CPCMX.JNT.SuSFSN.V2P1

Package leaflet: Information for the user

CO-AMOXICLAV 125/31.25mg/5ml AND 250/62.5mg/5ml POWDER FOR ORAL SUSPENSION

(Amoxicillin and Clavulanic acid)

Read all of this leaflet carefully before you start giving your child 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 is usually prescribed for a baby or child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's.

•    If any of the side effects get 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 Oral Suspension is and what it is used for

2.    Before you give Co-amoxiclav Oral Suspension

3.    How to give Co-amoxiclav Oral Suspension

4.    Possible side effects

5.    How to store Co-amoxiclav Oral Suspension

6.    Further Information

The name of your child's medicine is either Co-amoxiclav 125/31.25 mg/5 ml Powder for Oral Suspension or Co-amoxiclav 250/62.5 mg/5 ml Powder for Oral Suspension. It will be referred to as Co-amoxiclav Oral Suspension throughout this leaflet, as you will receive it in the form of an oral suspension from your doctor or pharmacist (please see section 3 for further information).

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 Oral Suspension is used in babies and children to treat the following infections:

•    middle ear and sinus infections

•    respiratory tract infections

•    urinary tract infections

•    skin and soft tissue infections including dental infections

•    bone and joint infections.

can affect the results of these types of tests.

Using other medicines

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines. This includes medicines that can be bought without a prescription and herbal medicines.

If your child is taking allopurinol (used for gout) with Co-amoxiclav Oral Suspension, it may be more likely that they will have an allergic skin reaction.

If your child is taking probenecid (used for gout), your doctor may decide to adjust the dose of Co-amoxiclav Oral Suspension.

If medicines to help stop blood clots (such as warfarin) are taken with Co-amoxiclav Oral Suspension then extra blood tests may be needed.

Co-amoxiclav Oral Suspension can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

Co-amoxiclav Oral Suspension may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

Pregnancy and breast-feeding

How to give Co-amoxiclav Oral Suspension

•    Always shake the bottle well before each dose

•    The measuring spoon provided is marked to show doses of 1.25 ml, 2.5 ml and 5 ml. If you are using the measuring spoon, take care to ensure it is filled to the correct dosage marking.

-    To measure 1.25 ml of suspension, carefully tilt the spoon and fill up to the dosing line marked 1.25 ml.

-    To measure 2.5 ml of suspension, keep the spoon level and fill up to the dosing line marked 2.5 ml.

-    To measure 5 ml of suspension, keep the spoon level and fill up to the brim.

Ask your doctor or pharmacist if you are unsure.

•    Give at the start of a meal or slightly before

•    Space the doses evenly during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.

•    Do not give your child Co-amoxiclav Oral Suspension for more than 2 weeks. If your child still feels unwell they should go back to see the doctor.

If you give more Co-amoxiclav Oral Suspension than you should

If you give your child too much Co-amoxiclav Oral Suspension, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to their doctor as soon as possible. Take the medicine bottle to show the doctor.

If you forget to give Co-amoxiclav Oral Suspension

If you forget to give your child a dose, give it as soon as you remember. You should not give your child the next dose too soon, but wait about 4 hours before giving the next dose.

If your child stops taking Co-amoxiclav Oral Suspension

Keep giving your child Co-amoxiclav Oral Suspension until the treatment is finished, even if they feel better. Your child needs every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.

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

Like all medicines, Co-amoxiclav Oral Suspension can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.

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)

•    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 your child gets 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 child's 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

•    stained teeth (in children), usually removed by brushing.

Side effects that may show up in 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 your child gets 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 (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

Conditions you need to look out for

Do not give your child Co-amoxiclav Oral Suspension if:

•    if they are allergic (hypersensitive) to amoxicillin and clavulanic acid, or any of the other ingredients of Co-amoxiclav Oral Suspension (listed in section 6).

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

Do not give Co-amoxiclav Oral Suspension to your child if any of the above apply to your child. If you are not sure, talk to their doctor or pharmacist before giving Co-amoxiclav Oral Suspension.

