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RESPILLIN 3G SACHET SUGAR FREE

Active substance(s): AMOXICILLIN TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

AMOXICILLIN 3g SACHET SUGAR FREE
Amoxicillin (as amoxicillin trihydrate)

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

1.

WHAT AMOXICILLIN 3g SACHET SUGAR
FREE IS AND WHAT IT IS USED FOR

What Amoxicillin 3g Sachet Sugar Free is
Amoxicillin 3g Sachet Sugar Free is an antibiotic.
The active ingredient is amoxicillin. This belongs to
a group of medicines called ‘penicillin’.
What Amoxicillin 3g Sachet Sugar Free is used
for
Amoxicillin 3g Sachet Sugar Free is used to treat
infections caused by bacteria in different parts of
the body. Amoxicillin 3g Sachet Sugar Free may
also be used in combination with other medicines
to treat stomach ulcers.

2.

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE AMOXICILLIN 3g SACHET
SUGAR FREE

Do not take Amoxicillin 3g Sachet Sugar Free:
• 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, swelling
of the face or throat.
Do not take Amoxicillin 3g Sachet Sugar Free if
any of the above apply. If you are not sure, talk to
your doctor or pharmacist before taking Amoxicillin
3g Sachet Sugar Free.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Amoxicillin 3g Sachet Sugar Free 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.
Blood and urine tests
If you are having:
• Urine tests (glucose) or 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 3g Sachet Sugar Free. This is because
Amoxicillin 3g Sachet Sugar Free can affect the
results of these tests.
Other medicines and Amoxicillin 3g Sachet
Sugar Free
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 3g Sachet Sugar Free, 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 3g Sachet Sugar Free.
• 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 3g Sachet Sugar Free
may be less effective
• If you are taking methotrexate (used for the
treatment of cancer and severe psoriasis)
Amoxicillin 3g Sachet Sugar Free may cause an
increase in side effects.
• If you are taking oral typhoid vaccine (may not
work if taken with Amoxicillin 3g Sachet Sugar
Free).
Pregnancy and breast-feeding
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 this medicine.
Driving and using machines
Amoxicillin 3g Sachet Sugar Free 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.
Amoxicillin 3g Sachet Sugar Free contains sorbitol
and sodium
• Amoxicillin 3g Sachet Sugar Free contains 5.4g
(grams) of sorbitol (E420). 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.
• The maximum single dose of 6g of Amoxicillin
contains 149mg of sodium. To be taken into
consideration by patients on a controlled
sodium diet.
TO TAKE AMOXICILLIN 3g SACHET
SUGAR FREE
3. HOW
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
• Put the content of the sachet in 10 to 20 ml of
water. Shake until a suspension is formed. Take
immediately.
• Space the doses evenly during the day, at least
4 hours apart.
The usual dose is:
Children weighing less than 40 kg
All doses are worked out depending on your child’s
body weight in kilograms.
• Your doctor will advise you how much
Amoxicillin 3g Sachet Sugar Free you should
give to your baby or child.
• The usual dose is 40 mg to 90 mg for each
kilogram of body weight a day given in two or
three divided doses.
The maximum recommended dose is 100 mg for
each kilogram of body weight a day.
Adults, elderly patients and children weighing
40 kg or more
The usual dose of Amoxicillin 3g Sachet Sugar
Free is 250 mg to 500 mg three times a day or
750 mg to 1 g every 12 hours, depending on the
severity and type of infection.
• Severe infections: 750 mg to 1 g three times a
day
• Urinary tract infection: 3 g twice daily for one
day
• Lyme disease (an infection spread by
parasites called ticks): Isolated erythema
migrans (early stage – red or pink circular rash):
4 g a day, Systemic manifestations (late stage –
for more serious symptoms or when the disease
spreads around your body): up to 6 g a day
• Stomach ulcers: one 750 mg or one 1 g dose
twice a day for 7 days with other antibiotic and
medicines to treat stomach ulcers.
• To prevent heart infection during surgery:
the dose will vary according to the type of
surgery. Other medicines may also be given at
the same time. Your doctor, pharmacist or nurse
can give you more details.
The maximum recommended dose is 6 g per day.
Kidney problems
If you have kidney problems, the dose might be
lower than the usual dose.
If you take more Amoxicillin 3g Sachet Sugar
Free than you should
If you have taken too much of the Amoxicillin 3g
Sachet Sugar Free, 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 this medicine to show the
doctor.
If you forget to take Amoxicillin 3g Sachet
Sugar Free
• 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 3g
Sachet Sugar Free for?
• Keep taking Amoxicillin 3g Sachet Sugar Free
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 fell 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 3g Sachet
Sugar Free is used for a long time. If this occurs
tell your doctor.
If you take Amoxicillin 3g Sachet Sugar Free 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

