Skip to Content

UK Edition. Click here for US version.

AMOXICILLIN SUGAR FREE 125 MG/5 ML POWDER FOR ORAL SUSPENSION

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

MICRO LABS LIMITED
Bangalore, INDIA

1) Product

: Amoxicillin Sugar Free Powder for Oral Suspension
- BBUK

2) Strength

: 125mg/ 5 ml & 250mg/ 5 ml

3) Component

: Leaflet

4) No. of Colours

: 1

5) Dimension

: 280 x 320 mm

6) Artwork Code

: NA

7) Pharma Code

: NA

8) Font Type and Size

: Arial, 9pt

Colours used

Black

Colours not for Printing

Keylines

9) Technical Specification : NA

WOA

Code No. :

Reason for Change
Approved
by

Contract Giver/
PL holder

NA

Revision: 00

WA
NA

Date: 14-07-2016
Packaging
Development

Regulatory
Affairs

Head Production/
Packing (Site)

Head QC
(Site)

Head QA
(Site)

Sign/
Date

130 mm

Pregnancy and breast-feeding

throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Amoxicillin Sugar Free Suspension contains:
Amoxicillin Sugar Free suspension comes in two strengths containing either 125 mg or 250 mg of
amoxicillin in each 5 ml.

PACKAGE LEAFLET: INFORMATION FOR THE USER

The active substance is amoxicillin

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

This medicine is supplied to your pharmacist as a powder. The pharmacist will have made it into a
suspension before it is given to you.

Each 5 ml dose of Amoxicillin Sugar Free 125 mg suspension contains 1.39 mg of sodium and 295 mg
of sorbitol.
Each 5 ml dose of Amoxicillin Sugar Free 250 mg suspension contains 2.78 mg of sodium and 590 mg
of sorbitol
What Amoxicillin Sugar Free Suspension looks like and contents of the pack
Amoxicillin Sugar Free suspension comes in a carton with 150ml HDPE bottle containing white to pale
yellow powder which produces a pale yellow to yellow coloured suspension upon reconstitution with or
without a dosing syringe of 5ml.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Ltd
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK.

Amoxicillin
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.

1.
2.
3.
4.

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.
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.
You should not take antibiotics that have been prescribed for other people even if they had an
infection that was similar to yours.
You should not give antibiotics that were prescribed for you to other people.
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
125mg/5ml:
Add 92ml of water to reconstitute the product. Close the cap securely. Shake the bottle vigorously to
dissolve the content. The product appears pale yellow to yellow colored suspension with fruity aromatic
odor after reconstitution.
250mg/5ml:
Add 88ml of water to reconstitute the product. Close the cap securely. Shake the bottle vigorously to
dissolve the content. The product appears pale yellow to yellow colored suspension with fruity aromatic
odor after reconstitution.

BBUK Code

4

Size: 280 x 320 mm
Front Side

Artwork Code

Do not take Amoxicillin Sugar Free 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 Sugar Free Suspension if any of the above apply. If you are
not sure, talk to your doctor or pharmacist before taking Amoxicillin Sugar Free
Suspension.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin Sugar Free Suspension if you:

have glandular fever (fever, sore, throat, swollen glands and extreme tiredness)

have kidney problems

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 Sugar Free Suspension.
Blood and urine tests
If you are having :

urine tests (glucose), 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 Sugar Free Suspension.
This is because Amoxicillin Sugar Free Suspension can affect the results of these tests.
Other medicines and Amoxicillin Sugar Free 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 Sugar Free 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 Sugar Free 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 Sugar Free
Suspension may be less effective.

If you are taking methotrexate (used for the treatment of cancer and severe
psoriasis) Amoxicillin Sugar Free Suspension may cause an increase in side
effects.



Space the dose evenly during the day, at least 4 hours apart





If any of the above happens stop taking the medicine and see your doctor straight away.

