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RESPILLIN 125MG/5ML ORAL SUSPENSION BP

Active substance(s): AMOXYCILLIN TRIHYDRATE / AMOXYCILLIN TRIHYDRATE

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CP.AMO.JNT.Su.100.AT.V2P1
P660/3

Package leaflet: Information for the user

AMOXICILLIN 125 mg/5 ml ORAL SUSPENSION BP
AMOXICILLIN 250 mg/5 ml ORAL SUSPENSION BP
Amoxicillin (as amoxicillin trihydrate)

PHARMACODE
AREA

READ FROM TOP TO BOTTOM

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 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.
What is in this leaflet
1. What Amoxicillin Oral Suspension is and what it is used for
2. What you need to know before you take Amoxicillin Oral Suspension
3. How to take Amoxicillin Oral Suspension
4. Possible side effects
5. How to store Amoxicillin Oral Suspension
6. Contents of the pack and other information

1.

WHAT AMOXICILLIN ORAL
SUSPENSION IS AND WHAT IT IS
USED FOR

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

2.

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE AMOXICILLIN ORAL
SUSPENSION

Do not take Amoxicillin Oral Suspension:
- 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 Oral Suspension if any of
the above apply. If you are not sure, talk to your
doctor or pharmacist before taking Amoxicillin
Oral Suspension.
Warnings and Precautions
Talk to your doctor or pharmacist before taking
Amoxicillin Oral Suspension if you:
• have kidney problems
• are not urinating regularly
• have glandular fever (fever, sore throat,
swollen glands and extreme tiredness)
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Amoxicillin Oral Suspension.
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 Oral Suspension. This is because
Amoxicillin Oral Suspension can affect the
results of these tests.
Other medicines and Amoxicillin Oral
Suspension
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 Oral Suspension, 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 Oral Suspension.
• 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 Oral Suspension may
be less effective.
• If you are taking methotrexate (used for the
treatment of cancer and severe psoriasis)
Amoxicillin Oral Suspension may cause an
increase in side effects.
• Oral typhoid vaccine (may not work if taken
with Amoxicillin Oral Suspension).
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 Oral Suspension 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.
Amoxicillin 125 mg/5 ml & 250 mg/5 ml Oral
Suspension BP contains sucrose and sodium
benzoate
Amoxicillin 250 mg/5 ml Oral Suspension BP
contains 2.72g of sucrose per 5ml, Amoxicillin
125 mg/5 ml Oral Suspension BP contains 2.68g
of sucrose per 5ml.
o This should be taken into account in patients
with diabetes mellitus.
o If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.

• Sodium benzoate (E211) is a mild irritant to
the eyes, skin and mucous membrane and
can cause an increased risk of jaundice in new
born babies.

3.

HOW TO TAKE AMOXICILLIN ORAL
SUSPENSION

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
• Shake bottle well before each dose
• 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 your
child’s body weight in kilograms.
• Your doctor will advise you how much
Amoxicillin Oral Suspension 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.

• 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 Oral
Suspension 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:
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 Oral Suspension will need to be
stopped.

Adults, elderly patients and children
weighing 40 kg or more
This suspension is not usually prescribed for
adults and children weighing more than 40 kg.
Ask your doctor or pharmacist for advice.

The other possible side effects are:
Common (may affect up to 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea.

Kidney problems
If you have kidney problems the dose might be
lower than the usual dose.

Uncommon (may affect up to 1 in 100 people)
• being sick (vomiting)

If you take more Amoxicillin Oral Suspension
than you should
If you have taken too much Amoxicillin Oral
Suspension, 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 Oral
Suspension
• 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 Oral
Suspension for?
• Keep taking Amoxicillin Oral Suspension 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 Oral
Suspension is used for a long time. If this occurs
tell your doctor.
If you take Amoxicillin Oral Suspension 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 Oral Suspension 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 Oral
Suspension, some signs include: rashes,
fever, joint pains and enlargement of the
lymph nodes especially under the arms

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.

6.

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Amoxicillin Oral Suspension BP
contains
- The active substance in each suspension is
125 mg or 250 mg of amoxicillin as amoxicillin
trihydrate.
- The other ingredients are: Sodium Benzoate
(E211), Disodium Edetate, Sodium Citrate
Anhydrous, Lemon Flavour Powder, Quinoline
Yellow (E104) and Sucrose.
What Amoxicillin Oral Suspension BP looks
like and contents of the pack
Amoxicillin 125 mg/5 ml and 250 mg/5 ml Oral
Suspension BP is available as a pale yellow
granular dry powder in a bottle for preparation of
a yellow suspension with a lemon odour and
flavour. When prepared by the pharmacist, the
125 mg/5 ml bottle contains 100 ml of
suspension and the 250 mg/5 ml bottle contains
100 ml of suspension.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Athlone Laboratories Limited, Ballymurray, Co.
Roscommon, Ireland.
The product is distributed by
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.
PL 06453/0021
PL 06453/0022
This leaflet was last revised in August 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.
Instructions for reconstitution
Check cap seal is intact before use.
Invert and shake bottle to loosen powder.
Fill the bottle with water to just below the mark
on the bottle label.
Invert and shake well, then top up with water to
the mark. Invert and shake again
Shake well before taking each dose.

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 ORAL
SUSPENSION

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 label. The expiry date
refers to the last day of that month.
Protect from light.
Dry powder
Do not store above 25°C.
Reconstituted suspension
Once made up, store for 7 days at 2°C-8°C in a
refrigerator.
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.

CP.AMO.JNT.Su.100.AT.V2P1
P660/3

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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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