Co-Amoxiclav 875mg/125mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Co-amoxiclav 875 mg /125 mg film-coated tablets
(Amoxicillin and clavulanic acid)
V PHARMAfFLiTICAl S
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 any further questions, ask your doctor or 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 become 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 is and what it is used for
2. Before you take Co-amoxiclav
3. How to take Co-amoxiclav
4. Possible side effects
5. How to store Co-amoxiclav
6. Further information
1. WHAT CO-AMOXICLAV IS AND WHAT IT IS USED FOR
Co-amoxiclav is a broad spectrum antibiotic used for treating a wide range of bacterial infections. It belongs to a group of antibiotics called “penicillins”. It contains two active ingredients: amoxicillin and clavulanic acid.
Amoxicillin works by killing the bacteria that can cause infections and clavulanic acid protects amoxicillin from bacterial degradation.
2. BEFORE YOU TAKE CO-AMOXICLAV
If you have any of the below conditions or you are unsure as to whether or not you should be taking Co-amoxiclav talk to your doctor or pharmacist.
Do not take Co-amoxiclav :
• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid or any of the ingredients of the medicinal product. Check the ingredients listed in Section 6
• if you have ever had a skin rash or swelling of the face or neck when taking any antibiotic
• if you know you are allergic to penicillin (or any other antibiotic)
• if the patient is under 12 years old
• if you have ever had liver problems when taking an antibiotic.
Take special care with Co-amoxiclav:
• if you are taking a contraceptive pill (in which case you will need to take extra contraceptive precautions such as using a condom)
• if you suffer from kidney or liver problems if you have glandular fever if you are suffering from diarrhoea or vomiting.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. In particular, please tell your doctor if you are taking any of the following as Co-amoxiclav may interfere with the way they work:
• warfarin, or any other medicine, used to prevent blood clots (anticoagulants)
• medicines to treat liver or kidney problems
• allopurinol, to treat gout, as this may increase the risk of skin reactions
• probenecid, also used to treat gout, since this can cause the increased levels of amoxicillin in the blood
• oral contraceptives.
Taking Co-amoxiclav with food and drink
Co-amoxiclav should be taken just before meals and swallowed whole with water. Do not chew them. Pregnancy and breast-feeding
Inform your doctor if you are pregnant, planning to become pregnant or if you are breast-feeding. Co-amoxiclav should not be used when pregnant or breast-feeding unless your doctor decides that the benefits outweigh the risks.
Driving and using machines
Co-amoxiclav Tablets has no known effect on the ability to drive and use machines. However, if you experience any side effects such as dizziness, your ability to drive or operate machines may be impaired. Important information about one of the ingredients of Co-amoxiclav:
Each Co-amoxiclav 875/125 mg Film- coated Tablets contains 25 mg (i.e. 0.64 mmol) of potassium.
3. HOW TO TAKE CO-AMOXICLAV
Always take Co-amoxiclav exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• These tablets are usually prescribed for adults and children over 12 years old and with the body weight of at least 40kg.
• The usual dose is one 875 mg/125 mg tablet, taken twice a day.
• Your doctor will prescribe the exact dosage.
• Never take more than the recommended daily dose.
• Co-amoxiclav should be swallowed whole with water - do not chew them.
• For the best results, take Co-amoxiclav just before meals.
• If you still feel unwell after finishing the treatment, go and see your doctor again.
• You should not use Co-amoxiclav beyond two weeks without seeing your doctor again.
Children
Co-amoxiclav is not recommended for use in children of 12 years and under.
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Kidney and Liver problems
• If you have kidney problems the dose might be changed.
• If you have liver problems you may have more frequent blood tests to see how your liver is working. If you take more Co-amoxiclav than you should
If you or someone else accidentally takes too many Co-amoxiclav Tablets, contact your doctor or nearest emergency department immediately. Show the doctor your pack of tablets.
If you forget to take Co-amoxiclav
If you forget to take a tablet, take it as soon as you remember. Then carry on as before. Try to wait about four hours before taking the next dose. Do not take two doses within one hour of each other.
If you stop taking Co-amoxiclav:
Finish the full course prescribed by your doctor even if you feel better. If you stop treatment too early, worsening or reappearance of infection is possible.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-amoxiclav can cause side effects, although not everybody will experience them.
If you experience any of the following side effects, stop taking Co-amoxiclav Tablets and seek immediate medical attention:
• skin rashes, itching
• blistering or peeling of the skin, with or without ulceration in the mouth and sore eyes and genitals
• joint pain and fever
• swelling of the face, lips, tongue or throat, or breathing problems
• sweating, rapid heart beat or loss of consciousness
• if you notice your skin or whites of your eyes turning yellow
• if you have a fit
• if you get severe diarrhoea with or without bleeding.
These are rare but serious side effects and require immediate medical attention.
Common (occurs in less than 1 in 10 but more than 1 person in 100)
• upset stomach or diarrhoea (these may be prevented if you take your tablets just before meals)
• thrush (yeast infection of the vagina, mouth or skin folds) after or during treatment
• Nausea, vomiting
Uncommon (occurs in less than 1 in 100 patients but more than 1 in 1000):
• dizziness, headache, indigestion
• raised liver enzymes on blood test results
Very rare (occurs in less than 1 in 10,000 patients):
• hyperactivity and convulsions (these symptoms are reversible)
• Inflammation of the kidney, crystals in the urine (usually only visible under a microscope) which may be characterised by cloudy urine or by difficulty/discomfort in passing urine. You should drink plenty of fluids (such as water and non-alcoholic and non-caffeine containing drinks) to reduce the risk of these symptoms.
Some of these reactions can be delayed for several weeks after finishing the treatment.
If you are having blood tests, tell your doctor you are taking Co-amoxiclav. This is because this medicinal product sometimes causes short-term changes in blood cell counts.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CO-AMOXICLAV
Do not store above 25°C.
Keep out of reach and sight of children.
Do not take your tablets after the expiry date printed on the package. The expiry date refers to the last day of that month.
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 Tablets contains
The active substances are amoxicillin and clavulanic acid.
Each tablet contains 875mg amoxicillin as amoxicillin trihydrate and 125mg clavulanic acid as potassium clavulanate.
The other ingredients are microcrystalline cellulose (E460) (AVICEL Ph 102), croscarmellose sodium, purified talc, magnesium stearate, hypromellose (E-15), Hydroxypropylcellulose, titanium dioxide ethylcellulose and propylene glycol.
What Co-amoxiclav looks like and contents of the pack
Co-amoxiclav 875 mg/125 mg Tablets are white to off-white, film-coated, oval- shaped tablets which are supplied in PVC/Al blister packs of 7, 10, 12, 14, 20, 21 and 24 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bluefish Pharmaceuticals AB, Torsgatan 11, SE-111 23 Stockholm, Sweden. Tel: +46 8 679 50 70 This leaflet was last approved in 06/2009
This medicinal product is authorised in the Member States of the EEA under the following names:
Czech Republic
Germany
Hungary
Ireland
Italy
Poland
Slovenia
Spain
United Kingdom
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