Consumer medicine information

Amoxycillin Generichealth 500 mg Capsules

Amoxicillin

BRAND INFORMATION

Brand name

Amoxycillin Generichealth

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Amoxycillin Generichealth 500 mg Capsules.

What is in this leaflet


This leaflet answers some common questions about Amoxycillin generichealth.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
This leaflet was last updated on the date at the end of this leaflet. More recent information may be available.
The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Amoxycillin generichealth against the benefits it 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 Amoxycillin generichealth is used for


Amoxicillin is an antibiotic used to treat infections in different parts of the body caused by bacteria. These may be infections of the chest (pneumonia), tonsils (tonsillitis), sinuses (sinusitis), urinary and genital tract, skin and fleshy tissues.
Amoxicillin will not work against infections caused by viruses such as colds or the flu.
Amoxicillin is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection.
Your doctor may have prescribed Amoxycillin generichealth for another reason.
Ask your doctor if you have any questions about why Amoxycillin generichealth has been prescribed for you.
Amoxicillin is not addictive.
This medicine is available only with a doctor’s prescription.

Before you take Amoxycillin generichealth

When you must not take it


Do not take Amoxycillin generichealth if you have an allergy to:
  • amoxicillin;
  • other penicillins or cephalosporins;
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the face, lips or tongue.
Do not take Amoxycillin generichealth if the packaging is torn or shows signs of tampering.
Do not take Amoxycillin generichealth if the expiry date (EXP) printed on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure whether you should start taking Amoxycillin generichealth, contact your doctor.

Before you start to take it


Tell your doctor if you have had an allergic reaction (such as a rash) to any antibiotics in the past.
Tell your doctor if you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
Tell your doctor if you have or have ever had any other health problems / medical conditions, including:
  • glandular fever (mononucleosis);
  • blood disorders such as leukaemia;
  • liver or kidney problems. The dosage of Amoxycillin generichealth may need to be changed or you may need to be given an alternative medicine.

Tell your doctor or pharmacist if your urine has to be tested for sugar levels while taking Amoxycillin generichealth.
Amoxicillin will produce false positive results when some of these tests are used. Your doctor will help you to identify the correct test.
Tell your doctor if you are pregnant or intend to become pregnant, or are breastfeeding.
Your doctor or pharmacist will discuss the possible risks and benefits involved. Amoxicillin can be used during pregnancy (Australian Use in Pregnancy Category A). Amoxicillin can pass to your baby from breast milk.
If you have not told your doctor about any of the above, tell them before you take Amoxycillin generichealth.

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 or health food shop.
Some medicines may interfere with amoxicillin. These include:
  • medicines used to treat gout (eg. probenecid or allopurinol);
  • other antibiotics (eg. tetracyclines);
  • anticoagulants (used to prevent blood clots) such as warfarin;
  • methotrexate, a medicine used to treat arthritis and some types of cancers

These medicines may be affected by amoxicillin, 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 will advise you.
Talk to your doctor about the need for an additional method of contraception while taking Amoxycillin generichealth.
Some antibiotics may decrease the effectiveness of some birth control pills.
Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking Amoxycillin generichealth.

How to take Amoxycillin generichealth


Follow all directions given to you by your doctor and pharmacist carefully.
These directions may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take


The usual adult dose is one capsule (250 mg or 500 mg) three times a day.

How to take it


Swallow Amoxycillin generichealth capsules whole with a glass of water.
Amoxycillin generichealth can be taken with or without food. The effects of Amoxycillin generichealth are not changed by food.
Space the doses as evenly as possible throughout the day.
For example, if you are taking Amoxycillin generichealth three times a day, take a dose about every eight hours.

How long to take it


Continue taking Amoxycillin generichealth until you finish the pack or until your doctor recommends.
Do not stop taking your capsules because you are feeling better.
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 capsules as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your capsules, 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 the Accident and Emergency department at your nearest hospital, if you think that you or anyone else may have taken too much Amoxycillin generichealth. Do this even if there are no signs of discomfort or poisoning.
Keep these telephone numbers handy.
If you take too much amoxicillin you may get diarrhoea and nausea.

While you are taking Amoxycillin generichealth

Things you must do


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.
If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
If you develop itching with swelling or skin rash or difficulty breathing while you are taking Amoxycillin generichealth, do not take any more and contact your doctor immediately.
If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after amoxicillin 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 anti-diarrhoea medicine without first checking with your doctor.
If you get a sore white mouth or tongue while taking or soon after stopping Amoxycillin generichealth, 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 amoxicillin allows fungi to grow and the above symptoms to occur. Amoxicillin does not work against fungi.
If you become pregnant while you are taking Amoxycillin generichealth, tell your doctor.
If you are about to start taking any new medicine, tell your doctor and pharmacist that you are taking Amoxycillin generichealth.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Amoxycillin generichealth.

