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AMOXICILLIN 3G SACHETS S.F

Active substance: AMOXICILLIN TRIHYDRATE

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TEVA UK Ref:

231-30-83834-C LEA AMOXICILLIN 3g SAC TUK
Version:

2

20 May 2015

TEVA UK Ref:

AMOXICILLIN 3 g SACHETS SF Important information about some
of the ingredients of Amoxicillin
SUGAR FREE

Children under 6 months old
• Amoxicillin sachets should not be
used for children under 6 months;
instead Amoxicillin oral
suspension 125 mg/5 ml should
be given.

• Amoxicillin sachets contain a
(amoxicillin trihydrate)
sugar substitute, sorbitol (E420). If
your doctor has told you that you
PACKAGE LEAFLET:
have an intolerance to some
INFORMATION FOR THE USER
sugars, contact your doctor before
Read all of this leaflet carefully
taking this medicine.
before you start taking this medicine. • Each 3 g sachet contains a
• Keep this leaflet. You may need to
minimum of 5.4 g of sorbitol. If
read it again.
you are taking the maximum daily
• If you have any further questions,
dose of 6 g of amoxicillin you will
ask your doctor or pharmacist.
also be taking a minimum of
• This medicine has been
10.8 g of sorbitol each day. At
prescribed for you. Do not pass it
daily doses of 10 g or more
on to others. It may harm them,
sorbitol may have a mild laxative
even if their symptoms are the
effect.
same as yours.
• Sorbitol also has a calorific value
• If you get any side effects, talk to
of 2.6 kcal per gram, so the
your doctor or pharmacist. This
sorbitol content in each
includes any possible side effects
Amoxicillin 3 g sachet is
not listed in this leaflet. See
equivalent to 14 kcal.
section 4.
• Each sachet also contains
1.22 mmol (or 28 mg) sodium and
IN THIS LEAFLET:
should be taken into consideration
if you are on a controlled sodium
1. What Amoxicillin is and what it is
diet.
used for
2. Before you take Amoxicillin
Pregnancy and breast-feeding
3. How to take Amoxicillin
• If you are pregnant, planning to
4. Possible side effects
become pregnant or are
5. How to store Amoxicillin
breast-feeding, ask your doctor for
6. Further information
advice before taking this
medicine.
WHAT AMOXICILLIN IS AND

Version:

231-30-83834-C LEA AMOXICILLIN 3g SAC TUK
2

Uncommon
• indigestion
• being sick (vomiting)
• urticaria (nettle rash)
• itching.

Very rare
• some people can get thrush (a
yeast infection of the vagina,
mouth or skin folds) during or
after treatment
• an excessive breakdown of red
blood cells causing a form of
anaemia.
• the blood may take longer to clot
than it normally would. You may
notice this if you have a
nosebleed or cut yourself
• abnormal increase in muscular
activity (hyperkinesia)
• dizziness
• fits (convulsions), seen in patients
on high doses or with kidney
problems
If you forget to take Amoxicillin
• the tongue may change to yellow,
If you forget to take a dose at the
brown or black and it may have a
right time, take one as soon as you
hairy appearance
remember, unless it is nearly time to • teeth may appear stained, usually
take the next one. DO NOT take a
returning to normal with brushing
double dose to make up for a
(this has been reported in
forgotten dose.
children)
• the skin and the whites of your
If you stop taking Amoxicillin
eyes becoming yellow (jaundice)
DO NOT stop taking your sachets as
• inflammation of the kidney which
soon as you feel better. Take all the
can cause swollen ankles or high
sachets your doctor or dentist has
blood pressure
given you to complete the course of
• crystals in the urine, which may
treatment.
be seen as cloudy urine, or
difficulty or discomfort in passing
If you have any further questions on
urine. Make sure you drink plenty
the use of this product, ask your
of fluids to reduce the chance of
doctor or pharmacist.
these symptoms.
If you take more Amoxicillin than
you should
If you (or someone else) take too
many sachets, or if you think a child
has swallowed any of the sachets,
contact your nearest hospital
casualty department or your doctor
immediately.
An overdose is likely to cause feeling
sick, being sick, diarrhoea, or
urinating a lot.
Please take this leaflet, any
remaining sachets, and the container
with you to the hospital or doctor so
that they know which sachets were
consumed.

