Skip to Content

UK Edition. Click here for US version.

AMOXICILLIN 125MG/5ML POWDER FOR ORAL SUSPENSION

Active substance(s): AMOXICILLIN TRIHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

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 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 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

• Contraceptive pills: there is a risk of contraceptive
pills not working to their greatest effect.
Amoxicillin with food and drink:
You can take Amoxicillin either before, during or
after meals.
Pregnancy, breast-feeding and fertility:
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.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. Don’t drive or
operate machinery unless you are feeling well.
Amoxicillin contains the sweetener aspartame, a
source of phenylalanine. This may be harmful for
people with phenylketonuria.

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

What you need to know before
you take Amoxicillin

Do not take Amoxicillin if:
• You are allergic to amoxicillin, penicillins,
cephalosporins or to any of the other
ingredients of this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor or pharmacist 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.
Other medicines and Amoxicillin
Tell your doctor or pharmacist, if you are taking,
have recently taken or might take 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

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.
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 3,000 mg daily in
divided doses.
In special cases (bronchitis), a dose of 1,000 mg
two times daily may be recommended.
For the prevention of heart infections: In adults,
3,000 mg are given in the hour before the surgery;
for children a dose of 50 mg/kg is recommended.
Continued on the next page >>

00000000

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:

• For 100 ml bottle add 94 ml of water.
250 mg/5 ml
• For 60 ml bottle add 55 ml of water

draft: 982329, 982330
laetus code: 000
mat.no.: 00000000

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

Continued on the next page >>

00000000

Artwork Proof Box
Ref: V071: QRD update + procedural updates
Proof no.
006.1

SZ00000LT000

Date prepared:
19/06/2015

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

Font size:
7.5pt
Fonts:
Helvetica

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 medicine, ask your doctor or pharmacist.

4

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.
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: 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 store above 25°C. Keep the bottle tightly
closed in order to protect from moisture.
Do not use this medicine 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: Store in a refrigerator
(2°C - 8°C). The reconstituted suspension should
be used within 14 days.
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.

Possible side effects

Like all medicines, this medicine 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 (may
affect up to 1 in 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 (may affect
up to1 in 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 (may affect
up to 1 in 10 people):
• Nausea, vomiting, loss of appetite, disturbance
of taste, dry mouth, eruptions in the mouth
(enanthema), wind, 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 (may
affect up to 1 in 100 people):
• Superinfections caused by resistant germs or
yeasts (such as oral or vaginal thrush)
• Moderate rise in liver enzymes.
Following side-effects are rare (may affect up to
1 in 1,000 people):
• Increase in certain white blood cells
(eosinophilia), abnormal breakdown of red
blood cells (haemolytic anaemia)
• Drug fever
• Dizziness, hyperactivity, convulsions
• Superficial tooth discolouration. The
discolouration can be removed by teeth brushing
• Hepatitis and cholestatic jaundice
• Inflammation of the kidneys (interstitial
nephritis), crystals in the urine.
Following side-effects are very rare (may affect
up to 1 in 10,000 people):
• Changes in blood count (decrease of red or

6

Contents of the pack and other
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
White to slightly yellowish powder.
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) and sealing membrane.
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.
Manufacturer:
Sandoz GmbH, Biochemiestrasse 10,
6250 Kundl, Austria.
This leaflet was last revised in 06/2015.

00000000
SZ00000LT000

• For 100 ml bottle add 92 ml of water.

Shake the bottle well before taking each dose.

Shake vigorously again.

draft: 982329, 982330
laetus code: 000
mat.no.: 00000000

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

00000000
SZ00000LT000

Artwork Proof Box
Ref: V071: QRD update + procedural updates
Proof no.
006.1

Date prepared:
19/06/2015

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

Font size:
7.5pt
Fonts:
Helvetica

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.

Hide