Co-Amoxiclav Tablets 500/125mg
Out of date information, search another*
(Amoxicillin and clavulanic acid)
Read all of this leaflet carefully before you
starttaking this medicine.
• Keep this leaflet. You may need to read it again.
• if you have further questions, please ask your doctororyourpharmacist
• This medicine has been prescribed for you (orforyourchild). Do notpassiton to others. It may harm them, even iftheirsymptoms are the same as yours.
• !f any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tellyourdoctororpharmacist.
In this leaflet:
1. What Co-amoxiclav film-coated tablets are and what are they used for
2. Before you take Co-amoxiclav film-coated tablets
3. How to take Co-amoxiclav film-coated tablets
4. Possible side effects
5. How to Store Co-amoxiclav film-coated tablets
6. Furtherinformation
1. WHAT CO-AMOXICLAV FILM-COATED TABLETS ARE AND WHAT ARE THEY USEDFOR
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 thisfrom happening.
Co-amoxiclav film-coated tablets are used in adults and children to treat the following infections:
• middle earand sinus infections
• chest infections (pneumonia, aggravation of bronchitis)
• kidney infections including infection of bladder
• skin and soft tissue infections including animal bites, dental infections (severe dental abscess)
• boneandjointinfections.
2. BEFORE YOU TAKE CO-AMOXICLAV FILM-COATED TABLETS
Conditions you need to look out for
Co-amoxiclav film-coated tablets can make some existing conditions worse, or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation ofthe large intestine. You mustlook out for certain symptoms while you are taking Co-amoxiclav film-coated tablets, to reduce the risk of any problems. See Serioussideeffects'in Section 4.
Blood andurine tests
Ifyou 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 film-coated tablets. This is because Co-amoxiclav film-coated tablets can affect the results of these types of tests.
Using other medicines
Please tell your doctor or pharmacist ifyou are using or have recently used any other medicines. This includes medicines that can be bought withouta prescription and herbal medicines.
Ifyou are taking allopurinol (used for gout) with Co-amoxiclav film-coated tablets, it may be more likely that you'll have an allergic skin reaction.
Ifyou are taking probenecid (used for gout), your doctor may decide to adjust your dose of Co-amoxiclavfilm-coated tablets.
If medicines to help stop blood clots (such as warfarin) are taken with Co-amoxiclav film-coated tablets then extra blood tests may be needed.
Co-amoxiclav film-coated tablets can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Pregnancy and Breast-feeding
If you are pregnant, you think you might be pregnant or ifyou are breast-feeding, please tell your doctor or pharmacist.
Ask you doctor or pharmacist for advice before taking anymedicine.
Driving and using machines
Co-amoxiclav film-coated tablets can have side effects and the symptoms may make you unfit to drive. Don'tdrive or operate machinery unless you are feeling well.
3. HOW TO TAKE CO-AMOXICLAV FILM-COATED TABLETS
If you take more Co-amoxiclav film-coated tablets than you should,
Ifyou take too much Co-amoxiclav film-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 medicinecartontoshowthe doctor.
If you forget to take Co-amoxiclav film-coated tablets
Ifyou forget to take a dose, take it as soon as you remember. You should nottake the next dose too soon, but wait about 4 hours before taking the next dose.
If you stop taking Co-amoxiclav film-coated tablets
Keep taking Co-amoxiclav film-coated tablets until the treatment is finished, even if you feel better. You need every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.
Ifyou have any further questions on the use of this product, askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Do nottakeCo-amoxiclavfilm-coated tablets
• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Co-amoxiclav film-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 ofthefaceorneck
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
Do not take Co-amoxiclav film-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 film-coated tablets.
Take special care with Co-amoxiclav film-coated tablets
Talk to your doctor or pharmacist before taking this medicine ifyou:
• haveglandularfever
• are being treated for liverorkidney problems
• are not passing water regularly
Ifyou are not sure if any ofthe above apply to you, talk to your doctor or pharmacist before taking Co-amoxiclav film-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 amoxicillin/clavulanic acid tablets ora different medicine.
Always take Co-amoxiclav film-coated tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist ifyou 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 40kg
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 film-coated tablets to children weighing Iessthan40kg.
Patients with kidney and liver problems
• Ifyou have kidney problems the dose might be changed. A different strength ora different medicine may be chosen byyourdoctor.
• Ifyou have liver problems you may have more frequent blood tests to check how your liver is working.
