Consumer medicine information

Bgramin Powder for oral suspension

Amoxicillin

BRAND INFORMATION

Brand name

Bgramin Powder for oral suspension

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Bgramin Powder for oral suspension.

What is in this leaflet

This leaflet answers some of the common questions about BGRAMIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed up the risks of you or your child taking BGRAMIN against the expected benefits.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What BGRAMIN is used for

The active ingredient in BGRAMIN is amoxycillin trihydrate (pronounced am-oxy-sil-lin try-hy-dr-ate). Amoxycillin trihydrate belongs to a group of antibiotic medicines called penicillins.

BGRAMIN is used to treat bacterial infections that occur in various parts of the body.

BGRAMIN works by killing the bacteria responsible for the infection. However BGRAMIN will not kill viruses such as colds or the flu.

Ask your doctor if you have any questions about why BGRAMIN has been prescribed for you/your child.

Your doctor may have prescribed BGRAMIN for another purpose.

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

There is no evidence that BGRAMIN is addictive.

Before using BGRAMIN

When BGRAMIN must not be taken

BGRAMIN must not be taken if you/your child has ever had an allergic reaction to:

  • medicines containing penicillins
  • medicines containing cephalosporins
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction to penicillins may include rash, itching, or hives on the skin, swelling of the face, lips and tongue or other parts of the body, shortness of breath, wheezing or troubled breathing.

BGRAMIN must not be taken if you/your child has ever had liver problems associated with amoxycillin therapy.

BGRAMIN must not be taken after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you/your child should take this medicine, talk to your doctor.

Before starting to take BGRAMIN

Tell the doctor if you/your child is allergic to any other medicines, or other substances such as foods, dyes or preservatives.

Tell the doctor if you/your child has or has had kidney disease.

Tell your doctor if you have been prescribed BGRAMIN and are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor or pharmacist about any of the above, tell him/her before starting BGRAMIN.

Taking other medicines

Tell your doctor if you/your child is taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and BGRAMIN may interfere with each other. These include:

  • probenecid and allopurinol (medicines used to treat gout)
  • oral contraceptive pills.

Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when using BGRAMIN with other medicines.

If you are taking BGRAMIN and use the oral contraceptive pill, talk to your doctor about the need for an additional method of contraception.

Some antibiotics may decrease the effectiveness of some contraceptive pills.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to use BGRAMIN

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How to use it

Shake the suspension well before measuring the dose in a suitable measure. Administer the dose as prescribed by your doctor.

When to use it

BGRAMIN can be taken with or without food.

BGRAMIN is generally taken three times a day (approximately every eight hours), or as instructed by your doctor or pharmacist.

How long to use it

Your doctor will instruct you on how long BGRAMIN should be used.

Ensure the whole course of BGRAMIN is taken. Do not stop BGRAMIN even if you/your child feels better because the infection may return.

If you forget to use it

If it is almost time for the next dose (within an hour or so), skip the dose that was missed and take/give the next dose at the time it is due. Otherwise, take/give BGRAMIN as soon as you remember and go back to the normal dose times.

Do not double a dose to make up for the dose that was missed.

If too much is taken (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much BGRAMIN. Do this even if there are no signs of discomfort or poisoning.

You/your child may need urgent medical attention. Keep telephone numbers of these places/services handy.

Too much BGRAMIN may cause diarrhoea, vomiting or nausea.

While using BGRAMIN

Things you must do

If the symptoms of the infection do not improve within a few days, or if they become worse, tell your doctor.

If you/your child develops a skin rash, itching with swelling or difficulty breathing while using BGRAMIN, do not take/give any more and contact your doctor immediately.

If you/your child get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after BGRAMIN has been stopped.

Diarrhoea may signify a serious bowel condition requiring urgent medical care. Do not take/give any diarrhoea medicine without first checking with your doctor.

If you/your child get a sore white mouth or tongue while taking or soon after stopping BGRAMIN, tell your doctor. Also tell your doctor if you/your child gets vaginal itching or discharge.

This may mean you/your child has a fungal infection called thrush. Sometimes the use of BGRAMIN allows fungi to grow and the above symptoms to occur. BGRAMIN does not work against fungi.

If you are taking BGRAMIN and become pregnant tell your doctor.

If you/your child are about to take a new medicine, tell your doctor and pharmacist that you/your child is taking BGRAMIN.

If you/your child have to have any blood or urine tests done tell your doctor and nurse BGRAMIN is being taken.

BGRAMIN can affect the results of some tests.

Tell all the doctors, dentists and pharmacists who are treating you/your child that BGRAMIN is being taken.

Things you must not do

Do not stop this medicine because you/your child is feeling better, unless advised to do so by your doctor.

If the full course prescribed by your doctor is not completed, all of the bacteria causing the infection may not be killed. These bacteria may continue to grow and multiply so that the infection may not clear completely or it may return.

Do not give BGRAMIN to anyone else even if they have the same condition.

Do not use BGRAMIN to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful of driving or operating machinery while you are taking BGRAMIN, until you know how it affects you.

BGRAMIN does not normally cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines BGRAMIN may cause dizziness in some people.

Side Effects

Tell your doctor or pharmacist as soon as possible if you/your child do not feel well while taking BGRAMIN.

This medicine 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 attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • nausea, vomiting, or mild diarrhoea
  • soreness of the mouth or tongue
  • dizziness.

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

  • rash, itching
  • unusual bleeding or bruising
  • yellowing of the skin or eyes
  • dark urine or pale stools
  • convulsions (fits).

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

If any of the following happen, stop using BGRAMIN and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • hives on the skin, swelling of the face, lips and tongue or other parts of the body, shortness of breath, wheezing or troubled breathing (these could be symptoms of an allergic reaction)
  • severe diarrhoea.

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Do not take/give any diarrhoea medicine without first checking with your doctor.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using BGRAMIN

Storage

Keep the suspension in the bottle until it is time to take it.

If you remove the suspension from the bottle it may not keep as well.

Keep the suspension in the refrigerator (4 to 8°C). Do not freeze it.

Do not store BGRAMIN or any other medicine in the bathroom or near a sink. Do not leave it in the car or on windowsills.

Heat and dampness can destroy some medicines.

Keep BGRAMIN where children cannot reach it.

Disposal

If your doctor tells you to stop taking this medicine, or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product Description

What it looks like

BGRAMIN Suspension is a white powder which will be mixed with water by the pharmacist before being dispensed.

Ingredients

BGRAMIN contains amoxycillin trihydrate as the active ingredient. It is available in two strengths (125 mg/5 mL and 250 mg/5 mL).

  • BGRAMIN 125 mg/5 mL also contains sorbitol, disodium edetate, sodium benzoate, silicon dioxide, silica-colloidal anhydrous, xanthan gum, saccharin sodium, Banana flavour (51464) and Forestberry flavour (502874).
  • BGRAMIN 250 mg/5 mL also contains sorbitol, disodium edetate, sodium benzoate, silicon dioxide, silica-colloidal anhydrous, xanthan gum, saccharin sodium, Sonaflo Passionfruit flavour 171011 and Sonaflo Vanilla flavour 080911.

BGRAMIN 125 mg/5 mL AUST R 59876
BGRAMIN 250 mg/5 mL AUST R 59875

Sponsor

Ascent Pharma Pty Ltd
151-153 Clarendon Street
South Melbourne VIC 3205
www.ascentpharma.com.au

For further information call 1800 554 414.

This leaflet was prepared in November 2012.

BRAND INFORMATION

Brand name

Bgramin Powder for oral suspension

Active ingredient

Amoxicillin

Schedule

S4