AMOXICILLIN 500MG CAPSULES HARD

Active substance: AMOXICILLIN TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin 250mg Capsules
Amoxicillin 500 mg Capsules
(Amoxicillin)
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 gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Amoxicillin capsules are and what it is used for
Before you take Amoxicillin capsules
How to take Amoxicillin capsules
Possible side effects
How to store Amoxicillin capsules
Further information

1. WHAT AMOXICILLIN CAPSULES IS AND WHAT IT IS USED FOR
Amoxicillin is an antibiotic (antibacterial medicine) for treating infections. It
belongs to a group of antibiotics called “Penicillins”. Amoxicillin works by
killing the bacteria that can cause infections. Amoxicillin can also be used to
prevent infections.
Your doctor has prescribed Amoxicillin capsules because, it can treat a wide
range of infections including those of the:
Ear, Nose and Throat
Ears - (Otitis media)
Nose - Sinuses (Sinusitis)
Throat - Pharynx (Pharyngitis)
Tonsils (Tonsillitis)
Chest (Bronchitis or Pneumonia)
Bladder or Urethra (the tube which carries urine from the bladder)
Bladder - (Cystitis)
Urethra - (Urethritis)

Kidneys (Pyelonephritis)
Abdomen (Gastro-intestinal infections)
Heart (Endocarditis)
2. BEFORE YOU TAKE AMOXICILLIN CAPSULES

Do not take Amoxicillin if:
 you are allergic to penicillin or similar types of antibiotics such as
cephalosporins. If you have ever had an allergic reaction (such as a rash)
when taking an antibiotic you
should tell your doctor before you take
amoxicillin.
 you have ever had an allergic reaction to amoxicillin or any of the
ingredients listed toward the end of this leaflet. (See “Ingredients”)
 you have a viral infection, cancer of white blood cells (acute lymphatic
leukaemia) or glandular fever
 the expiry date (EXP) printed on the pack has passed.
Take Special Care with Amoxicillin Capsules
Let your doctor know if any of the following apply to you:







if you suffering from diarrhoea or sickness
if you have asthma
if you are breast-feeding
if you have been treated for kidney problems
if you are pregnant or think you may be pregnant
if you are having urine or blood tests because Amoxicillin may affect the
results

If any of the above apply to you, let your doctor know. Your doctor may decide
that you need a different dose of amoxicillin or a different medicine instead of
amoxicillin. If you have not told your doctor about any of these things, tell them
before you take Amoxicillin.
Taking other medicines
Amoxicillin capsules may occasionally interfere with other medicines, so it is
important that you tell your doctor about all the medicines you are taking,
including those obtained without a doctor's prescription. In particular tell your
doctor if you are taking any of the following:







the contraceptive pills (you may need to use extra birth control methods
e.g. condoms.)
medicines used to treat gout e.g. allopurinol and probenecid
medicine used to treat heart failure e.g. digoxin
medicines used to prevent blood clots (anticoagulants) e.g. warfarin
any other antibiotics

If you are taking these medicines you should talk to your doctor before taking
Amoxicillin capsules.
Taking Amoxicillin capsules with food and drink
Amoxicillin capsules do not have known interactions with any food or drink.
Alcohol may irritate your stomach if taken with amoxicillin, so use it with
moderation.
Pregnancy and breast-feeding
Ask your Doctor for advice before taking amoxicillin capsules.
Driving and using machines
Amoxicillin capsules have not been shown to have any effect on ability to drive
and use machines. Nevertheless, consideration should be given to the potential for
amoxicillin to cause dizziness and convulsions
Important information about some of the ingredients of Amoxicillin Capsules
Amoxicillin Capsules contain sunset yellow E110 and carmoisine E122, which
may cause allergic reactions, Also, methyl parahydroxybenzoate and propyl
parahydroxybenzoate which may cause allergic reactions (possibly delayed).
3. HOW TO TAKE AMOXICILLIN CAPSULES.
Follow your doctor's instructions about how and when to take Amoxicillin. Your
doctor will advise on dosage strength, number of capsules to be taken each day,
and for how long you will need to take Amoxicillin.
Always take Amoxicillin capsules exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure. Do not stop taking the
medication just because you feel better as the infection can return.

