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21/03/2016

PACKAGE LEAFLET: INFORMATION FOR THE USER

Co-amoxiclav 500mg/100mg & 1000mg/200mg Powder for solution for injection or infusion

AmoxiciMin/clavulanic acid

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 again

•    If you have any further questions, ask your doctor, pharmacist or nurse

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

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 is used in adults and children to treat the following infections:

•    severe ear, nose and throat infections

•    respiratory tract infections

•    urinary tract infections

•    skin and soft tissue infections including dental infections

•    bone and joint infections

•    intra-abdominal infections

•    genital organ infections in women.

Co-amoxiclav is also used in adults and children to prevent infections associated with major surgical procedures.

You should not be given Co-amoxiclav:

•    if you are allergic (hypersensitive) to amoxicillin, clavulanic acid or penicillin

•    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 neck

•    if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

You should not be given Co-amoxiclav if any of the above apply to you.

If you are not sure, talk to your doctor, pharmacist or nurse before you are given Co-amoxiclav.

Warning and precaution

Talk to your doctor, pharmacist or nurse before you are given 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 apply to you, talk to your doctor, pharmacist or nurse before you are given 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.

Conditions you need to look out for

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.

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

Other medicines and Co-amoxiclav

Tell your doctor, pharmacist or nurse if you are using or have recently used or might use any other medicines. This includes medicines that can be bought without a prescription and also herbal medicines.

If you are taking allopurinol (for gout) with Co-amoxiclav, it may be more likely that you'll have an allergic skin reaction.

If you are taking probenecid (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 works (methotrexate is a medicine used to treat cancer or rheumatic diseases).

Your doctor will want to monitor you more closely during and after treatment with Co-amoxiclav if you are also taking mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.

Important information about some of the ingredients of Co-amoxiclav

Co-amoxiclav 500 mg/100 mg contains approximately 31.5 mg (1.4 mmol) of sodium and Co-amoxiclav 1000 mg/200 mg contains approximately 62.9 mg (2.7 mmol) of sodium. This should be considered if you are on a controlled sodium diet.

Co-amoxiclav 500 mg/100 mg contains approximately 19.6 mg (0.5 mmol) of potassium and Co-amoxiclav 1000 mg/200 mg contains approximately 39.3 mg (1.0 mmol) of potassium. This should be considered by patients with kidney problems or patients on a controlled potassium diet.

You will never give yourself this medicine. A qualified person, like a doctor or a nurse, will give you this medicine.

The recommended doses are:

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INFORMA TION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended for medical or healthcare professionals only. Please refer to the Summary of Product Characteristics for further information.

A transient pink colouration may or may not develop during reconstitution. Reconstituted solutions are normally colourless or a pale straw colour. Administer by i.v. injection within 20 minutes of reconstitution.

Dilution for infusion:

The reconstituted solution should be added without delay to either 50 ml (Co-amoxiclav 500/100mg) or 100ml (Co-amoxiclav 1000/200mg) of infusion fluid using a minibag or in-line burette.

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used, immediately, in-use storage times and conditions are the responsibility of the user.

Children weighing less than 40kg

All doses are worked out depending on the child's bodyweight in kilograms.

Patients with kidney and liver problems

•    If you have kidney problems you may be given a different dose A different strength or a different medicine may be chosen by your doctor

•    If you have liver problems your doctor will keep a close check on you and you may have more regular liver function tests

How Co-amoxiclav will be given to you

•    Co-amoxiclav will be given as an injection into a vein or by intravenous infusion

•    Make sure you drink plenty of fluids while being treated with Co-amoxiclav

•    You will not normally be given Co-amoxiclav for longer than 2 weeks without the doctor reviewing your treatment

If more Co-amoxiclav is given to you than recommended

It is unlikely you will be given too much but if you think you have been given

too much Co-amoxiclav, tell your doctor, pharmacist or nurse immediately.

Signs may be an upset stomach (feeling sick, being sick or diarrhoea) or

convulsions (fits).

If you have any further questions about how this medicine is given, ask your

doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects listed below may occur with this medicine.

Conditions you need to look out for

Allergic reactions:

•    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 mouth (angioedema), causing difficulty in breathing

•    collapse.

Contact a doctor immediately if you get any of these symptoms. Stop taking Co-amoxiclav.

Inflammation of large intestine

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

Contact your doctor as soon as possible for advice if you get these symptoms.

Common side effects (these may affect up to 1 in 10 people)

•    thrush (candida - a yeast infection of the vagina, mouth or skin folds)

•    diarrhoea

Uncommon side effects (these may affect up to 1 in 100 people)

•    skin rash, itching

•    raised itchy rash (hives)

•    feeling sick (nausea), especially when taking high doses, if affected take Co-amoxiclav before food

•    vomiting

•    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

•    swelling and redness along a vein which is extremely tender when touched

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

Other side effects

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

•    Allergic reactions (see above)

•    Inflammation of the large intestine (see above)

•    Inflammation of the protective membrane surrounding the brain (aseptic meningitis). Symptoms may include fever, nausea, vomiting, headache, stiff neck, rash and extreme sensitivity to light

•    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).

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

•    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

•    convulsions (in people taking high doses of Co-amoxiclav or who have kidney problems).

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

Reporting of side effects

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 at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

Co-amoxiclav is for use in hospital only and the expiry date and storage instructions stated on the label are for the doctor, nurse or pharmacist's information. The doctor, pharmacist or nurse will make up your medicine. It should be used within 20 minutes of reconstitution.

Do not store above 25°C.

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 after "EXP”. The expiry date refers to the last day of that month.

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 to protect the environment.

What Co-amoxiclav contains:

The active substances are amoxicillin and clavulanic acid.

Co-amoxiclav 1000mg/200mg: Each vial contains 1000mg amoxicillin (as amoxicillin sodium) and 200mg clavulanic acid (as clavulanate potassium). Co-amoxiclav 500mg/100mg: Each vial contains 500mg amoxicillin (as amoxicillin sodium) and 100mg clavulanic acid (as clavulanate potassium). The vials contain no other ingredients.

What Co-amoxiclav looks like and contents of the pack:

Co-amoxiclav is a white powder in a glass vial.

Each carton contains 1,5, 10, 20 or 50 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Ibigen S.r.l. Via Fossignano, 2 - Aprilia (LT), Italy.

Manufacturer:

Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. Via di Fossignano, 2 -Aprilia (LT), Italy.

This leaflet was last revised in 03/2016

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Dosage

Adults and children > 40 kg

For treatment of infections: Co-amoxiclav 1000/200 mg every 8 hours.

For surgical prophylaxis: For procedures less than 1 hour in duration, the recommended dose of Co-amoxiclav is 1000/200mg to 2000/200 mg given at induction of anaesthesia. (Doses of 2000/200mg can be achieved by using an alternative intravenous formulation of Co-amoxiclav). For procedures greater than 1 hour in duration, the recommended dose is 1000/200 mg to 2000/200mg given at induction of anaesthesia, with up to 3 doses of 1000/200 mg in 24 hours. Clear clinical signs of infection at operation will require a normal course of intravenous or oral therapy post-operatively.

Children < 40 kg

Children aged 3 months and over: 25 mg/5 mg per kg every 8 hours Children aged less than 3 months or weighing less than 4 kg: 25 mg/5 mg per kg every 12 hours.

Elderly: No dose adjustment is considered necessary.

800633/06

Hepatic impairment: Dose with caution and monitor hepatic function at regular intervals.