Patient leaflet - Co-amoxiclav tablets 500/125 mg
1. What Co-amoxiclav lm-coated tablets are and what are they 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 lm-coated tablets are used in adults and children to treat the following infections:
- middle ear and sinus infections · respiratory tract infections
- urinary tract infections
skin and soft tissue infections including
dental infections
- bone and joint infections.
2. What you need to know before you take Co-amoxiclav lm-coated tablets
Do not take Co-amoxiclav lm-coated tablets
if you are allergic (hypersensitive) to
amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Co-amoxiclav lm-coated tablets (listed in section 6).
if you have ever had a severe allergic
(hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat
if you have ever had liver problems or
jaundice (yellowing of the skin) when taking an antibiotic.
Do not take Co-amoxiclav lm-coated tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Co-amoxiclav lm-coated tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
- have glandular fever
are being treated for liver or kidney
problems
- are not passing water regularly
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Co-amoxiclav lm-coated tablets.
In some cases, your doctor may investigate the type of bacteria that is causing your infection. Depending on the results, you may be given a different strength of Co-amoxiclav lm-coated tablets or a different medicine.
Conditions you need to look out for
Co-amoxiclav lm-coated tablets can make some existing conditions worse, or cause serious side effects. These include allergic reactions, convulsions ( ts) and in ammation of the large intestine. You must look out for certain symptoms while you are taking Co-amoxiclav lm-coated tablets, to reduce the risk of any problems. See Section 4.
Blood and urine tests
If you are 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 you are taking Co-amoxiclav lm-coated tablets. This is because Co-amoxiclav lm-coated tablets can affect the results of these types of tests.
Other medicines and Co-amoxiclav lm-coated tablets
Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or might take/use any other medicines. This includes medicines taken without a prescription.
If you are taking allopurinol (used for gout) with Co-amoxiclav lm-coated tablets, it may be more likely that you'll have an allergic skin reaction.
Probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If medicines to help stop blood clots (such as warfarin) are taken with Co-amoxiclav lm-coated tablets then extra blood tests may be needed.
Methotrexate (used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate causing a potential increase in side effects.
Co-amoxiclav lm-coated tablets may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, or if you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Co-amoxiclav lm-coated tablets can have side effects and the symptoms may make you un t to drive. Don't drive or operate machinery unless you are feeling well.
Co-amoxiclav lm-coated tablets contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
3. How to take Co-amoxiclav lm-coated tablets
Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg and over
The usual dose is
1 tablet three times a day
Children weighing less than 40 kg
Children aged 6 years or less should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets.
Ask your doctor or pharmacist for advice when giving Co-amoxiclav lm-coated tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.
Patients with kidney and liver problems
If you have kidney problems the dose
might be changed. A different strength or a different medicine may be chosen by your doctor.
If you have liver problems you may have
more frequent blood tests to check how your liver is working.
How to take Co-amoxiclav lm-coated tablets
Swallow the tablets whole with a glass of
water with a meal.
Space the doses evenly during the day, at
least 4 hours apart. Do not take 2 doses in 1 hour.
Do not take Co-amoxiclav lm-coated
tablets for more than two weeks. If you still feel unwell you should go back to see your doctor.
If you take more Co-amoxiclav lm-coated tablets than you should,
If you take too much Co-amoxiclav lm-coated tablets, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to your doctor as soon as possible. Take the medicine carton to show the doctor.
If you forget to take Co-amoxiclav lm-coated tablets
If you forget to take a dose, take it as soon as you remember. You should not take the next dose too soon, but wait about 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Co-amoxiclav lm-coated tablets
Keep taking Co-amoxiclav lm-coated tablets until the treatment is nished, even if you feel better. You need every dose to help ght the infection. If some bacteria survive they can cause the infection to come back.
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. The side effects below may happen with this medicine.
Conditions you need to look for
Allergic reactions:
in ammation 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
fever, joint pain, swollen glands in the
neck, armpit or groin
swelling, sometimes of the face or throat
(angioedema), causing difficulty in breathing
- Collapse
Chest pain in the context of allergic
reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)
Contact a doctor immediately if you get any of these symptoms. Stop taking Co-amoxiclav tablets.
