•    bloodtakeslongertoclot

•    hyperactivity

•    convulsions(in peopletakinghigh doses of Co-amoxiclav Tablets or who have kidney problems)

•    blacktongue which lookshairy

Side effects that may show up in your blood

•    low number of red blood cells (haemolytic

•    crystals in urine.

Reporting ofsideeffects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide s information on the safety of this

tablet contains 500mg amoxicillin as amoxicillin trihydrate and 125mg of clavulanic acid as potassium clavulanate, diluted.

Cellulose, microcrystalline (E460) Sodiumstarch glycolate,TypeA Silica, Colloidal anhydrous (E551) Magnesium Stearate (E572)

Film coat

Titanium dioxide (E171) Hypromellose (E464) Polyethyleneglycol

11 ■ I ■ 1111 ■■

Pharmacode 11 ■ I ■ 1111 ■ ■

m

Package leaflet: Information for the user

Co-amoxiclav 250mg/125mg film-coated Tablets Co-amoxiclav 500mg/125mg film-coated Tablets

(Amoxicillin/clavulanic acid)

convulsions (fits) and inflammatioi large intestine. You must lookout for ci symptoms while you are taking Coproblems. See 'Conditions you need to look outfo/'in Section 4.

Blood and urinetests:

If you are having blood tests (such as red blood cell status tests or liver function tests) or urinetests (for glucose), let the doctor or nurse know that you are taking Co-amoxiclav. This is because Co-amoxiclav can affect the results of these types of tests.

Other medicines and Co-amoxiclav

HowtotakeCo-amoxiclavTablets

Always take Co-amoxiclav tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you

;h of children.

Do not store above 25°C.

Do not take Co-amoxiclav tablets after the expiry date which is stated on the carton and blister strip after EXP. The expiry date refers to the last day of that month.

250roa/125roa Tablets: White, capsule shaped, film coated tablet debossed with 'I 05'on one side and plain on the other.

500ma/125maTab/ets: White, capsuleshaped film-coated tablet, debossed with 'I 06'on onesideand plain on the other.

The tablets are packaged in aluminium blister strips consisting of: 4, 5, 6, 7, 8, 10, 12,14,15,16,20,21,25, 30, 35,40, 50,100 &500tablets

Not all packsizes maybe marketed

Holder and

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

-    Keep this leaflet. You may need to read it

-    If you have any further questions, ask your doctor or pharmacist.

^_    prescribed for

to others.

- If you get any side effect doctor or pharmacist. This possible side effects not leaflets. See section 4.

at Co-aff sed for

iv Tablets is

urinarytractinfections

skin and soft tissue infections including

dental infections

Done and joint infections.

.^before you'

Medicines should not be disposed of vi wastewater or household waste. Ask yoi pharmacist howto dispose of medicines n longer required. These measures will hel to protect the environment.

What Co-amoxiclav tablets contains:

• The active substances are Amoxicillin Trihydrate and Potassium Clavulanate., Diluted

Tablets: Each film-coated tablet contains 250mg amoxicillin as amoxicillin trihydrate and 125mg of clavulanic acid as potassium clavulanate, diluted.

500mq/125ma Tablets: Each film-coated

Brown & Burk UK Ltd

5 Marryat Close

Hounslow West

Middlesex

TW4 5DQ

UK.

This medicinal product is authorised in the Member States of the EEA under the following names:

UK & IE: Co-amoxiclav 250mg/125mg Film-500mg/125mg Film-coated Tablets 250mg/125mg filmdragerade tabletter & 500mg/125mgfilmdrageradetabletter This leaflet was last approved on 07/2014

2.    What you need to know before you take Co-amoxiclav Tablets

3.    Howto use Co-amoxiclav Tablets.

4.    Possible side effects

5.    Howto store co-amoxiclav tablets

6.    Content ofthe pack and other information

any of the other ingredients of Co-amoxiclav (listed in section 6)

(hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck • if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Co-amoxiclav if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Co-amoxiclav Tablets.

Please tell your doctor or pharmacist ifyou are using or have recently used any other

can be bought without a prescription and

If you are taking allopurinol (used for gout) with Co-amoxiclav, it maybe more likely that you will have an allergicskin reaction.

