Co-Amoxiclav 875mg/125mg Film-Coated Tablets
Contents of the pack and other information
What Co-amoxiclav Tablets contains:
- The active substances are Amoxicillin Trihydrate and Potassium Clavulanate., Diluted
Each film-coated tablet contains 875mg amoxicillin as amoxicillin trihydrate and 125mg of davulanic acid as potassium clavulanate, diluted.
- The other ingredientsare:
Cellulose, microcrystalline (E460)
Sodium starch glycolate, TypeA Silica, Colloidal anhydrous (E551)
Magnesium Stearate (E470b)
Film coat
Titaniurndioxide (E171)
Hypromellose(E464j
Macrogol
What Co-amoxiclav looks like and contents of the
White, capsule-shaped film-coated tablet, debossed with '107'ononeside and plain on theother.
The tablets are packaged in aluminium blister strips consisting of: 4, 5,6, 7,8,10,12,14,15,16,20,21, 25,30,35,40,50,100&500 tablets
Mot all pack sizes may be marketed Marketing Authorisation Holder and
Brown & Burk UK Ltd 5MarryatClose Hounslow West Middlesex TW4 5DQ UK
This medicinal product is authorised in the Member States of the EEA under the following
UK & IE: Co-amoxiclav 875mg/125mg Film-coated Tablets
SE: Amoxicillin/ Clavulanic acid BB 875mg/125mg filmd ragerade tabletter
This leafletwas last approved on 07/2014
BBUK Code
11 ■ I ■ 11 ■ ■ 11
Package leaflet: Information for the user Co-amoxiclav 875mg/125mg film-coated Tablets
(Amoxiciinn/ciavuianic acid)
Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou
- Keepthisleafiet. You may need to read itagain.
- If you have any further questions, ask your doctor or pharmacist.
- This med icine has been prescribed for you on ly. Do
their sig nsof illnessare the same as you rs.
- If you get any side effects, talk to your doctor or pharmacist. This includesany possibleside effects not listed in this leaflet Seesection4.
What is in this leaflet:
1. What Co-amoxiclav Tablet isand whatit is used for
2. What you need to know before you take Co-amoxiclav Tablets
3. How to take Co-amoxiclav Tablets
4. Possible side effects
5. How to store Co-amoxiclav tablets
6. Contentsofthe packandotherinformation
(hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling ofthe face
• if you have ever had Ifver problems or jaundice (yellowing ofthe skinjwhen taking an antibiotic.
Do not take Co-amoxiclav if any of the above applytoyou. If you are not sure, talk to your doctor or pharmacistbefore taking Co-amoxiclavTablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicineifyou:
• haveglandulatfever
• ate being treated for liver or kidney problems
• ate not passing water regularly.
If you ate notsure if any of the above apply to you, talk to your doctor or pharmacist before taking these
1. What Co-amoxiclav Tablets is andwhatitis usedfor
Co-amoxiclav is an antibiotic and works by killing bacteria that cause infections. Itcontainsbwodifferent medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins" that can sometimes be stopped from working (made inactfve). The other active component (clavulan icacioj stopstms from happen ing.
Co-amoxiclav is used in adults and children to treat the following infections:
• middleear and sinus infections
• respiratory tractinfecfions
• urinary tract infections
• skin and soft tissue infections including dental infections
• bone and jointinfecfions.
2. What you need to know before you take Co-amoxiclav Tab lets
Do not take Co-amoxiclav:
• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins or any of the other ingredients of Co-amoxiclav tablets (listed in section 6)
In some cases, your doctor may investigate the type of bacteria that is causing your infection. Depending on the results, you may be given adifferent strength of Co-amoxiclavoradifferent medicine.
Conditions you need to look outfor:
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 you are taking Co-amoxiclav, 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 Ifver function tests) or urine tests (for glucose), let the doctor or nurse know that you are taking Co-amoxiclav. This is because Co-amoxiclav can affect the results of these types of tests.
