Amoxicillin 250mg Capsules Bp
Out of date information, search anotherTEVA UK Ref: 231-30-21266-Y LEA AMOXICILLIN A/S CAP TUK XATH Version: 2 22 August 2014
AMOXICILLIN 250 mg CAPSULES BP AMOXICILLIN 500 mg CAPSULES BP
Package leaflet: Information for the patient
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them even if their symptoms or their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
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What is in this leaflet
1. What Amoxicillin is and what it is used for
2. What you need to know before you take Amoxicillin
3. How to take Amoxicillin
4. Possible side effects
5. How to store Amoxicillin
6. Contents of the pack and other information
What Amoxicillin is and what it is used for
Amoxicillin is one of a group of antibiotic medicines called penicillins. Amoxicillin works by interfering with the bacteria that cause the infection.
Amoxicillin can treat a wide range of infections including those of the following:
skin bone teeth
heart (endocarditis) gums (abscesses)
chest (bronchitis or pneumonia) tonsils (tonsillitis) ears (otitis media) sinuses (sinusitis) kidneys
blood (septicaemia) abdomen (intra-abdominal sepsis and peritonitis)
the bladder or the urethra (the tube which carries urine from the bladder)
the female reproductive system including infections caused by difficulties during childbirth
(puerperal sepsis and septic abortion).
Amoxicillin can also be used to treat:
• gonorrhoea (a sexually transmitted infection)
• infections associated with pregnancy
• typhoid and paratyphoid (fevers caused by a group of bacteria called Salmonella).
Amoxicillin may also be used in combination with other medicines to treat stomach ulcers.
Do not take Amoxicillin if
• You are allergic to amoxicillin or any of the other ingredients of this medicine (listed in section 6)
• You have ever had a bad reaction or allergy to any penicillin-type antibiotic
• You have ever had a skin rash or swelling of the face or neck or shortness of breath when taking any antibiotic.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin if:
• You suffer from kidney disease or kidney problems, as you may require a lower dose than normal
• You are not passing urine regularly
• You have glandular fever.
Other medicines and Amoxicillin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, even those not prescribed by a doctor. In particular tell your doctor if you are taking
any of the following:
• The contraceptive pill (in which case you will have to take extra contraceptive measures such as using a condom)
• Anticoagulants e.g. warfarin, phenindione
• Chemotherapy drugs e.g. methotrexate
• Drugs used to treat gout (which can be caused by the build up of uric acid) e.g. probenecid, allopurinol, sulfinpyrazone
• Some other antibiotics (e.g. neomycin and tetracyclines can reduce the effect of amoxicillin)
• Oral typhoid vaccine (may not work if taken with amoxicillin)
• Some penicillins may increase the effects of muscle-relaxing drugs given as part of an anaesthetic for surgery. Tell the doctor you are taking amoxicillin if you need to have an anaesthetic.
Having urine or blood tests
If you are having urine tests for diabetes (sugar in the urine) or blood tests for liver function let the doctor know. Amoxicillin can affect the results of these tests.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
How to take Amoxicillin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The maximum daily dose is 6 g given in divided doses.
Adults including the elderly:
• The usual dose of Amoxicillin Capsules is 250 mg three times a day
• For more severe infections this may be doubled to 500 mg three times a day
• High doses may be used in the following conditions:
• For severe or recurrent chest infections a dose of 3 g twice daily given orally is usually recommended
• For simple urinary tract infections an adult dose of two 3 g doses given orally with 10 to 12 hours between doses (short course)
• For the treatment of dental abscesses two 3 g doses given orally with 8 hours between doses is recommended
• For gonorrhoea a single 3 g dose given orally is recommended
• For stomach ulcers, the following may be prescribed with other antibiotics: 1 x 750 mg or
1 x 1 g twice a day for 7 days.
The following are the usual adult dosages for preventing infection during dental procedures and other surgery:
•If a general anaesthetic is not used, 3 g given orally one hour before surgery and another dose six hours later if necessary
•If a general anaesthetic is used, 3 g given orally four hours before anaesthesia and 3 g six hours after the initial dose.
Children
It is recommended that children be given amoxicillin as a suspension instead of as capsules. • Children weighing more than 40 kg should be given the usual adult dosage
• Children weighing less than 40 kg who are able to swallow capsules:
All doses are worked out depending on the child's body weight in kilograms.
Your doctor will advise you how much medicine you should give to your baby or child.
The usual dose is 40 mg to 90 mg for each kilogram of body weight a day, given in two or three divided doses.
