SUMMARY CMI

APO-AMOXYCILLIN

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I taking APO-AMOXYCILLIN?

APO-AMOXYCILLIN contains a penicillin called amoxicillin (as trihydrate) as the active ingredient.

APO-AMOXYCILLIN belongs to the penicillin group of antibiotics.

APO-AMOXYCILLIN is used to treat a range of infections caused by bacteria. These may be infections of the chest (pneumonia), tonsils (tonsillitis), sinuses (sinusitis), urinary and genital tract, skin and fleshy tissue.

For more information, see Section 1. Why am I taking APO-AMOXYCILLIN? in the full CMI.

2. What should I know before I take APO-AMOXYCILLIN?

Do not take if you are allergic to penicillin or similar types of antibiotics (such as cephalosporins), or any of the ingredients listed at the end of the CMI. If you have ever had an allergic reaction (such as a rash) when taking an antibiotic you should tell your doctor before you take APO-AMOXYCILLIN.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I take APO-AMOXYCILLIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-AMOXYCILLIN and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take APO-AMOXYCILLIN?

• Follow the directions given to you by your doctor and pharmacist. Their directions may differ from the information contained in this leaflet.

More instructions can be found in Section 4. How do I take APO-AMOXYCILLIN? in the full CMI.

5. What should I know while taking APO-AMOXYCILLIN?

For more information, see Section 5. What should I know while taking APO-AMOXYCILLIN? in the full CMI.

6. Are there any side effects?

Less serious side effects are diarrhoea, indigestion, feeling sick (nausea), vomiting. White furry, sore tongue and mouth (oral thrush). Soreness or itching of the vagina or vaginal discharge (vaginal thrush). Headache, dizziness, tiredness. Teeth discolouration. Unusually active (hyperactivity).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

APO-AMOXYCILLIN

Active ingredient: amoxicillin (as trihydrate)

Consumer Medicine Information (CMI)

This leaflet provides important information about taking APO-AMOXYCILLIN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking APO-AMOXYCILLIN.

Where to find information in this leaflet:

1. Why am I taking APO-AMOXYCILLIN?
2. What should I know before I take APO-AMOXYCILLIN?
3. What if I am taking other medicines?
4. How do I take APO-AMOXYCILLIN?
5. What should I know while taking APO-AMOXYCILLIN?
6. Are there any side effects?
7. Product details

1. Why am I taking APO-AMOXYCILLIN?

APO-AMOXYCILLIN contains the active ingredient amoxicillin (as trihydrate).

APO-AMOXYCILLIN belongs to the penicillin group of antibiotics.

APO-AMOXYCILLIN is used to treat a range of infections caused by bacteria. These infections may affect the chest (e.g. pneumonia), tonsils (e.g. tonsilitis), sinuses (e.g. sinusitis), urinary and genital tract, skin and fleshy tissues.

APO-AMOXYCILLIN works by killing the bacteria that causes infections. APO-AMOXYCILLIN can also be used to prevent infection.

Your doctor may prescribe APO-AMOXYCILLIN for another use. If you want more information, ask your doctor.

There is no evidence that APO-AMOXYCILLIN is addictive.

2. What should I know before I take APO-AMOXYCILLIN?

Warnings

Do not take APO-AMOXYCILLIN if:

• you are allergic to amoxicillin (as trihydrate), penicillin or similar types of antibiotics (such as 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 in breathing and swelling of the face or tongue.
• the expiry date (EXP) printed on the pack has passed.
• the packaging is torn or shows signs of tampering.

Always check the ingredients to make sure you can take APO-AMOXYCILLIN.

Do not give APO-AMOXYCILLIN to anyone else; your doctor has prescribed it specifically for you and your condition.

Check with your doctor if you:

• have ever had an allergic reaction (such as a rash) to antibiotics or other substances in the past.
• are allergic to foods, dyes, preservatives or any other medicines.
• have glandular fever (mononucleosis) or lymphatic leukaemia.
• have any kidney or liver problems.
  The dosage of APO-AMOXYCILLIN may need to be changed or you may need to be given an alternative medicine.
• have to test your urine for sugar.
  APO-AMOXYCILLIN may affect the results of these tests.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss with you the possible risks and benefits of taking APO-AMOXYCILLIN during pregnancy or while you are breastfeeding. APO-AMOXYCILLIN passes to your baby from breast milk.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements 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:

• acenocoumarol, warfarin or other medicines used to prevent blood clots.
• medicines used to treat gout (e.g. probenecid or allopurinol).
• other antibiotics (e.g. tetracyclines). These may interfere with the actions of APO-AMOXYCILLIN.
• methotrexate (a medicine used to treat cancer or rheumatic diseases).
• contraceptive pill. As with other antibiotics, you may need to use extra birth control methods (e.g. condoms) while taking APO-AMOXYCILLIN.

