Co-Amoxiclav 500mg/125mg Film-Coated Tablets
NOUMED LIFE SCIENCES 5 Cattle Market, Hexham, Northumberland NE46 1NJ, United Kingdom
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• stained teeth (in children), usually removed by brushing.
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.
5. How to Store Co-amoxiclav 500 mg/125 mg Tablets
Do not take the tablets after the expiry date printed on the pack. The expiry date refers tothe last day of the month
Store in original package.
Keep all medicines out of the reach and sight of children.
If your doctor tells you to stop taking this medicine, or for any reason you have some tablets left over, please return them to your pharmacist.
Once a full pouch has been opened, use enclosed tablets within 30 days.
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 500 mg/125 mg Tablets contain
Co-amoxiclav 500 mg/125 mg Tablets contain 575.0 mg amoxicillin trihydrate equivalent to 500 mg amoxicillin and 148.875 mg potassium clavulanate equivalent to125 mg clavulanic acid. Both of these ingredients are antibiotics and together they are known as Co-amoxiclav.
Tablet core:- microcrystalline cellulose, croscarmellose sodium, purified talc, magnesiumstearate
Tablet coating:- Opaspray KI-7000, hypromellose, ethylcellulose, propylene glycol.
What Co-amoxiclav 500 mg/125 mg Tablets look like and contents of the pack.
Co-amoxiclav 500 mg/125 mg Tablets are white, oval shaped film-coated tablets with CA625 on one face which are supplied in foil pouches in packs of 21 tablets.
This leaflet was last revised on September 2014
Marketing Authorization Holder:
Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
Co-amoxiclav 500 mg/125 mg film-coated Tablets -PL 44041/0006
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Co-amoxiclav 500mg/125mg film-coated Tablets
Amoxicillin and Clavulanic Acid
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 further questions, please ask your doctor or your 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 get serious of if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Co-amoxiclav 500 mg/125 mg Tablets are and what they are used for
2. Before you take Co-amoxiclav 500 mg/125 mg Tablets
3. How to take Co-amoxiclav 500 mg/125 mg Tablets
4. Possible side effects
5. How to store Co-amoxiclav 500 mg/125 mg Tablets
6. Further information.
1. What Co-amoxiclav 500 mg/125 mg Tablets are and what they are used for?
Co-amoxiclav is an antibiotic and works by killing bacteria that cause infections. It belongs to a group of antibiotics called 'penicillins'. 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:
• 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 take Co-amoxiclav 500 mg/125 mg Tablets
Do not take Co-amoxiclav 500 mg/125 mg Tablets
• If you are allergic (hypersensitive) to amoxicillin or clavulanic acid or any of the ingredients of this product (listed in section 6).
• 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.
Do not take Co-amoxiclav if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before taking Co-amoxiclav 500 mg/125 mg Tablets.
Take special care with Co-amoxiclav 500 mg/125 mg Tablets
Talk to your doctor or pharmacist before taking 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 or pharmacist before taking Co-amoxiclav 500 mg/125 mg Tablets.
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 500 mg/125 mg Tablets or a different medicine.
Conditions you need to look out for Co-amoxiclav 500 mg/125 mg Tablets 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 500 mg/125 mg Tablets, 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 500 mg/125 mg Tablets. This is because Augmentin can affect the results of these types of tests.
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Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used any other medicines. This includes medicines that can be bought without a prescription and herbal medicines.
If you are taking allopurinol (used for gout) with Co-amoxiclav 500 mg/ 125 mg Tablets, it may be more likely that you'll have an allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Co-amoxiclav 500 mg/125 mg Tablets.
If medicines to help stop blood clots (such as warfarin) are taken with Co-amoxiclav 500 mg/125 mg Tablets then extra blood tests may be needed.
Co-amoxiclav 500 mg/125 mg Tablets can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Co-amoxiclav 500 mg/125 mg Tablets may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) 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. Driving and using machines
Co-amoxiclav 500 mg/125 mg Tablets can have side effects and the symptoms may make you unfit to drive.
Don't drive or operate machinery unless you are feeling well.
3. How to take Co-amoxiclav 500 mg/125 mg Tablets
Always take your tablets 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 and over
One Co-amoxiclav 500 mg/125 mg tablet to be taken three times a day. Children weighing less than 40 kg
Children aged 6 years or less should preferably be treated with Co-amoxiclav 500 mg/125 mg oral suspension or sachets.
Ask your doctor or pharmacist for advice when giving Co-amoxiclav 500 mg/125 mg Tablets to children weighing less than 40 kg.
Patients with kidney and liver problems
• If you have kidney problems the dose might be changed. A different strength or a different medicine may be chosen by your doctor.
• If you have liver problems you may have more frequent blood tests to check how your liver is working.
How to take Co-amoxiclav 500 mg/125 mg Tablets
• Swallow the tablets whole with a glass of water 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 take Co-amoxiclav 500 mg/125 mg Tablets for more than 2 weeks. If you still feel unwell you should go back to see the doctor.
If you take more Co-amoxiclav 500 mg/125 mg Tablets than you should
If you take too much Augmentin, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to your doctor as soon as possible. Take the medicine carton or bottle to show the doctor.
If you forget to take Co-amoxiclav 500 mg/125 mg Tablets
If you forget to take a dose, take it as soon as you remember. You should not take the next dose too soon, but wait about 4 hours before taking the next dose.
If you stop taking Co-amoxiclav 500 mg/125 mg Tablets
Keep taking Augmentin until the treatment is finished, even if you feel better. You need 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 500 mg/125 mg Tablets can cause side effects, although not everyone gets them.
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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 500 mg/125 mg Tablets.
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 you get 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 take Augmentin before food
^ if affected take Co-amoxiclav before food
• vomiting
• diarrhoea (in children)
Uncommon side effects
• skin rash, itching
• raised itchy rash (hives)
• 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.
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)
• 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 epidermalnecrolysis)
- widespread red skin rash with small pus-containing blisters (bullous exfoliativedermatitis)
- a red, scaly rash with bumps under the skin and blisters (exanthemouspusfu/os/s)
^ 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
• hyperactivity
• convulsions (in people taking high doses of Augmentin or who have kidney problems)
• black tongue which looks hairy
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