AMOXICILLIN 125MG/5ML ORAL SUSPENSION

Active substance: AMOXICILLIN TRIHYDRATE

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TO THE PHARMACIST: To prepare,
add 58ml of potable water and shake
until all the powder is dispersed.
Each 5ml contains 125mg
Amoxicillin (as trihydrate) as the
active ingredient.
Also includes: colour E110 (see
leaflet for further information).
TO THE PATIENT: for oral use. Use
as instructed by a physician. Please
read the leaflet enclosed. Keep
tightly closed. Shake well before
each use. Use within 7 days of
preparation. Complete the
prescribed course of treatment.

PL 17907/0008
Code: BL502

KEEP OUT OF REACH AND SIGHT
OF CHILDREN.
Do not store above 25oC.

TO THE PHARMACIST: To prepare,
add 58ml of potable water and shake
until all the powder is dispersed.
Each 5ml contains 125mg Amoxicillin
(as trihydrate) as the active
ingredient.
Also includes: colour E110 (see
leaflet for further information).
TO THE PATIENT: for oral use. Use
as instructed by a physician. Please
read the leaflet enclosed. Keep tightly
closed. Shake well before each use.
Use within 7 days of preparation.
Complete the prescribed course of
treatment.
KEEP OUT OF REACH AND SIGHT
OF CHILDREN.
Do not store above 25oC.

4. Possible Side Effects
Like all medicines, AmoxicilIin Oral Suspension may sometimes cause side effects,
although not everybody gets them.
STOP TAKING this medicine and see a doctor straight away, if you notice any of the
following serious side effects – they may need urgent medical treatment:
The following are very rare (affects less than 1 in 10,000 people)
· 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 be associated with joint pain (arthritis) and kidney problems
· a delayed allergic reaction can occur usually 7 to 12 days after having
Amoxicillin, 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 your child 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 private parts.
· A severe form of allergic reaction called DRESS syndrome which may show up
with the following symptoms: fever, skin rash, joint pain, swelling of glands,
abnormalities of blood including increase in blood cells called eosinophils,
abnormalities of kidney and liver function.
· 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
high temperature (fever), chills, a sore throat or other signs of an infection, or if they bruise easily.
These may be signs of a problem with their blood cells
· inflammation of the large bowel (colon) with diarrhoea sometimes containing blood, pain and fever
· serious liver side effects may occur which are often reversible. They are mainly associated with
people having treatment over a long period, males and the elderly.
- 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.
If any of the above happen to your child stop giving them the medicine and see your doctor straight
away.
Sometimes your child may get less severe skin reactions such as:
· a mildly itchy rash (round, pink-red patches), 'hive-like' swollen areas on their forearms, legs, palms,
hands or feet. This is uncommon (affects less than 1 in 100 people).
The other possible side effects are:
The common (affects less than 1 in 10 people):
· diarrhoea and nausea
· skin rash
The Uncommon (affects less than 1 in 100 people):
· being sick (vomiting).
·

The very rare side effects (affects 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
· kidney problems
· tooth discolouration, the colour usually returns to normal with brushing
· interstitial nephritis (inflammation of the kidney)
· excessive body movements such as hyperkinesias (excessive activity), dizziness or convulsions
· leucopenia and thrombocytopenia (reduction (reversible) in blood cell counts including anaemia or a
longer time taken for blood to clot) Signs include: tiredness, headaches, shortness of breath,
dizziness, looking pale and yellowing of the skin and the whites of the eyes.
· crystalluria (forming of crystals in the urine)
· hypersensitivity or severe reaction including swelling of the rash, fever, swelling of the skin or difficulty
in breathing
· jaundice (notice your skin or the white of your eyes turning yellow)
Tell your doctor that you are taking amoxicillin if you are going to have urine or blood test as this medicine
may have an effect on your results.
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.
5. How to store this medicine
· Keep the medicine in a safe place where children cannot see or reach it
· Store in a cool dry place, below 25°C.
· Store in the original container. Do not transfer your medicine to another container.
· Do not use the medicine after the expiry date shown on the label.
·

Return any left over medicine back to your pharmacist for safe disposal.
6. Further Information
What Amoxicillin Oral Suspension contains:
· There are two strengths available, each 5ml of the suspension either contains 125mg or 250mg
of the active ingredient Amoxicillin (as amoxicillin trihydrate).
· The other ingredients are: sodium benzoate (E211), disodium edentate, sodium citrate, flavour
orange/bramble, yellow FD & C No 6 (E110) and sucrose.
Amoxicillin Oral Suspension is a citrus flavoured suspension.
Amoxicillin Oral Suspension is presented as a powder in bottles for preparing 100ml of
suspension.
Marketing Authorisation Holder
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, United Kingdom, HP4 1EG
Telephone:
0044 (0)1442 200922
Fax:
0044(0)1442 873717
Email:
info@bristol-labs.co.uk
Amoxicillin 125mg/5ml Oral Suspension BP; PL 17907/0008
This leaflet was last revised in February 2012
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder
at the address (or telephone, fax, email) above.
·

Ph. Code

381 mm

Read all of this leaflet carefully before you start taking this medicine. Even if you have used
this medicine or a similar product before, you should read this text carefully as the
information may have changed.
· Keep this leaflet. You may need to read it again.
· If you have any further queries, 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 effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take this medicine
3. How to take this medicine
4. Possible Side Effects
5. How to store this medicine
6. Further Information
1. What this medicine is and what it is used for
· Amoxicillin is an antibiotic used for treating infections. It belongs to a group of antibiotics called
'penicillins'. Amoxicillin works by killing the bacteria that can cause infections.
· Amoxicillin can treat a wide range of infections including those of the chest (bronchitis or
pneumonia), chronic bronchial sepsis, tonsils (tonsillitis), ears (otitis media), sinuses
(sinusitis), the bladder or the urethra (the tube that carries urine from the bladder), kidneys, the
female reproductive system including infections caused by difficulties during childbirth
(puerperal sepsis and septic abortion), abdomen (intra-abdominal sepsis and peritonitis),

heart (endocarditis), blood (septicaemia), skin and soft tissue, teeth and gums (abscesses).
· Amoxicillin can also be used to treat gonorrhoea (a sexually transmitted infection), infections

associated with pregnancy and typhoid and paratyphoid (fevers caused by a group of bacteria called
Salmonella).
· Amoxicillin may also be used in combination with other medicines to treat duodenal and gastric ulcer
disease.
2. Before you take this medicine
Do not take this medicine if you:
· have ever had a bad reaction or are you allergic (hypersensitive) to any penicillin-type of antibiotics or
history of allergy to beta-lactam antibiotics (e.g. cephalosporins)
· have ever been told you are allergic (hypersensitive) to amoxicillin or any other ingredients (these are
listed in Section 6, Further Information)
Do not give Amoxicillin to your child if any of the above apply. If you are not sure, talk to their doctor or
pharmacist before giving Amoxicillin
Take special care with Amoxicillin:
Check with their doctor or pharmacist before giving your child this medicine if they:
· suffer from any kidney problems
· have or think you have glandular fever (viral infection) which causes a sore throat, high temperature
(above 39°C (102.2°F)), tiredness, muscle pains and headache
· are not passing water regularly.
If you are not sure if any of the above apply to your child, talk to their doctor or pharmacist before giving
Amoxicillin.
Special care will be taken by the doctor or nurse if Amoxicillin is being given to your premature or newborn

baby.
Having urine or blood tests
If your child is having tests on their water (urine glucose tests) or blood tests for liver function, let the doctor
or nurse know that they are on Amoxicillin. This is because Amoxicillin can affect the results of these tests.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even
those not prescribed, for example, herbal remedies and health supplements from a pharmacy,
supermarket or health food shop, as this medicine may interact with other drugs.
Examples of medicines which can affect amoxicillin are:
· probenecid (used to treat gout), your doctor may decide to adjust their dose of amoxicillin.
· Allopurinol (used for gout) with Amoxicillin, it may be more likely that they will have an allergic skin
reaction.
· oral contraceptives
· anti-coagulants (to prevent clotting such as warfarin) are taken with Amoxicillin then extra blood tests
may be needed.
Pregnancy and breast-feeding
· Ask your doctor or pharmacist for advice before taking any medicine if you think you might be or if you
are pregnant, or if you are breast-feeding
Important information about some of the ingredients of this medicine
· This medicine contains SUCROSE.
· Each 5ml dose of Amoxicillin125mg/5ml Oral Suspension 3.082g of sucrose.
· Each 5ml dose of Amoxicillin 250mg/5ml Oral Suspension 2.913g of sucrose.
· This should be taken into account in patients with diabetes mellitus.

381 mm

· If you have been told by your doctor that you or your child have intolerance to some sugars, contact

your doctor before taking this medicine.

· This medicine also contains sunset yellow FD&C No 6 (E110) which may cause allergic reactions.

3. How to take this medicine
· Always take this medicine as advised by your doctor. You should check with your doctor or pharmacist
if you are not sure.
· Complete the prescribed course of treatment as if you stop the condition may recur.
· Shake the bottle well before use. Use within 7 days of preparation.
· Give at the start of a meal or slightly before unless the label specifies particular times.
· Space the doses evenly during the day, at least 4 hours apart.
· Never give 2 doses in 1 hour.
· Do not give doses of Amoxicillin at night.
The usual doses are as follows:
ADULTS:
· To treat an infection, you have to usually take one 250mg of your medicine three times a day. This is
10ml (two 5ml spoonfuls) of Amoxicillin Oral suspension 125mg/5ml or 5ml (one 5ml spoonful) of
Amoxicillin Oral Suspension 250mg/5ml.
· The maximum dose needed for most infections is 6g daily given in divided doses.
· Doses may be lower in subjects with kidney problems.
CHILDREN under 40 kg:
· Your doctor will tell you how much amoxicillin your child needs each day based upon your child's
weight and the infection that they have. The medicine is usually given three times a day. High doses
may be given twice daily. For treatment before surgery, a single dose may be given one hour before.

· Children weighing more than 40 kg will be given the usual adult dose.
· If your child has kidney problems, then the length of time between doses may be increased and you

should follow the instructions given by your doctor.

· Paediatric Suspension is recommended for children under six months of age.

It is important that you take your medicine at the right times of day. Space the doses out as evenly as
possible throughout the day.
Your doctor may advise you to take your medicine in a different way, for example if your infection is more
serious, your dose may be doubled.
If you take more medicine than you should
If you accidently take too much Amoxicillin Suspension, tell your doctor immediately or contact your
nearest Hospital Casualty/Accident and Emergency Department even if there are no signs of discomfort.
Take this medicine in its original packaging with you in order to enable the doctor to identify your
medication easily.
If you forget to take this medicine:
Take it as soon as you remember. Then carry on as before, but do not take two doses within one hour of
each other.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.
If you stop taking this medicine
Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel
better. If you stop taking this medicine, your condition may recur or get worse.

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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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