Co-Amoxiclav 250/62 Oral Suspension Sugar-Free
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CO-AMOXICLAV ORAL SUSPENSION Sugar-Free
What you should know about Co-amoxiclav Oral Suspension Sugar-Free?
Please read this leaflet carefully before giving this medicine to your child. It provides a summary of information about your medicine. If you are not sure about anything or have any questions, please ask your pharmacist or doctor. This leaflet applies only to Co-amoxiclav Oral Suspension Sugar-Free.
What is Co-Amoxiclav Oral Suspension Sugar-Free?
The name of your medicine is Co-amoxiclav Oral Suspension Sugar-Free. Your medicine is available in two different strengths Co-amoxiclav 125/31 Oral Suspension Sugar-Free and Co-amoxiclav 250/62 Oral Suspension Sugar-Free. Each spoonful (5ml) of the suspension contains a combination of amoxicillin trihydrate (equivalent to 125mg or 250mg of amoxicillin) and potassium clavulanate (equivalent to 31.25 mg or 62.5 mg of clavulanic acid). It also contains the inactive ingredients colloidal anhydrous silica, sorbitol (E420), sodium benzoate (E211), sodium citrate, aspartame (E951), butyl hydroxy toluene (E321), xanthan gum, monosodium citrate and passion fruit flavour.
Co-amoxiclav Oral Suspension Sugar-Free is available in bottles as a white to off-white powder. The powder forms 100 ml of a white to off-white suspension when the correct amount of water is added (your pharmacist will do this for you).
Co-amoxiclav Oral Suspension Sugar-Free is made by Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co-Tipperary, Republic of Ireland. The Marketing Authorisation Holder is Aptil Pharma Ltd, 9th Floor CP House, 97-107 Uxbridge Road Ealing, London W5 5TL
What is Co-amoxiclav Oral Suspension Sugar-Free used for?
Co-amoxiclav is an antibiotic for treating various infections caused by bacteria. It belongs to the group of drugs called penicillin antibiotics. Antibiotics help the body fight infections.
This combination of amoxicillin and clavulanic acid is used for the treatment of a wide range of bacterial infections. These include infections of the ear, sinuses, tonsils and chest such as sinusitis, tonsillitis, bronchitis and pneumonia. It also treats infections of the skin, teeth, gums (e.g. abscesses) and urinary system (e.g. bladder).
Read the following carefully and let your doctor know if any of these conditions apply.
• Has your child ever had an allergic reaction to antibiotics such as amoxicillin or other penicillins or cephalosporins or clavulanic acid or to any other ingredients of this medicine? (An allergic reaction may include rash, itching, swelling or breathing difficulties)
• Has your child ever had liver problems (e.g. jaundice) when taking an antibiotic?
• Does your child have liver/kidney disease or is your child on dialysis?
• Does your child have glandular fever (also called infectious mononucleosis)?
• Does your child suffer from asthma or other allergies?
• Does your child have severe vomiting or loose motions?
• Has your child been diagnosed to have a type of blood cancer known as lymphatic leukaemia?
• Was your child born with a condition called "phenylketonuria"?
• Is your child taking any other medicine(s), especially- other antibiotics (such as tetracyclines, sulfonamides, erythromycin,
roxithromycin)
- aspirin, warfarin or any other blood thinning medicines (anticoagulants)
- probenecid (medicine for treating gout as well as used along with other antibiotics for treating severe infections)
- disulfiram (used in the treatment of alcoholism)
- allopurinol (medicine for treating gout)
- digoxin (used in the treatment of certain heart conditions)
- methotrexate (medicine for treating certain tumours and immune disorders)
- sulfasalazine (medicine used for treating colitis, a bowel disease in which recurrent diarrhoea occurs).
If you are taking this medicine, please let your doctor know if you are pregnant (or if you think you could be) or if you are breast-feeding. Also, do let your doctor know if you are taking any hormonal contraceptives.
Also, if your child needs a laboratory investigation such as a urine test, do inform your doctor about this medicine.
You should know the following about the inactive ingredients contained (in small amounts) in your medicine:
Aspartame (E951) contains a source of phenylalanine; you would need to discuss this with your doctor in case your child has a condition called phenylketonuria. Butyl hydroxy toluene (E321) can cause irritation to eyes, skin and mucous membranes (this may manifest as stomach irritation and/or diarrhoea). Sodium benzoate (E211) is a mild irritant to the skin, eyes and mucous membranes (this may manifest as stomach irritation and/or diarrhoea). It may increase the risk of jaundice in new born babies. The suspension also contains potassium, which is harmful to people on a low potassium diet. Increased potassium levels can cause stomach upset and diarrhoea following oral administration. Also, when taken according to the dosage recommendations, each dose of 5 ml supplies
approximately up to 0.7g of sorbitol. Sorbitol is unsuitable in individuals with a condition called hereditary fructose intolerance and can cause stomach upset and diarrhoea.
