AMOXICILLIN 125MG/5ML POWDER FOR ORAL SUSPENSION

Active substance: AMOXICILLIN TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Amoxicillin 125 mg/5 ml Powder for Oral Suspension
Amoxicillin 250 mg/5 ml Powder for Oral Suspension

Amoxicillin (as trihydrate)

Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1. What Amoxicillin is and what it is used for
2. Before you take Amoxicillin
3. How to take Amoxicillin
4. Possible side effects
5. How to store Amoxicillin
6. Further information

1

What Amoxicillin is and what it
is used for

Amoxicillin is an antibiotic. It belongs to a group
of antibiotics called penicillins. It is used to treat
infections caused by bacteria which are sensitive
to amoxicillin.

Amoxicillin is used to treat:
• Infections of the ear, throat, nose or sinuses
• Chest infections such as bronchitis and pneumonia
• Infections of the bladder
• Prevention of heart infections during mouth or
throat surgery.

2

Before you take Amoxicillin

Do not take Amoxicillin if:
• You are allergic (hypersensitive) to amoxicillin,
penicillins, cephalosporins or to any of the
other ingredients of this medicine (See Further
Information in Section 6).

Take special care with Amoxicillin
Tell your doctor before taking Amoxicillin if you have:
• Kidney disease: your doctor may have to
adjust the dose.
• Infectious mononucleosis (a viral infection) or
leukaemia: you may have a higher risk of skin
reactions.
• Fits (epilepsy): you may have a higher risk of
seizures (fits).
• A bladder catheter. If so, drink plenty of liquid
to prevent the forming of crystals in your urine.
This medicine can also alter the results of urine
tests or blood tests for sugar. If you have
diabetes and routinely test your urine or your
blood, tell your doctor. This is because other
tests may have to be used.

Taking other medicines:
Please tell your doctor or pharmacist, if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription. Some medicines can cause
problems if you take them with Amoxicillin.

Take care with the following medicines:
• Allopurinol (used to treat gout): you may have
a higher risk of skin reactions
• Methotrexate (used to treat arthritis): the
toxicity of methotrexate may be increased
• Digoxin (used to treat certain heart diseases):
the absorption of digoxin may be increased
• Anticoagulants (to prevent blood clotting) such
as warfarin: the tendency to bleed may be
increased
• Contraceptive pills: there is a risk of contraceptive
pills not working to their greatest effect

Taking Amoxicillin with food and drink:
You can take Amoxicillin either before, during or
after meals.

Pregnancy and breast-feeding:
Ask your doctor for advice before taking any
medicine. Data on a limited number of exposed
pregnancies indicate no adverse effects of
amoxicillin on pregnancy or on the health of the
foetus or newborn child. As a precautionary
measure, amoxicillin should only be used during
pregnancy if in the judgement of the physician the
potential benefits outweigh the possible hazards.
This medicine passes into breast milk in small
quantities, therefore in some cases it may be
necessary to stop breast-feeding.

Driving and using machines:
Amoxicillin can have side effects and the symptoms
may make you unfit to drive. Donʼt drive or
operate machinery unless you are feeling well.
Important information about some of the
ingredients of this medicine
Amoxicillin contains the sweetener aspartame, a
source of phenylalanine. This may be harmful for
people with phenylketonuria.

3

How to take Amoxicillin

Always take Amoxicillin exactly as your doctor
has told you. You should check with your doctor
or pharmacist, if you are not sure.

To reconstitute the suspension fill the bottle with
fresh tap water approximately 1 cm below the
filling mark, close and shake well at once. After
the foam has settled, slowly add fresh tap water
exactly to the filling mark. Shake vigorously
again. The white to slightly yellowish suspension
is now ready for use. Shake the bottle well before
every withdrawal.

Your doctor will tell you the exact dose (in millilitres
or measuring spoon) you should take each day.
The usual dose for children under 40 kg
bodyweight is 40 - 90 mg/kg/day in two to three
divided doses.
The usual dose for adults and children over
40 kg bodyweight is 750 mg to 3000 mg daily in
divided doses.
In special cases (bronchitis), a dose of 1000 mg
two times daily may be recommended.

For the prevention of heart infections: In adults,
3000 mg are given in the hour before the surgery;
for children a dose of 50 mg/kg is recommended.
Continued on the next page >>

The following information is intended for medical or healthcare professionals only:

For the preparation of the suspension fill the
bottle with the following amount of water:

125 mg/5ml
• For 60 ml bottle add 56 ml of water

• For 100 ml bottle add 94 ml of water.

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250 mg/5 ml
• For 60 ml bottle add 55 ml of water

Continued on the next page >>

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A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: V062 - Amendment of an excipient
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Date prepared:
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Date approved:
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Your doctor will tell you how long you will need to
keep taking your medicine.

People with kidney disease
Your doctor may have to lower the dose.

If you take more Amoxicillin than you should:
If you take too much of this medicine (overdose),
talk to your doctor or go to a hospital straight
away, and show them the pack. The most likely
signs of overdose are: nausea, vomiting,
diarrhoea, abdominal pain.

