Amoxicillin 500mg Capsules
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Patient Information Leaflet Amoxicillin 250mg Capsules BP Amoxicillin 500mg Capsules BP
This medicine will be called Amoxicillin Capsules in this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• This medicine is only for you. Do not give it to anyone else to take. It may harm them, even if their symptoms are the same as yours.
• If you have any further questions, please ask your doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Amoxicillin Capsules are and what they are used for
2. Before you take Amoxicillin Capsules
3. How to take Amoxicillin Capsules
4. Possible side effects
5. How to store Amoxicillin Capsules
6. Further information
These capsules are available in two different strengths containing either 250mg or 500mg of the active ingredient, amoxicillin (as trihydrate). Amoxicillin is one of a group of antibiotics called penicillins. It is used to kill bacteria which cause infections in your body.
Amoxicillin Capsules are used to treat bacterial infections of the ear, respiratory tract (e.g. lungs and chest), urinary tract (e.g. kidneys and bladder), skin and gastrointestinal tract, such as typhoid. It may also be used for other infections determined by your doctor.
Taking other medicines
Amoxicillin Capsules and other medicines you may be taking may affect how each other work. Make sure your doctor knows if you are taking any of the following:
• Anticoagulants (to prevent blood clotting) e.g. warfarin or phenindione
• Probenecid or allopurinol (used to treat gout)
• Oral contraceptives (as it may not work properly and you will need to use other means of contraception e.g. a condom)
• Methotrexate (a cancer drug which can also be used to treat psoriasis)
• Dietary fibre supplements.
If you are having tests on your water (urine glucose tests) or blood tests for liver function, let the doctor or nurse know you are taking amoxicillin because amoxicillin can affect the results of these tests.
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.
Other special warnings
Thrush (a yeast infection of moist areas of the body) may develop if amoxicillin is used for a long time. If this occurs, tell your doctor.
The colours sunset yellow (E110) and carmoisine (E122) in the capsule shell may cause allergic reactions. The capsule shell contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Driving and using machinery
Amoxicillin Capsules may very rarely cause dizziness and convulsions. Do not drive or operate machinery if they have this effect on you.
Some people must not take these capsules.
Do not take these capsules If:
• You know you are allergic to amoxicillin, penicillin or to any of the other ingredients (these are listed in section 6)
• You have ever had an allergic reaction (e.g. rash, itching, shortness of breath) to another antibiotic in the past such as cephalosporins e.g. cefaclor.
You must be especially careful if:
• You have glandular fever or lymphocytic leukaemia
• You are pregnant or trying to become pregnant
• You are breastfeeding
• You are not passing water regularly
• You suffer from any kidney problems.
If any of the conditions above apply to you, please discuss
your treatment with your doctor before taking this
medicine.
The capsules should be swallowed whole with a drink of water.
The doctor will decide what dose of capsules you need to take. Always take the capsules exactly as the doctor has told you. The dose will be on the pharmacist’s label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor. The usual doses are as follows:
Adults: To treat an infection, you should usually take one 250mg capsule three times a day and in more severe infections it may be increased to 500mg three times a day. Children: The doctor will advise you of the dose.
Children may be given a mixture of amoxicillin instead of capsules.
It is important that you take your medicine at the right times of day. Space the doses out as evenly as possible throughout the day. Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may reoccur or get worse.
Continued, please turn over
If you take more capsules than you should
You should contact your doctor or go to your nearest hospital casualty department immediately. Take your capsules or the pack with you so that the doctor knows what you have taken.
If you forget to take a dose of Amoxicillin Capsules
Take it as soon as you remember. Then carry on as before, but do not take two doses within one hour of each other.
Amoxicillin Capsules are suitable for most people, but, like all medicines they can sometimes cause side effects. Some side effects can be serious.
Stop taking the capsules and tell your doctor straightaway if you notice the following very rare effects (may occur in less than 1 in 10,000 people):
• Swelling of the face, lips or throat, difficulty in breathing or dizziness. These may be signs of a severe allergic reaction.
• Rash or pinpoint flat red round spots under the skin surface or bruising of the skin due to inflammation of blood vessel walls caused by an allergic reaction
• A delayed allergic reaction may occur 7 to 12 days after taking the capsules. Symptoms may include rash, fever, joint pains and enlargement of the lymph nodes especially under the arms
• Blistering of the skin, mouth, eyes and genitals, other serious skin reactions including itchy reddish purple patches on the skin, hives, pustules, swelling, peeling, redness, pain, itching and scaling. These may be associated with fever, tiredness, headache and aching body
• Blood disorders including severe reduction in the number of white or red blood cells which may cause pale yellow skin, weakness, breathlessness, increased risk of bruising or bleeding, and make infections more likely
• Diarrhoea sometimes containing blood, pain and fever caused by inflammation of the large bowel (colon)
• Yellowing of the skin or whites of the eyes, pale stools and dark urine, loss of appetite, stomach discomfort caused by liver or blood problems.
The following side effects have also been reported:
Less than 1 In 10 people have experienced:
• Diarrhoea, indigestion, feeling sick
• Skin rash.
Less than 1 In 100 people have experienced:
• Itching, hives
• Being sick.
Less than 1 in 10,000 people have experienced:
• Tiredness, headache, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes. These may be symptoms of a type of anaemia
• Thrush (a yeast infection of the vagina, mouth or skin folds)
• Increased or decreased urine output, fever, rash,
swelling of any area of the body or weight gain caused by kidney problems
• Fits (convulsions) which may be seen in patients taking high doses or with kidney problems, hyperactivity, dizziness
• Crystals in the urine which may cause cloudy urine or difficulty or discomfort when passing urine
• An increase in the length of time it takes to stop bleeding if you cut yourself or have a nosebleed
• Black hairy tongue
• Tooth discolouration in children which usually returns to normal with brushing.
If any of the side effects gets serious, or If you notice
any side effects not listed In this leaflet, please tell your
doctor or your pharmacist.
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package (carton) / Keep the container tightly closed (bottle) in order to protect the capsules from moisture. Do not transfer your medicine to another container.
Do not use your medicine after the expiry date shown on the label or carton.
If your doctor tells you to stop taking the capsules, please take any unused medicine back to your pharmacist to be destroyed.
Ingredients
Each capsule contains either 250mg or 500mg of the active ingredient, amoxicillin (as trihydrate). The other ingredient is magnesium stearate. The capsule shells contain gelatin and the colours sunset yellow (E110), carmoisine (E122), brilliant blue (E133), quinoline yellow (E104) and titanium dioxide (E171), methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
What the medicine looks like
The capsules are red/buff coloured and are printed with
“AMOXY 250” (250 mg strength) and “AMOXY500”
(500 mg strength). They are supplied to your pharmacist in packs of 21,100, 250, 500 or 1000 capsules. Not all pack sizes may be available.
Product licence holder and manufacturer The product licence holder is Special Concept Development (UK) Ltd, Units 1-7 Colonial Way,
Watford, Flertfordshire, WD24 4YR.
Manufactured by Crescent Pharma Ltd., Quidhampton Business Units, Polhampton Lane, Overton, Flants,
RG25 3ED.
Product licence numbers
PL 36722/0001 PL 36722/0002 Date of revision: April 2011.
If you would like this leaflet in a different format, please contact the licence holder at the above address.