Things you must not do


Do not stop taking your capsules 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 and be more difficult to treat.
Do not give Amoxycillin generichealth to anyone else, even if they have the same condition as you.
Do not use Amoxycillin generichealth 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 Amoxycillin generichealth affects you.
Amoxicillin generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, amoxicillin may cause dizziness/drowsiness/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 Amoxycillin generichealth.
Amoxicillin helps most people with infections, but it may have unwanted side effects in a few people.
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.
Tell your doctor if you notice any of the following and they worry you:

  • soreness of the mouth or tongue;
  • diarrhoea (several loose bowel movements per day), indigestion, feeling sick or being sick;
  • overgrowth of yeast infections (thrush).

These side effects are usually mild.
Tell your doctor immediately if you notice any of the following:
  • itching, rash;
  • unusual bleeding or bruising;
  • yellowing of the skin or eyes;
  • dark urine or pale stools;
  • difficulty or pain on passing urine;
  • severe diarrhoea.

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.
If any of the following happen, stop taking Amoxycillin generichealth and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital:
  • wheezing;
  • swelling of the lips/ mouth;
  • difficulty in breathing;
  • hayfever;
  • lumpy rash (hives);
  • fainting.

These could be symptoms of an allergic reaction.
These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Ask your doctor or pharmacist if you don’t understand anything in this list.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.

After taking Amoxycillin generichealth

Storage


Keep your capsules in the blister pack until it is time to take them.
If you take the capsules out of the blister 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 the capsules or the capsules have passed their expiry date, ask your pharmacist what to do with any capsules that are left over.

Product description

What it looks like


Amoxycillin generichealth 250 mg are yellow, hard gelatine capsule imprinted with “RX 654” in black on both cap and body.
Amoxycillin generichealth 500 mg are maroon/yellow, hard gelatine capsule, imprinted with “RX 655” in black.
Available in blister packs of 20 capsules.

Ingredients


Active ingredient
Amoxycillin generichealth capsules contain 250 mg or 500 mg of amoxicillin (as trihydrate) as the active ingredient.
Other ingredients
  • sodium lauryl sulfate;
  • colloidal anhydrous silica;
  • croscarmellose sodium;
  • microcrystalline cellulose;
  • magnesium stearate;
  • iron oxide yellow
  • iron oxide red (500 mg capsule only);
  • iron oxide black;
  • titanium dioxide;
  • gelatin;
  • TekPrint SW-9008 Black Ink (PI 2328).

Amoxycillin generichealth does not contain lactose, sucrose, gluten or tartrazine.

Australian Registration Numbers


Amoxycillin generichealth 250 mg capsules:
AUST R 207004.
Amoxycillin generichealth 500 mg capsules:
AUST R 207005.

Distributor


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 February 2024.

BRAND INFORMATION

Brand name

Amoxycillin Generichealth

Active ingredient

Amoxicillin

Schedule

S4

 

Notes

Distributed by Generic Health Pty Ltd

1 Name of Medicine

Amoxicillin trihydrate.

2 Qualitative and Quantitative Composition

Amoxycillin Generichealth capsules contain 250 mg or 500 mg amoxicillin (as trihydrate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Amoxycillin Generichealth 250 mg capsules. Yellow, hard gelatin capsules imprinted with "RX 654" in black on both cap and body.
Amoxycillin Generichealth 500 mg capsules. Maroon/yellow, hard gelatin capsules imprinted with "RX 655" in black.

4 Clinical Particulars

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and symptoms of water/electrolyte imbalance should be treated symptomatically. During the administration of high doses of amoxicillin, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special Warnings and Precautions for Use).
Amoxicillin can be removed from the circulation by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Amoxicillin trihydrate is a white or almost white, crystalline powder, slightly soluble in water and in alcohol.
Amoxicillin trihydrate is a semi-synthetic antibiotic and is a member of the penicillinase stable group of penicillins derived from the penicillin nucleus, 6-aminopenicillanic acid, isolated at Beecham Research Laboratories.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMOXTR.gif Chemical Name: (2S,5R,6R)-6[(R)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7- oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
Molecular Formula: C16H19N3O5S.3H2O.
Molecular Weight: 419.4.
CAS number. 61336-70-7.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/AMOXGHST.gif