Take special care with Co-amoxiclav Oral Suspension

Check with their doctor or pharmacist before giving your child this medicine if they:

•    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 your child, talk to their doctor or pharmacist before giving Co-amoxiclav Oral Suspension.

In some cases, your doctor may investigate the type of bacteria that is causing your child's infection. Depending on the results, your child may be given a different strength of Co-amoxiclav or a different medicine.

Conditions you need to look out for

Co-amoxiclav Oral Suspension 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 your child is taking Co-amoxiclav Oral Suspension, to reduce the risk of any problems. See ‘Conditions you need to look out for in Section 4.

Blood or urine tests

If your child is 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 they are taking Co-amoxiclav Oral Suspension. This is because Co-amoxiclav Oral Suspension

Important information about some of the ingredients of Co-amoxiclav Oral Suspension

Co-amoxiclav Oral Suspension contains aspartame (E951) which is a source of phenylalanine. This may be harmful for children born with a condition called 'phenylketonuria'.

This product is supplied to your doctor or pharmacist as a powder. He/she will use this powder to form an oral suspension which will be provided to you for use. If you have any questions please check with your doctor or pharmacist.

Always give Co-amoxiclav Oral Suspension exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and children weighing 40 kg or over • This suspension is not usually recommended for adults and children weighing 40 kg and over.

Ask your doctor or pharmacist for advice.

Children weighing less than 40 kg

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

Your doctor will advise you how much Co-amoxiclav Oral Suspension you should give to your baby or child.

You may be provided with a plastic measuring spoon. You should use this to give the correct dose to your baby or child (see ‘How to give Co-amoxiclav Oral Suspension' for further information).

Usual dose - 20 mg/5 mg to 60 mg/15 mg for each kilogram of body weight a day, given in three divided doses.

Patients with kidney and liver problems

If your child has kidney problems the dose might be lowered. A different strength or a different medicine may be chosen by your doctor.

If your child has liver problems they may have more frequent blood tests to see how their liver is working.

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 your child gets any of these symptoms. Stop taking Co-amoxiclav Oral Suspension.

Inflammation of large intestine

Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever. Contact your doctor as soon as possible for advice if your child gets 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 Oral Suspension before food

•    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 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.

Keep out of the reach and sight of children.

Store at 2-8°C. Do not freeze. Keep container tightly closed.

Do not use Co-Amoxiclav Oral Suspension after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.

After reconstitution to form an oral suspension, this medicine should only be used for up to 7 days from the dispensing date stated on the label.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Co-amoxiclav Oral Suspension contains:

Co-amoxiclav Oral Suspension is available in two strengths (125/31.25mg/5ml and 250/62.5mg/5ml).

The active ingredients are amoxicillin 125mg and clavulanic acid 31.25mg per 5ml or amoxicillin 250mg and clavulanic acid 62.5mg per 5ml. This combination of antibiotics is also known as Co-amoxiclav.

Co-amoxiclav Oral Suspension also contains: anhydrous citric acid, trisodium citrate, aspartame, talc, guar galactomannan, colloidal silicon dioxide, flavouring agents (lemon, peach-apricot and orange containing essence of bergamot).

What Co-amoxiclav Powder for Oral Suspension looks like and contents of the pack:

Co-amoxiclav Powder for Oral Suspension comes in a bottle containing 100ml of suspension. Co-amoxiclav Oral Suspension is off-white in colour with a fruity flavour.

Marketing Authorisation Holder and Manufacturer

Product Licence Holder:

Sandoz Ltd, Frimley Business Park, Frimley, Camberley,

Surrey, GU16 7SR, UK.

Manufacturer:

Sandoz GmbH, A-6250 Kundl, Tyrol, Austria.

Distributed by:

Kent Pharmaceuticals Limited, Repton Road, Measham,

DE12 7DT, U.K.

This leaflet was last revised in 04/2014

CP.CMX.JNT.SuSF.SN.V2P1

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