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RESPILLIN 250MG/5ML ORAL SUSPENSION BP

Active substance(s): AMOXYCILLIN TRIHYDRATE

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CP.AMO.JNT.Su.100.AT.V1P3
P660/2

Package leaflet: Information for the patient

AMOXICILLIN 125mg/5ml &
250mg/5ml ORAL SUSPENSION BP
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 only. Do not pass it on to others. It may harm
them even if their symptoms or 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 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

1.

WHAT AMOXICILLIN IS AND WHAT IT
IS USED FOR

Amoxicillin is one of a group of antibiotic
medicines called penicillins. Amoxicillin works by
interfering with the bacteria that cause the
infection.
Amoxicillin can treat a wide range of infections
including those of the following:
• chest (bronchitis or pneumonia)
• tonsils (tonsillitis)
• ears (otitis media)
• sinuses (sinusitis)
• kidneys
• heart (endocarditis)
• blood (septicaemia)
• the bladder or the urethra (the tube which
carries urine from the bladder)
• the female reproductive system including
infections associated with pregnancy and
childbirth (puerperal sepsis and septic abortion)
• abdomen (intra-abdominal sepsis and
peritonitis)
• skin, bone, teeth and gums (abscesses)
• gonorrhoea (a sexually transmitted infection)
• typhoid and paratyphoid (fevers caused by a
group of bacteria called Salmonella)
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 or any of the
other ingredients of this medicine (listed in
section 6)
• You have ever had a bad reaction or allergy to
any penicillin-type antibiotic
• You have ever had a skin rash or swelling of
the face or neck or shortness of breath when
taking any antibiotic
Warnings and precautions
Talk to your doctor or pharmacist before taking
Amoxicillin if:
• You suffer from kidney problems, as you may
require a lower dose than normal
• You are not passing urine regularly
• You have glandular fever, cytomegalovirus
(CMV) infection or certain types of leukaemia you may be at greater risk of developing a
rash when you take this medicine
• You have an intolerance to some sugars or
have diabetes mellitus, as this medicine
contains sucrose.
Other medicines and Amoxicillin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, even those not prescribed by a
doctor. In particular tell your doctor if you are
taking any of the following:
• Anticoagulants e.g. warfarin, phenindione
• Chemotherapy drugs e.g. methotrexate
• Drugs used to treat gout (which can be
caused by the build up of uric acid) e.g.
probenecid, allopurinol, sulfinpyrazone
• Some other antibiotics (e.g. neomycin and
tetracyclines can reduce the effect of
amoxicillin)

Customer: AT

• Oral typhoid vaccine (may not work if taken
with amoxicillin)
• Some penicillins may increase the effects of
muscle-relaxing drugs given as part of an
anaesthetic for surgery. Tell the doctor you are
taking amoxicillin if you need to have an
anaesthetic.
Having urine or blood tests
If you are having urine tests for diabetes (sugar
in the urine) or blood tests for liver function let
the doctor know. Amoxicillin can affect the results
of these tests.
Pregnancy and breast-feeding
Check with your doctor before you take this
medicine 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.
Amoxicillin Oral Suspension BP contains
sucrose
Amoxicillin 250mg/5ml Oral Suspension BP
contains 2.72g of sucrose per 5ml, Amoxicillin
125mg/5ml Oral Suspension BP contains 2.68g
of sucrose per 5ml.
• This should be taken into account in patients
with diabetes mellitus.
• If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.

3.

HOW TO TAKE AMOXICILLIN

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
You may give/take amoxicillin before, with or
after food. Space the doses as evenly as
possible throughout the day. You should make
sure you/your child have several more drinks of
water each day unless told otherwise by your
doctor.
Dosage
Note: One teaspoon is equivalent to 5ml
Adults (including the elderly):
The maximum daily dose should not be more
than 6g per day in total.
• The usual dose for most infections is 5ml of
250mg/5ml suspension to be taken 3 times a
day.
• For more serious infections the dose may be
doubled to 10ml of 250mg/5ml suspension 3
times a day.
• The following doses may be given in the
following conditions:
- Severe or recurrent chest infections: 3g
twice daily
- Simple urinary tract infections: two 3g doses
with 10 to 12 hours between doses (short
course)
- Dental abscesses: two 3g doses with 8
hours between doses
- Gonorrhoea: a single 3g dose
• For stomach ulcers, the following may be
prescribed with other antibiotics:
1 x 750 mg or 1 x 1 g twice a day for 7 days