Some medicines may interfere with APO-AMOXYCILLIN and affect how it works. Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APO-AMOXYCILLIN.

4. How do I take APO-AMOXYCILLIN?

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 APO-AMOXYCILLIN, talk to your doctor or pharmacist.

How much to take

Your doctor will tell you the dose of APO-AMOXYCILLIN you will need to take each day. This depends on the condition being treated and whether other medicines are being taken.

When to take it

Space the doses as evenly as possible throughout the day. For example if you are taking APO-AMOXYCILLIN three times a day, take a dose about every eight hours.

How to take it

APO-AMOXYCILLIN can be taken with or without food. The effects of APO-AMOXYCILLIN are not changed by food.

Swallow APO-AMOXYCILLIN capsule whole with a full glass of water.

How long to take it for

Keep taking APO-AMOXYCILLIN until the course is finished or for as long as your doctor tells you.

Do not stop taking APO-AMOXYCILLIN just because you feel better as the infection can return.

Do not stop taking APO-AMOXYCILLIN, or change the dose, without first checking with your doctor.

If you forget to take APO-AMOXYCILLIN

If it is almost time for your next dose, 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 APO-AMOXYCILLIN as directed by your doctor.

Do not take a double dose to make up for the dose you missed. Taking more than the prescribed dose can increase the chance of unwanted side-effects.

If you take too much APO-AMOXYCILLIN

If you think that you have taken too much APO-AMOXYCILLIN, you may need urgent medical attention.

You should immediately:

• drink plenty of water
• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

Symptoms of overdose include mild to severe nausea, vomiting, cramps and diarrhoea.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while taking APO-AMOXYCILLIN?

Things you should do

• Take APO-AMOXYCILLIN exactly as your doctor has prescribed.
• Tell your doctor if, for any reason, you have not taken APO-AMOXYCILLIN exactly as directed. Otherwise your doctor may think that it was not working as it should and change your treatment unnecessarily.
• Tell your doctor if the symptoms of your infection become worse, or do not improve within a few days of starting APO-AMOXYCILLIN.
• Tell your doctor if you develop itching, swelling or a skin rash when taking APO-AMOXYCILLIN, do not take any more APO-AMOXYCILLIN and tell your doctor immediately.
• Tell your doctor if you develop severe diarrhoea either when taking APO-AMOXYCILLIN or within several weeks after treatment, tell your doctor immediately. Diarrhoea may mean you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any medication to stop the diarrhoea (e.g. Lomotil^® or Imodium^®).
• Tell your doctor if you get a sore white mouth or tongue while taking or soon after stopping APO-AMOXYCILLIN.
• Tell your doctor if you have vaginal itching or discharge. This may mean you have a fungal infection called vaginal thrush. Sometimes taking APO-AMOXYCILLIN allows fungi to grow and the above symptoms occur.
• If you have to test your urine for sugar while you are taking APO-AMOXYCILLIN, ensure your doctor knows which type of test you use. APO-AMOXYCILLIN may affect the results of some of these tests.
• Remind any doctor, dentist or pharmacist you visit that you are taking APO-AMOXYCILLIN before starting any other medicines. Some medicines may affect the way other medicines work.

Things you should not do

• Do not stop taking APO-AMOXYCILLIN 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 APO-AMOXYCILLIN to anyone else, even if their symptoms seem similar to yours.
• Do not take APO-AMOXYCILLIN to treat any other complaints unless your doctor says to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APO-AMOXYCILLIN affects you.

Generally, this medicine does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, APO-AMOXYCILLIN may cause dizziness or tiredness in some people.

Looking after your medicine

Keep your capsules in the original pack until it is time to take them. If you take the capsules out of its original pack it may not keep well.

Store in a cool dry place, away from moisture where the temperature stays below 25°C. Do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to take APO-AMOXYCILLIN or it is out of date, take it to any pharmacy for safe disposal.

Do not take APO-AMOXYCILLIN after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

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 APO-AMOXYCILLIN.

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.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

APO-AMOXYCILLIN is only available with a doctor's prescription.

What APO-AMOXYCILLIN Capsules contains

APO-AMOXYCILLIN does not contain lactose, sucrose, gluten or tartrazine.

Do not take APO-AMOXYCILLIN if you are allergic to any of these ingredients.

What APO-AMOXYCILLIN Capsules looks like

APO-AMOXYCILLIN 250 mg Capsule

Yellow/yellow capsules, with "RX 654" printed in black on both cap and body.

