PACKAGE LEAFLET: INFORMATION FOR THE USER

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Co-amoxiclav 500/100 mg Powder for Solution for Injection/Infusion

Amoxicillin/Clavulanic Acid    A SANDOZ

Read all of this leaflet carefully before you start taking this

medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Co-amoxiclav is and what it is used for

2.    Before you are given Co-amoxiclav

3.    How to take Co-amoxiclav

4.    Possible side effects

5.    How to store Co-amoxiclav

6.    Further information

1. What Co-amoxiclav is and what it is used for

Co-amoxiclav is an antibiotic. It belongs to a group of antibiotics called penicillins. It is used to treat infections caused by certain bacteria which are sensitive to the combination of amoxicillin/clavulanic acid.

Co-amoxiclav is used to treat infections of

•    the skin and layers just underneath the skin

•    the respiratory system

•    the kidneys and urinary tract

•    the abdomen

•    genital organs

•    general infections like blood poisoning

2. Before you are given Co-amoxiclav

You should not be given Co-amoxiclav if:

•    you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, cephalosporins or any of the other ingredients of this medicine (See Further information in Section 6).

•    you have severe liver disease or ever had any liver disease caused by amoxicillin/clavulanic acid.

•    you have glandular fever (a viral infection) or leukaemia: you may have a higher risk of skin reactions.

Take special care with Co-amoxiclav:

Tell your doctor before taking Co-amoxiclav if you have, or have ever

had:

•    Liver disease or if you are aged above 60 years: your doctor may have to ask you for a blood sample to monitor your liver function.

•    Kidney disease: your doctor may have to adjust the dose.

•    Severe allergies or asthma: you may have a higher risk of allergic reactions.

•    A bladder catheter: if so, drink plenty of liquid to prevent crystals forming in your urine.

•    Diarrhoea that is serious, lasts a long time or has blood in it.

This medicine can also alter the results of urine tests for sugar. If you

have diabetes and routinely test your urine, tell your doctor.This is

because other tests may have to be used.

Taking other medicines:

Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without prescription. Some medicines can cause problems if you take them with Co-amoxiclav.

Take care with the following medicines:

•    Antibiotics such as macrolides, tetracyclines, chloramphenicol, suphonamides: the effect of Co-amoxiclav may be reduced.

•    Probenecid (used to treat gout): the levels of amoxicillin may be increased in your blood and bile.

•    Allopurinol (used to treat gout): you may have a higher risk of skin reactions.

•    Methotreaxate (used to treat arthritis): the toxicity of methotrexate may be increased.

•    Digoxin (used to treat certain heart disease): the absorption of digoxin may be increased.

•    Anticoagulants (to prevent blood clotting) such as cumarine: the tendency to bleed may be increased.

•    Contraceptive pills: there is a risk of contraceptive pills not working at their greatest effect.

•    Disulfiram (used to treat alcoholism) should not be used together with Co-amoxiclav.

This medicine can also alter the results of urine tests for sufar. If you have diabetes and routinely test your urine, tell your doctor.This is because other tests may have to be used.

Pregnancy and breast-feeding:

Data on a limited number of exposed pregnancies show no adverse effects of amoxicillin/clavulanic acid on pregnancy or on the health of the foetus or newborn child. It is possible that this medicine may increase the risk of a serious inflammation of the intestine in the newborn. As a precautionary measure, amoxicillin/clavulanic acid should only be given during pregnancy if, in the judgement of the doctor, the potential benefits outweigh the possible hazards.

This medicine passes into breast milk in small quantities, therefore in some cases it may be necessary to stop breast-feeding.

Driving and using machines:

Co-amoxiclav may sometimes have side effects such as mental confusion, rarely dizziness and even less often, convulsions that may impair the ability to drive a vehicle, to operate machines and/or to work safely.

Important information about some of the ingredients of this medicine

Co-amoxiclav contains 1.7 mmol sodium per vial. Take this into consideration if you are on controlled sodium diet.

Co-amoxiclav contains 0.5 mmol potassium per vial. Take this into consideration if you have kidney problems or are on a controlled potassium diet.

3. How to take Co-amoxiclav

Co-amoxiclav is administered by means of slow intravenous injection or infusion. It will be given to you by a doctor or nurse.

Dosage:

The usual total daily dose of Co-amoxiclav depend on the indication, your age, weight and the severity of the infection and on how well your liver and kidneys are working. The dose will be worked out by your doctor.

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The following information is intended for medical or healthcare professionals only:    ^sz00000lt°⁰⁰

Co-amoxiclav 500/100 mg Powder for Solution for Injection/Infusion Amoxicillin/Clavulanic Acid

This is an extract from the Summary of Product Characteristics (SmPC) to assist in the administration of Co-amoxiclav. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the SmPC.

INCOMPATIBILITIESWITH DILUENTS AND OTHER MEDICINAL PRODUCTS

Co-amoxiclav 500/100 mg Powder for Solution for Injection/Infusion must not be mixed with amino acid solutions, lipid emulsions, blood and glucose solutions.

Co-amoxiclav 500/100 mg Powder for Solution for Injection/Infusion is less stable in infusions containing dextran or bicarbonate. Reconstituted solution should therefore, not be added to such infusions but may be injected into the drip tubing over a period of three to four minutes.

Because of the inactivation of aminoglycosides by amoxicillin, in-vitro mixing should be avoided.

Cloudiness can occur in individual cases when mixed with a lidocaine solution. It is then recommended that the solution should be discarded.

