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AMOXICILLIN SUGAR FREE 250 MG/5 ML POWDER FOR ORAL SUSPENSION

Active substance(s): AMOXICILLIN TRIHYDRATE

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MICRO LABS LIMITED
Bangalore, INDIA

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Description

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No. of Colours

1

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Dimension

280 x320 mm

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Pharma Code : 2250

Amoxicillin Sugar Free Suspension Leaflet

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Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Other side effects
Other side effects have occurred in a small number of people but their exact frequency is
unknown
If you get side effects
Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if
you notice any side effects not listed in this leaflet.

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

Pregnancy and breast-feeding
If you are pregnant, you think you might be pregnant or if you are breast-feeding,
please tell your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any medicine.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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Read all of this leaflet carefully before you start taking this medicine or start
giving it to your child.
• 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
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Driving and using machines
Amoxicillin Sugar Free Suspension can have side effects and the symptoms may
make you unfit to drive. Don't drive or operate machinery unless you are feeling
well.

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

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this leafle!:
WhatAmoxiciliin Sugar Free Suspension is and what it is used for
Before you give or take Amoxicllin Sugar Free Suspension
How to use Amoxicillin Sugar Free Suspension
Possible side effects
How to store Amoxicillin Sugar Free Suspension
Further information

This medicine also contains sodium benzoate (E211), which may increase the risk
of jaundice in newborn babies.
3. HOW TO TAKE AMOXICILLIN SUGAR FREE SUSPENSION
Amoxicillin Sugar Free Suspension is usually given to children, although it can be
given to adults who have difficulty swallowing tablets. The dose that your doctor
tells you to give will depend on the type of infection your child has.

1. WHAT AMOXICILLIN SUGAR FREE SUSPENSION IS AND WHAT IT IS
USED FOR

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This medicine is for you ONLY, do not give it to anyone else. Unless advised by your doctor, do
not keep this medicine for longer than you need.
Medicines should 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

Your doctor's instructions should be on the bottle. Read them carefully. If you have
any questions talk to your doctor or pharmacist.

Amoxicillin Sugar Free Suspension is an antibiotic for treating
infections. It belongs to a group of antibiotics called
"penicillins". Amoxicillin Sugar Free Suspension works by
killing the bacteria that can cause infections.
Amoxicillin Sugar Free Suspension is used in adults and
children above the age of 6 month to treat the following
infections:

chest (bronchitis or pneumonia), ears (acute otitis media) and cystitis.
Amoxicillin Sugar Free Suspension can be used as part of treatment to prevent
infections of the heart lining (endocarditis).
2. BEFORE YOU GIVE OR TAKE AMOXICILLIN SUGAR FREE SUSPENSION
Do not take Amoxicillin Sugar Free Suspension:
• if you are allergic (hypersensitive) to amoxicillin, penicillin or any of the other
ingredients of Amoxicillin Sugar Free Suspension (listed in section 6)
• if you have ever had a severe allergic (hypersensitive) reaction to any other
antibiotic. This can include a skin rash or swelling of the face or neck

What Amoxicillin Sugar Free Suspension contains:
The active substance is amoxicillin.
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.
Amoxicillin Sugar Free Suspension comes in two strengths containing either 125 mg or 250 mg
of amoxicillin in each 5 ml.
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).
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.

Do not take Amoxicillin Sugar Free Suspension if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin
Sugar Free Suspension.
Take special care with Amoxicillin Sugar Free Suspension
Talk to your doctor or pharmacist before taking this medicine if you:
• have glandular fever
• are not passing water 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.
Conditions you need to look out for
Amoxicillin Sugar Free Suspension can make some existing conditions worse, or
cause serious side effects. These include allergic reactions, convulsions (fits) and
inflammation of the large intestine. You must look out for certain symptoms while
you are taking Amoxicillin Sugar Free Suspension to reduce the risk of any
problems.See 'Conditions you need to look out for' in Section 4.
Blood and urine tests
If you are having urine tests (for glucose), let the doctor or nurse know that you
are taking Amoxicillin Sugar Free Suspension. This is because Amoxicillin Sugar
Free Suspension can affect the results of these types of tests.

This leaflet was last approved on OS/2013

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During treatment with Amoxicillin Sugar Free Suspension:
• you should make sure your child has several more drinks of water each day
or
• if you are taking Amoxicillin Sugar Free Suspension, you should drink several more glasses
of water each day unless told otherwise by your doctor.
Try to give or take this medicine as part of the daily routine - for example at mealtimes. You may
give or take Amoxicillin Sugar Free Suspension before, with or after food, unless the label
advises a specific time.

amoxicillin trihydrate

Reconstituted Suspension: Store upto 14 days at 2°C - 8°C in a refrigerator.

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BROWN & BURK

Dry Powder: Store powder in a dry place below 25'C.

Keep out of the reach and sight of children.

Production

If you are taking allopurinol (used for gout) with Amoxicillin Sugar Free
Suspension, it may be more likely that you'll have an allergic skin reaction.
If medicines to help stop blood clots (such as warfarin) are taken with Amoxicillin
Sugar Free Suspension then extra blood tests may be needed.

5. HOW TO STORE AMOXICILLIN SUGAR FREE SUSPENSION

Keep the medicine in its original bottle. This medicine should not be used beyond 14 days from
when it was dispensed. Do not use this medicine after the expiry date shown on the packaging.
This medicine should be stored in a dry place in the container supplied. Do not transfer it to
another container.

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Thrush (a yeast infection of the vagina, mouth or skin folds). You can get treatment for thrush
from your doctor or pharmacist
Inflammation of the large bowel (colon) with diarrhoea (sometimes containing blood), pain
and fever
The tongue may change to black colour and may have a hairy appearance
Tooth discolouration. The colour usually returns to normal with brushing
Serious liver side effects may occur.
abnormal liver function tests, hepatitis (inflammation of the liver)
darker urine or paler stools
yellowing of the skin or the whites of the eyes Uaundice)
Inflammation of the kidney.
Tell your doctor that you or your child are taking Amoxicillin Sugar Free Suspension if you or
your child are having urine tests because Amoxicillin Sugar Free Suspension may affect the
results
Excessive body movements(hyperkinesia), dizziness or convulsions (fits). People who are on
high doses of Amoxicillin Sugar Free Suspension or whose kidneys do not work properly may
experience convulsions
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. Reduction of white blood cells which may make you more
likely to develop an infection
Tell your doctor that you or your child are taking Amoxicillin Sugar Free Suspension if you or
your child are having blood tests
Crystalluria, forming of crystals in the urine.

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Dated : 06-04-2013

WA
Client Approval

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Revision : 01

Item Code: UKI-003/B

Code No.:

Colours used

Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used any
other medicines. This includes medicines that can be bought without a prescription
and herbal medicines.

It is not normally necessary to arrange to have a dose in the middle of the night - unless your
doctor has told you to do so. But remember, space the doses as evenly as possible throughout
the day.
If you take more Amoxicillin Sugar Free Suspension than you should
If you take too much Amoxicillin Sugar Free Suspension, signs might include an upset stomach
(feeling sick, being sick or diarrhoea) or convulsions. Talk to your doctor as soon as possible.
Take the medicine carton to show the doctor.
If you forget to take Amoxicillin Sugar Free Suspension
If you forget to take a dose, take it as soon as you remember. You should not take the next dose
too soon, but wait about 4 hours before taking the next dose.
If you stop taking Amoxicillin Sugar Free Suspension
Keep taking Amoxicillin Sugar Free Suspension until the treatment is finished, 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. Treatment should be continued for 2 to 3 days after the symptoms
have gone. It is recommended that atleast 10 days treatment be given for any infection caused
by beta-haemolytic streptococci in order to achieve eradication of the organism.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

Usual Dosages for children:
Your chemist will give you a spoon to give your child the right dose. Or the chemist
may give you a syringe. In both cases shake the bottle well before removing the
cap. If the chemist has given you a syringe follow these simple rules.

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1. After shaking the bottle, remove the cap and replace with the syringe.
2. Use the syringe to measure out the right dose.
3. Put the syringe tip into your child's mouth and drip the medicine in gently. Don't
hurry your child, allow time for him or her to swallow the medicine slowly.
4. After each dose, wash the syringe well. When you have finished, put the bottle
and syringe somewhere safe, out of the reach of children.

Usual Dosages for Adults:
If you are taking Amoxicillin Sugar Free Suspension Syrups, for most infections
you have to take 250-500mg three times a day. This can be increased to 1g three
times a day if the infection is severe.
For severe or frequent chest infections your doctor may recommend taking 3 g two
times a day.
Infections of the bladder or urethra (water infections) can be treated with two 3 g
doses taken within 10-12 hours of each other.

Usual Dosage for Preventing Endocarditis:
Prophylaxis for endocarditis:
3g amoxicillin given as a single dose one hour preceding the surgical procedure.

Children weighing < 40 kg:
The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses
(not exceeding 3 g/day) depending on the indication, severity of the disease and
the susceptibility of the pathogen (see special dosage recommendations below
and sections 4.4, 5.1 and 5.2).
Children weighing more than 40 kg should be given the usual adult dosage.

Like all medicines, Amoxicillin Sugar Free Suspension can cause side effects,
although not everybody gets them. The side effects below may happen with this
medicine.
Conditions you need to look out for
• Skin rash
• Severe skin reactions with blisters and peeling skin which may involve the lining of
the mouth or genitals e.g erythema multiforme, Stevens-Johnson syndrome, toxic
epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised
exanthematous pustulosis (AGEP)
• Convulsions
• Difficulty or discomfort in passing urine or have cloudy urine.
• Watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
• Notice your skin or the white of your eyes turning yellow
• Notice your urine becoming darker or your faeces becoming paler
• Swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing

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Contact a doctor immediately if you get any of these symptoms. Stop taking Amoxicillin
Sugar Free Suspension.
Common side effects
These may affect less than 1 in 10 people
• Nausea (feeling of sickness) or diarrhoea
• Skin rash.
Uncommon side effects
These may affect less than 1 in 100 people
• Vomiting
• Allergic skin reactions with itching e.g. 'hives' or 'nettle' rash. If you or your child start to itch
or get a rash, STOP taking Amoxicillin Sugar Free Suspension and tell your doctor at once.


Pruritus

Very rare side effects
These may affect less than 1 in 10,000 people

Special dosage recommendation
Prophylaxis for endocarditis: 50 mg amoxicillin/kg body weight given as a single
dose one hour preceding the surgical procedure.

Further information for all patients:
The maximum dose needed for most infections is 6 g daily given in divided doses.
Doses may be lower than those listed above in patients with kidney problems.
Incase of haemodialysis: One usual dose should be administered at the end of the
procedure

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Hypersensitivity or severe allergic reaction including swollen face or breathing problems.
A skin reaction known as 'erythema multiforme' where your child may develop: itchy reddish
purple patches on the skin especially on the palms of the hands or the soles of the feet,
'hivelike' raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes
and private parts. Your child may have a fever and be very tired.
Other severe skin reactions (see under "conditions to look out for") 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 and feeling
generally very unwell.

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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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