Howto take Co-amoxiclav film-coated tablets
• Swallow the tablets whole with a glass of water at the start of a meal or slightly before.
• Space the doses evenly during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do nottake Co-amoxiclav film-coated tablets for more than two weeks. If you still feel unwellyou should go backto seeyour doctor.
Like all medicines, Co-amoxiclav film-coated tablets may cause side effects, although not everybodygetsthem.
Serioussideeffects
If any of these serious side effects happen, stop taking the medicine and tell your doctor immediately or goto the emergency room atyour nearest hospital.
Allergic reactions:
• inflammation of blood vessels ( )
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 mouth (angioedema), causing difficulty in breathing
• collapse
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (
syndrome), and a more severe form, causing extensive peeling ofthe skin (more than 30% of the body surface - toxic epidermal necrolysis)
• 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)
• widespread red skin rash with small pus-containing blisters {buiious exfoliative dermatitis)
• a red, scaly rash with bumps under the skin and blisters (exanthemouspustulosis).
The following serious side effects have also been reported:
• inflammation ofthe large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever
• inflammation ofthe liver (hepatitis)
• jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your skin and whites ofthe eyesappearyellow
• convulsions (in people taking high doses of Co-amoxiclav film-coated tablets or who have kidney problems)
• blood takes longerto clot.
Other side effects
If you get any of these side effects, talk to your doctor as soon as possible.
Very common side effects
These may affect more than 1 in 10 people
• diarrhoea.
Common side effects
These may affect upto 1 in 10 people
• thrush [Candida - a yeast infection of the vagina, mouth orskin folds)
• feeling sick (nausea), especially when taking high doses
^ if affected take Co-amoxiclav film-coated tablets before food
• vomiting.
Uncommon side effects
These may affect upto 1 in 100 people
• skin rash, itching
• raised itchy rash (hives)
• indigestion
• dizziness
• headache.
Side effects that may show up in your blood tests:
• increase in some substances (enzymes) produced bythe liver.
Raresideeffects
These may affect up to 1 in 1000 people
Side effects that may show up in your blood tests:
• lownumberofcells involved in blood clotting
• low numberofwhite blood cells.
Other side effects. The frequency of these side
effects isnotknown
• inflammation oftubes in the kidney
• hyperactivity
• blacktongue which looks hairy
Side effects that may show up in your blood or
urine tests:
• severe reduction in the numberofwhite blood cells
• low number of red blood cells ( anaemia)
• crystals in urine.
Ifyou getside effects
^ Tell your doctor or pharmacist if any ofthe side effects become severe or troublesome, or ifyou notice any side effects notlisted in this leaflet
5. HOW TO STORE CO-AMOXICLAV FILM-COATED TABLETS
Store in the original package in order to protect from light.
Do not store above 25°C.
Keep out ofthe sight and reach ofchildren.
Do nottake afterthe expiry date on the labelling. The tablets should be used within 30 days of openingof the pouch.
If your doctor tells you to stop taking the film-coated tablets, please take them back to the pharmacist.
6. FURTHERINFORMATION
The active substances are amoxicillin and clavulanic acid.
One film-coated tablet contains 573.96 mg amoxicillin trihydrate equivalent to 500 mg amoxicillin and 297.81 mg potassium clavulanate equivalent to 125 mg clavulanic acid.
The other ingredients are Cellulose microcrystalline, Sodium starch glycolate, Silica colloidal anhydrous, Povidone, Eudragit E100, Magnesium stearate, Hypromellose, Titanium dioxide(E171), Macrogol 400, Talc.
Co-amoxiclav 500mg/125mg Film-coated tablets are white to off-white film-coated oval shaped tablets debossed with RX713 on one side and plain on the other side.
Packs sizes of 10,12,14,15,16,20,21,24,30,40 or 50 film-coated tablets packed in PVC/PVdC/Alu blister pack in pouch (Polyester film/Aluminium foil/Polyester film/Polyethylene) with 1g sachet containing desiccant.
Do not eat the desiccant sachet contained inside the pouch.
Not all pack sizes may be marketed.
Manufacturer Ranbaxy Ireland Limited,
Cashel, Co.Tipperary,
Ireland.
Marketing Authorisation Holder Ranbaxy (UK) Limited,
Building 4, Chiswick Park,
566 ChiswickHigh Road,
London, W4 5YE,
United Kingdom.
This leaflet was last revised in August 2013.
Font Size: 9 pt.