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AMOXIL 3G SACHETS SUCROSE-FREE

Active substance(s): AMOXYCILLIN

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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,
pharmacist or nurse. 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.

Amoxil 3g sachets sucrose-free
(amoxicillin)

What Amoxil contains
The active substance in Amoxil is amoxicillin.
Each sachet contains 3g amoxicillin (as
amoxicillin trihydrate).
The other ingredients are saccharin sodium,
xanthan gum (E415), peach, strawberry and
lemon dry flavours and sorbitol (E420).

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.
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.

See also ‘Important information about
some of the ingredients of Amoxil’ in
section 2.
What Amoxil looks like and contents of the
pack
The sachet contains a white to off-white, free
flowing powder with characteristic odour which
on reconstitution with water forms a white to offwhite coloured suspension.
Each pack contains 2 sachets.
Manufactured by: Laboratorios Reig Jofre, Calle
Jarama, s/n, Poligono Industrial, 45007 Toledo,
Spain.

By reporting side effects you can help provide
more information on the safety of this medicine.

Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.

5. How to store Amoxil

Amoxil 3g sachets sucrose-free

Keep out of the sight and reach of children.
Do not take the medicine after the expiry
date which is stated on the carton and sachet
label 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 take the medicine if the sachets have
been tampered with or opened.
Take immediately following reconstitution.
If the medicine becomes discoloured or show
any signs of deterioration, seek the advice of
your pharmacist.
Medicines should not be disposed of via
waste water or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

Package Leaflet: Information for the user

6. Contents of the pack and
other information

POM

The name of your medicine is Amoxil 3g sachets
sucrose-free but will be referred to as Amoxil
throughout this leaflet
What is in this leaflet
1. What Amoxil is and what it is used for
2. What you need to know before you take
Amoxil
3. How to take Amoxil
4. Possible side effects
5. How to store Amoxil
6. Contents of the pack and other information

PL 18799/2444
Leaflet date: 12.05.2016

1. What Amoxil is and what it is
used for

1

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

2. What you need to know
before you take Amoxil
Do not take Amoxil:
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 Amoxil if any of the above apply. If
you are not sure, talk to your doctor or
pharmacist before taking Amoxil.
Warnings and Precautions
Talk to your doctor or pharmacist before taking
Amoxil 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 Amoxil.
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
Amoxil. This is because Amoxil can affect the
results of these tests.
Other medicines and Amoxil
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 Amoxil, 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 Amoxil.
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) Amoxil may be less effective.
If you are taking methotrexate (used for the
treatment of cancer and severe psoriasis)
Amoxil may cause an increase in side
effects.
Pregnancy and breast-feeding
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
Amoxil 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 unless you
are feeling well.
Important information about some of the
ingredients of Amoxil
Amoxil does not contain sugar.
Amoxil contains 4.2g of sorbitol (E420). If
you have been told by your doctor that you
have an intolerance to some sugars, talk to
your doctor before taking this medicine.
Each sachet contains 18mg of sodium. This
should be considered if you are on a
controlled sodium diet.

How to information
take Amoxil
53.H Important
about some of
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Put the content of the sachet in 10 to 20ml of
water. Shake until a suspension is formed.
Take immediately.
Space the doses evenly during the day, at
least 4 hours apart.
The usual dose is:
Children weighing less than 40kg
All doses are worked out depending on the
child’s body weight in kilograms
Your doctor will advise you how much Amoxil
you should give to your baby or child
The usual dose is 40mg to 90mg for each
kilogram of body weight a day, given in two
or three divided doses
The maximum recommended dose is 100mg
for each kilogram of body weight a day

