Amoxicillin 500mg Capsules
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PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN 250mg and 500mg CAPSULES BP
Amoxicillin (as amoxicillin trihydrate)
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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
he name of your medicine is Amoxicillin.
In this leaflet:
What Amoxicillin is and what it is used for Before you take Amoxicillin How to take Amoxicillin Possible side effects How to store Amoxicillin Further information
1. What Amoxicillin is and what it is used for
|What Amoxicillin is
Amoxicillin is one of a group of antibiotic medicines called penicillins. Amoxicillin works by killing bacteria that can ause infections
What Amoxicillin is used for
Amoxicillin is used to treat a range of bacterial infections: Chest (bronchitis or pneumonia)
Tonsils (tonsillitis), ears (otitis media), sinuses (sinusitis) The bladder or urethra (the tube which carries urine from the bladder), the kidneys
The female reproductive system including infections caused by difficulties during childbirth (puerperal sepsis and septic abortion), infections associated with pregnancy
Abdomen (intra-abdominal sepsis and peritonitis)
Heart (endocarditis), blood (septicaemia)
Skin, teeth and gums (abscesses)
Gonorrhoea (a sexually transmitted infection)
Typhoid and paratyphoid (fevers caused by a group bacteria called Salmonella)
May also be used in combination with other medicines to treat duodenal and gastric ulcer disease.
Do not take Amoxicillin:
• If you are allergic (hypersensitive) to penicillin, amoxicillin or any other antibiotic. This can include a skin rash or swelling of the face or neck.
• If you are allergic (hypersensitive) to any of the other ingredients in this medicine (listed in section 6)
• If you have a viral infection called infectious mononucleosis or glandular fever
Do not take Amoxicillin if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin.
Take special care with Amoxicillin
Tell your doctor or pharmacist before you start to take this medicine if you:
• Are pregnant or are breast-feeding
• have glandular fever
• are being treated for kidney problems
• are not passing water regularly
• Are having blood tests or urine tests for glucose as amoxicillin may affect the results
• If you have reduced urine output and inadequate fluid intake.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Amoxicillin.
Having urine or blood tests
If you are having tests on your water (urine glucose tests) or blood tests for liver function, let the doctor or nurse know that you are on Amoxicillin. This is because Amoxicillin can affect the results of these tests.
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. This is because Amoxicillin can affect the way some other medicines work. Also some other medicines can affect the way Amoxicillin works.
• The contraceptive pill, as amoxicillin may reduce the effect of the pill, you should therefore take extra contraceptive precautions such as using a condom or a diaphragm with spermicide
• Medicines used to prevent blood clots such as acenocoumarol or warfarin as the time it takes the blood to clot may be even longer while you are taking amoxicillin and you may need extra blood tests because of this
• Allopurinol used to treat gout because the risk of allergic skin rashes is increased
• Concurrent use of Probenecid (used for gout) with amoxicillin may result in increased and prolonged blood levels of amoxicillin.
Taking Amoxicillin capsules with food and drink
Amoxicillin capsules do not have known interactions with food or drink.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to become pregnant discuss this with your doctor before taking any medicine.
Small amounts of amoxicillin may enter the breast milk and can occasionally cause diarrhoea or mouth infections in infants. Infants may become allergic to amoxicillin. If you are breast-feeding, discuss this with your doctor before you take| amoxicillin.
Driving and using machines
Amoxicillin capsules have not been shown to have any effect on ability to drive and use machines.
Important information about some of the ingredients o Amoxicillin
The capsules contain E110 Sunset yellow, this may cause allergic type reactions including asthma. An allergy is more likely in those people allergic to aspirin.
3. How to take Amoxicillin
When taking Amoxicillin
• Swallow the capsules 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
• Never take 2 doses in 1 hour
• The maximum recommended dose is 6 g per day given as 2 x 3 g doses.
The usual dose is:
Children aged under 10 years who are able to swalloJ capsules
• Severe infections: 1 x 250 mg capsule three times a day.
• For children aged 3 to 10 years only with severe or continuous ear infections: 750 mg (3 x 250 mg|
capsules or 1 x 500 mg capsule and 1 x 250 mg capsule) may be given twice a day for 2 days. '
Adults, elderly patients and children over 10 years
• Standard dose: 1 x 250 mg capsule 3 times a day.
• Severe infections: 1 x 500 mg capsule 3 times a day.
• Severe or recurrent chest infection: 3 g (6 x 500 mg
capsules) twice a day.
• Urinary tract (water) infection: 2 x 3 g doses (6 x 50 mg capsules) with 10 to 12 hours between each dose.
• Dental abscess (infection under the gums and teeth):
2 x 3 g doses (6 x 500 mg capsules) with 8 hours between each dose.
• Gonorrhoea (a sexually transmitted infection): 1 x 3 g
dose (6 x 500 mg capsules).
• Stomach ulcers: 1 x 750 mg dose (3 x 250 mg capsules or 1 x 500 mg capsule and 1 x 250 mg capsule) or 1 x 1 g dose (2 x 500 mg capsules) twice a day for 7 days with other antibiotics.
To stop infection during surgery
• The dose will vary according to the type of surgery. Other medicines may also be given at the same time.
• Your doctor, pharmacist or nurse can give you more details.
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Kidney problems
|lf you have kidney problems the dose might be lower than the usual dose.
