Attachment I Oregon Medication leaflet27June2022.pdf

Consumer Medicine Information Attachment I

AMILOXYN Capsules amoxicillin (as trihydrate)

Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before you take AMILOXYN.

This leaflet answers some common questions about

AMILOXYN. 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

Amoxycillin AN against the risks this medicine could have for you.

Take AMILOXYN as instructed.

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 AMILOXYN is used for

AMILOXYN contains a penicillin called amoxycillin as the active ingredient.

AMILOXYN belongs to a group of medicines called penicillins

AMILOXYN is used to treat a range of infections caused by bacteria. These may be infections of the chest

(pneumonia), tonsils

(tonsillitis), bacteria that cause these infections.

AMILOXYN can also be used to prevent infection.

Your doctor may have prescribed AMILOXYN for another reason.

There is no evidence that

AMILOXYN is addictive.

Before you take

AMILOXYN

When you must not be take it

• You are allergic to penicillin or similar types of antibiotics such as cephalosporins. If you have ever had an allergic reaction

(such as a rash) when taking an antibiotic you should tell your doctor before you take

AMILOXYN.

• You have ever had an allergic reaction to amoxycillin or any of the ingredients listed toward the end of this leaflet. (See

"Ingredients")

• the expiry date printed on the pack has passed.

• the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if:

• You are allergic to foods, dyes, preservatives or any other medicines.

• You have ever had an allergic reaction (such as a rash) to any antibiotics in the past.

• You have glandular fever feeding. AMILOXYN may be used during pregnancy

(Australian Use in Pregnancy

Category A). AMILOXYN can pass to your baby from breast milk.

• You have liver or kidney problems. The dosage of

AMILOXYN may need to be changed or you may need to be given an alternative medicine.

• You are taking any other medicines, including medicines you buy without a prescription.

In particular tell your doctor if you are taking any of the following:

* medicines used to treat gout eg probenecid or allopurinol.

* the contraceptive pill. As with other antibiotics, you may need to use extra birth control methods eg. condoms.

* other antibiotics. These may interfere with the actions of

AMILOXYN.

* Anticoagulants (used to prevent blood clots) such as warfarin.

Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able sinuses (sinusitis), urinary and genital tract, skin and fleshy tissues.

AMILOXYN works by killing the

(mononucleosis) or a blood disorder.

• You are pregnant or think you may be pregnant or are breast

Follow your doctor's instructions about how and when to take

AMILOXYN. Your doctor will advise how many doses are to tell you which medicines are safe to take with AMILOXYN.

If you have not told your doctor about any of these things, tell them before you take any AMILOXYN.

How to take AMILOXYN needed each day, and for how long you will need to take AMILOXYN .

Please read the direction label carefully. If you have any concerns about how to take AMILOXYN , talk to your doctor or pharmacist.

How much AMILOXYN to take

Take AMILOXYN as directed by your doctor or pharmacist.

The usual dose of AMILOXYN is one dose taken three times a day.

How to take AMILOXYN

Swallow AMILOXYN 250mg and 500mg capsules whole with a glass of water.

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

Amoxycillin AN can be taken with or without food. The effects of AMILOXYN are not changed by food.

How long to take AMILOXYN

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

Do not stop taking AMILOXYN just because you feel better as the infection can return.

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

If you forget to take it

If you forget to take a dose of

AMILOXYN, take it as soon as you remember. Then go back to taking it as directed by your doctor.

Do not take a double dose to make up for the dose that you have missed. Do not take two doses within an hour or so of each other. Taking more than the prescribed dose can increase the chance of unwanted side effects.

If you take too much

(overdose)

If you (or someone else) has taken a large amount of

AMILOXYN all at once, give plenty of water to drink and immediately telephone your doctor or Poisons Information

Centre (telephone 131126) for advice, if you think you or anyone else may have taken too much AMILOXYN, even if there are no signs of discomfort or poisoning.

If you are not sure what to do, contact your doctor, pharmacist or nearest hospital.

While you are taking

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.

Tell your doctor or pharmacist you are taking AMILOXYN before starting any other prescribed medicine. Some medicines may affect the way other medicines work.

If you develop itching, swelling or a skin rash when you are taking

AMILOXYN, do not take any more AMILOXYN and tell your doctor at once.

If you develop severe diarrhoea when taking AMILOXYN tell your doctor as soon as possible. Do not take any medication to stop the diarrhoea (eg Lomotil or

Imodium).

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use AMILOXYN to treat any other complaints unless your doctor says to.

Things to be careful of

Be careful driving or operating machinery until you know how AMILOXYN affects you.

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

AMILOXYN, even if the problem is not listed below.

Like other medicines, AMILOXYN 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.

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, feeling sick or being sick.

* soreness of the mouth or tongue * overgrowth of yeast infections

(thrush).

MORE SERIOUS EFFECTS

• 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.

• Stop taking AMILOXYN and contact your doctor or go to the emergency department of your nearest hospital if any of the following happens:

* Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be symptoms of an allergic reaction.

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 AMILOXYN.

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

Storage

Keep your medication in the pack until it is time to take them.

Keep this medicine where children cannot reach it, such as in a locked cupboard.

Keep the pack in a cool dry place where the temperature stays below 25 degrees C. 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 some medicines.

Return any unused or expired medicine to your pharmacist.

Product description

What AMILOXYN looks like

Amoxycillin AN (250 & 500 mg amoxycillin as trihydrate) are presented in pack size of 20 tablets in blister.

AMILOXYN 250 mg

(AUST R 185795)

Maroon/yellow size ‘1’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘A’ on maroon cap and ‘85’ on yellow body with black ink.

AMILOXYN 500 mg

(AUST R 185797)

Maroon/yellow size ‘0EL’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘A’ on maroon cap and ‘86’ on yellow body with black ink.

Ingredients

Active Ingredient:

Amoxicillin as trihydrate.

Each capsule may contain 250 mg (AUST R 185793) & 500 mg (AUST R 185798) of Amoxicillin as trihydrate.

Other Ingredients:

• Microcrystalline cellulose

• Magnesium stearate

The capsule shells contain gelatin, carmoisine (E122), iron oxide yellow (E172), patent blue V (E131), titanium dioxide (E171), sodium lauryl sulfate.

Name and Address of the

Sponsor

Arrow Pharma Pty Ltd

15-17 Chapel St, Cremorne VIC 3121 Australia www.arrowpharma.com.au

Date of Preparation July 2019 http://www.arrowpharma.com.au/ http://www.arrowpharma.com.au/