In ammation of large intestine
In ammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
Acute in ammation of the pancreas (acute pancreatitis)
If you have severe and on-going pain in the stomach area this could be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
DIES has been reported mainly in children receiving amoxicillin/clavulanate. It is a certain kind of allergic reaction with the leading symptom of repetitive vomiting (1-4 hours after drug. Further symptoms could comprise abdominal pain, lethargy, diarrhoea and low blood pressure.
Contact your doctor as soon as possible
for advice if you get these symptoms.
Very common (may affect more than 1 in 10 people)
- diarrhoea (in adults)
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 when
taking high doses
→ if affected take Co-amoxiclav lm-
coated tablets with a meal
- vomiting
- diarrhoea (in children)
Uncommon (may affect up to 1 in 100 people)
- skin rash, itching
- raised itchy rash (hives)
- indigestion
- dizziness
- headache
Uncommon side effects that may show up in your blood tests:
increase in some substances (enzymes)
produced by the liver
Rare (may affect up to 1 in 1,000 people)
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 multi- forme)
If you notice any of these symptoms contact a doctor urgently.
Rare side effects that may show up in your blood tests:
low number of cells involved in blood
clotting
- low number of white blood cells
Not known (frequency cannot be estimated from the available data)
- Allergic reactions (see above)
In ammation of the large intestine (see
above)
in ammation of the membranes that
surround the brain and spinal cord (aseptic meningitis)
- Serious skin reactions:
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)
widespread red skin rash with small pus-
containing blisters (bullous exfoliative dermatitis)
a red, scaly rash with bumps under the
skin and blisters (exanthemous pustulosis)
u-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))
Rash with blisters arranged in a circle with
central crusting or like a string of pearls (linear IgA disease)
Contact a doctor immediately if you get any of these symptoms.
In ammation of the liver (hepatitis) · jaundice, caused by increases in the blood
of bilirubin (a substance produced in the liver) which may make your skin and whites of the eyes appear yellow · in ammation of tubes in the kidney · blood takes longer to clot
- hyperactivity
convulsions (in people taking high doses
of Amoxicillin/clavulanic acid or who have kidney problems)
- black tongue which looks hairy
- overgrowth of non-susceptible organisms
Side effects that may show up in your blood or urine tests:
severe reduction in the number of white
blood cells
low number of red blood cells (haemolytic
anaemia)
crystals in urine leading to acute renal
injury
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this lea et. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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 lm-coated tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry
date which is stated on the carton and foil after 'EXP'. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Do not store above 25°C.
The tablets should be used within 30 days of opening of the pouch.
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 infor-mation
What Co-amoxiclav lm-coated tablets contain
The active substances are amoxicillin and clavulanic acid. Each lm-coated tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).
The other ingredients are Cellulose micro-crystalline, sodium starch glycolate, silica colloidal anhydrous, povidone, Eudragit E100, Magnesium stearate, Hypromellose, Titanium dioxide (E171), Macrogol 400, Talc.
What Co-amoxiclav lm-coated tablets look like and contents of the pack
Co-amoxiclav are white to off-white lm-coated oval shaped tablets debossed with RX713 on one side and plain on the other side.
Pack sizes of 10, 12, 14, 15, 16, 20, 21, 24, 30, 40 or 50 lm-coated tablets packed in PVC/PVdC/Alu blister pack in pouch (Polyester lm/Aluminium foil/Polyester lm/Polyethylene) with 1g sachet containing desiccant.
Do not eat the desiccant sachet contained inside the pouch.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
SUN PHARMA UK LIMITED
6-9 The Square,
Stockley Park,
Uxbridge, UB11 1FW
United Kingdom
Manufacturer
Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Alkaloida Chemical Company Zrt.
Kabay János u. 29.
Tiszavasvári 4440
Hungary
This lea et was last revised in November 2023.
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.
- 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.
- 2. You should not take an antibiotic unless it has been prescribed speci cally for you and you should use it only to treat the infection for which it was prescribed.
- 3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.
- 4. You should not give antibiotics that were prescribed for you to other people.
- 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. Package Lea et: Information for the patient Co-amoxiclav 500mg/125 mg Film-coated Tablets
(amoxicillin and clavulanic acid)