Patients with kidney problems
If you have kidney problems, the dose prescribed by your doctor may be lower than the usual dose. When to take your medicine
Try to give/take this medicine as part of the daily routine, for example at mealtimes. You may give/take amoxicillin before, with or after food, unless the label advises a specific time. It is not normally necessary to arrange to have a dose in the middle of the night, unless your doctor has told you to do so. But remember, space the doses as evenly as possible throughout the day.
Do not give/take more than one dose every four hours.
If you take more Amoxicillin than you should
If you take more capsules than you should, tell your doctor immediately or go to the nearest hospital. You should take this leaflet and any capsules you still have to show the doctor.
Severe cases of nausea, vomiting and diarrhoea can be treated with rehydration therapy, by drinking fluids containing sodium, water and sugar to prevent dehydration.
If you forget to take Amoxicillin
If you forget to take a dose, take it as soon as you remember, unless it is within an hour of your next dose, then carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amoxicillin REMEMBER:
Keep taking this medicine until it is finished or your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, some bacteria may survive and cause the infection to come back, or your condition may re-occur or get worse.
You should make sure you have several more drinks of water each day unless told otherwise by your doctor.
If you are still unwell after taking all the medicine, go and see your doctor. Never give/take more than the recommended dose each day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following events STOP taking your medicine and tell your doctor or go to your nearest hospital immediately:
• Hypersensitivity or severe allergic reaction including swollen face or breathing problems. If these symptoms occur, STOP taking amoxicillin right away and tell your doctor.
• Severe diarrhoea with bleeding
• Allergic skin reactions with itching e.g. hives, nettle rash, blistering or peeling of the skin. If you start to itch or get a rash, STOP taking amoxicillin and tell your doctor immediately.
• Convulsions may occur in patients on high doses or with kidney problems
• Notice your urine becoming darker or your faeces becoming paler
• Notice your skin or the white of your eyes turning yellow (jaundice)
• Difficulty or discomfort in passing urine or having cloudy urine.
The following symptoms are less serious but you may wish to discuss them with your doctor if they become troublesome or last a long time.
Common side effects of amoxicillin (i.e. have been reported in more than 1 in 100 people taking it) include:
• Nausea (feeling sick) or diarrhoea.
Uncommon side effects (i.e. have been reported in between 1 in 100 and 1 in 1,000 people taking amoxicillin) include:
• Vomiting.
Very rare side effects (i.e. reported in less than 1 in 10,000 people) include:
• Thrush (a yeast infection of the vagina, mouth or skin folds). You can get treatment for thrush from your doctor or pharmacist.
• Tooth discolouration. The colour usually returns to normal with brushing.
• Blackening of the tongue
• Inflammation of the kidney
• Excessive body movements (hyperkinesia) or dizziness
• Reduction (reversible) in blood cell counts including anaemia (a reduction in the body's red blood cells or haemoglobin which may be characterised by feeling weak or light-headed) or a longer time taken for blood to clot. Tell your doctor that you are taking amoxicillin if you are having blood tests
• Crystalluria (forming of crystals in the urine).
Not known: frequency cannot be estimated from available data
• Meningitis (signs may include stiff neck, fever and vomiting.
Reporting of side effects
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. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Amoxicillin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP The expiry date refers to the last day of that month. Store below 25°C and protect from light and moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Amoxicillin Capsules contain:
• The active ingredient is amoxicillin. Each capsule contains either 250 mg or 500 mg of amoxicillin as amoxicillin trihydrate.
• The other ingredients are magnesium stearate, maize starch, gelatin, erythrosin (E127), quinoline yellow (E104), titanium dioxide (E171) and red iron oxide (E172).
What Amoxicillin Capsules look like and contents of the pack
• Amoxicillin Capsules are scarlet and ivory opaque hard gelatin capsules, each capsule is marked with the characters "AMOX 250" or "AMOX 500"
• Securitainers are available in pack sizes of 15, 18, 20, 21, 28, 30, 50, 100, 500 & 1000 capsules, the pack size of 1000 is available for the 250 mg strength only.
Blister packs are available in pack sizes of 15, 16, 18, 20, 21, 28, 30, 50, 100, 500 & 1000 capsules, the pack size of 1000 is available for the 250 mg strength only and the pack size of 16 is available for the 500 mg strength only. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.
The product is distributed by: TEVA UK Limited, Eastbourne, BN22 9AG.
PL 06453/0017 and PL 06453/0018
Date of revision June 2014 P258/10 21266-Y