How to give your child Co-amoxiclav Oral Suspension Sugar-Free?
Co-amoxiclav 125/31 Oral Suspension Sugar-Free is for children under six years of age. The usual dose is one spoonful (5ml) of medicine three times a day for children between the ages of one and six years. If your child is below one year of age, the dose is calculated using your child's weight (e.g. a child weighing 7.5 kg would require 2 ml of Co-amoxiclav 125/31 Oral Suspension Sugar-Free three times a day).
Co-amoxiclav 250/62 Oral Suspension Sugar-Free is for children over six years and up to 12 years of age. The usual dose is one spoonful (5ml) of medicine three times a day.
Give your child this medicine as instructed by your doctor. You should check the label of the bottle for how much of the medicine to take and how often. Your pharmacist or doctor can help, if you are not sure.
Your doctor may prescribe a lower dose of this medicine in case your child has any kidney or liver problems.
Shake the bottle well before giving your child each dose of Co-amoxiclav Oral Suspension Sugar-Free.
You may be given a syringe instead of a spoon so as to make it easier for you to give the right dose to your child. Ask your pharmacist how to use it and make sure you sterilise the syringe as you would do for the baby's bottle.
For best results, you may give Co-amoxiclav Oral Suspension Sugar-Free, just before meals. It is not normally necessary to arrange to give a dose in the middle of the night unless your doctor has told you to do so.
You must keep giving this medicine for as long as your doctor has told you to. This will usually be for 7 to 14 days. Do not stop giving your child the medicine just because he/ she starts feeling better, as some bacteria may survive and the infection may then return.
If your child misses a dose, give it as soon as you remember. Do not give the next dose too soon. Try to space the doses as evenly as possible through the day. You should wait about four hours before giving the next dose. Do not give two doses within one hour or so.
If your child has taken too much of Co-amoxiclav Oral Suspension Sugar-Free, go to the nearest hospital casualty department or contact your doctor immediately.
What about side effects?
As with most medicines, Co-amoxiclav Oral Suspension Sugar-Free can cause some side effects. Consult your doctor immediately if your child develops rashes, itching or any other unusual problems such as swollen face or breathing problems. These are extremely rare.
Sometimes, children may develop an upset stomach or diarrhoea. Usually, the symptoms are mild and you can prevent them by giving each dose of the medicine just before meals. Your child may also have loss of appetite, taste disturbances, dry mouth, indigestion, nausea (feeling sick) or vomiting (being sick). Most of these side effects are mild and usually do not need medical attention unless these continue or are bothersome. Some children may get thrush (a fungal infection of the mouth, vagina or skin folds) during treatment or soon after. You can get treatment for thrush from your doctor or pharmacist.
In rare cases, your child may get severe diarrhoea (which may contain blood or mucous); do inform your doctor at once if this happens. Do not give any medicine for diarrhoea without consulting your doctor first. Also, if you notice your child's skin or whites of eyes becoming yellow or if you notice your child's urine becoming darker or faeces (stools) becoming paler, see your doctor straightaway.
In rare instances, there may be changes to some cells or other parts of blood, which may show up as unusual bleeding or increased tendency to bleed, persistent sore throat and frequent infections. Do contact your doctor if you notice your child having any of these problems.
Rarely, children may get slight yellow/ brown staining of the teeth. Such staining can usually be removed by brushing. Also, very rarely there may be black discolouration of your child’s tongue.
Very rarely, some individuals experience hyperactivity, headache and dizziness; these effects are reversible.
Inflammation of the kidney can also occur rarely. If you notice passing dark bloody or cloudy urine or observe any change in your urine output, do consult your doctor at once.
As with most medicines, Co-amoxiclav suspension can sometimes cause rare and serious reactions. See your doctor straightaway if:
• your child gets severe diarrhoea with bleeding;
• your child develops convulsions;
• you notice your child’s urine becoming darker or his/her faeces becoming paler; or
• you notice your child’s skin or the whites of his/her eyes turning yellow.
Some of these reactions can be delayed for several weeks after finishing the treatment.
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor or pharmacist.
If your child needs a blood test or urine test, do tell your doctor that your child is taking this medicine. Co-amoxiclav sometimes causes short-term changes in blood cell counts.
Do not take Co-amoxiclav Oral Suspension Sugar-Free after expiry date shown on the bottle.
Keep the suspension in a refrigerator (at 2°C-8°C) and keep the container tightly closed. Do not freeze. Throw away any unused medicine after 7 days.
If your doctor tells you to stop giving this medicine to your child or if for any reason there is some medicine left over, please take it back to the pharmacist. Only keep the medicine if your doctor tells you to.
Keep all medicines out of the reach of children.
REMEMBER: This medicine is just for your child. Only a doctor can prescribe it. Never give it to others. It may harm them, even if their symptoms appear to be the same as your child's.