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AMOXICILLIN 3G SACHETS S.F

Active substance(s): AMOXICILLIN TRIHYDRATE

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TEVA UK Ref:

Version:

231-30-83834-D LEA AMOXICILLIN 3g SAC TUK
4

• 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 acenocoumarol
Package leaflet:
warfarin), you may need extra blood
Information for the user
tests.
Read all of this leaflet carefully before
• If you are taking other antibiotics (such
you start taking this medicine because it
as tetracycline) Amoxicillin may be less
contains important information for you.
effective.
• Keep this leaflet. You may need to read • If you are taking methotrexate (used for
it again.
the treatment of cancer and severe
• If you have any further questions, ask
psoriasis) Amoxicillin may cause an
your doctor or pharmacist.
increase in side effects.
• This medicine has been prescribed for
you (or for your child) only. Do not pass Pregnancy and breast-feeding
it on to others. It may harm them, even If you are pregnant or breast-feeding,
if their signs of illness are the same as think you may be pregnant or are
yours (or your child’s).
planning to have a baby, ask your doctor,
• If you get any side effects, talk to your pharmacist or dentist for advice before
doctor or pharmacist. This includes any taking this medicine.
possible side effects not listed in this
Driving and using machines
leaflet. See section 4.

Amoxicillin 3 g sachets SF
Sugar free
(amoxicillin trihydrate)

The name of your medicine is
Amoxicillin 3 g sachets SF. It will be
referred to as Amoxicillin throughout the
remainder of the leaflet.

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 machinery
What is in this leaflet
unless you are feeling well.
1. What Amoxicillin is and what it is used
Amoxicillin contains sorbitol and sodium
for
• Amoxicillin contain a sugar substitute,
2. What you need to know before you
sorbitol (E420). If your doctor has told
take Amoxicillin
you that you have an intolerance to
3. How to take Amoxicillin
some sugars, contact your doctor
4. Possible side effects
before taking this medicine.
5. How to store Amoxicillin

Each 3 g sachet contains a minimum of
6. Contents of the pack and other
5.4 g of sorbitol. If you are taking the
information
maximum daily dose of 6 g of
you will also be taking a
1 What Amoxicillin is and what it amoxicillin
minimum of 10.8 g of sorbitol each day.
is used for
At daily doses of 10 g or more sorbitol
Amoxicillin contains the active
may have a mild laxative effect.
ingredient amoxicillin. Amoxicillin is an
• Sorbitol also has a calorific value of
antibiotic. It belongs to a group of
2.6 kcal per gram, so the sorbitol
medicines called ‘penicillin’.
content in each Amoxicillin 3 g sachet
is equivalent to 14 kcal.
Amoxicillin is used to treat a variety of
• Each sachet also contains 1.22 mmol
infections caused by a wide range of
(or 28 mg) sodium and should be taken
bacteria, such as:
into consideration if you are on a
• severe infections of the respiratory
controlled sodium diet.
tract (airways)
• middle ear infections (including severe
3 How to take Amoxicillin
and re-occurring ear infections in
children)
Always take this medicine exactly as your
• urinary tract infections (“water works”) doctor, pharmacist or dentist has told
e.g. cystitis, urethritis or pyelonephritis you. You should check with your doctor,
• infection that may occur during
pharmacist or dentist if you are not sure.
childbirth or after an abortion
• Put the content of the sachet in 10 to
• gonorrhoea
20 ml of water. Shake until a suspension
• inflammation or infections in the
abdomen (peritonitis, abdominal sepsis) is formed. Take immediately.
• Space the doses evenly during the day,
• infections in the blood (septicaemia)
at least 4 hours apart
• infections of the heart valves or inner
surfaces (endocarditis)
The recommended dose is:
• digestive problems that cause
dehydration and diarrhoea (typhoid or Children weighing less than 40 kg
All doses are worked out depending on
paratyphoid)
the child’s body weight in kilograms.
• skin and soft tissue infections
• Your doctor will advise you how much
• inflammation of the bone and bone
Amoxicillin you should give to your
marrow (osteomyelitis)
baby or child.
• dental abscesses.
• The recommended dose is 40 mg to
Amoxicillin may also be used before
90 mg for each kilogram of body weight
dental procedures such as having your
a day, given in two or three divided doses
teeth out, if you are at risk of getting
• The maximum recommended dose is
endocarditis.
100 mg for each kilogram of body
weight
a day
Amoxicillin may also be used in
combination with other medicines to
Adults, elderly patients and children
treat stomach ulcers.
weighing 40 kg or more
The recommended dose of Amoxicillin is
2 What you need to know before 250 mg to 500 mg three times a day or
you take Amoxicillin
750 mg to 1 g every 12 hours, depending
on the severity and type of infection.
DO NOT take Amoxicillin:
• Severe infections: 750 mg to 1 g three
• if you are allergic to the active
times a day.
substance or any of the other
• Urinary tract infection: 3 g twice daily
ingredients of this medicine (listed in
for one day.
section 6).
• Lyme disease (an infection spread by
• if you are allergic to penicillin or to any
parasites called ticks): Isolated
other penicillin antibiotics or to other
erythema migrans (early stage – red or
beta-lactam antibiotics e.g.
pink circular rash): 4 g a day, Systemic
cephalosporin.
manifestations (late stage – for more
• if you have ever had an allergic
serious symptoms or when the disease
reaction to any antibiotic. This can
spreads around your body): up to 6 g a
include a skin rash or swelling of the
day.
face or throat.
• Stomach ulcers: one 750 mg or one 1 g
• if you are suffering from glandular fever.
dose twice a day for 7 days with other
• if you have severe kidney disease.
antibiotics and medicines to treat
stomach ulcers.
Do not take Amoxicillin if any of the
above applies to you. If you are not sure, • To prevent heart infection during
surgery: the dose will vary according to
talk to your doctor pharmacist or dentist
the type of surgery. Other medicines
before taking Amoxicillin.
may also be given at the same time.
Warnings and Precautions
Your doctor, pharmacist or dentist can
Talk to your doctor pharmacist or dentist
give you more details.
before taking Amoxicillin if you:
• The maximum recommended dose is
• have an intolerance to some sugars
6 g per day
e.g. fructose
Kidney problems
• have kidney problems, as your dose
If
you have kidney problems the dose
may need to be reduced
might be lower than the usual dose and
• know that you are allergic to pollen,
a different dosage form may be more
fur, dust, cosmetics etc
appropriate.
• have an infection caused by a virus
known as cytomegalovirus
For children (weighing less than 40 kg)
• have acute or chronic lymphocytic
who have severe infections such as
leukaemia.
tonsillitis, recurrent ear infection, kidney
• have glandular fever (fever, sore throat, problems or dental problems
swollen glands, and extreme tiredness) • Your doctor will decide the correct dose
• are not urinating regularly.
for you.
If you are not sure if any of the above
Children under 6 months old
applies to you, talk to your doctor
• This medicine should not be used in
pharmacist or dentist before taking
children under 6 months; instead
Amoxicillin.
Amoxicillin oral suspension 125 mg/
5 ml should be given.
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, pharmacist or dentist
that you are taking Amoxicillin. This is
because Amoxicillin can affect the results
of these tests.
Other medicines and Amoxicillin
Tell your doctor, pharmacist or dentist if
you are taking, have recently taken or
might take any other medicines especially
• If you are taking allopurinol (used for
gout) with Amoxicillin, it may be more
likely that you will have an allergic skin
reaction.

