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AMOXICILLIN 3G SACHET SUGAR FREE

Active substance(s): AMOXICILLIN TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

AMOXICILLIN 3G SACHET SUGAR FREE
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, please ask your doctor or pharmacist (chemist).
• 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.

WHAT AMOXICILLIN IS AND WHAT IT IS
USED FOR

Amoxicillin is one of a group of antibiotic medicines
called penicillins. Amoxicillin works by interfering
with the bacteria that cause the infection.
Amoxicillin can treat a wide range of infections
including those of the following:
• chest (bronchitis or pneumonia)
• tonsils (tonsillitis)
• ears (otitis media)
• sinuses (sinusitis)
• kidneys
• heart (endocarditis)
• blood (septicaemia)
• skin, bone, teeth and gums (abscesses)
• abdomen (intra-abdominal sepsis and peritonitis)
• gonorrhoea (a sexually transmitted infection)
• the bladder or the urethra (the tube which
carries urine from the bladder)
• typhoid and paratyphoid (fevers caused by a
group of bacteria called salmonella)
• the female reproductive system including
infections associated with pregnancy and
childbirth (puerperal sepsis and septic abortion)
WHAT YOU NEED TO KNOW BEFORE
TAKE AMOXICILLIN
2. YOU
Do not take Amoxicillin if:
• You have ever had a bad reaction or allergy to
any penicillin-type antibiotic
• You have ever had a skin rash, swelling of the
face or neck or shortness of breath when taking
any antibiotic
• You are allergic to any of the ingredients
contained in this medicine (listed in section 6)
• You have an intolerance to some sugars
(hereditary fructose intolerance)
Warnings and precautions
Talk to your doctor or pharmacist before taking
Amoxicillin if:
• You suffer from kidney disease or kidney
problems, as you may require a lower dose than
normal
• You have glandular fever
• You are not passing urine regularly.

Important information about some of the
ingredients in your medicine
Each sachet contains 5.4g (grams) of sorbitol.
Sorbitol may cause stomach upset and diarrhoea.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.
The maximum single dose of 6g of Amoxicillin
contains 11g of sorbitol.
May have a mild laxative effect. Calorific value 2.6
kcal/g sorbitol.
The maximum single dose of 6g of Amoxicillin
contains 149mg of sodium. To be taken into
consideration by patients on a controlled sodium
diet.

3. HOW TO TAKE AMOXICILLIN
Always take this medicine exactly as your doctor or
pharmacist has told you. Their directions may differ
from the information contained in this leaflet. Your
doctor may advise you to take your medicine in a
different way, so you should always follow your
doctor's advice about when and how to take your
medicine and always read the label. Your
pharmacist may be able to help if you are not sure.
You should empty the powder from the sachet into
a glass of water, stir the mixture and swallow it at
once. You may take the medicine with or after
food, unless the label advises a specific time.
The highest recommended adult dose is 3g (one
sachet) twice a day. These high dose sachets are
not suitable for children.
Adult (including the elderly) dose:
• For severe or recurrent chest infections a dose
of 3g twice daily given orally is usually
recommended
• For simple urinary tract infections the adult dose
is two 3g doses given orally with 10 to 12 hours
between doses (short course)
• For the treatment of dental abscesses two 3g
doses given orally with 8 hours between doses
is recommended
• For gonorrhoea a single 3g dose given orally is
recommended

Other medicines and Amoxicillin
Tell your doctor or pharmacist if you are taking, or
have recently taken any other medicines even
those not prescribed by a doctor. In particular tell
your doctor if you are taking any of the following:
• Anticoagulants used to thin your blood e.g.
Warfarin, Acenocoumarol
• Chemotherapy drugs used to treat cancer e.g.
Methotrexate
• Drugs used to treat gout e.g. Probenecid,
Allopurinol, Sulfinpyrazone
• Oral typhoid vaccine (may not work if taken with
amoxicillin)

The following are the usual adult dosages for
preventing infection during dental procedures
and other surgery:
• If a general anaesthetic is not used, 3g given
orally one hour before surgery and another dose
six hours later if necessary
• If a general anaesthetic is used, 3g given orally
four hours before anaesthesia and 3g six hours
after the initial dose

Having urine or blood tests
If you are having urine tests for diabetes (sugar in
the urine) or blood tests for liver function let the
doctor know. Amoxicillin can affect the results of
these tests.

If you forget to take Amoxicillin
If you forget to take a dose, take it as soon as you
remember, unless it is within an hour of your next
dose, then carry on as before. Do not take a
double dose to make up for the dose you have
missed.
If you take more Amoxicillin than you should
If too many of the sachets have been swallowed,
or you think a child has accidentally swallowed
any, contact your nearest hospital casualty
department or doctor immediately.