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL

The reconstitution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter prior to administration. The solution should only be used if the solution is clear and free from particles. Any unused solution should be discarded. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the injection and infusion solutions should be use immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

New born infants

The usual dose is 50/5 mg/kg every 8 hours.

Children between 3 months and 12 years of age

The usual dose is 25/2.5 mg/kg every 6 hours.

The usual dose for serious infections is 50/5 mg/kg every 6 hours.

Duration of treatment:

Your doctor will tell you how long you will need to keep taking your medicine.Treatment should not last for more than 14 days without a control by your doctor.

People with liver disease

Your doctor may have to ask you for a blood sample to check how well your liver is working.

People with kidney disease

Your doctor may have to lower the dose.

If you think the effect of Co-amoxiclav is too strong or too weak, talk to your doctor.

If you are given more Co-amoxiclav than you should:

If you are given too much of this medicine (overdose), the most likely signs are nausea, vomiting, diarrhoea, abdominal pain, convulsions (fits).

If you stop taking Co-amoxiclav:

Always keep taking this medicine until the course is finished, even if you feel better. If you stop taking this medicine too soon, the infection may come back. Also, the bacteria may become resistant to the medicine.

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

Following side effects are rare (affect less than 1 out of 1,000 people):

•    Increase in blood platelets (thrombocytotis), abnormal breakdown of red blood cells (haemolytic anaemia)

•    Yeast infections (intestinal candidiasis)

•    Itching, nettle rash, inflammation of blood vessels

•    Drug fever

•    Inflammation of the liver and jaundice. Signs usually appear during or soon after treatment, but in some cases they only appear some weeks after treatment has been stopped.

•    Dizziness, headache, convulsion

•    Moderate rise in liver enzymes

Following side effects are very rare (affects less than 1 out of 10,000

people):

•    Changes in blood count (decrease of red or white blood cells and of platelets), prolongation of bleeding time. These may cause symptoms such as fever, a sore throat, rash, nose bleeds or bruising. These symptoms are reversible after stopping the treatment.

•    Discolouration of the tongue (so called black tongue)

•    Hyperactivity, anxiety, sleeplessness, mental confusion, aggression

•    Liver reactions have been seen very rarely in children. The risk increases when the duration of treatment is longer than 14 days.

•    Inflammation of the kidneys (intestinal nephritis), crystals in the urine (crystalluria)

If any of the side effects gets serious, or if you notice any side effects

not listed in this leaflet, please tell the doctor.

5. How to store Co-amoxiclav

4. Possible side effects

Like all medicines, Co-amoxiclav can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, talk to your doctor immediately or go to a hospital straight away:

Following serious side effects are rare (affect less than 1 out of 1,000 people):

•    Sudden difficulty in breathing, speaking and swallowing

•    Painful swelling of the lips, tongue, face or neck

•    Extreme dizziness or collapse

•    Severe or itchy skin rashes, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs

•    Diarrhoea that is serious, lasts a long time or has blood in it: This can be a sign of serious bowel inflammation.

Following serious side effects are very rare (affect less than 1 out of 10,000 people):

•    Yellowing of the skin or whites of the eyes, or urine getting darker and stools paler: This is a sign of liver problems.

Other possible side effects during treatment:

Following side effects are common (affect less than 1 out of 10 people):

•    Nausea, vomiting, diarrhoea or soft stools. These effects are mostly mild and disappear during treatment or very soon after completion of therapy.

•    “Fifth day” skin rash, which resembles measles

Following side effects are uncommon (affect less that 1 out of 100 people):

•    Inflammation of the vein (thrombophlebitis) at the site of injection

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Do not use the medicine after the expiry date.

Do not store above 25°C.

Keep the container in the outer carton.

For storage conditions of the reconstituted, diluted medicinal product, see the area of the package leaflet headed ‘The following information is intended for medicinal or healthcare professionals only'.

You should not throw away any medicine through wastewater or household waste. Ask your pharmacist how to dispose of medicines that you no longer need. This will help to protect the environment.

6. Further information

What Co-amoxiclav contains

•    Each vial contains 500 mg amoxicillin (as the sodium salt) and 100 mg clavulanic acid (as the potassium salt).

•    The active substance is amoxicillin.

What Co-amoxiclav looks like and contents of the pack

20 ml vials of colourless glass type II with halogenated butyl rubber stopper and flip-off aluminium cap.

Pack sizes of 1,5, 10, 20, 30, 50 and 100 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. Manufacturer:

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria.

This leaflet was last approved in 11/2010 (tba) SZ00000LT000

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For single use only.

Preparation of intravenous injections:

Vials of 500/100 mg are diluted with 10 ml or up to 20 ml of water for injections.

* data based on laboratory studies

Vials of 500/100 mg are diluted with 25 ml or up to 50 ml of water for injections or with the following fluids: Physiological saline, Sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.

If the product is dissolved in water for injections as specified, this solution may be mixed with the following solvents: Water for injections, Physiological saline, Sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.

Solutions for intravenous infusion should be administered in full within 60 minutes of preparation.

After dissolution in water for injection, a transient pink colour may occur; the solution will become clear again rapidly afterwards.

Preparation of intravenous infusions:

The reconstitution of the ready to use solution for infusion has to take place in two steps in order to allow the reconstitution of the necessary volume for solution for infusion:

The vial of 500/100 mg is first reconstituted with one of the compatible intravenous fluids in its vial. This solution has then to be transferred into a suitable infusion bag which should contain the same compatible fluid as used for reconstitution. Controlled and validated aseptic conditions have to be observed.

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