If you forget to take Amoxicillin:
If you forget to take your dose of this medicine,
take the forgotten dose as soon as you
remember. Do not take a double dose to make
up for forgotten individual doses.

If you stop taking Amoxicillin:
Always keep taking this medicine until the course
is finished, even if you feel better. If you stop
taking this medicine too soon, the infection may
come back. Also, the bacteria may become
resistant to the medicine.

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Amoxicillin can cause side
effects, although not everybody gets them.

If you notice any of the following serious side
effects, talk to your doctor immediately or go
to a hospital straight away:
Following serious side-effects are rare (affect
less than 1 out of 1,000 people):
• Sudden difficulty in breathing, speaking and
swallowing
• Painful swelling of lips, tongue, face or neck
• Extreme dizziness or collapse
• Severe or itchy skin rashes, especially if this
shows blistering and there is soreness of the
eyes, mouth or genital organs
• Yellowing of the skin or whites of the eyes, or
urine getting darker and stools paler: This is a
sign of liver problems.

Following side-effects are very rare (affect less
than 1 out of 10,000 people):
• Diarrhoea that is serious, lasts a long time or
has blood in it: This can be a sign of serious
bowel inflammation.

Other possible side-effects during treatment:
Following side-effects are common (affect less
than 1 out of 10 people):
• Nausea, vomiting, loss of appetite, disturbance
of taste, dry mouth, eruptions in the mouth
(enanthema), winds, diarrhoea or soft stools.
These effects are mostly mild and disappear
during treatment or very soon after completion
of therapy. They can be reduced by taking this
medicine with food
• Urticaria, itching, “fifth day” skin rash, which
resembles measles.

Following side-effects are uncommon (affect
less than 1 out of 100 people):
• Superinfections caused by resistant germs or
yeasts (such as oral or vaginal thrush)
• Moderate rise in liver enzymes.

• Inflammation of the kidneys (interstitial
nephritis), crystals in the urine.

Following side-effects are very rare (affect less
than 1 out of 10,000 people):
• Changes in blood count (decrease of red or
white blood cells and of platelets), prolongation
of bleeding time. These may cause symptoms
such as fever, a sore throat, rash, nose bleeds
or bruising. These effects are reversible after
stopping the treatment
• Black tongue.

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

5

How to store Amoxicillin

Keep out of the reach and sight of children.

Do not store above 25°C. Keep the container
tightly closed.
Do not use Amoxicillin after the expiry date which
is stated on the carton after EXP. The expiry date
refers to the last day of that month.

Reconstituted suspension: Do not store above
25°C. The reconstituted suspension should be
used within 14 days.

Medicines should be not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6

Further information

What Amoxicillin contains
The active substance is amoxicillin.

5 ml reconstituted suspension contains:
Amoxicillin trihydrate corresponding to 125 or
250 mg amoxicillin.

Other ingredients are: Citric acid anhydrous
(E330); Sodium Benzoate (E211); Aspartame
(E951); Talc (E553b); Sodium citrate, anhydrous
(E331); Guar (E412); Silicon dioxide, precipitated
(E551); Lemon flavouring, powdered;
Peach-apricot flavouring, powdered; Orange
flavouring, powdered.

What Amoxicillin looks like and contents of
the pack
Amber glass bottles containing 5.10 g or 6.6 g
powder for 60 ml oral suspension, respectively
containing 8.50 g or 11 g powder for 100 ml oral
suspension with polypropylene screw closure
(press + turn).
The packaged measuring spoon with filling marks
at 1.25 ml, 2.5 ml and 5.0 ml is made of
polypropylene.
Individual packs of
Hospital packs of

60 ml and 100 ml
10 x 60 ml, 20 x 60 ml,
40 x 60 ml,
10 x 100 ml and 40 x 100 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Following side-effects are rare (affect less than 1
out of 1,000 people):
• Increase in certain white blood cells
(eosinophilia), abnormal breakdown of red
blood cells (haemolytic anemia)
• Drug fever
• Dizziness, hyperactivity, convulsions
• Superficial tooth discolouration. The
discolouration can be removed by teeth brushing
• Hepatitis and cholestatic jaundice

This leaflet was last approved in 07/2012 (to
be amended upon approval).

• For 100 ml bottle add 92 ml of water.

Shake the bottle well before every withdrawal.

Shake vigorously again.

Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, 6250
Kundl, Austria.

SZ00000LT000

The white to slightly yellowish suspension is now
ready for use.

00000000
SZ00000LT000

Artwork Proof Box

draft: 982329
laetus code: 000
mat.no.: 00000000

A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: V062 - Amendment of an excipient
Proof no.
004.0

Date prepared:
20/07/2012

Prepared by:
TB

RA Approved?
Yes

Date approved:
20/07/2012

Approved by:
PR
Fonts:
Helvetica

Colours:
Black
Black 20%
Dimensions: 140 x 315 mm

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 7.5pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

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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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