Adults, elderly patients and children weighing
40kg or more
The usual dose of Amoxil is 250mg to 500mg
three times a day or 750mg to 1g every 12 hours,
depending on the severity and type of infection.
Severe infections: 750mg to 1g three times
a day.
Urinary tract infection: 3g twice daily for
one day.
Lyme disease (an infection spread by
parasites called ticks): Isolated erythema
migrans (early stage – red or pink circular
rash): 4g a day, Systemic manifestations
(late stage – for more serious symptoms or
when the disease spreads around your
body): up to 6g a day.
Stomach ulcers: one 750mg or one 1g 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 6g per
day
Kidney problems
If you have kidney problems the dose might be
lower than the usual dose.
If you take more Amoxil than you should
If you have taken too much Amoxil, 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 Amoxil
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 Amoxil for?
Keep taking Amoxil 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 Amoxil is used
for a long time. If this occurs tell your doctor.
If you take Amoxil 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, Amoxil can cause side
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Amoxil 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 Amoxil, 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 Amoxil 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. This is uncommon
(may affect up to 1 in 100 people).
If you have any of these talk to your doctor as
Amoxil 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
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,
pharmacist or nurse. 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

6. Contents of the pack and
other information
What Amoxicillin contains
The active substance in Amoxicillin is
amoxicillin.
Each sachet contains 3g amoxicillin (as
amoxicillin trihydrate).
The other ingredients are saccharin sodium,
xanthan gum (E415), peach, strawberry and
lemon dry flavours and sorbitol (E420).

Amoxicillin 3g sachets sucrose-free
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.
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.

See also ‘Important information about
some of the ingredients of Amoxicillin’ in
section 2.
What Amoxicillin looks like and contents of
the pack
The sachet contains a white to off-white, free
flowing powder with characteristic odour which
on reconstitution with water forms a white to offwhite coloured suspension.
Each pack contains 2 sachets.
Manufactured by: Laboratorios Reig Jofre, Calle
Jarama, s/n, Poligono Industrial, 45007 Toledo,
Spain.
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Amoxicillin 3g sachets sucrose-free

Keep out of the sight and reach of children.
Do not take the medicine after the expiry
date which is stated on the carton and sachet
label 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 take the medicine if the sachets have
been tampered with or opened.
Take immediately following reconstitution.
If the medicine becomes discoloured or show
any signs of deterioration, seek the advice of
your pharmacist.
Medicines should not be disposed of via
waste water or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

Package Leaflet: Information for the user

PL 18799/2444
Leaflet date: 12.05.2016

The name of your medicine is Amoxicillin 3g
sachets sucrose-free but will be referred to as
Amoxicillin throughout 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

POM

1. What Amoxicillin is and what
it is used for

1

What Amoxicillin is
Amoxicillin is an antibiotic. The active ingredient
is amoxicillin. This belongs to a group of
medicines called ‘penicillin’.
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 and breast-feeding
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 machinery unless you
are feeling well.
Important information about some of the
ingredients of Amoxicillin
Amoxicillin does not contain sugar.
Amoxicillin contains 4.2g of sorbitol (E420). If
you have been told by your doctor that you
have an intolerance to some sugars, talk to
your doctor before taking this medicine.
Each sachet contains 18mg of sodium. This
should be considered if you are on a
controlled sodium diet.

How to information
take Amoxicillin
53.H Important
about some of
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Put the content of the sachet in 10 to 20ml of
water. Shake until a suspension is formed.
Take immediately.
Space the doses evenly during the day, at
least 4 hours apart.
The usual dose is:
Children weighing less than 40kg
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 40mg to 90mg for each
kilogram of body weight a day, given in two
or three divided doses
The maximum recommended dose is 100mg
for each kilogram of body weight a day

Adults, elderly patients and children weighing
40kg or more
The usual dose of Amoxicillin is 250mg to 500mg
three times a day or 750mg to 1g every 12 hours,
depending on the severity and type of infection.
Severe infections: 750mg to 1g three times
a day.
Urinary tract infection: 3g twice daily for
one day.
Lyme disease (an infection spread by
parasites called ticks): Isolated erythema
migrans (early stage – red or pink circular
rash): 4g a day, Systemic manifestations
(late stage – for more serious symptoms or
when the disease spreads around your
body): up to 6g a day.
Stomach ulcers: one 750mg or one 1g 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 6g 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, Amoxicillin can cause side
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

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. 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

Expand view ⇕

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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