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RESPILLIN 250MG/5ML ORAL SUSPENSION SUGAR FREE BP

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

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Package leaflet: Information for the user

Amoxicillin 125 mg/5 ml Oral Suspension Sugar Free BP
Amoxicillin 250 mg/5 ml Oral Suspension Sugar Free BP
Amoxicillin (as amoxicillin trihydrate)
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.

What is in this leaflet

1 What Amoxicillin Oral Suspension

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

1 What Amoxicillin Oral Suspension

Sugar Free is and what it is used for

• If you are taking other antibiotics (such as
tetracycline) Amoxicillin Oral Suspension
Sugar Free may be less effective.
• If you are taking methotrexate (used for the
treatment of cancer and severe psoriasis)
Amoxicillin Oral Suspension Sugar Free may
cause an increase in side effects.
• Oral typhoid vaccine (may not work if taken
with Amoxicillin Oral Suspension Sugar
Free).

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 Sugar Free 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 and
250 mg/5 ml Oral Suspension Sugar
Free BP contains sorbitol and sodium
benzoate

• Sorbitol may cause stomach upset and
diarrhoea. 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 Sugar Free

What Amoxicillin Oral Suspension
Sugar Free is

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.

What Amoxicillin Oral Suspension
Sugar Free is used for

The usual dose is:

Amoxicillin Oral Suspension Sugar Free is an
antibiotic. The active ingredient is amoxicillin.
This belongs to a group of medicines called
‘penicillins’.

Amoxicillin Oral Suspension Sugar Free is
used to treat infections caused by bacteria in
different parts of the body. Amoxicillin Oral
Suspension Sugar Free 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 Sugar Free

Do not take Amoxicillin Oral
Suspension Sugar Free:

• 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
Sugar Free if any of the above apply. If you
are not sure, talk to your doctor or pharmacist
before taking Amoxicillin Oral Suspension
Sugar Free.

Warnings and Precautions

Talk to your doctor or pharmacist before
taking Amoxicillin Oral Suspension Sugar Free
if you:
• have kidney problems,
• 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 apply to
you, talk to your doctor or pharmacist before
taking Amoxicillin Oral Suspension Sugar
Free.

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
Sugar Free. This is because Amoxicillin Oral
Suspension Sugar Free can affect the results
of these tests.

Other medicines and Amoxicillin Oral
Suspension Sugar Free

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 Sugar Free,
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 Sugar Free.
• If you are taking medicines to help stop
blood clots (such as warfarin), you may need
extra blood tests.

Continued top of next column
AAAJ1962

Children weighing less than 40kg

All doses are worked out depending on your
child’s body weight in kilograms.
• Your doctor will advise you how much
Amoxicillin Oral Suspension Sugar Free 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 100 mg
for each kilogram of body weight a day.

Adults, elderly patients and children
weighing 40kg or more

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

Kidney problems

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

If you take more Amoxicillin Oral
Suspension Sugar Free than you
should

If you have taken too much Amoxicillin Oral
Suspension Sugar Free, 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 Sugar Free

• 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 Sugar Free for?

• Keep taking Amoxicillin Oral Suspension
Sugar Free 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 Sugar Free is used for a long
time. If this occurs tell your doctor.
If you take Amoxicillin Oral Suspension Sugar
Free 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.

Continued over page

4 Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Stop taking Amoxicillin Oral Suspension
Sugar Free 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 Sugar Free, 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 Oral
Suspension Sugar Free 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:
- severe diarrhoea with bleeding
- blisters, redness or bruising of the skin
- darker urine or paler stools
- 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 Sugar Free
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.

5 How to store Amoxicillin Oral

Suspension Sugar Free

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.

Dry powder

Do not store above 25°C.
Store in original package. Keep the bottle
tightly closed.

Reconstituted suspension

Once made up, store up to 14 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.

6 Contents of the pack and other

information

What Amoxicillin Oral Suspension
Sugar Free 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,
Orange Bramble Flavour, Quinoline Yellow
(E104), Citric Acid Monohydrate, Colloidal
Anhydrous Silica, Xanthan Gum, Sorbitol
(E420) and Saccharin Sodium.

What Amoxicillin Oral Suspension
Sugar Free BP looks like and contents
of the pack
The suspensions are pale yellow with a
characteristic odour.
Amoxicillin Oral Suspensions Sugar Free BP
are available in bottles of 100ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Athlone Laboratories Limited, Ballymurray, Co.
Roscommon, Ireland.
The product is distributed by:
Actavis, Barnstaple, EX32 8NS, UK
PL 06453/0049
PL 06453/0050
This leaflet was last revised in August 2016.
The product is distributed by:
Actavis, Barnstaple, EX32 8NS, UK

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.

Continued top of next column
AAAJ1962

Actavis, Barnstaple, EX32 8NS, UK

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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