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If you take too much Amoxicillin
'If you have too much Amoxicillin, signs might be an upset stomach (feeling sick, being sick or diarrhoea) or crystals in the urine, which may be seen as cloudy urine, or problems passing urine.
|Talk to your doctor as soon as possible. Take the medicine to show the doctor.
If you forget to take Amoxicillin
• If you forget to take a dose don't worry, take it as soon as | you remember.
• Don't take the next dose too soon, wait about 4 hours I before taking the next dose.
How long should you take Amoxicillin for?
• Keep taking Amoxicillin 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. Treatment should be continued for 2 to 3 days after the symptoms have gone.
• Do not take Amoxicillin for more than 2 weeks. If you still | feel unwell you should go back to see the doctor.
Thrush (a yeast infection of moist areas of the body) may |develop if Amoxicillin is used for a long time. If this occurs and you have been taking Amoxicillin for longer than Recommended, tell your doctor.
f you have any further questions on the use of this product, |ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Amoxicillin can cause side effects, Although not everybody gets them.
Stop taking Amoxicillin and see a doctor straight away, if you notice any of the following serious side effects you may need urgent medical treatment:
|The following are very rare (affects less than 1 in 10,000 people)
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• allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips, tongue, body or breathing
| difficulties. These can be serious and occasionally deaths have occurred
• rash or pinpoint flat red round spots under the skin
| surface or bruising of the skin. This is due to inflammation
of blood vessel walls due to an allergic reaction. It can be
I associated with joint pain (arthritis) and kidney problems
• a delayed allergic reaction can occur usually 7 to 12 days after having Amoxicillin, some signs include: rashes,
| fever, joint pains and enlargement of the lymph nodes especially under the arms
• a skin reaction known as 'erythema multiforme' where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or soles of the
I feet, 'hive-like' raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and private parts. You may have a fever and be very tired
• other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches
• high temperature (fever), chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells
• inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever
• serious liver side effects may occur which are often reversible. They are mainly associated with people having treatment over a long period, males and the elderly. You must tell your doctor urgently if you get:
■ severe diarrhoea with bleeding
■ blisters, redness or bruising of the skin
■ darker urine or paler stools
■ yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice.
These can happen when having the medicine or for up to several weeks after.
If any of the above happen stop taking the medicine and see your doctor straight away. Sometimes you may get less severe skin reactions such as:
• a mildly itchy rash (round, pink-red patches), 'hive-like' swollen areas on forearms, legs, palms, hands or feet. This is uncommon (affects less than 1 in 100 people).
If you have any of these talk to your doctor as Amoxicillin will need to be stopped.
The following side effects have been reported at the approximate frequencies shown:
Common (affecting fewer than one person in 10 but more than one person in 100):
• Upset stomach or diarrhoea. The symptoms are usually mild
• Skin rash
Uncommon (affecting fewer than one person in 100 but more than one person in 1000):
• Being sick (vomiting)
• Unpleasant itching sensation that leads to intensive scratching (Pruritus)
Very Rare (affecting fewer than one person in 10,000):
• thrush (a yeast infection of the vagina, mouth or skin folds), you can get treatment for thrush from your doctor or pharmacist
• Discolouration of teeth (tooth colour returns to normal with brushing)
• Excessive body movements (hyperkinesia)
• Dizziness
• Convulsions or fits. Particularly in patients with kidney disorders 01' if high doses are being taken
• Inflammation of the kidney
• Hepatitis and cholestatic jaundice
• hyperactivity
• crystals in the urine, which may be seen as cloudy urine, or difficulty or discomfort in passing urine. Make sure you drink plenty of fluids to reduce the chance of these symptoms
• the tongue may change to yellow, brown or black and it| may have a hairy appearance
• an excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes
• the blood may take longer to clot than it normally would.. You may notice this if you have a nosebleed or cut yourself.
If any of the side effects get serious, or if you notice any side1 effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Amoxicillin
Keep out of the reach and sight of children.
The capsules must be kept in their original package and stored in a dry place below 25°C. Do not use Amoxicillin aftei] the expiry date that is stated on the outer packaging. 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.
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6. Further information
What Amoxicillin contains:
• The active ingredient is Amoxicillin (as amoxicillinl trihydrate)
• The other ingredients are Magnesium Stearate (E572) and Colloidal Anhydrous Silica. The capsule shells contain Gelatin, Erythrosine (E127), Patent Blue (E131),, Sunset Yellow (E110), Titanium Dioxide (E171), and Yellow Iron Oxide (E172). The printing ink contains] Platinum Carbon.
What Amoxicillin looks like and contents of the pack:
• Amoxicillin 250mg Capsules are Ivory/Scarlet hard gelatin capsules printed with AMOXI on cap and 250 on| body.
• Amoxicillin 500mg Capsules are Ivory/Scarlet hard1 gelatin capsules printed with AMOXI on cap and 500 on body.
• Amoxicillin 250mg capsules come in blister packs of 10, 15, 21,28 and 504 capsules and 500mg capsules come] in blister packs of 10, 15, 21,28 and 105 capsules.
Not all pack sizes may be marketed. .
Marketing Authorisation Holder and Manufacturer |
Accord Healthcare Limited, Sage House, 319, Pinner Road,
North Harrow, Middlesex, HA1 4HF, United Kingdom '
PL 20075/0263 & PL 20075/0264
This leaflet was last revised: {09/2012} ,
POM
10 4105 0 613181
