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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your 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 film-coated tablets are and what are they used for
2. What you need to know 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. Contents of the pack and other information

• 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 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 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.

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 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 Co-amoxiclav film-coated tablets or a different medicine.

Co-amoxiclav film-coated tablets 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 film-coated tablets, to reduce the risk of any problems. See 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 film-coated tablets. This is because Co-amoxiclav film-coated tablets can affect the results of these types of tests.

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 film-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 film-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 film-coated tablets may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

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.

Co-amoxiclav film-coated tablets can have side effects and the symptoms may make you unfit to drive. Don’t 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 amoxicillin/clavulanic acid oral suspension or sachets.

Ask your doctor or pharmacist for advice when giving Co-amoxiclav film-coated tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.

• 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.

• 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 film-coated tablets for more than two weeks. If you still feel unwell you should go back to see your doctor.

If you 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 medicine carton 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 about 4 hours before taking the next dose. Do not take a double dose to make up for a forgotten dose.

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.

Allergic reactions:

• 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 tablets.

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/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 film-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 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

Not known (frequency cannot be estimated from the available data)

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• inflammation 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)
  • 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))
  • 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 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

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 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.

The active substances are amoxicillin and clavulanic acid. Each film-coated tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate).

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 are white to off-white film-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 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.