Pregnancy and breast-feeding
Check with your doctor before you take this
medicine if you are pregnant or breast-feeding.

If you have kidney problems, you may have to take
a lower dose than those above, and it may be
more suitable to take the medicine in another form.

www.pmdc.co.uk

Each sachet contains 3g Amoxicillin as amoxicillin
trihydrate. It also contains sodium citrate, disodium
edetate, colloidal anhydrous silica, sorbitol, lemon
flavour powder, quinoline yellow (E104) and
xanthan gum.

+44 (0)1489 878780

The powder in Amoxicillin 3g Sachet Sugar Free is
a cream / pale yellow colour.

The sachets are available in boxes of 2 and 14.
Your medicine is manufactured by:
Laboratorio REIG JOFRE, Calle Jarama, s/n,
Poligono Industrial, 45007 Toledo, Spain.
The Product Licence Holder is:
Athlone Laboratories Limited, Ballymurray,
Co. Roscommon, Ireland.

100

The Product is distributed by:
Almus Pharmaceuticals, 43 Cox Lane,
Chessington, KT9 1SN, UK
PL 06453/0054

90

Date of last revision: December 2015

80

The following symptoms are less serious but
you may wish to discuss them with your doctor
or pharmacist if they last a long time.

OF THE PACK AND OTHER
INFORMATION
6. CONTENTS

Date: 29.1.2016

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
If you experience any of the following events
STOP taking your medicine and tell your doctor
or go to your nearest hospital immediately:
• Hypersensitivity or severe allergic reaction
including swollen face or breathing problems. If
these symptoms occur, STOP taking amoxicillin
right away and tell your doctor.
• Severe diarrhoea with bleeding
• Allergic skin reactions with itching e.g. hives,
nettle rash, blistering or peeling of the skin. If
you start to itch or get a rash, STOP taking
amoxicillin and tell your doctor immediately.
• Convulsions may occur in patients on high
doses or with kidney problems
• Notice your urine becoming darker or your
faeces becoming paler
• Notice your skin or the white of your eyes
turning yellow (jaundice)
• Difficulty or discomfort in passing urine or
having cloudy urine

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 protect the
environment.

Queries regarding this artwork,
please contact: Steve Hobbs or
Paul Adams

4. POSSIBLE SIDE EFFECTS

Do not use your medicine after the expiry date
shown on the label.
Do not store above 25°C. Store in the original
package.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
If your doctor tells you to stop your treatment,
return any left over to the pharmacist. Only keep it
if your doctor tells you to.

pmdc design llp
Lower Test Studios
Sheardley Lane, Droxford
Hampshire SO32 3QY

REMEMBER:
Keep taking this medicine until it is finished or your
doctor tells you to stop. Do not stop taking it just
because you feel better. If you stop taking the
medicine, some bacteria may survive and cause
the infection to come back, or your condition may
re-occur or get worse.
You should make sure you have several more
drinks of water each day unless told otherwise by
a doctor.
If you are still unwell after taking all the medicine,
go and see your doctor. Never give or take more
than the recommended dose each day.

5. HOW TO STORE AMOXICILLIN

Checked by: Paul Adams

You should take this leaflet and any sachets you
still have to show the doctor.
Severe cases of nausea, vomiting and diarrhoea
can be treated with rehydration therapy, by
drinking fluids containing sodium, water and sugar
to prevent dehydration.

This scale measures 100mm when artwork is 100%
0
10
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Patient Information Leaflet

PHARMA CODE TBA
ALMUS CODE A0087a/Lt4

SUPPLIER ISSUE DATE: 29.1.2016

Item(s):

10321 / UK
Amoxicillin S/F Sachet
3g x 2
Project:

REASON FOR CHANGE: Safety text update

Client:

VERSION: 4 (KENT)

A0087a/Lt4

REVISED ARTWORK FOR MHRA APPROVAL

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
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

DIMENSIONS 160mm x 370mm

Not known: frequency cannot be estimated
from available data
• Meningitis (signs may include stiff neck, fever
and vomiting)

DRAFT ISSUE: 1

Almus UK

50

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 pharmacist.
• Crystalluria, forming of crystals in the urine
• Excessive body movements (hyperkinesia),
dizziness or convulsions.
• Tooth discolouration. The colour usually returns
to normal with brushing.
• Blackening of the tongue
• Inflammation of the kidneys (cause pain in the
lower back, blood in the urine or decreased
urine output)
• Inflammation of the liver (hepatitis)
• 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. Tell your
doctor that you are taking amoxicillin if you are
having blood tests.

60

Uncommon: may affect up to 1 in 100 people
• Vomiting

PMS
280

Colours used:

70

Common: may affect up to 1 in 10 people
• Nausea (feeling sick) or diarrhoea

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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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