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If you take more Amoxicillin than you
should
If you (or someone else) take too much
of this medicine, or if you think a child
has swallowed any of the content of the
sachets, contact your nearest hospital
casualty department or your doctor
immediately.
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.
Please take this leaflet, any remaining
sachets, and the container with you to
the hospital or doctor so that they know
which medicine was consumed.

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Version:

231-30-83834-D LEA AMOXICILLIN 3g SAC TUK
4

• 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
DO NOT stop taking your medicine as
• low number of white blood cells
soon as you feel better. Take all the
• low number of cells involved with
medicine your doctor, pharmacist or
blood clotting
dentist has given you to complete the
• the blood may take longer to clot than
course of treatment.
it normally would. You may notice this
if you have a nosebleed or cut yourself.
Keep taking your medicine for as long as
your doctor has told you to, even if you
Reporting of side effects
feel better. You need every dose to help
If you get any side effects, talk to your
fight the infection. If some bacteria
doctor or pharmacist. This includes any
survive they can cause the infection to
possible side effects not listed in this
come back.
leaflet. You can also report side effects
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.

Once you finish treatment, if you still feel directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
unwell you should go back to see the
By reporting side effects you can help
doctor.
provide more information on the safety
Thrush (a yeast infection of moist areas of this medicine.
of the body which can cause soreness,
itching and white discharge) may
5 How to store Amoxicillin
develop if Amoxicillin is used for a long
time. If this occurs tell your doctor.
Keep this medicine out of the sight and
If you take Amoxicillin for a long time,
reach of children.
your doctor may perform additional tests
Do not use this medicine after the expiry
to check your kidneys, liver and blood
date which is stated on the carton. The
are working normally.
If you have any further questions on the expiry date refers to the last day of that
use of this medicine, ask your doctor or month.
pharmacist.
Do not store above 25oC.

4

Do not use this medicine if there are
visible signs of deterioration.

Possible side effects

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
Stop taking Amoxicillin and see a doctor medicines you no longer use. These
measures will help protect the
straight away or go to the casualty
environment.
department at your nearest hospital, if
you notice any of the following serious
side effects – you may need urgent
6 Contents of the pack and other
information
medical treatment:
• 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
• the Jarisch-Herxheimer reaction which
occurs during treatment with
Amoxicillin for Lyme disease 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:
o severe diarrhoea with bleeding
o blisters, redness or bruising of the
skin
o darker urine or paler stools
o 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.
If you have any of these talk to your
doctor as Amoxicillin will need to be
stopped.
Other side effects:













feeling sick (nausea)
diarrhoea.
being sick (vomiting).
thrush (a yeast infection of the vagina,
mouth or skin folds), you can get
treatment for thrush from your doctor,
pharmacist or dentist
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
teeth may appear stained, usually
returning to normal with brushing (this
has been reported in children)

What Amoxicillin contains:
• The active ingredient in each sachet is
3g amoxicillin.
• The other ingredients are: sodium
citrate, citric acid, colloidal anhydrous
silica, sorbitol (E420), saccharin
sodium, orange bramble flavour,
quinoline yellow (E 104),
monoammonium glycyrrhizinate and
xanthan gum.
What Amoxicillin looks like and contents
of the pack:
• The powder in amoxicillin sugar free
sachets is a cream/pale yellow colour.
• The sachets come in boxes of 2 and 14.
Not all pack sizes may be marketed.
The Marketing Authorisation Holder is:
TEVA UK Limited. Eastbourne, BN22 9AG.
The Manufacturer is:
Laboratrio Reig Jofre S.A., C/Jarama S/N,
(Poligono Industrial), 45007 Toledo, Spain.
This leaflet was last revised: February
2016
PL 00289/1590

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

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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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