1

WHAT IT IS USED FOR
Driving and using machines
• Amoxicillin is not known to affect
Amoxicillin belongs to a group of
your ability to drive or operate
drugs known as penicillin antibiotics.
machinery.
Amoxicillin is used to treat a variety
of infections caused by a wide range 3 HOW TO TAKE AMOXICILLIN
of bacteria, such as:
• severe infections of the
Always take Amoxicillin exactly as
respiratory tract (airways)
your doctor or dentist has told you.
• middle ear infections (including
You should check with your doctor,
severe and re-occurring ear
dentist or pharmacist if you are not
infections in children)
sure.
• urinary tract infections (“water
You should empty the powder from
works”) e.g. cystitis, urethritis or
the sachet into a glass of water, stir
pyelonephritis
the mixture, and swallow it
• infection that may occur during
immediately.
childbirth or after an abortion
The usual dose is:
• gonorrhoea
• inflammation or infections in the
abdomen (peritonitis, abdominal Adults and the Elderly
The standard dose for treatment of
sepsis)
infections is normally 250 mg three
• infections in the blood
times daily increasing to 500 mg
(septicaemia)
three times daily for more severe
• infections of the heart valves or
infections. The maximum adult dose
inner surfaces (endocarditis)
is 3 g (1 sachet) twice a day.
• digestive problems that cause
The dosage for treatment of some
dehydration and diarrhoea
specific conditions is given below:
(typhoid or paratyphoid)
• Urinary tract infections
• skin and soft tissue infections
The recommended treatment is a
• inflammation of the bone and
3 g dose (1 sachet), repeated after
bone marrow (osteomyelitis)
10-12 hours.
• dental abscesses.
• Gonorrhoea
A single dose of 3 g (1 sachet).
Amoxicillin may also be used before
• Dental abscesses
dental procedures such as having
The recommended treatment is a
your teeth out, if you are at risk of
3 g dose (1 sachet), repeated after
getting endocarditis.
8 hours.
• Before dental treatment
2 BEFORE YOU TAKE
• If you are NOT having an
AMOXICILLIN
anaesthetic
DO NOT take Amoxicillin if you:
You will be given a 3 g dose
• are allergic (hypersensitive) to
orally an hour before the
Amoxicillin or any of the other
procedure, followed by a
ingredients of this medicine, to
second dose of 3 g if needed
any other penicillin antibiotics or
6 hours later.
to other beta-lactam antibiotics
• If you are having an anaesthetic
e.g. cephalosporin
(where oral antibiotics are
• are suffering from glandular fever
appropriate)
• have severe kidney disease.
You will be given a 3 g dose
orally 4 hours before the
Take special care with Amoxicillin
procedure, followed by either a
Tell your doctor before you start to
second dose of 3 g orally or an
take this medicine if you:
injection of 1 g given to you
• have an intolerance to some
either into a vein or into a
sugars e.g. fructose
muscle, as soon as possible
• have kidney problems, as your
after the operation.
dose may need to be reduced
• If you are having an anaesthetic
• know that you are allergic to
(where oral antibiotics are NOT
pollen, fur, dust, cosmetics etc
appropriate)
• have an infection caused by a
You will be given an injection of
virus known as cytomegalovirus
a 1 g dose either into a vein or
• have acute or chronic lymphocytic
into a muscle immediately
leukaemia.
before the anaesthetic is given,
followed by 500 mg orally
Having urine or blood test
6 hours later.
If you have any tests such as blood
or urine tests while you are taking
Patients with kidney problems
Amoxicillin Sachets, make sure you The dose you should take may be
tell your doctor or nurse, as
lower than those given above, and a
amoxicillin can affect the results of
different dosage form may be more
some tests, e.g.
appropriate.
• blood test for cell counts
• urine test for glucose.
Children weighing more than
40 kilogram (kg)
Taking other medicines
• They should be given the usual
Talk to your doctor if you are taking
adult dose.
any of the following:
• are taking methotrexate (for
Children weighing less than 40 kg
psoriasis, rheumatoid arthritis or • The dose depends on your
cancer)
weight.
• probenecid or allopurinol (for
• The usual starting dose is
gout)
between 40-90 mg/kilogram daily
• anticoagulants such as
(in two or three doses).
acenocoumarol or warfarin (to
• The maximum dose is 3g daily.
thin the blood)
For children (weighing less than
• the oral contraceptive pill.
40 kg) who have severe infections
Please tell your doctor, pharmacist,
such as tonsillitis, recurrent ear
or dentist if you are taking or have
infection, kidney problems or dental
recently taken any other medicines, problems
including medicines obtained
• Your doctor will decide the correct
without a prescription.
dose for you.