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.
Kidney problems
If you have kidney problems the dose might be lower than the usual dose.
If you take more Amoxicillin Sugar Free Suspension than you should
If you take too much Amoxicillin Sugar Free 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 Sugar Free Suspension




be associated with joint pain (arthritis) and kidney problems
a delayed allergic reaction can occur usually 7 to 12 days after having Amoxicillin
Sugar Free Suspension, 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 Sugar Free
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:
• 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.

These can happen when having the medicine or for up to several weeks after.

All doses are worked out depending on the child's body weight in kilograms.

Your doctor will advise you how much amoxicillin you should give to your baby or
child.

The usual dose is 40 mg to 90 mg for each kilogram of bodyweight a day given in
two to three divided doses

The maximum recommended dose is 100 mg for each kilogram of body weight a
day.

Amoxicillin Sugar Free Suspension is an antibiotic. The active
ingredient is amoxicillin. This belongs to a group of medicines
called 'penicillin'.

2. What you need to know before you take Amoxicillin Sugar Free Suspension

Shake bottle well before each dose.

Children weighing less than 40kg:

320 mm

320 mm

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections
caused by viruses.



The usual dose is:

What Amoxicillin Sugar Free Suspension is

Amoxicillin Sugar Free Suspension is used to treat infections
caused by bacteria in different parts of the body. Amoxicillin Sugar Free Suspension may
also be used in combination with other medicines to treat stomach ulcers.



Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

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

Pharma Code

This medicine contains sorbitol (E420). 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 Sugar Free Suspension

What Amoxicillin Sugar Free Suspension is used for

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.



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.

These Suspensions are available in multiple strengths but will be referred to as
Amoxicillin Sugar Free Suspension throughout this leaflet.

This leaflet was last approved on 07/2016

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to
reduce the chance of bacteria becoming resistant to them.

Driving and using machines



This medicinal product is authorised in the Member States of the EEA under the following
names:
United Kingdom: Amoxicillin Sugar Free 125mg/ 5 ml & 250mg/5 ml Powder for Oral Suspension
Germany:
Amoxicillin-Micro Labs 125 mg/ 5 ml & 250mg/5 ml Pulver zur Herstellung einer
Suspension zum Einnehmen

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.



Important information about some of the ingredients of Amoxicillin Sugar Free
Suspension

1. What Amoxicillin Sugar Free Suspension is and what it is used for

General advice regarding the use of antibiotics

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 any medicine.

Amoxicillin Sugar Free 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.

135 mm

The other ingredients are disodium edetate, sodium benzoate (E211), sodium saccharin, colloidal
silicon dioxide, xanthan gum (E415), orange and raspberry flavours, golden caramel and sorbitol
(E420).

150 mm

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 Sugar Free Suspension

Keep taking Amoxicillin Sugar Free 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 Sugar Free Suspension is used for a
long time. If this occurs tell your doctor.
If you take Amoxicillin Sugar Free 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 product, ask your doctor or
pharmacist.
4. Possible side effects

Sometimes you may get less severe skin reactions such as:


a middle 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 Sugar Free Suspension
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 chances 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 form 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 in 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.
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 website
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 Sugar Free Suspension
Keep this medicine out of the sight and reach of children.

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

Do not use this medicine after the expiry date shown on the bottle and the carton after EXP. The expiry
date refers to the last day of that month.

Stop taking Amoxicillin Sugar Free Suspension and see a doctor straight away, if
you notice any of the following serious side effects –you may need urgent medical
treatment:

This medicine should be stored in a dry place in the container supplied. Do not transfer it to another
container.

The following are very rare (may affect up to 1 in 10,000 people)

Dry Powder: Store powder in a dry place below 25°C.
Reconstituted Suspension: Store upto 14 days at 2°C - 8°C in a refrigerator.




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

1

2

Size: 280 x 320 mm
Back Side

Keep the medicine in its original bottle. This medicine should not be used beyond 14 days from when it
was dispensed. If dilution of the reconstituted product is required, water should be used.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
3

135 mm

130 mm

Pharma Code

150 mm

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.

Hide