contains the active ingredients amoxycillin and clavulanic acid
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Clamoxyl 125/31.25 Syrup.
It does not contain all the available information. It does not take the place of talking to your child’s doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of your child taking Clamoxyl 125/31.25 Syrup against the benefits they expect it will have for your child.
Clamoxyl 125/31.25 Syrup must be given to your child as instructed. If you have any concerns about giving this medicine to your child. Ask your doctor or pharmacist.
If you have any concerns about giving this medicine to your child, talk to your doctor or pharmacist.
Please read this leaflet carefully and keep it with your medicine. You may need to read it again.
What Clamoxyl 125/31.25 Syrup is used for
Clamoxyl 125/31.25 Syrup contains two active ingredients. One of these active ingredients is amoxycillin which is an antibiotic that belongs to a group of medicines called penicillins. The other active ingredient is clavulanic acid which is used to increase the effectiveness of amoxycillin against certain types of bacteria.
Clamoxyl 125/31.25 Syrup is used to treat certain types of bacterial infections in the body such as:
- skin infections
- urinary tract infections, including bladder and kidney infections
- respiratory tract infections, including infections of the throat, airways,chest, lungs or sinuses
- ear infections
Clamoxyl 125/31.25 Syrup works by killing the bacteria that cause these infections.
Your doctor may have prescribed Clamoxyl 125/31.25 Syrup for another reason.
Ask your doctor if you have any questions about why Clamoxyl 125/31.25 Syrup has been prescribed for your child. Clamoxyl 125/31.25 Syrup is available only with a doctor’s prescription.
There is no evidence that Clamoxyl 125/31.25 Syrup is addictive.
Before you give Clamoxyl 125/31.25 Syrup
When you must not give it
Do not give Clamoxyl 125/31.25 Syrup if your child is allergic to:
- medicines containing amoxycillin or any other penicillin (eg. ampicillin)
- cephalosporin antibiotics
- any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips, mouth or throat, which may cause difficulty with swallowing or breathing.
Do not give Clamoxyl 125/31.25 Syrup if your child has ever had liver problems after taking Clamoxyl 125/31.25 Syrup or any other medicine.
Check with your doctor or pharmacist if you are not sure about any of the above. This medicine is for the person named by the doctor. Do not give this medicine to anyone else.
Do not give Clamoxyl 125/31.25 Syrup if the expiry date (EXP) printed on the pack has passed. If you give this medicine after the expiry date, it may not work as well.
Do not give Clamoxyl 125/31.25 Syrup if the packaging shows signs of tampering or the medicine does not look quite right.
Before your child starts to take it
Tell your doctor if your child is allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if your child has ever had an allergic reaction (such as a rash) to any antibiotic in the past.
Tell your doctor if your child has, or has had, any other medical conditions, especially the following:
- glandular fever
- blood disorders
- liver problems
- kidney problems
The dose of Clamoxyl 125/31.25 Syrup may need to be changed or your child may need to be given an alternative medicine.
If you have not told your doctor about any of the above, tell him/her before you start giving Clamoxyl 125/31.25 Syrup to your child.
Taking other medicines
Tell your doctor if you are giving your child any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may be affected by Clamoxyl 125/31.25 Syrup or may affect how well it works. These include:
- probenecid and allopurinol, medicines used to prevent gout
- warfarin or other medicines used to prevent blood clots
- other antibiotics. These may interfere with actions of Clamoxyl 125/31.25 Syrup
Your doctor can tell you what to do if you are giving your child any of these medicines.
If you have not told the doctor about any of these things, tell them before you give your child any Clamoxyl Syrup 125/31.25.
If you are not sure whether you are giving your child any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while giving Clamoxyl 125/31.25 Syrup.
How to give Clamoxyl 125/31.25 Syrup to your child
Follow all directions given to you by your doctor and pharmacist carefully. The doctor will advise how many doses are needed each day and how long the child will need to take Clamoxyl 125/31.25 Syrup.
Please read the directions on the label carefully.They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist.
How much to give
The dose varies from person to person.
Your doctor will tell you how much Clamoxyl 125/31.25 Syrup you need to give to your child each day.
The usual dose of Clamoxyl 125/31.25 Syrup is one dose taken three times a day.
The dose depends on your child’s condition and his/her weight.
Children with kidney problems may need smaller doses.
How to give it
Shake the bottle well before measuring out the correct dose in a suitable measure.
Make sure that your child swallows the whole dose each time.
When to give it
Give Clamoxyl 125/31.25 Syrup immediately before or with the first mouthful of food. Giving Clamoxyl 125/31.25 Syrup in this way increases the effectiveness of this medicine, and also helps prevent stomach upsets. However, it will still work if taken without food.
Give Clamoxyl 125/31.25 Syrup at about the same time each day will have the best effect. It will also help you remember when to give it.
Space the doses as evenly as possible throughout the day. If your child is taking Clamoxyl 125/31.25 Syrup three times a day, give a dose about every eight hours.
How long to give it for
Keep giving Clamoxyl 125/31.25 Syrup until you finish the bottle, or for as long as your doctor recommends.
Do not stop giving Clamoxyl 125/31.25 Syrup even if your child feels better, unless advised to by your doctor. If you stop giving Clamoxyl 125/31.25 Syrup too soon, the infection may not clear completely or your child’s symptoms may return.
Do not stop giving Clamoxyl 125/31.25 Syrup or change the dose without first checking with the doctor.
If you forget to give it
If it is almost time for the next dose, skip the dose you missed and give the next dose when you are meant to.
Otherwise, give the missed dose as soon as you remember, and then go back to giving this medicine as you would normally.
Do not give a double dose to make up for the dose you missed. Giving more than the prescribed dose can increase the chance of unwanted side-effects.