Originated by: TC (AWG)

Colours

Product: Amoxicillin JNT Oral Suspension
Dimensions: 148mm x 335mm
Item Code: CP.AMO.JNT.Su.100.AT.V1P3
Proof No and Date: 1 12/01/2016
Revision:
ARTWORK FOR SUBMISSION
Supersedes: n/a

Pantone Blue
280

• The following are the usual adult dosages for
preventing infection during dental or other
surgery:
- If a general anaesthetic is not used, 3g one
hour before surgery and another dose six
hours later if necessary
- If a general anaesthetic is used, 3g four
hours before anaesthesia and 3g six hours
after the initial dose
Children:
• Children weighing more than 40kg should be
given the usual adult dosage.
• 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 medicine 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.
Patients with kidney problems
If you have kidney problems, the dose prescribed
by your doctor may be lower than the usual
dose.
If you take more Amoxicillin than you should
If you (or somebody else) accidentally take too
much of your medicine, speak to your doctor or
pharmacist immediately. You should take this
leaflet and any medicine you still have to show
the doctor.
Severe cases of nausea, vomiting and diarrhoea
can be treated with rehydration therapy, by
drinking fluids containing sodium, water and
sugar to prevent dehydration.
If you forget to take Amoxicillin
If you forget to take a dose, take it as soon as
you remember, unless it is within an hour of your
next dose, then carry on as before. Do not take a
double dose to make up for the dose you have
missed.
If you stop taking Amoxicillin
Keep taking this medicine until it is finished or
your doctor tells you to stop. Do not stop taking it
just because you feel better. If you stop taking
the medicine, some bacteria may survive and
cause the infection to come back, or your
condition may re-occur or get worse.
If you/your child are still unwell after taking all the
medicine, go and see your doctor. Never
give/take more than the recommended dose
each day.
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.
If you experience any of the following events
STOP taking your medicine, tell your doctor
or go to your nearest hospital immediately:
• Hypersensitivity or severe allergic reaction
including swollen face or breathing problems.
• Severe diarrhoea with bleeding
• Allergic skin reactions with itching e.g. hives,
nettle rash, blistering or peeling of the skin. If
you start to itch or get a rash, STOP taking
amoxicillin and tell your doctor immediately.
• Convulsions may occur in patients on high
doses or with kidney problems
• Notice your urine becoming darker or your
faeces becoming paler
• Notice your skin or the white of your eyes
turning yellow (jaundice)
• Difficulty or discomfort in passing urine or
having cloudy urine
The following symptoms are less serious but
you may wish to discuss them with your
doctor or pharmacist if they become
troublesome or last a long time.
Common side effects (i.e. more than 1 in 100
people):
• Nausea (feeling sick) or diarrhoea
Uncommon side effects (i.e. between 1 in 100
and 1 in 1,000 people):
• Vomiting

Very rare side effects (i.e. less than 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.
• Tooth discolouration. The colour usually
returns to normal with brushing.
• Blackening of the tongue
• Inflammation of the kidney
• Excessive body movements (hyperkinesia) or
dizziness
• Reduction (reversible) in blood cell counts
including anaemia (a reduction in the body’s
red blood cells or haemoglobin which may be
characterised by feeling weak or light-headed)
or a longer time taken for blood to clot.
• Crystalluria (forming of crystals in the urine)
Not known: frequency cannot be estimated from
available data
• Meningitis (signs may include stiff neck, fever
and vomiting)
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 label. The expiry date to
be followed is that included by the pharmacist
after the medicine is made up for you.
Protect from light.
Dry powder: Store in a dry place below 25°C.
Reconstituted suspension: Store for 7 days at
2°C-8°C in a refrigerator.
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 BP
contains
• The active ingredient is amoxicillin. Each 5ml
spoonful of Amoxicillin 125mg/5ml or
250mg/5ml Oral Suspension BP contains
either 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 125mg/5ml and 250mg/5ml 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.
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 January 2016.

CP.AMO.JNT.Su.100.AT.V1P3
P660/2

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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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