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AMOXICILLIN 250MG HARD CAPSULES

Active substance(s): AMOXYCILLIN TRIHYDRATE / AMOXICILLIN TRIHYDRATE / AMOXYCILLIN TRIHYDRATE / AMOXICILLIN TRIHYDRATE / AMOXYCILLIN TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Amoxicillin 250 mg Capsules
Amoxicillin 500 mg Capsules
Amoxicillin (as trihydrate)
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 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.
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

What Amoxicillin is
Amoxicillin is an antibiotic. The active ingredient
is amoxicillin. This belongs to a group of
medicines called penicillins.
What Amoxicillin is used for
Amoxicillin is used to treat infections caused by
bacteria in different parts of the body. Amoxicillin
may also be used in combination with other
medicines to treat stomach ulcers.

2

What you need to know before
you take Amoxicillin

Do not take Amoxicillin:
• If you are allergic to amoxicillin, penicillin or
any of the other ingredients of this medicine
(listed in Section 6).
• if you have ever had an allergic reaction to
any antibiotic. This can include a skin rash or
swelling of the face or throat.
Do not take Amoxicillin if any of the above
apply. If you are not sure, talk to your doctor or
pharmacist before taking Amoxicillin.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Amoxicillin if you:
• have glandular fever (fever, sore throat,
swollen glands and extreme tiredness)
• have kidney problems
• are not urinating regularly.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Amoxicillin.
Blood and urine tests
If you are having:
• Urine tests (glucose) or blood tests for liver
function
• Oestriol tests (used during pregnancy to
check the baby is developing normally)
Tell your doctor or pharmacist that you are
taking Amoxicillin. This is because Amoxicillin
can affect the results of these tests.
Other medicines and Amoxicillin
Tell your doctor or pharmacist, if you are taking,
have recently taken or might take any other
medicines.
• If you are taking allopurinol (used for gout)
with Amoxicillin, it may be more likely that you
will have an allergic skin reaction.
• If you are taking probenecid (used for gout),
your doctor may decide to adjust your dose of
Amoxicillin.
• If you are taking medicines to help stop blood
clots (such as warfarin), you may need extra
blood tests.
• If you are taking other antibiotics (such as
tetracycline) Amoxicillin may be less effective.
• If you are taking methotrexate (used for the
treatment of cancer and severe psoriasis).
Amoxicillin may cause an increase in side
effects.
Pregnancy, breast-feeding and fertility:
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.
Driving and using machines:
Amoxicillin can have side effects and the
symptoms (such as allergic reactions, dizziness
and convulsions) may make you unfit to drive.
Do not drive or operate machines unless you
are feeling well.

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 not sure.
• Swallow with water without opening the
capsule.
• Space the doses evenly during the day, at
least 4 hours apart.
The usual dose is
Children weighing less than 40 kg
All doses are worked out depending on the
child’s body weight in kilograms.
• Your doctor will advise you how much
Amoxicillin 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.
• The maximum recommended dose is 100 mg
for each kilogram of body weight a day.
Adults, elderly patients and children
weighing 40 kg or more
The usual dose of Amoxicillin is 250 mg to

500 mg three times a day or 750 mg to 1 g
every 12 hours, depending on the severity and
type of infection.
• Severe infections: 750 mg to 1 g three times a
day.
• Urinary tract infection: 3 g twice daily for one
day.
• Lyme disease (an infection spread by
parasites called ticks): Isolated erythema
migrans (early stage – red or pink circular
rash): 4 g a day, Systemic manifestations (late
stage – for more serious symptoms or when
the disease spreads around your body): up to
6 g a day.
• Stomach ulcers: one 750 mg or one 1 g dose
twice a day for 7 days with other antibiotics
and medicines to treat stomach ulcers.
• To prevent heart 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.
• The maximum recommended dose is 6 g per
day.
Kidney problems
If you have kidney problems the dose might be
lower than the usual dose.
If you take more Amoxicillin than you
should:
If you have taken 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
urinating. 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, take it as soon as
you remember.
• Do not take the next dose too soon, wait
about 4 hours before taking the next dose.
• Do not take a double dose to make up for a
forgotten dose.
How long should you take Amoxicillin for?
• Keep taking Amoxicillin for as long as your
doctor has told you to, 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.
• Once you finish treatment, if you still feel
unwell you should go back to see the doctor.
Thrush (a yeast infection of moist areas of the
body which can cause soreness, itching and
white discharge) may develop if Amoxicillin
is used for a long time. If this occurs tell your
doctor.
If you take Amoxicillin for a long time, your
doctor may perform additional tests to check
your kidneys, liver and blood are working
normally.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine 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 (may affect up to
1 in 10,000 people)
• 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 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
feet, ‘hive-like’ raised swollen areas on the
skin, tender areas on the surfaces of the
mouth, eyes and genitals. 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
• 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
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• the Jarisch-Herxheimer reaction which occurs
during treatment with Amoxicillin for Lyme
disease and causes fever, chills, headache,
muscle pain and skin rash.
• inflammation of the large bowel (colon) with
diarrhoea (sometimes containing blood), pain
and fever
• serious liver side effects may occur. 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 happens 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 (may
affect up to 1 in 100 people).
If you have any of these talk to your doctor as
Amoxicillin will need to be stopped.
The other possible side effects are:
Common (may affect up to 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea.
Uncommon (may affect up to 1 in 100 people)
• being sick (vomiting).
Very rare (may affect up to 1 in 10,000 people)
• thrush (a yeast infection of the vagina, mouth
or skin folds), you can get treatment for thrush
from your doctor or pharmacist
• kidney problems
• fits (convulsions), seen in patients on high
doses or with kidney problems
• dizziness
• 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 type of anaemia. Signs include:
tiredness, headaches, shortness of breath,
dizziness, looking pale and yellowing of the
skin and the whites of the eyes
• low number of white blood cells
• low number of cells involved with blood
clotting
• the blood may take longer to clot than it
normally would. You may notice this if you
have a nosebleed or cut yourself.

