AMOXICILLIN 250MG HARD CAPSULES

Active substance: AMOXYCILLIN TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Amoxicillin 250mg and 500mg Hard Capsules
Amoxicillin trihydrate (referred to as Amoxicillin in the
remainder of the leaflet)

Read all of this leaflet carefully before
you start taking this medicine because if
contains important information for you.
- Keep this leaflet. You may need to read it
again.
- If you have any further questions, please
ask your doctor or pharmacist.
- This medicine is prescribed for you only.
Do not pass it on to others. It may harm
them even if 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.
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
1. What Amoxicillin is and what it is
used for
The name of your medicine is Amoxicillin
250mg or 500mg Hard Capsules. The
capsules contain a medicine called
amoxicillin trihydrate. Amoxicillin belongs to
a group of medicines called aminopenicillin
antibiotics. Amoxicillin works by killing
bacteria that can cause infections.
Amoxicillin is used in adults and children
to treat or prevent infections caused by
bacteria in different parts of the body when
the bacteria are susceptible to amoxicillin.
These include infections in the heart, lungs,
genitals, urinary tract, stomach, skin and
teeth.
2. What you need to know before you
take Amoxicillin
You should not take Amoxicillin if you
• are allergic (hypersensitive) to amoxicillin,
penicillin or any other ingredient in this
medicine (see section 6)
• have had an allergic (hypersensitive)
reaction to any antibiotic
• have previously been told that your
infection cannot be treated with amoxicillin
or ampicillin.
You should not take Amoxicillin if any of
the above applies to you. If you are unsure
speak to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor before you are given
Amoxicillin if you:
• have a history of allergies, especially
allergies to drugs
• have problems passing water (urine) or
suffer from repeat urinary tract infections
• have glandular fever
• have problems with the functions of your
kidneys. Your doctor may monitor you
during treatment
• have a severe or persistent case of
diarrhoea
• have syphilis or leptospirosis, because of
the risks of a condition known as JarischHerxheimer reaction (see also section 4)
• have undiagnosed sore throat (pharyngitis)
or a type of cancer known as lymphatic
lymphoma, which affects white blood cells.
• have experienced severe or persistent
diarrhoea after taking amoxicillin, as this
could indicate a stomach condition known
as ‘pseudomembranous colitis’
• have HIV
If any of the above applies to you speak to
your doctor before being given Amoxicillin.
Children
Care should be taken in newborns and
young infants as there is the chance of
higher levels of amoxicillin in the blood.
In the case of premature children and
newborns, the kidneys, liver and blood may
be monitored by your doctor.

Other medicines and Amoxicillin
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription. The
following medicines can affect or be affected
by treatment with Amoxicillin:
• any other antibiotics
• oral anticoagulants, medicines that stop
your blood clotting
• oral contraceptives
• a medicine known as methotrexate, used
in the treatment of cancer
• other types of antibacterial treatments,
such as bacteriostatic agents (e.g.
chloramphenicol) and tetracyclines
• medicines used to treat gout, such as
probenecid and allopurinol.
Tell your doctor if you are taking Amoxicillin
as it may affect the results of blood or urine
tests.
Pregnancy and Breast-feeding
If you are pregnant, think you may be
pregnant or are planning to have a baby ask
your doctor or pharmacist for advice before
you taking this medicine.
Small amounts of this medicine can be
passed into breast milk. Ask your doctor for
advice before breastfeeding.
3. 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 unsure.
Your doctor will decide on the appropriate
dose to suit the severity and type of infection
you have. Always read the label.
To treat or prevent infections the usual
doses are:
Adults, the elderly, or children over 10
years old
• Standard dose: 250mg every eight hours
or 500mg every eight hours for more
severe infections.
• High dose therapy: up to 6 g daily in
divided doses.
• To prevent infections after surgery:
the dose will vary according to the type of
surgery. Your doctor will tell you exactly
how much medicine you will need and
when you will need it.
You may need to have 1g or 3g before
surgery, sometimes with another medicine
called gentamicin. This may be followed
by a further dose after surgery.
Children up to 10 years of age
• Standard dose (children weighing
over 40kg): 125mg every eight hours or
250mg every eight hours for more severe
infections.
• Standard dose (children weighing
under 40kg): 40 – 90mg for every
kilogram of body weight in equal doses
throughout the day.
• To prevent infections after surgery:
the dose will vary according to the type of
surgery. Your doctor will tell you exactly
how much medicine you will need and
when you will need it.
-  or children aged 5 to 10 years, the
F
dose is usually half the adult dose, see
above.
-  or children aged up to 5 years, the
F
dose is usually one-quarter of the adult
dose, see above.
Patients with kidney problems
If you have kidney problems the dose might
be lower and more frequent than the usual
dose. Amoxicillin is removed by dialysis
(artificial filtration and purification of the
blood). Therefore, patients receiving dialysis
may require another dose of Amoxicillin at
the end of their dialysis session.
If you take too much Amoxicillin
If you or someone else takes too much
Amoxicillin, contact your doctor or nearest
hospital emergency department immediately.
Take the box and any capsules that are left
over with you, if you can.
The symptoms of an overdose may include
the presence of crystals in the urine which
cannot be seen by the patient.

The doctor will assess your condition and
decide how to treat an overdose.
If you forget to take Amoxicillin
If you miss a dose, take it as soon as you
remember and carry on as before. If it
almost time for your next dose, skip the
missed dose and continue as usual. Do not
take a double dose to make up for a missed
dose.
If you have further questions on the use of
this medicine, ask your doctor or pharmacist.
5. How to store Amoxicillin

4. Possible side effects
Like all medicines, Amoxicillin can cause side
effects, although not everybody gets them.
Tell your doctor straight away if you
notice any of the following serious side
effects:
• severe allergic reaction (anaphylaxis).
Symptoms include rash or itching of the
skin, swelling of the face, lips, mouth,
tongue or throat that may cause difficulty
in swallowing or breathing
• if you develop a skin rash, your doctor
may give you a different medicine
• patients with syphilis or leptospirosis may
experience a condition known as JarischHerxheimer reaction, which can cause
high temperature (fever), chills, headache
and worsening of skin lesions.
Other side effects of Amoxicillin may include:
• delayed allergic reaction (that can occur
more than seven days after starting
treatment with Amoxicillin), symptoms
include rashes, high temperature (fever),
joint pain, and enlargement of lymph
nodes (glands)
• reduction in red blood cells (shown in
blood tests), which can make the skin pale
and cause you to feel tired, weak, dizzy, or
short of breath
• kidney problems that may lead to back
pain, and pain when passing water (urine)
• other severe skin reactions such as:
changes in skin colour, bumps under the
skin, blistering, pustules, peeling, redness,
pain, itching and scaling
• difficulty breathing, or shortness of breath
• changes in the levels of white blood cells
(shown in blood tests), which can make
infections more likely
• reductions in the levels of blood platelets
in the blood (shown in blood tests), which
may lead to bruising more easily or
bleeding for longer if you cut yourself or
have a nosebleed
• fits or hallucinations (hearing or seeing
things that aren’t there)
• changes in your salt and electrolyte levels
(shown in blood tests)
• patients with glandular fever and other
lymphoid disorders (e.g. lymphatic
leukaemia or HIV) may be at higher risk
of developing a rash (see also “Warnings
and precautions” in section 2).
• feeling or being sick, sore mouth and
tongue, diarrhoea, indigestion, stomach
discomfort or candida (yeast) infection. In
cases of severe of persistent diarrhoea,
the possibility of a digestive condition
known as ‘pseudomembranous colitis’
may be considered by your doctor
and your treatment stopped (see also
“Warnings and precautions” in section 2).
• inflammation of the large bowel with
diarrhoea that may contain blood, pain,
and high temperature (fever)
• a skin reaction known as ‘erythema
multiforme’ which has symptoms such as:
itchy reddish purple patches on the skin,
especially on the palms of the hands and
soles of the 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 high temperature
(fever) and feel very tired
• a rare allergic reaction called StevensJohnson syndrome which causes severe
illness with ulcers on the mouth, lips and
skin
• coma
• liver problems such as hepatitis and
jaundice, which may cause yellowing of
the skin or whites of the eyes, pale stools
or dark urine, blisters, redness or bruising
of the skin.

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. The
expiry date refers to the last day of that
month.
• Store below 25ºC, in the original container.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines you
no longer use. These measures will help
protect the environment.
6. Contents of the pack and other
information
What Amoxicillin contains
The active ingredient is amoxicillin trihydrate.
Each 250mg capsule contains 293mg
amoxicillin trihydrate, equivalent to 250.0mg
amoxicillin
Each 500mg capsule contains 586mg
amoxicillin trihydrate, equivalent to 500.0mg
amoxicillin
The other ingredients are magnesium
stearate, indigo carmine (E132), erythrosine
(E127), titanium dioxide (E171), gelatin,
yellow iron oxide (E172), shellac (E904),
dehydrated alcohol, isopropyl alcohol, butyl
alcohol, propylene glycol (E1520) strong
ammonia solution, black iron oxide (E172),
potassium hydroxide (E525) and purified
water.
What Amoxicillin looks like and the
contents of the pack
Amoxicillin 250mg Hard Capsules are
opaque red and yellow capsule with ‘’AMX
250’’ printed in black.
Amoxcillin 500mg Hard Capsules are
opaque red and yellow capsules with “AMX
500” printed in black.
Amoxicillin 250mg and 500mg capsules
are supplied in either a polypropylene or
polyethylene container containing 100 or
500 capsules or PVC/aluminium blisters
with outer cardboard carton, containing 21
capsules.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free
of charge:
0800 198 5000 (UK only).
Please be ready to give the following
information:
Product name

Reference numbers

Amoxicillin 250 mg
Hard Capsules

PL 29831/0244

Amoxicillin 500 mg
Hard Capsules

PL 29831/0243

This is a service provided by the Royal
National Institute of Blind People.
For the Republic of Ireland please call
+ 353 52 36253.
Leaflet Prepared: September 2012.

If you get any side effects, talk to your
doctor. This may include any possible side
effects not listed in the leaflet.

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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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