4

POSSIBLE SIDE EFFECTS

Other effects you may experience
include:
• the sachets contain sorbitol which
can cause gas to be produced in
the stomach and this can cause
wind and belching and your
Stop taking Amoxicillin sachets and
stomach to feel swollen
tell your doctor immediately or go to
the casualty department at your
Reporting of side effects
nearest hospital if the following
If you get any side effects, talk to
happens:
your doctor or pharmacist. This
includes any possible side effects not
• an allergic reaction causing
listed in this leaflet. You can also
swelling of the lips, face or neck
report side effects directly via the
leading to severe difficulty in
Yellow Card Scheme at:
breathing, or severe skin rash or
www.mhra.gov.uk/yellowcard
hives
By reporting side effects you can
• a skin reaction known as
help provide more information on
‘erythema multiforme’ where you
the safety of this medicine.
may develop: itchy reddish purple
patches on the skin especially on
HOW TO STORE AMOXICILLIN
the palms of the hands or soles of 5
the feet, ‘hive-like’ raised swollen
areas on the skin, tender areas on Keep out of the reach and sight of
children.
the surfaces of the mouth, eyes
and private parts. You may have a You should keep these sachets in a
dry place, below 25°C. Keep them in
fever and be very tired
the pack they came in. Do not put
• rash or pinpoint flat red round
them into another container.
spots under the skin surface or
bruising of the skin. This is due to Do not use Amoxicillin Sachets after
the expiry date that is stated on the
inflammation of blood vessel
walls due to an allergic reaction. It outer packaging. The expiry date
can be associated with joint pain refers to the last day of that month.
Medicines should not be disposed of
(arthritis) and kidney problems
via wastewater or household waste.
• other severe skin reactions can
Ask your pharmacist how to dispose
include: changes in skin colour,
bumps under the skin, blistering, of medicines no longer required.
These measures will help to protect
pustules, peeling, redness, pain,
the environment.
itching, scaling. These may be
associated with fever, headaches
and body aches
6 FURTHER INFORMATION
• high temperature (fever), chills, a
sore throat or other signs of an
What Amoxicillin Sachets contain:
infection, or if you bruise easily.
• The active ingredient is
These may be signs of a problem
Amoxicillin Trihydrate, equivalent
with your blood cells
to amoxicillin 3 grammes (g).
• a delayed allergic reaction can
• The other ingredients (inactive
occur usually 7 to 12 days after
ingredients) are sodium citrate,
having amoxicillin, some signs
citric acid, colloidal anhydrous
include: rashes, fever, joint pains
silica, sorbitol (E420), saccharin
and enlargement of the lymph
sodium, orange bramble flavour,
nodes especially under the arms
quinoline yellow (E 104),
• inflammation of the large bowel
monoammonium glycyrrhizinate
(colon) with diarrhoea sometimes
and xanthan gum.
containing blood, pain and fever
What Amoxicillin Sachets look like
• serious liver side effects may
and contents of the pack:
occur which are often reversible.
• The powder in amoxicillin sugar
They are mainly associated with
free sachets is a cream/pale
people having treatment over a
yellow colour.
long period, males and the
• The sachets come in boxes of
elderly.
2 and 14.
You must tell your doctor urgently
Not all pack sizes may be
if you get:
marketed.
• severe diarrhoea with bleeding
• blisters, redness or bruising of The Marketing Authorisation
Holder is:
the skin
TEVA UK Limited. Eastbourne,
• darker urine or paler stools
BN22 9AG.
• yellowing of the skin or the
whites of the eyes (jaundice).
The Manufacturer is:
See also anaemia below which
Laboratrio Reig Jofre S.A.,
might result in jaundice.
C/Jarama S/N, (Poligono Industrial),
These are very serious but rare side 45007 Toledo, Spain.
effects. You may need urgent
This leaflet was last revised:
medical attention or hospitalisation.
May 2015
The following side effects have been
PL 00289/1590
reported at the approximate
frequencies shown
Like all medicines, Amoxicillin can
cause side effects, although not
everybody gets them.

Common
• skin rash
• diarrhoea
• feeling sick (nausea).
83834-C

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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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