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AMOXICILLIN 3G SACHETS S.F

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

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Amoxicillin 3 g sachets SF
Sugar free
(amoxicillin trihydrate)
Package leaflet:
Information for the user

• 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 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.

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 (or for your child) only. Do
not pass it on to others. It may harm
them, even if their signs of illness are
the same as yours (or your child’s).
• 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.

Pregnancy and breast-feeding

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.

What is in this leaflet

If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor,
pharmacist or dentist for advice before
taking this medicine.
Driving and using machines

Do not drive or operate machinery
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
and re-occurring ear infections in
children)
• urinary tract infections (“water works”)
e.g. cystitis, urethritis or pyelonephritis
• infection that may occur during
childbirth or after an abortion
• gonorrhoea
• inflammation or infections in the
abdomen (peritonitis, abdominal sepsis)
• infections in the blood (septicaemia)
• infections of the heart valves or inner
surfaces (endocarditis)
• digestive problems that cause
dehydration and diarrhoea (typhoid or
paratyphoid)
• skin and soft tissue infections
• inflammation of the bone and bone
marrow (osteomyelitis)
• dental abscesses.
Amoxicillin may also be used before
dental procedures such as having your
teeth out, if you are at risk of getting
endocarditis.
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 the active
substance or any of the other
ingredients of this medicine (listed in
section 6).
• if you are allergic to penicillin or to any
other penicillin antibiotics or to other
beta-lactam antibiotics e.g.
cephalosporin.
• if you have ever had an allergic
reaction to any antibiotic. This can
include a skin rash or swelling of the
face or throat.
• if you are suffering from glandular fever.
• if you have severe kidney disease.
Do not take Amoxicillin if any of the
above applies to you. If you are not sure,
talk to your doctor pharmacist or dentist
before taking Amoxicillin.
Warnings and Precautions
Talk to your doctor pharmacist or dentist
before taking Amoxicillin if you:
• have an intolerance to some sugars
e.g. fructose
• have kidney problems, as your dose
may need to be reduced
• know that you are allergic to pollen,
fur, dust, cosmetics etc
• have an infection caused by a virus
known as cytomegalovirus
• have acute or chronic lymphocytic
leukaemia.
• have glandular fever (fever, sore throat,
swollen glands, and extreme tiredness)
• are not urinating regularly.
If you are not sure if any of the above
applies to you, talk to your doctor
pharmacist or dentist 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, 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.

3

How to take Amoxicillin

Always take this medicine exactly as your
doctor, pharmacist or dentist has told
you. You should check with your doctor,
pharmacist or dentist if you are not sure.
• Put the content of the sachet in 10 to
20 ml of water. Shake until a
suspension is formed. Take
immediately.
• Space the doses evenly during the
day, at least 4 hours apart
The recommended 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 recommended 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 recommended 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 dentist 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 and
a different dosage form may be more
appropriate.
For children (weighing less than 40 kg)
who have severe infections such as
tonsillitis, recurrent ear infection, kidney
problems or dental problems
• Your doctor will decide the correct dose
for you.
Children under 6 months old
• This medicine should not be used in
children under 6 months; instead
Amoxicillin oral suspension
125 mg/5 ml should be given.
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.

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.
DO NOT stop taking your medicine as
soon as you feel better. Take all the
medicine your doctor, pharmacist or
dentist has given you to complete the
course of treatment.
Keep taking your medicine 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 or go to the casualty
department at your nearest hospital, if
you notice any of the following serious
side effects – you may need urgent
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
• rash, fever, swollen glands,
inflammation of internal organs,
increase in white blood cells
caused due to exposure to certain
medications (DRESS syndrome)
• 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 protective
membrane surrounding the brain
(aseptic meningitis)
• 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:
Common (may affect up to 1 in 10 people):
• feeling sick (nausea)
• diarrhoea.
Uncommon (may affect up to 1 in 100
people):
• being sick (vomiting).
Very Rare (may affects 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, 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)
• 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.
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 at:
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. The
expiry date refers to the last day of that
month.
Do not store above 25oC.
Do not use this medicine if there are
visible signs of deterioration.
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 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.
Marketing Authorisation Holder
TEVA UK Limited. Eastbourne, BN22 9AG.
Manufacturer
Laboratrio Reig Jofre S.A., C/Jarama S/N,
(Poligono Industrial), 45007 Toledo, Spain.
This leaflet was last revised in May 2017
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

EAS1104a

170 x 520

Expand Transcript

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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