medicine, ask your doctor or pharmacist.

5. SACHET SUGAR FREE

HOW TO STORE AMOXICILLIN 3g

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

Keep this medicine out of the sight and reach of
children.

Stop taking Amoxicillin 3g Sachet Sugar Free
and see a doctor straight away, if you notice
any of the following serious side effects – you
may need urgent medical treatment:
The following are very rare (may affect up to 1 in
10,000 people)

Do not use your medicine after the expiry date
shown on the label. The expiry date refers to the
last day of that month.
Do not store above 25°C. Store in the original
package.

What Amoxicillin 3g Sachet Sugar Free
contains

Checked by: Paul Adams

The Product Licence Holder is
Athlone Laboratories Limited, Ballymurray,
Co. Roscommon, Ireland.
The Product is distributed by:
Almus Pharmaceuticals, 43 Cox Lane,
Chessington, KT9 1SN, UK.
PL 06453/0054
This leaflet was last revised 09/2016.

www.pmdc.co.uk

Your medicine is manufactured by
Laboratorio REIG JOFRE, Calle Jarama, s/n,
Poligono Industrial, 45007 Toledo, Spain.

Date: 3.10.2016

Not all pack sizes may be marketed.

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

The sachets are available in boxes of 2 and 14.

General advice regarding the use of
antibiotics

90

100

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

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.

A0087a/Lt4

60
50
This scale measures 100mm when artwork is 100%
0
10
20
30

40

Patient Information Leaflet

PHARMA CODE TBA
ALMUS CODE A0087a/Lt4

SUPPLIER ISSUE DATE: 3.10.2016

Item(s):

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

REASON FOR CHANGE: Safety text update

1. 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.
2. 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.
3. You should not take antibiotics that have been
prescribed for other people even if they had an
infection that was similar to yours.
4. You should not give antibiotics that were
prescribed for you to other people.
5. 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.

Almus UK

Uncommon (may affect up to 1 in 100 people)
• being sick (vomiting)

PMS
280

Colours used:

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

70

80

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.

The other possible side effects are:
Common (may affect up to 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea.

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
• forming of crystals in the urine (crystalluria),
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 type 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 with 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.

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

What Amoxicillin 3g Sachet Sugar Free look
like and contents of the pack
Amoxicillin 3g Sachet Sugar Free is a lemon
coloured, dry, and free flowing powder with a
characteristic lemon flavour.

+44 (0)1489 878780

- The active substance in each sachet is 3g
amoxicillin as amoxicillin trihydrate.
- The other ingredients are: Sodium citrate,
Disodium edetate, Colloidal anhydrous silica,
Sorbitol, Lemon flavour powder, Quinoline
yellow (E104) and Xanthan gum.

Client:

If you have any of these talk to your doctor as
Amoxicillin 3g Sachet Sugar Free will need to
be stopped.

OF THE PACK AND OTHER
INFORMATION
6. CONTENTS

DRAFT ISSUE: 4

Sometimes you may get less severe skin
reactions such as:
• a mildly 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).

Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These
measures will help protect the environment.

VERSION: 4 (KENT)

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

Do not use this medicine if there are visible signs
of deterioration.

REVISED ARTWORK FOR MHRA APPROVAL

• 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 3g Sachet
Sugar Free, some signs include: rashes, fever,
joint pains and enlargement of the lymph nodes
and 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 and 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 3g Sachet
Sugar Free for Lyme disease 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.

DIMENSIONS 160mm x 470mm

4. POSSIBLE SIDE EFFECTS

Expand view ⇕

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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