Co-Amoxiclav 457mg/5ml Suspension
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Some of these reactions can be delayed and appear several weeks after finishing the treatment.
If your child gets any other problems while taking this medicine, tell your doctor or pharmacist.
5. HOW TO STORE CO-AMOXICLAV ORAL SUSPENSION
Keep out of sight and reach of children.
* Do not use Co-amoxiclav Oral Suspension after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
* The suspension will be prepared by the pharmacist and is only suitable for use for up to 7 days after reconstitution. If any medicine is left after 7 days, return it to your pharmacist.
* Powder for suspension: Do not store above 25°C. Keep the bottle tightly closed.
Reconstituted suspension: Store at 2°- 8°C. Do not freeze.
Medicines should not be disposed of via the wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. FURTHER INFORMATION
What Co-Amoxidav Oral Suspension contains
* The active substances are amoxicillin (400mg) and clavulanic acid (57mg) in every 5ml. Both of these ingredients are antibiotics and together they are known as co-amoxiclav.
* The other ingredients are: xanthan gum (E415), aspartame (E951), silicon dioxide (E551), colloidal silica, anhydrous citric acid, hypromellose, golden syrup, orange and raspberry flavours.
What Co-Amoxidav Oral Suspension looks like and the contents of the pack
* When the powder has been reconstituted, Co-amoxiclav Oral suspension contains 400mg of amoxicillin (as trihydrate) and 57mg clavulanic acid (as potassium salt), per 5ml.
* Co-Amoxiclav Oral Suspension comes in a bottle containing 70 ml of an off-white liquid mixture called a suspension.
Pack size is a bottle containing 70 mis.
POM
PL 21880/0011
Date of leaflet preparation:December 2012.
Marketing Authorisation Holder & Manufacturer: MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
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PACKAGE LEAFLET - INFORMATION FOR THE USER
Co-Amoxidav 457mg/5ml Suspension
Amoxicillin and Clavulanic Acid
Read all of this leaflet carefully before giving your child this medicine
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's.
* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Co-Amoxidav Oral Suspension is and what it is used for
2. Before you give your child Co-Amoxidav Oral Suspension
3. How to take Co-Amoxidav Oral Suspension
4. Possible side effects
5. How to store Co-Amoxidav Oral Suspension
6. Further information
1. WHAT CO-AMOXICLAV ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Co-Amoxiclav Oral Suspension is an antibiotic for treating infections. It belongs to a group of antibiotics called 'penicillins'. Co-Amoxiclav Oral Suspension works by killing the bacteria that can cause infections. Co-Amoxiclav Oral Suspension can treat a wide range of bacterial infections including those of the chest (bronchitis or pneumonia), tonsils (tonsillitis), sinuses (sinusitis), ears, skin (including animal bites), the bladder or the urethra (the tube which carries urine from the bladder), kidneys and teeth and gums (abscesses).
2. BEFORE YOU GIVE CO-AMOXICLAV ORAL SUSPENSION TO YOUR CHILD
Do not give to your child if:
* You know that your child is allergic to penicillin (or any other antibiotic).
* Your child has ever had a skin rash or swelling of the face or neck when taking an antibiotic.
* Your child has ever had a serious complaint - such as liver problems -when taking an antibiotic.
* Your child has glandular fever.
* Your child was born with a condition called 'phenylketonuria' as this product contains aspartame.
Take special care with Co-Amoxiclav Oral Suspension
* Your child is being treated for liver or kidney problems.
* Your child is being treated with any medicine (such as warfarin) to prevent blood clots.
* Your child is being treated with allopurinol for conditions such as gout which can be caused by uric acid build-up.
* Your child has severe diarrhoea.
* Your child has a catheter.
* Your child suffers from severe allergies or asthma.
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Your doctor may decide to give your child a different medicine or change the dose of Co-Amoxiclav Oral Suspension.
Taking other medicines
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without prescription.
