Patient leaflet - CO-AMOXICLAV 125 MG / 31.25 MG / 5 ML POWDER FOR ORAL SUSPENSION
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– This medicine is usually prescribed for a baby or child. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as your child’s.
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– If your child gets any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
If you are an adult who has been given this medicine, this information applies to you.
What is in this leaflet
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1. What Co-amoxiclav is and what it is used for
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2. What you need to know before you give Co-amoxiclav
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3. How to give Co-amoxiclav to your child
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4. Possible side effects
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5. How to store Co-amoxiclav
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6. Contents of the pack and other information
1. what co-amoxiclav is and what it is used for
Co-amoxiclav is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening.
Co-amoxiclav is used in adults, babies and children to treat the following infections:
- middle ear and sinus infections
- respiratory tract infections
- urinary tract and kidney infections
- skin and soft tissue infections including animal bites and dental infections
- bone and joint infections.
You must talk to a doctor if your child does not feel better or if your child feels worse after 14 days.
2. what you need to know before you give co-amoxiclav your child is allergic to amoxicillin trihydrate, clavulanic acid or any of the other ingredients of this medicine listed in section 6.
- your child is allergic to penicillin or any other antibiotic
- your child has ever experienced liver problems (e.g. jaundice) when taking an antibiotic
Warnings and precautions
Talk to your doctor or pharmacist before giving Co-amoxiclav to your child if:
- your child has kidney or liver problems
- your child has glandular fever
- your child is suffering from severe stomach upset with diarrhoea and vomiting
- your child has a serious blood disorder (lymphatic leukemia)
- your child is not passing water regularly
In some cases, your doctor may investigate the type of bacteria that is causing your child’s infection. Depending on the results, your child may be given a different strength of Co-amoxiclav or a different medicine.
Conditions you must look out for while you are giving Co-amoxiclav
Co-amoxiclav can make some existing conditions worse, or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation of the large intestine. If your child experiences an allergic reaction, your child must stop taking Co-amoxiclav and your doctor will change the medicine. See section 4.
Other medicines and Co-amoxiclav
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines, or the following:
- allopurinol (your child may have a higher risk of skin reactions) or probenecid, to treat gout
- anticoagulants (medicine to help stop blood clots such as warfarin); the tendency to bleed may
increase. Extra blood tests may be needed.
- other antibiotics e.g. erythromycin, oxytetracycline, chloramphenicol, co-trimoxazole
- methotrexate (a medicine used to treat cancer or rheumatic diseases)
- mycophenolate mofetil (a medicine used after an organ transplant).
Blood and urine tests : If your child is having blood tests (such as red blood cell status tests or liver function tests) or urine tests (for glucose), let the doctor or nurse know that they are taking Co-amoxiclav. This is because Co-amoxiclav can affect the results of these types of tests.
Pregnancy and breast-feeding
This formulation of the medicine is usually given to children, but if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should only use Co-amoxiclav whilst pregnant if your doctor tells you to. This medicine may be harmful to the baby.
Amoxicillin and clavulanic acid may pass into breast milk. If you breast-feed while taking this medicine, the baby may be more likely to get diarrhoea or an infection. If this happens, you may need to stop breast-feeding. You should only use Co-amoxiclav whilst breast-feeding if your doctor tells you to.
Co-amoxiclav contains aspartame
This medicine contains 8.5mg aspartame in each 5ml dose. Aspartame is a source of phenylalanine. It may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Co-amoxiclav contains dextrose, maltodextrin (glucose) and sorbitol
If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before taking this medicine.
Co-amoxiclav 125 mg/31.25 mg/5 ml powder for oral suspension contains 328 mg sorbitol in each 5 ml dose.
Co-Amoxiclav 250 mg/62.5 mg/5 ml powder for oral suspension contains 326 mg sorbitol in each 5 ml dose.
This medicine contains less than 1 mmol sodium (23mg) per 5ml dose, that is to say essentially “sodium free”.
Driving and using machines
Co-amoxiclav can have side effects such as allergic reactions, dizziness or fits that may make you unfit to perform activities such as driving, riding bikes or using machinery.
Do not drive, ride a bike or use machinery unless you are feeling well.
3. How to give Co-amoxiclav to your child
Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Use in adults and children weighing 40 kg or over
This suspension is not usually recommended for adults and children weighing 40 kg and over. Ask your doctor or pharmacist for advice.
- The recommended daily dose is one 500 mg/125 mg dose taken three times daily.
Use in children weighing less than 40 kg
All doses are worked out depending on the child’s bodyweight in kilograms.
- Your doctor will advise you how much Co-amoxiclav you should give to your baby or child and how often.
- You will be provided with a plastic measuring spoon. You should use this to give the correct dose to your baby or child.
- The recommended dose is 20 mg/5 mg to 60 mg/15 mg for each kilogram of body weight a day, given in three divided doses.
Do not give more than the dose your doctor has recommended.
Always shake the bottle well before each dose- Use the measuring spoon provided to give the suspension.
- Give with a meal
- Space the doses evenly throughout the day, at least 4 hours apart. For example, if you have been told
to give Co-amoxiclav three times a day:
o give the first dose just before breakfast
o give the next dose just before lunch
o give the last dose just before dinner.
- Do not give your child Co-amoxiclav for more than 2 weeks. If your child still feels unwell they should go back to see the doctor.
Your pharmacist will have prepared the suspension for you.
Children with kidney or liver problems
- If your child has kidney problems the dose might be lowered. A different strength or a different medicine may be chosen by your doctor.
- If your child has liver problems they may have more frequent blood tests to see how their liver is working.