If you are not sure what to do, ask your doctor or pharmacist.
If you give too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think your child or anyone else may have taken too much Clamoxyl 125/31.25 Syrup.
Do this even if there are no signs of discomfort or poisoning. Your child may need urgent medical attention.
While you are giving Clamoxyl 125/31.25 Syrup
Things you must do
Before starting any new medicine, tell your doctor or pharmacist that your child is taking Clamoxyl 125/31.25 Syrup.
Tell all the doctors, dentists and pharmacists who are treating your child that he/she is taking Clamoxyl 125/31.25 Syrup.
Tell your doctor if your child’s symptoms do not improve within a few days, or if they become worse.
If your child develops itching with swelling or skin rash or difficulty breathing while taking Clamoxyl 125/31.25 Syrup, do not give him/her any more and tell your doctor immediately.
If your child gets severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after he/she stopped taking Clamoxyl 125/31.25 Syrup. Diarrhoea may be a sign of a serious condition affecting your child’s bowel. He/she may need urgent medical care.
Do not give your child any anti-diarrhoeal medicines (eg. Lomotil) without checking with your doctor.
Tell your doctor if your child’s urine has to be tested for sugar. Clamoxyl 125/31.25 Syrup may affect the results of these tests.
Tell your doctor if, for any reason, you have not given Clamoxyl 125/31.25 Syrup exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your child’s treatment unnecessarily.
Things you must not do
Do not stop giving Clamoxyl 125/31.25 Syrup even if your child feels better after a few days, unless advised to by your doctor. If you stop giving Clamoxyl 125/31.25 Syrup too soon, the infection may not clear completely or your child’s symptoms may return.
Do not use Clamoxyl 125/31.25 Syrup to treat any other conditions unless your doctor tells you to.
Do not give Clamoxyl 125/31.25 Syrup to anyone else, even if they have the same symptoms as your child.
Side effects
Tell your doctor or pharmacist as soon as possible if your child does not feel well while taking Clamoxyl 125/31.25 Syrup. Clamoxyl 125/31.25 Syrup helps most people with their infections, but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. Your child may need medical treatment if he/she gets some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Do not be alarmed by this list of possible side effects. Your child may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
- mild diarrhoea (several loose bowel movements per day)
- indigestion or stomach pain
- feeling sick (nausea) or vomiting
- headache, dizziness, tiredness or hot flushes
- overgrowth of yeast infections (thrush)
- soreness of the mouth or tongue, abnormal taste, “hairy” tongue (oral thrush)
- soreness or itching of the vagina and/or discharge (vaginal thrush).
- unusually active (hyperactivity)
The above list includes the milder side effects of Clamoxyl 125/31.25 Syrup.
Tell your doctor immediately if you notice any of the following:
- itching, rash
- watery and severe diarrhoea, which may also be bloody
- severe stomach cramps
- bleeding or bruising more easily than normal
- yellowing of the skin or eyes (jaundice)
- dark urine or pale stools
The above side effects are serious and may require medical attention.
Stop giving Clamoxyl 125/31.25 Syrup and tell your doctor immediately or take your child to Accident and Emergency at the nearest hospital if you notice any of the following:
- wheezing, fainting, swelling of the lips/mouth, difficulty in breathing or swallowing, hayfever, lumpy rash (hives), joint discomfort or swelling, swollen lymph glands, nausea and vomiting . These could be symptoms of an allergic reaction or other reaction.
- fever, in combination with at least one of the above
The above side effects are very serious and may require urgent medical attention or even hospitalisation.
Rare events that have been reported with Clamoxyl 125/31.25 Syrup include:
- inflammation of the bowel (colitis)
- inflammation of the liver or kidney
- blood disorders
- crystals in the urine (crystalluria)
Tell your doctor or pharmacist as soon as possible if you notice anything that is making your child feel unwell.
This is not a complete list of all possible side effects. Other side effects not listed above may also occur in some people.
After giving Clamoxyl 125/31.25 Syrup
Storage
Keep Clamoxyl 125/31.25 Syrup where children cannot reach it.
Keep Clamoxyl 125/31.25 Syrup in the refrigerator where the temperature stays between 2°C and 8°C but do not store in the freezer.
Do not use any mixture left in the bottle after 7 days after collecting from the pharmacy. Ask your pharmacist what to do with any doses that are left over.
Do not leave Clamoxyl 125/31.25 Syrup in the car or on window sills. Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop giving Clamoxyl 125/31.25 Syrup, or the medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.
Product description
What it looks like
Clamoxyl 125/31.25 Syrup is available as an off-white sugar-free syrup.
Each 145 mL bottle contains 75 mL of mixture.
Ingredients
The active ingredients in Clamoxyl 125/31.25 Syrup are amoxycillin (as amoxycillin trihydrate) and clavulanic acid (as potassium clavulanate).
Each 5 mL of syrup contains:
- 125 mg of amoxycillin, and
- 31.25mg of clavulanic acid
Clamoxyl 125/31.25 Syrup also contains the following inactive ingredients:
- hypromellose
- aspartame
- silica – colloidal anhydrous
- silicon dioxide
- succinic acid
- xanthan gum
- mixed fruit flavour
Clamoxyl 125/31.25 Syrup is sugar-free.
Clamoxyl 125/31.25 Syrup does not contain sucrose, lactose, gluten, tartrazine or any other azo dyes.
Supplier
Clamoxyl 125/31.25 Syrup is supplied by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au
Australian registration number:
Clamoxyl 125/31.25 Syrup –
AUST R 146789
This leaflet was prepared on
17 July 2013.
Clamoxyl125/31.25_cmijul13/00
Published by MIMS October 2013