store all medicines out of the reach of children, such as in a locked cupboard.
Disposal
If your doctor tells you to stop taking AmoxyClav generichealth tablets or if the expiry date has passed, ask your pharmacist what to do with any tablets that are left over.
Product description
What it looks like
AmoxyClav generichealth 500/125 tablets are white, oval shaped, film coated tablet with marking “CA625” on one side. AmoxyClav generichealth 875/125 tablets come as white elongated capsule shaped film coated tablet.
AmoxyClav generichealth 500/125 and AmoxyClav generichealth 875/125 tablets come in blister packs of ten tablets.
Ingredients
Active ingredients
AmoxyClav generichealth tablets contain amoxycillin (as trihydrate) and potassium clavulanate.
Other ingredients
AmoxyClav generichealth 500/125 tablets contain the following inactive ingredients:
- magnesium stearate;
- croscarmellose sodium;
- purified talc;
- dichloromethane;
- ethylcellulose;
- hypromellose;
- isopropyl alcohol;
- propylene glycol;
- microcrystalline cellulose.
- OPASPRAY colour coating dispersion K-1-7000 WHITE.
AmoxyClav generichealth 875/125 tablets contain the following inactive ingredients:
- magnesium stearate;
- croscarmellose sodium;
- purified talc;
- dichloromethane;
- ethylcellulose;
- hypromellose;
- isopropyl alcohol;
- propylene glycol;
- microcrystalline cellulose.
- OPASPRAY color coating dispersion K-1-7000 WHITE.
AmoxyClav generichealth 500/125 and AmoxyClav generichealth 875/125 tablets do not contain sucrose, lactose, gluten or tartrazine.
AmoxyClav generichealth 500/125 and AmoxyClav generichealth 875/125 tablets are available only with a doctor’s prescription.
Australian Registration Numbers
AmoxyClav generichealth 500/125:
AUST R 255077
AmoxyClav generichealth 875/125:
AUST R 255076
Sponsor
Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia
E-mail: ghinfo@generichealth.com.au
Telephone: +61 3 9809 7900
Website: www.generichealth.com.au
This leaflet was prepared in October 2020.
Published by MIMS December 2020