Other medicinesand Co-amoxiclav Tablets
Please tell your doctor or pharmacist if you are using or have recently used any other medicines. This includes medicines mat can oe oougnt without a
If you are taking allopurinol (used for gout) with Co-amoxidav, it may be more likely that you will have an allergicskin reaction.
If you ate taking probenecid (used for gout), your doctor may decide to adjust your dose of Co-amoxiclav.
If medicines to help stop blood clots (such as warfarin) are taken with Co-amoxiclav Tablets then extra blood tests may be needed.
• If you have kidney problems the dose might be changed. A different strength or a different med icme 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.
Howto take Co-amoxiclav 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 Donottake2dosesin 1 hour.
• Do not take Co-amoxiclav for more than 2weeks. If
you still feel ur
Id go ba
Co-amoxiclav can affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organ jworks.
This medicine contains 0.63 mmol (or 24.632 mg) potassium per tablet To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
:e too much Co-amoxiclav, 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 forgetto take Co-amoxiclav Tablets
If you are pregnant, you think you might be pregnant or if you ate breast-feeding, please tell your doctor or pharmacist
taking any medicine.
Driving and using machines
Co-amoxiclav can have side effects ; symptoms may make you u nfit todrive.
Dont drive or operate machinery unless feeling well.
If youstop taking Co-amoxiclav Tablets
Keep taking Co-amoxiciav until uie 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.
these symptoms. Stop taking Co-amoxiclav 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 sideeifects
These may affect morethanl inlOpeople
• diarrhoeajin adults).
Common side effects
These may affect uptol in 10people
• thrush [Candida - a yeast infection of the vagina, mouth or skin folds)
• feeling sick (nausea), especially when taking high
If affected take Co-amoxiclav before food
• vomiting.
• Diarrhoeajin children)
U ncommon side effects
• Infiammafionofthelarge intestinejseeabove)
• Serious skin reactions:
• awidespread 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 -
containing blisters (bulloous exfoliative dermatitis)
• a red, scaly rash with bumps under the skin and
• Inflammation of the protective membrane sor rund ing the brain (aseptic mening itis)
• inflammation of the liver (hepatitis)
bilirubin (a substance produced in the liver)which may make your skin and whites of eyes appear yellow
• mnammation of tubes in the kidney
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of Co-amoxiclavorwho have kidney problems)
• black tongue which looks hairy
Always take Co-amoxiclav Tablets exactly at doctor has told you. You should check witf doctor or pharmacist if you are not sure.
Adults and children weighing 40 kg and over
Conditions you need to look out for
Allergic reactions:
These may affect uptol in 100 people
• 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
Raresideeffects
These may affect uptol in 1000 people
targets (central dark spots surrounded by a paler area, with a dark ring around the edge-erythema multiforme)
Side effects that may show up in your blood or urine
• severe redu ction in the nu mber of wh ite blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in urine.
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, website www.mhra.gov.uk/yellowcard. By reporting
thesafetyof this medicine.
c
Howto store Co-amoxiclav Tablets
Keep this medicine out of the sight and reach of children.
Children weighing less than 40 kg
Ask your doctor or pharmacist for advice when giving Co-amoxiclav tablets to children weighing less than 40 kg. The tablets ate not suitable for children weighing less than 25kg.
Patients with kidney and liver problems
• inflammation of blood vessels [vasculitis) which may be visible as red or purple raised spots on the skin, butcan affect other partsof the body
• fever, joint pain, swollen glands in the neck, armpit orgroin
• swelling, sometimes of the face or mouth (ang/oedema), causingdifficulty in breathing
Contact a doctor immediately if you get any of
If you notice any of these symptoms contact a doctor urgently.
Rare side effects that may show up in your blood
• low number of cells involved in blood clotting
• low number of white blood cells.
Othersideeffects
Other side effects have occurred in a very small number of people but their exact frequency is unknown.
• Allergic reactions (see above)
Do not store above 25°C.
Do not take Co-amoxiclav tablets after the expiry date which is stated on the carton and blister strip after E>P. The expiry date refers to the last day of that
Do not take Co-amoxiclav Tablets if you notice any visible signsof deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measu res will helpto protect the environment.