hospital packs of 500 and 1000 hard capsules in
blisters in carton box
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing authorisation holder:
Sandoz Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK
Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, 6250
Kundl, Austria
This leaflet was last revisedin 03/2016.
General advice regarding the use of
antibiotics
Antibiotics are used to treat infections
caused by bacteria. They have no effect
against infections caused by viruses.
Sometimes an infection caused by bacteria
does not respond to a course of an antibiotic.
One of the commonest reasons for this
to occur is because the bacteria causing
the infection are resistant to the antibiotic
that is being taken. This means that they
can survive and even multiply despite the
antibiotic.
Bacteria can become resistant to antibiotics
for many reasons. Using antibiotics carefully
can help to reduce the chance of bacteria
becoming resistant to them.
When your doctor prescribes a course
of an antibiotic it is intended to treat only
your current illness. Paying attention to
the following advice will help prevent the
emergence of resistant bacteria that could
stop the antibiotic working.
1-It is very important that you take the
antibiotic at the right dose, at the right times
and for the right number of days. Read the
instructions on the label and if you do not
understand anything ask your doctor or
pharmacist to explain.
2-You should not take an antibiotic unless it
has been prescribed specifically for you and
you should use it only to treat the infection
for which it was prescribed.
3-You should not take antibiotics that have
been prescribed for other people even if they
had an infection that was similar to yours.
4-You should not give antibiotics that were
prescribed for you to other people.
5-If you have any antibiotic left over when
you have taken the course as directed by
your doctor you should take the remainder to
a pharmacy for appropriate disposal.

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: www.mhra.gov.uk/yellowcard By
reporting side effects you can help provide more
information on the safety of this medicine.

5

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 carton after EXP. The
expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original
package in order to protect from 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.

6

Contents of the pack and other
information

What Amoxicillin contains
The active substance is amoxicillin (as
trihydrate).
Each capsule contains 250mg or 500 mg
amoxicillin.
The other ingredients are:
- capsule content: magnesium stearate,cellulose
microcrystalline - capsule shell:yellow iron oxide
(E172), titanium dioxide (E171), gelatin - black
printing ink: propylene glycol, shellac, black iron
oxide (E172).
What Amoxicillin looks like and contents of
the pack
Capsule, hard
Amoxicillin 250 mg hard capsules:
Yellow, opaque hard gelatin capsules no. 2
with axial black imprints, alternately “AMX”
and “250”, containing white to cream-coloured
powder.
Amoxicillin 500 mg hard capsules:
Yellow, opaque hard gelatin capsules no. 0 with
axial black imprints “AMOX 500”, containing
white to cream-coloured powder.
Blister consisting of a clear polyvinyl chloride foil
with a coating of polyvinylidene chloride (PVC/
PVDC) and aluminium foil.
Amoxicillin 250 mg hard capsules:
single packs of 12, 21 and 100 hard capsules in
blisters in carton box
hospital packs of 500 and 1000 hard capsules
in blisters in carton box
Amoxicillin 500 mg hard capsules:
single packs of 10, 12, 16, 20, 21, 24, 30 and
100 hard capsules in blisters in carton box

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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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