Pregnancy and breast- feeding
IF YOU ARE AN ADULT TAKING Co-Amoxiclav Oral Suspension let your doctor know if you are pregnant (or if you think you could be).
Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines
Co-amoxiclav Oral suspension may cause confusion, dizziness or convulsions. IF YOU ARE AN ADULT TAKING Co-amoxiclav Oral Suspension make sure you are not affected before driving or using machinery.
Important information about some of the ingredients of Co-amoxiclav Oral Suspension
This product contains aspartame therefore if your child suffers from phenylketonuria contact your doctor before giving this medicine.
Do not give this medicine to your child if you have ever been told by their doctor that they have an intolerance to some sugars.
3. HOW TO GIVE CO-AMOXICLAV ORAL SUSPENSION
Always use Co-amoxiclav oral suspension exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. For children under two years the dose is based on the weight of your child.
The usual oral dose is given in the table below.
|
Age of child |
Usual dose |
|
2 months to 2 years 2 to 6 years 7 to 12 years |
25/3.6 mg/kg/day to 45/6.4 mg/kg/dayas two daily doses 2.5 ml or 5 ml twice a day 5 ml or 10 ml twice a day |
Shake the bottle well before removing the cap. Slowly pour the medicine into the measuring cup provided.
Try to give your child Co-Amoxiclav Oral Suspension
• just before meals.
• evenly through the day.
• as part of the daily routine for example at the start of a meal, once in the morning and once in the evening.
• no more than one dose every 8 hours and never give two doses within about four hours of each other.
Keep giving your child the medicine for the prescribed number of days, even if he or she seems to be better.
Your child needs every dose to help fight off the infection. If you stop giving your child this medicine before the end of the prescribed time, some bacteria may survive and cause the infection to come back. However you should not give your child this product for beyond two weeks without seeing your doctor again first.
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What if my child has been given more Co-Amoxiclav Oral Suspension than they should?
If your child has been given too much Co-Amoxiclav Oral Suspension, contact your doctor or local hospital casualty department at once. Show the doctor the medicine bottle. Signs of overdose include nausea, sickness and diarrhoea, which may then be followed by sleepiness and fitting.
What if I forget to give a dose of Co-Amoxiclav Oral Suspension?
If you forget to give a dose don't worry - just give it as soon as you remember. But don't give your child the next dose too soon. Try to wait about four hours before giving the next dose. Always try to keep the doses evenly spaced. Do not give a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-Amoxiclav Oral Suspension can cause side effects, although not everybody gets them.
See your doctor straight away if:
• Your child gets severe diarrhoea with bleeding
• You notice your child's urine becoming darker or faeces (otherwise known as poo) becoming paler
• You notice your child's skin or the whites of your child's eyes turning yellow.
Common (between 1 in 10 and 1 in 100 patients)
• Diarrhoea, upset stomach, nausea (feeling sick) or vomiting (being sick).
If this happens, the symptoms are usually mild and you may prevent them by giving your child each dose just before meals.
• Rash
If your child starts to itch or gets a rash, stop giving Co-Amoxiclav Oral Suspension and tell your doctor at once.
Uncommon (between 1 in 100 and 1 in 1000 patients)
• Thrush (a yeast infection of the mouth, vagina or skin folds).
Rare (between 1 in 1000 and 1 in 10,000 patients)
• Slight yellow/brown staining of the teeth.
Such staining usually disappears shortly after treatment if teeth are brushed regularly.
• Remind your doctor if your child is having blood tests as Co-Amoxiclav sometimes causes short term changes in blood cell counts. It can also cause an increase in bleeding time.
• Swollen face and breathing problems.
Very rare (less than 1 in 10,000 patients)
• Hyperactivity, dizziness headache, anxiety, sleeplessness, aggression or convulsions. These symptoms are reversible.
• This medicine may form crystals in the urine (usually only visible under a microscope) which may be characterised by cloudy urine or by difficulty/discomfort in passing urine.
• Black tongue.
Tell your doctor straightaway if your child has any of these symptoms.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.