Ifyou are taking probenecid (used for gout), your doctor may decide to adjust your dose of Co-amoxiclav.

Adults and children weighing 40 kg and

250 mo/125 mo film-coated tablets:

The usual dose is 1 tabletthreetimesaday 500 mo/125 mo film-coated tablets:

The usual dose is 1 tabletthreetimesaday Children weighing Iessthan40kg

before taking the next dose.

Ifyou stop taking Co-amoxiclav Tablets

Keep taking Co-amoxiclav until the treatment is finished, even ifyou feel better.

infection. If some bacteria survive they can

Ifyou have any further questions on the use of this product, ask your doctor or pharmacist.

Uncommon side effects

These may affect up to 1 in 100 people

•    skin rash, itching

•    indigestion

side effects, although not everybody gets

Conditions you need to look out for

Allergic reactions:

Uncommon side effects that mayshowupin

•    increase in some substances (enzymes) produced bytheliver

Rare side effects

These may affect up to 1 in 1000 people

•    skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark

multiforme)

It you notice any ot these symptoms contact a doctor urgently.

rheumaticdiseases)works.

amoxiclav Tablets

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 is used in adults and children to treat the following infections: 250 mg film-coated tablets:

■ urinarytractinfections

•    skin infections

•    dentalinfections.

500 mg/125 mg film-coated

•    middleearandsinusinfections

•    respiratorytractinfections

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine ifyou:

•    haveglandularfever

•    are being treated for liver or kidney

•    arenotpassingwaterregularly.

Ifyou are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking these 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 or a different medicine.

Conditions you need to look out for:

Co-amoxiclav can make some existing conditions worse, or cause serious side effects. These include allergic reactions,

This medicine contains 0.63 mmol (or 24.632 mg) potassium per tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

Pregnancy and breast-feeding

If you are pregnant, you thinkyou might be pregnant or if you are breast-feeding, please tell your doctor or pharmacist.

Ask your doctor or pharmacist for advice

when giving Co-amoxiclav tablets to

children weighing less than 40 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.

Howto take Co-amoxiclav 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 take2 doses in

•    Do nottake Co-amoxiclavfor morethan2 weeks. If you still feel unwell you should go back to see the doctor.

•    inflammation of blood vessels (vasculitis)

which may be visible as red or purple blood tests: raised spots on the skin, but can affect • low number of i other parts of the body    clotting

•    fever, joint pain, swollen glands in the • lownumberofwh neck, armpit orgroin

• swelling, sometimes of the face or mouth    Other side effects (angioedema), causing difficulty in breathing

•    collapse.

Rare side effects that mayshow upin your • low number of cells involved in blood

Contact a doctor immediately if you get

any of these symptoms. Stop taking Co-amoxiclav Tablets.

Inflammation of large intestine

Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/orfever.

Very common side effects

mayaffect more than 1 in lOpeople ioea(in adults).

Driving and using machines

Co-amoxiclav can haveside effects ar symptoms may make you unfit to drive Don't drive or operate machinery unles are feeling well.

Ifyou take too much Co-amoxiclav Tablets, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to your doctor as soon as possible. Take th medicine carton or bottle toshowthedoctor.

If you forget to take Co-amoxiclav

Common side effects

These may affect up to 1 in 10 people

• thrush (    Candida    - a yeast infection of thi

vagina, mouth or skin folds)

•    feeling sick (nausea), especially whei taking high doses

If affected take Co-amoxiclav before food

•    vomiting.

Other side effects have occurred in a very small number of people but their exact frequency is unknown.

•    Allergicreactions(seeabove)

•    Inflammation of the large intestine (see above)

•    Serious skin reactions:

-    a widespread rash with blisters and peeling skin, particularly around the

(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

pustulosis).

•    Inflammation ofthe protective membrane sorrunding the brain (asepticmeningitis)

Contact a doctor immediately ifyou get any of these symptoms:

•    inflammation of the liver (hepatitis)

blood of bilirubin (a substance produced in the liver)which may makeyourskin and whites of eyes appear yellow

•    inflammation oftubesin the kidney