CO-AMOXICLAV 250 MG / 62.5 MG / 5ML POWDER FOR ORAL SUSPENSION - patient leaflet, side effects, dosage

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 by searching MHRA Yellow Card on Google Play or Apple App Store.

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

5. how to store co-amoxiclav 250mg/62.5mg/5ml oral suspension

Keep out of sight and reach of children.

Do not use Co-Amoxiclav after the expiry date which is stated on the carton.

The expiry date refers to the last day of the month.

Powder for suspension: Do not store above 25°C. Keep the bottle tightly closed.

Reconstituted suspension: Store in refrigerator at 2–8°C. Do not freeze.

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.

6. contents of the pack and other information

What Co-Amoxiclav Oral Suspension contains

• The active substances are amoxicillin 250mg and clavulanic acid 62.5 mg (present as Potassium Clavunate) in every 5 ml of suspension. Both of these ingredients are antibiotics and together they are known as co-amoxiclav.
• The other ingredients are: xanthan gum (E415), aspartame (E951), silicon dioxide (E551), colloidal silica, anhydrous citric acid, hypromellose, golden syrup, orange and raspberry flavours.

What Co-Amoxiclav Oral Suspension looks like and the contents of the pack

• When the powder has been reconstituted, Co-amoxiclov Oral suspension contains 250 mg of amoxicillin (as trihydrate) and 62.5 mg clavulanic acid (as potassium salt), per 5 ml.
• Co-Amoxiclav Oral Suspension comes in a bottle containing 100 ml of an off-white liquid mixture called a suspension.

Pack size is a bottle containing 100 ml

Date of leaflet preparation: June 2018 |POM|

MA Holder:

M medreich PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF UK

E-mail :

To listen to or request a copy of this leaflet in Braille, large print or audio please call, 02088311580 (UK only)

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Product name CO-AMOXICLAV 250mg/

62.5mg/5ml Oral Suspension

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PACKAGE LEAFLET – INFORMATION FOR THE USER Co-Amoxiclav 250mg/62.5mg/5ml Powder for Oral Suspension Amoxicillin and Clavulanic Acid

Read all of this leaflet carefully before giving your child this medicine because it contains important information for them.

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

What is in this leaflet

1. What Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension is and what it is used for

2. What you need to know before you give Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension

• 3. How to give Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension

4. Possible side effects

5. How to store Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension

6. Contents of the pack and other information

1. what co-amoxiclav 250mg/62.5mg/5ml oral suspension is and what it is used for

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 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.

2. what you need to know before you give co-amoxiclav 250mg/62.5mg/5ml oral suspension

Do not give your child Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension:

• if they are allergic (hypersensitive) to amoxicillin, clavulanic acid or any of the other ingredients of Co-Amoxiclav (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 250mg/62.5mg/5ml 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. Warnings and precautions

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.

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 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, 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, let the doctor or nurse know that they are

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

Other medicines and Co-Amoxiclav

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, 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.
• If medicines to help stop blood clots (such as warfarin) are taken with Co-Amoxiclav then extra blood tests may be needed.
• Co-amoxiclav oral suspension should not be combined with bacteriostatic chemotherapeu­tics/antibiotics (such as tetracyclines, macrolides, sulphonamides or chloramphenicol) since an antagonistic effect has been observed in vitro.
• Co-Amoxiclav can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
• Aminopenicillin may reduce the plasmatic concentration of sufasalasin.
• An increase in absorption of digoxin is possible on concurrent administration with Co-amoxiclav oral suspension.
• Co-amoxiclav oral suspension cannot be used concomitantly with disulfiram.
• In rare cases amoxicillin can adversely affect the efficacy of hormonal contraceptives. Supplementary non-hormonal contraceptive measures should be taken.
• Co-Amoxiclav can affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

Pregnancy, breast-feeding and fertility

If you are pregnant, you think you might be pregnant or if you are breast-feeding, please tell your doctor or pharmacist.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Co-Amoxiclav Oral Suspension can have side effects and the symptoms may make you unfit to drive.

Do not drive or operate machinery unless you are feeling well.

• Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension contains aspartame Co-Amoxiclav contains aspartame (E951) which is a source of phenylalanine.

This may be harmful for children born with a condition called ’phenylketonuria’.

• 3. HOW TO GIVE CO-AMOXICLAV 250mg/62.5mg/5ml ORAL SUSPENSION

Always give Co-Amoxiclav 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 you should give to your baby or child.
• You may be provided with a plastic measuring spoon or measuring cup.You should use this to give the correct dose to your baby or child.
• 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.

How to give Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension

• Always shake the bottle well before each dose
• 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 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 250mg/62.5mg/5ml Oral Suspension than you should

If you give your child too much Co-Amoxiclav, 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 250mg/62.5mg/5ml 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 250mg/62.5mg/5ml Oral Suspension Keep giving your child Co-Amoxiclav 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.

4. possible side effects

Like all medicines, Co-Amoxiclav can cause side effects, although not everybody gets them. The side effects below may happen 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 your child gets any of these symptoms.

Stop taking Co-Amoxiclav 250mg/62.5mg/5ml 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 effect (may affect more than 1 in 10 people)

• diarrhoea (in adults).

Common side effects (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).
• mucocutaneous candidosis

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

• skin rash, itching raised itchy rash (hives)
• indigestion dizziness
• headache rises in AST and/or ALT5
• pruritus urticaria

Uncommon side effects that may show up in blood tests:

• increase in some substances (enzymes) produced by the liver

Rare side effects (may affect up to 1 in 1000 people)

• reversible leucopenia (including neutropenia)
• thrombocytopenia erythema multiforme
• 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 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: