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AMOXICILLIN 125 MG/5 ML ORAL SUSPENSION

Active substance(s): AMOXICILLIN

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100 ml Amoxicillin

Powder for Oral Suspension.
Use as directed by the physician.
Shake the bottle well before use.
To reconstitute: Add 59 ml water, replace the lid
and shake the bottle well. Once reconstituted use
within 14 days. It is not recommended to further
dilute the reconstituted product.
Store in the original container. Do not store above
25°C prior to reconstitution. After reconstitution, store
suspension at 2°C-8°C. Do not freeze.
Store out of the reach and sight of children.

Peel here but do not remove
Please read the leaflet enclosed

50 mm

Oral Suspension
Each 5 ml dose contains
amoxicillin trihydrate equivalent to
125 mg amoxicillin, also contains
sucrose, quinoline yellow (E104)
and sodium benzoate (E211)
PL 33414/0007
POM

PL holder:
Chelonia Healthcare Ltd.,
Boumpoulinas 11, 3rd floor,
Nicosia, P.C. 1060, Cyprus.

WARNING:
Each 5 ml of product contains 2.86 g sucrose.
It is unsuitable in hereditary fructose intolerance,
glucose-galactose malabsorption syndrome, or
sucrase-isomaltase deficiency.

Storing your medicine
You must keep the medicine in a safe place where children cannot get it. Your
medicine could harm them.
Store your medicine in the original container. Do not store above 25oC prior to
reconstitution by a pharmacist. After reconstitution, store suspension at 2oC - 8oC.
Do not freeze.Do not use this medicine after the expiry date, but return it to your
doctor or pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to someone else, even if his or
her symptoms are the same as yours.
This leaflet does not contain the complete information about your medicine. If you
have any questions or are not sure about anything, ask your doctor or pharmacist
who have access to additional information.
CL0007/O/LL/CL1

125 mg / 5 ml

Amoxicillin 125 mg / 5 ml Oral Suspension PL33414/0007
Amoxicillin 250 mg / 5 ml Oral Suspension PL 33414/0008
Prescription Only Medicines
This leaflet was revised in 09/2017.

90 mm

Children weighing less than 40 kg:
Your doctor will advise you how much Amoxicillin you should give your child
depending on the child’s bodyweight. The usual dose is 40-90 mg/kg/day, given in
two or three divided doses.
The dose may be reduced for the elderly and for patients with kidney problems.
Your doctor may prescribe different doses to those given above. If this applies
discuss it with your doctor if you have not already done so.
What to do if too much amoxicillin is taken
If you accidentally take more medicine than recommended, contact your doctor at once.
If you miss a dose, skip the missed dose and go back to your regular dosage
schedule. Do not take two doses at once.
What side effects can Amoxicillin Oral Suspension have?
On rare occasions severe allergic reactions can occur. These may result in
swelling of certain parts of the body, including the face and neck, accompanied by
difficulty breathing. If this occurs contact your doctor immediately.
Most side effects are caused by hypersensitivity. Skin reactions are the most
common side effect with rashes and itchiness. If you develop any form of skin
reaction while taking this product stop taking it and consult your doctor.

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malabsorption syndrome, or sucrase-isomaltase deficiency. This product also
contains sodium benzoate, which is a mild irritant to the skin, eyes and mucous
membrane. It may increase the risk of jaundice in newborn babies.
Tell your doctor if you are suffering from the following conditions:
• Infectious mononucleosis (glandular fever)
• Lymphatic leukaemia
• HIV infection (AIDS)
It is important that you tell your doctor if you are pregnant, or likely to become
pregnant, or if you are breast feeding. Make sure to tell your doctor or pharmacist
if you have any other medical problems such as kidney disease.
Amoxicillin should not be used for the prevention of infection by patients who have
received more than a single dose of penicillin in the previous month.
Can you take Amoxicillin Oral Suspension with other medicines?
Tell your doctor of any other medicines you are taking (even those bought without a
prescription); in particular, be sure to tell your doctor if:
• You are taking anti-coagulants such as warfarin or phenindione, which prevents
the clotting of blood, because clotting time may be increased by an interaction
with amoxicillin.

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PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR
MEDICINE. KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED
ALL THE PRESCRIBED COURSE OF AMOXICILLIN. IF YOU HAVE ANY QUESTIONS
CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE
INFORMATION

Oral Suspension
Each 5 ml dose contains
amoxicillin trihydrate equivalent to
125 mg amoxicillin, also contains
sucrose, quinoline yellow (E104)
and sodium benzoate (E211)
PL 33414/0007
POM

PL holder:
Chelonia Healthcare Ltd.,
Boumpoulinas 11, 3rd floor,
Nicosia, P.C. 1060, Cyprus.

Powder for Oral Suspension.
Use as directed by the physician.
Shake the bottle well before use.
To reconstitute: Add 59 ml water, replace the lid
and shake the bottle well. Once reconstituted use
within 14 days. It is not recommended to further
dilute the reconstituted product.
Store in the original container. Do not store above
25°C prior to reconstitution. After reconstitution, store
suspension at 2°C-8°C. Do not freeze.
Store out of the reach and sight of children.
WARNING:
Each 5 ml of product contains 2.86 g sucrose.
It is unsuitable in hereditary fructose intolerance,
glucose-galactose malabsorption syndrome, or
sucrase-isomaltase deficiency.

125 mm

Printer to add barlines

125 mg / 5 ml

CL0007/O/LL/CL1

100 ml Amoxicillin

BN :
EXP :

5000000 0 0 0 0 00

What is in your medicine?
Amoxicillin is a penicillin antibiotic. It is one of a group of antibiotics called
broad-spectrum antibiotics. It is available in powder in both 60 ml and 100 ml bottles
for preparation by the pharmacist, and is available in two strengths.
After the powder has been reconstituted, each 5 ml of mixture contains either 125
mg or 250 mg amoxicillin as amoxicillin trihydrate. It also contains sodium benzoate
(E211), sodium citrate (E331), colloidal anhydrous silica, saccharin sodium,
dispersible cellulose, quinoline yellow (E104), sucrose and lemon flavouring powder.

Who makes it?
The Product Licence holder is: Chelonia Healthcare Limited,
Boumpoulinas 11, 3rd floor, Nicosia, P.C. 1060, Cyprus.
The manufacturer is: DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London SW5 9JQ, England.
Why have you been prescribed Amoxicillin?
Amoxicillin is used to treat infections caused by bacteria that are susceptible to
amoxicillin. It is mostly used to treat bronchitis, middle ear infections and urinary tract
infections. It may also be used to prevent infection during surgical procedures such
as dental extractions and patients at risk of developing bacterial inflammation of the
heart lining (endocarditis).
Check before taking your medicine
Before taking this medicine, tell your doctor if you have ever had any unusual or
allergic reactions to amoxicillin, ampicillin or any other penicillin or cephalosporin
antibiotic, or to any other ingredient of the product (see above). Each 5 ml dose of
Amoxicillin 125 mg/5 ml Oral Suspension contains 2.86 g sucrose and each 5 ml
dose of Amoxicillin 250 mg/5 ml Oral Suspension contains 2.74 g sucrose. This
product is unsuitable in hereditary fructose intolerance, glucose-galactose

PATIENT INFORMATION LEAFLET

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

50 mm

CL0007/O/LL/CL1

Other reactions include stomach upsets, diarrhoea and vomiting, inflammation of the
colon (colitis), swollen glands, fluid retention, painful joints, fevers and tiredness.
Very rare side-effects:
• 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
• Flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test
results (including increased white blood cells (eosinophilia) and liver enzymes)
(Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
On very rare occasions various anaemias, characterised by paleness, shortness of
breath, headache, dizziness and tiredness, and increased bleeding time may
occur. Kidney problems, liver problems and jaundice characterised by yellowing of
the skin and eyes also rarely occur.
Convulsions and tingling sensations in the hands and legs have also been
reported.
If you suffer from any of the above side effects or from any other unusual effects,
contact your doctor or pharmacist.

• You are taking probenecid (used to treat gout) because excretion of penicillins
such as amoxicillin is reduced by probenecid.
• You are taking oral contraceptives because their effect may be reduced when
given together with amoxicillin. You should take extra precautions to prevent
pregnancy, e.g., barrier methods such as a condom or cap.
When and how to take Amoxicillin Oral Suspension
Amoxicillin Oral Suspension should be taken by mouth and only in the doses
prescribed by your doctor. Do not take more of it, and do not take it more often or
for a longer time than your doctor ordered.
Do not stop taking your medicine or change the dose unless your doctor tells you to.
Dosages:
Your doctor will decide on the appropriate dose to suit the severity and type of
infection you have. Shake the bottle well before use.
Adults and Children weighing 40 kg or over:
The usual dose is 250 mg to 500 mg every 8 hours. This is equivalent to one or two
spoonfuls (5-10 ml) of the 250 mg / 5 ml product or two to four spoonfuls (10-20 ml)
of the 125 mg / 5 ml product.

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