Co-amoxiclav 250mg/125mg Film-coated Tablets

• 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 you (or for your child) only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Co-amoxiclav is and what it is used for
2. What you need to know before you take Co-amoxiclav
3. How to take Co-amoxiclav
4. Possible side effects
5. How to store Co-amoxiclav
6. Contents of the pack and other information

• if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (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 if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Co-amoxiclav.

Talk to your doctor or pharmacist before taking Co-amoxiclav 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 apply to you, talk to your doctor or pharmacist before taking Co- amoxiclav.

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.

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. You must look out for certain symptoms while you are taking Co-amoxiclav, to reduce the risk of any problems. See 'Conditions you need to look out for' in section 4.

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. This is because Co- amoxiclav can affect the results of these types of tests.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

• If you are taking allopurinol (used for gout) with Co-amoxiclav, it may be more likely that you will have an allergic skin reaction.
• If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Co-amoxiclav.
• If medicines to help stop blood clots (such as warfarin) are taken with Co-amoxiclav then extra blood tests may be needed.
• Co-amoxiclav can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
• Co-amoxiclav may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

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.

Co-amoxiclav can have side effects and the symptoms may make you unfit to drive. Do not drive or operate machinery unless you are feeling well.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

The usual dose is:

• 1 tablet three times a day

Children aged 6 years or less should preferably be treated with Co-amoxiclav oral suspension or sachets. Co-amoxiclav tablets are not recommended.

• If you have kidney problems the dose might be changed. A different strength or 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.

• Take with a meal.
• Swallow the tablets whole with a glass of water.
• 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 for more than 2 weeks. If you still feel unwell you should go back to see the doctor.

If you take too much Co-amoxiclav, 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 or bottle to show the doctor.

• 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 around 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.

Keep taking Co-amoxiclav 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.

• skin rash
• 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
• 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.

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

If you have severe and on-going pain in the stomach area this could be a sign of acute pancreatitis.

DIES has been reported mainly in children receiving amoxicillin/clavulanic acid. It is a certain kind of allergic reaction with the leading symptom of repetitive vomiting (1-4 hours after drug administration).

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 side effects

These may affect more than 1 in 10 people

• diarrhoea (in adults).

Common side effects

These 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 with a meal
• vomiting
• diarrhoea (in children).

Uncommon side effects

These 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 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 ring around the edge - erythema multiforme)
• 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.

Frequency not known

Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the protective membrane surrounding the brain (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).
• 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))
• a red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, neck (Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE)).

Contact a doctor immediately if you get any of these symptoms.

• rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease)
• inflammation 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
• inflammation of tubes in the kidney
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of Co-amoxiclav or who have kidney problems)
• black tongue which looks hairy

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 kidney injury.

If you get 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 Yellow Card Scheme, Website: 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.

• The active substances are amoxicillin trihydrate and potassium Clavulanate.

Each film-coated tablet contains amoxicillin trihydrate equivalent to 250 mg amoxicillin and potassium clavulanate equivalent to 125 mg clavulanic acid.

• The other ingredients are:
  Tablet core: microcrystalline cellulose, crospovidone (Type B), sodium starch glycolate (Type A), ethyl cellulose dispersion (Type B), anhydrous colloidal silica, magnesium stearate. Tablet coat: hypromellose 2910 (5cps), hypromellose 2910 (15cps), macrogol 4000, macrogol 6000, titanium dioxide (E171).

Co-amoxiclav 250 mg /125 mg tablets are white to off-white, oval shaped, film coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side. The size is 18.1 mm × 8.6 mm.

The tablets are packaged in blisters. Each pack contains 21 film-coated tablets.

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