If you give more Co-amoxiclav than you should
Contact your doctor or nearest hospital emergency department immediately. Take the bottle and any remaining suspension with you. Signs of overdose might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions (fits).
If you forget to give Co-amoxiclav
Give the next dose as soon as you remember unless it is almost time for your child’s next dose. Do not give your child a double dose to make up for a forgotten dose, wait about 4 hours before giving the next dose.
If your child stops taking Co-amoxiclav
Keep giving your child this medicine until the course is finished. Do not stop just because he/she feels better. If you stop too soon the infection may come back again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Co-amoxiclav and tell your doctor immediately or go to your nearest hospital emergency department if you notice any of the following:
Rare (may affect up to 1 in 1,000 people)
- frequent infections causing fever, severe chills, sore throat or mouth ulcers (these may be signs of a low number of white blood cells)
Frequency Not known (cannot be estimated from the available data)
- signs of a serious allergic reaction which can include:
o sudden itching, red skin rash or swelling of the face, lips, tongue, throat or neck, difficulty breathing or swallowing.
o collapse
o inflammation of blood vessels (vasculitis ) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body.
o fever, joint pain, swollen glands in the neck, armpit or groin.
- tiredness, headaches, shortness of breath when exercising, dizziness, pale or yellowing of the skin or eyes (haemolytic anaemia)
- sensitivity to light, stiff neck, body aches, sore throat, severe headache, flu-like symptoms (these may indicate you have a type of meningitis that can’t be passed on to others)
- diarrhoea, possibly with blood or mucus, stomach pain or fever (these may be signs of an inflamed intestine)
- yellowing of the skin or whites of the eyes, dark urine, pale stools, tiredness, fever, nausea, weakness, drowsiness and abdominal pain, with blood test results showing abnormal liver function (these may be signs of serious problems with your liver)
- Serious skin reactions:
o a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome ), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface toxic epidermal necrolysis )
o widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis )
o a red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis )
o flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including
increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
- pain passing urine, lower back pain or fever (these may be signs ofa serious kidney problem (interstitial nephritis)
- fits (especially if your child takes high doses of Co-amoxiclav or if your child has kidney problems)
Other side effects:
Common (may affect up to 1 in 10 people)
- thrush (candida – a yeast infection of the vagina, mouth or skin folds)
- feeling sick (nausea), especially if your child takes high doses
- being sick (vomiting)
- diarrhoea
Uncommon (may affect up to 1 in 100 people)
- skin rash, itching
- raised itchy rash (hives)
- indigestion
- dizziness
- headache.
- increase in some substances (enzymes) produced by the liver (detected by a blood test)
Rare (may affect up to 1 in 1,000 people)
- unexplained bruising or bleeding more easily than normal (these may be signs of a low number of cells involved in blood clotting)
- skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme)
Frequency Not known (cannot be estimated from the available data)
- hyperactivity
- black tongue which looks hairy
- stained teeth (in children), usually removed by brushing.
- other infections that are difficult to treat (over-growth of non-susceptible organisms).
- crystals in urine (seen as cloudy urine or in a urine test).
Reporting of side effects
If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store co-amoxiclav
Keep this medicine out of the sight and reach of children.
The medicine should only be used for up to 7 days from the dispensing date stated on the label after “Dispensing date”.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the bottle tightly closed.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other informationco-amoxiclav is available in two strengths (125 mg/31.25 mg/ 5 ml and 250 mg/62.5 mg/5 ml). the active substances are amoxicillin trihydrate (corresponding to 125 mg or 250 mg amoxicillin) and potassium clavulanate (corresponding to 31.25 mg or 62.5 mg clavulanic acid).
The other ingredients are anhydrous citric acid, sodium citrate, aspartame (see section 2 ‘Co-amoxiclav contains aspartame’), talc, guar, colloidal anhydrous silica, flavouring agents (lemon containing dextrose and maltodextrin (glucose), peach-apricot containing maltodextrin (glucose) and sorbitol (E420) and orange containing essence of bergamot and maltodextrin (glucose)).
What Co-amoxiclav looks like and contents of the pack
Co-amoxiclav powder for oral suspension is off-white in colour with a fruity flavour.
Co-amoxiclav powder for oral suspension comes in a bottle containing 100 ml of suspension with a child proof screw cap and a plastic measuring spoon.
Marketing Authorisation Holder
Mylan, Potters Bar, Herts, EN6 1TL.
Manufacturer:
Generics [UK] Limited, Potters Bar, Herts, EN6 1TL, United Kingdom.
Mylan UK Healthcare Limited, 20 Station Close, Potters Bar, EN6 1TL, United Kingdom.
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Tyrol, Austria
This leaflet was last revised in
August 2021
Other sources of information
Advice/medical education
Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses. Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic. Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.
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1. It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.
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2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.
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3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.
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4. You should not give antibiotics that were prescribed for you to other people.
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5. If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.
Instructions for reconstitution
After opening of the screw cap, ensure that the bottle cap seal is intact and tightly attached to the bottle rim. Do not use if not intact. Shake the bottle to loosen the powder. Add volume of water (as indicated below), invert and shake well. Do not use the reconstituted suspension if the colour is not off-white.
Alternatively, shake bottle to loosen powder, then fill the bottle with water to just below the line on the bottle or label. Invert and shake well, then top up with water exactly to the line. Invert and again shake well.
| Strength | Volume of water to be added at reconstitution (ml) | Final volume of reconstituted oral suspension (ml) |
| 125 mg/31.25 mg/5 ml | 95 | 100 |
| 250 mg/62.5 mg/5 ml | 90 | 100 |
Shake the bottle well before each dose.