AUST R 208147. Available in pack size of 20 capsules.

APO-AMOXYCILLIN 500 mg Capsule

Maroon/yellow capsules with "RX 655" printed in black on both cap and body.

AUST R 208144. Available in pack size of 20 capsules.

Who distributes APO-AMOXYCILLIN Capsules

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel St,
Cremorne VIC 3121

www.arrotex.com.au

This leaflet was prepared in September 2024.

Published by MIMS October 2024

1 Name of Medicine

Amoxicillin (as amoxicillin trihydrate).

2 Qualitative and Quantitative Composition

Each capsule contains 250 mg or 500 mg amoxicillin (as trihydrate).

Excipient with known effect.

3 Pharmaceutical Form

APO-Amoxycillin 250 mg capsules.

APO-Amoxycillin 500 mg capsules.

4 Clinical Particulars

4.1 Therapeutic Indications

It is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms.

Note.

Skin and skin structure.

Respiratory (acute and chronic).

Genitourinary tract (complicated and uncomplicated, acute and chronic).

Gonorrhoea.

Prophylaxis of endocarditis.

4.2 Dose and Method of Administration

APO-Amoxycillin 250 mg and 500 mg capsules are intended for oral administration.

Dosage. Normal renal function.

Adults and children (over 20 kg).

Children (under 20 kg).

Adults.

Children (under 20 kg).

Adults.

Adults.

Use in neonates.

Use in children.

Renal impairment.

Chronic urinary tract infections.

Duration of treatment.

Prophylaxis of endocarditis.

4.3 Contraindications

Amoxicillin is a penicillin and should not be given to patients with a history of hypersensitivity to β-lactam antibiotics (e.g. penicillins, cephalosporins).

4.4 Special Warnings and Precautions for Use

Serious, and occasionally fatal, hypersensitivity reactions (anaphylaxis, anaphylactoid and severe cutaneous reactions) have been reported in patients receiving β-lactam antibiotics. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see Section 4.8 Adverse Effects (Undesirable Effects)). These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. Before commencing therapy with any penicillin careful enquiry should be made concerning previous hypersensitivity reactions to penicillin's, cephalosporins or other allergens. If an allergic reaction occurs, appropriate therapy should be instituted and amoxicillin therapy discontinued. Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation should also be administered as indicated. Drug induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin (see Section 4.8 Adverse Effects (Undesirable Effects)). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after administration of amoxicillin) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise of abdominal pain, diarrhoea, hypotension, or leucocytosis with neutrophilia. There have been severe cases including progression to shock.
Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. Before commencing therapy with any penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, appropriate therapy should be instituted and amoxicillin therapy discontinued.
Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. Clostridium difficile associated diarrhoea (CDAD) has been reported with the use of nearly all antibacterial agents and may range in severity from mild diarrhoea to fatal colitis. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further. Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibiotic agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.
Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Amoxicillin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
As with any potent drug, periodic assessment of renal, hepatic and haematopoietic function should be made during prolonged therapy. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.
Amoxicillin, an aminopenicillin, is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxicillin is used.
Amoxicillin should be given with caution to patients with lymphatic leukaemia, since they are especially susceptible to ampicillin induced skin rashes.
Following single dose therapy of acute lower urinary tract infections, the urine should be cultured. A positive culture may be evidence of a complicated or upper urinary tract infection and call for a longer or larger course of therapy.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients. Similar reactions can be expected with amoxicillin.
In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen re-absorption and reduced efficacy of combined oral contraceptives.
In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.
Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

Methotrexate.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins.
The following adverse reactions have been reported as associated with the use of amoxicillin.

Cardiac disorders.

Infections and infestations.

Gastrointestinal.

Skin and subcutaneous tissue disorders.

Hypersensitivity reactions.

Note.

Hepatic.

Haemic and lymphatic systems.

Renal and urinary tract disorders.

CNS effects.

Miscellaneous.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Streptococcus pneumoniae.

Note.

Note.

Cross resistance.

Resistance mechanisms.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Magnesium stearate, microcrystalline cellulose, gelatin, sodium lauryl sulphate, colloidal anhydrous silica, croscarmellose sodium, titanium dioxide, iron oxide yellow, iron oxide red (500 mg capsules), iron oxide black (500 mg capsules). The capsules are printed with TekPrint SW-9008 Black Ink (proprietary ingredient # 2328).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C, protect from moisture.

6.5 Nature and Contents of Container

APO-Amoxycillin 250 mg capsules.

APO-Amoxycillin 500 mg capsules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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 semisynthetic 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.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes