Co-Amoxiclav 250mg/ 62.5mg/ 5ml Powder For Oral Suspension
- 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.
Sideffects 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 anemia)
• crystals in urine
If your child gets side effects
Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.
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. FURTHER 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 1 00 ml of an off-white liquid mixture called a suspension.
Pack size is a bottle containing 1 00 ml
PL No.: 21880/0010 |POMl
Date of leaflet preparation: December 2012 MA Holder:
Mmedreich plc
Warwick House, Plane Tree Crescent, Feltham TW1 3 7HF, UK E-mail : info@medreich.co.uk
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PACKAGE LEAFLET - INFORMATION FOR THE USER
Co-Amoxidav 250mg/62.5mg/5ml Powder for Oral Suspension Amoxicillin and Clavulanic Acid
Read all of this leaflet carefully before giving your child this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask you 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.
In this leaflet
1. What Co-Amoxidav 250mg/62.5mg/5ml Oral Suspension is and what it is used for
2. 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. Further 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. BEFORE YOU GIVE CO-AMOXICLAV 250mg/62.5mg/5ml ORAL SUSPENSION
Do not give your child Co-Amoxidav 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-Amoxidav 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.
Take special care with Co-Amoxiclav 250mg/62.5mg/5ml 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.
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.
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, 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 can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Pregnancy and breast-feeding
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.
Important information about some of the ingredients of Co-Amoxiclav 250mg/62.5mg/5ml Oral Suspension
• 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/1 5 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.
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If you forget to give Co-Amoxidav 250mg/62.5mg/5ml Oral Suspension
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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 effects
These may affect more than 1 in 1 0 people
• diarrhoea (in adults).
Common side effects
These may affect up to 1 in 1 0 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 before food
• vomiting
• diarrhoea (in children).
Uncommon side effects
These may affect up to 1 in 1 0 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 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 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)
• Serious skin reactions:
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