Amoxicillin capsules should be swallowed whole with water.
Adults
For most infections you have to take one 250 mg capsule three times a day. This
can be increased to 500 mg amoxicillin three times a day if the infection is severe.
For severe or frequent chest infections your doctor may recommend taking 3 g
amoxicillin twice a day
Infections of the bladder or urethra (urine infections) can be treated with two 3 g
doses taken with 10-12 hours between doses.
People who have had heart problems may need an antibiotic when they go to the
dentist or if they have to go into hospital for surgery to prevent them from getting
a heart infection (endocarditis). For prevention of heart infection (endocarditis),
patients who are not having general anaesthetic, 3 g amoxicillin are given in the
hour preceding the surgical procedure, followed by (6 hours later) a further 3 g
dose, if considered necessary.
Children (under 12 years)
For infants and children oral suspensions containing amoxicillin are
recommended
Children weighing less than 40 kg who are able to swallow capsules
All doses are worked out depending on the child’s bodyweight in kilograms.
•Your doctor will advise you how many Amoxicillin Capsules you should give to
your baby or child.
•Usual dose – 40mg to 90mg for each kilogram of body weight a day given in two
or three divided doses
Kidney Problems
Doses may be lower than those listed above in patients with kidney problems.
If you take more Amoxicillin Capsules than you should
Never take more than the recommended dose each day. If you or someone else
swallows several of these capsules all together, contact your doctor, pharmacist or
hospital emergency department immediately. Always take any capsule left over
with you and also the box, as this will allow easier identification of the capsules.
If you forget to take Amoxicillin Capsules

If you miss a dose, just carry on with the next one as normal. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Amoxicillin capsules
If you stop taking Amoxicillin capsules without medical advice then discuss what
to do with your doctor
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amoxicllin capsules can cause side effects, although not
everybody gets them.
The more common side effects of Amoxicillin that have been reported in more
than 1 in 100 people taking it include:

Nausea (feeling of sickness) or diarrhoea

Skin rash.
Uncommon side effects that have been reported in between 1 in 100 and 1 in
1,000 people taking amoxicillin include:

Vomiting

Allergic skin reactions with itching. If you start to itch or get a rash,
STOP taking Amoxicillin and tell your doctor at once.
Very rare side effects that have been reported in less than 1 in 10,000 people
taking Amoxicillin include:
 Hypersensitivity or severe allergic reaction including swollen face or
breathing problems. Tell your doctor straight away if you notice any of
these symptoms and STOP taking Amoxicillin.
 Thrush (a yeast infection of the vagina, mouth or skin folds). You can get
treatment for thrush from your doctor or pharmacist
 Tooth discoloration. The colour usually returns to normal with brushing
Tell your doctor that you are taking Amoxicillin
 Excessive body movements (hyperkinesia), dizziness or convulsions.
People who
are on high doses of Amoxicillin or whose kidneys do not work properly
may
experience convulsions
 A reversible reduction in the number of cells circulating in the blood. This
may cause anaemia (a reduction in the number of circulating red blood



cells that result in feeling weak or light-headed) or a longer time taken for
blood to clot and wounds or cuts to stop bleeding.
Crystalluria, forming of crystals in the urine.

See your doctor straight away if you experience any of the following very rare
side effects:






Severe diarrhoea with bleeding
Notice your urine becoming darker or your faeces (body waste) becoming
paler
Notice your skin or the white of your eyes turning yellow (jaundice)
Convulsions
Difficulty or discomfort in passing urine or passing urine that is cloudy.

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.
5.

HOW TO STORE AMOXICILLIN CAPSULES
Store below 30°C.
Keep all medicines well out of the reach and sight of children - it’s best to lock
them in a cupboard or medicine cabinet.
If your doctor tells you to stop taking this medicine, or if for any other reason you
have some capsules left over, please return them to the pharmacist.
Remember, this medicine is just for you. Do not give it to anyone else. It may not
be suitable for them, even if their symptoms seem to be the same as yours

6.

FURTHER INFORMATION
What Amoxicillin Capsules contains
The active substance is Amoxicillin Trihydrate.
The other ingredients are Croscarmellose Sodium, Magnesium stearate, Sunset
yellow E110, Carmosine E122, Brilliant blue E133, Quinoline Yellow E104,
Titanium dioxide E171, Methyl parahydroxybenzoate Propyl
parahydroxybenzoate, Shellac, Black iron oxide E172, Gelatin, Propylene glycol
and Sodium lauryl sulfate.
What Amoxicillin Capsules looks like and contents of the pack

Amoxicillin 250mg capsules are Red / Buff coloured
‘AMOXY 250’ in black ink.
Amoxicillin 500mg capsules are Red / Buff coloured
‘AMOXY 500’ in black ink.

capsules printed with
capsules printed with

Amoxicillin 250mg and 500mg are supplied in blister packs of 21 capsules.
Marketing Authorization Holder
Morningside Healthcare Ltd
115 Narborough Road,
Leicester, LE3 0PA
UK
Site responsible for batch release:
Morningside Pharmaceuticals Ltd
5 Pavilion Way, Castle Business Park,
Loughborough,
Leicestershire, LE11 5GW
UK
PL 20117/0214

This leaflet was last revised in June 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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