AMOXIL CAPSULES 250MG

Active substance: AMOXYCILLIN TRIHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
GSK-FRA-Mayenne (Terras 2)-FRMAY

PHARMA CODE
READING DIRECTION

1

Amoxil® Capsules 250 mg
and 500 mg
amoxicillin
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine is usually prescribed for adults and for
children who are able to swallow capsules. 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.

K

NPL170_315_40_C80

In this leaflet:
1 What Amoxil is and what it is used for
2 Before you take Amoxil
3 How to take Amoxil
4 Possible side effects
5 How to store Amoxil
6 Further information

1 What Amoxil is and what it is used for
What Amoxil is
Amoxil Capsules 250 mg and 500 mg (called Amoxil in
this leaflet) are antibiotics. The capsules contain a
medicine called amoxicillin. This belongs to a group of
medicines called ‘penicillins’.

What Amoxil is used for
Amoxil is used to treat infections in different parts of
the body caused by bacteria. It is also used to stop
infections when you have a tooth removed or other
surgery. Amoxil may also be used in combination with
other medicines to treat stomach ulcers.

TYPE SIZE: 8/8.6
HORIZONTAL SCALE: 100%

Page 1 of 2

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.

3 How to take Amoxil
Always take Amoxil exactly as your doctor has told
you. You should check with your doctor or pharmacist
if you are not sure.

When taking Amoxil
• Swallow the capsules whole with a glass of water at
the start of a meal or slightly before
• Space the doses evenly during the day, at least
4 hours apart
• Never take 2 doses in 1 hour
• The maximum recommended dose is 6 g per day
given as 2 x 3 g doses.
The usual dose is:
Children weighing less than 40 kg who are able to
swallow capsules
All doses are worked out depending on the child’s
body weight in kilograms.
• Your doctor will advise you how much Amoxil you
should give to your baby or child.
• Usual dose – 40 mg to 90 mg for each kilogram of
body weight a day, given in two or three divided
doses.

Adults, elderly patients and children weighing
more than 40 kg

• are allergic (hypersensitive) to amoxicillin, penicillin
or any of the other ingredients of Amoxil (listed in
section 6)
• have ever had an allergic (hypersensitive) reaction to
any antibiotic. This can include a skin rash or
swelling of the face or neck.
Do not take Amoxil if any of the above apply. If you
are not sure, talk to your doctor or pharmacist before
taking Amoxil.

• Standard dose: 1 x 250 mg capsule 3 times a day.
• Severe infections: 1 x 500 mg capsule 3 times a day.
• Severe or recurrent chest infection:
3 g (6 x 500 mg capsules) twice a day.
• Urinary tract (water) infection:
2 x 3 g doses (6 x 500 mg capsules) with 10 to
12 hours between each dose.
• Dental abscess (infection under the gums and
teeth): 2 x 3 g doses (6 x 500 mg capsules) with
8 hours between each dose.
• Gonorrhoea (a sexually transmitted infection):
1 x 3 g dose (6 x 500 mg capsules).
• Stomach ulcers: 1 x 750 mg dose (3 x 250 mg
capsules or 1 x 500 mg capsule and 1 x 250 mg
capsule) or 1 x 1 g dose (2 x 500 mg capsules) twice a
day for 7 days with other antibiotics.

Take special care with Amoxil

To stop infection during surgery

2 Before you take Amoxil

FRONT PAGE

• If you are taking probenecid (used for gout), your
doctor may decide to adjust your dose of Amoxil.
• If medicines to help stop blood clots (such as
warfarin) are taken with Amoxil then extra blood
tests may be needed.
Amoxil may stop the contraceptive pill working.
You will need to use extra contraceptive precautions,
such as using a condom. If you need any advice, talk to
your doctor or pharmacist.

Do not take Amoxil if you:

Check with your doctor or pharmacist before taking
this medicine if you:
• have glandular fever
• are being treated for kidney problems
• 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 Amoxil.

Having urine or blood tests
If you are having tests on your water (urine glucose
tests) or blood tests for liver function, let the doctor or
nurse know that you are on Amoxil. This is because
Amoxil can affect the results of these tests.

Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes medicines that can be bought without a
prescription and herbal medicines. This is because
Amoxil can affect the way some other medicines work.
Also some other medicines can affect the way Amoxil
works.
• If you are taking allopurinol (used for gout) with
Amoxil, it may be more likely that you’ll have an
allergic skin reaction.

• 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.

Kidney problems
If you have kidney problems the dose might be lower
than the usual dose.

If you take too much Amoxil
If you have too much Amoxil, 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 passing urine. Talk to your doctor
as soon as possible. Take the medicine to show the
doctor.

If you forget to take Amoxil
• If you forget to take a dose don’t worry, take it as
soon as you remember.
• Don’t take the next dose too soon, wait about
4 hours before taking the next dose.

PHARMA CODE
READING DIRECTION

amoxicillin

Package Leaflet: Information for the User

United Kingdom-GBR
Amoxil

Amoxil® Capsules 250 mg and 500 mg

PHARMA CODE
READING DIRECTION

5127783020

PHARMA CODE
READING DIRECTION

3

V3
5127783020

3
5127783020
GSK-FRA-Mayenne (Terras 2)-FRMAY
United Kingdom-GBR
Amoxil
1

K

NPL170_315_40_C80

BACK PAGE
TYPE SIZE: 8/8.6
HORIZONTAL SCALE: 100%

Page 2 of 2

How long should you take Amoxil for?
• Keep taking Amoxil 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.
• Do not take Amoxil for more than 2 weeks. If you still
feel unwell you should go back to see the doctor.
Thrush (a yeast infection of moist areas of the body)
may develop if Amoxil is used for a long time. If this
occurs and you have been taking Amoxil for longer
than recommended, tell your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Amoxil can cause side effects,
although not everybody gets them. The following side
effects may happen with this medicine.
Stop taking Amoxil 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 (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 Amoxil, 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 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 private parts. 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, 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 you bruise easily.
These may be signs of a problem with your
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. 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.

If any of the above happen stop taking the
medicine and see your doctor straight away.
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 (affects less than
1 in 100 people).

If you have any of these talk to your doctor as
Amoxil will need to be stopped.

The other possible side effects are:
Common (affects less than 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea.
Uncommon (affects less than 1 in 100 people)
• being sick (vomiting).
Very rare (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
• fits (convulsions), seen in patients on high doses or
with kidney problems
• dizziness
• hyperactivity
• crystals in the urine, which may be seen as cloudy
urine, or difficulty or discomfort in passing urine.
Make sure you drink plenty of fluids to reduce the
chance 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
form of anaemia. Signs include: tiredness,
headaches, shortness of breath, dizziness, looking
pale and yellowing of the skin and the whites of the
eyes
• the blood may take longer to clot than it normally
would. You may notice this if you have a nosebleed
or cut yourself.
If any of the side effects gets serious, or if you have
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5 How to store Amoxil
• Keep out of the reach and sight of children.
• Do not use Amoxil after the expiry date which is
stated on the carton. The expiry date refers to the
last day of that month.
• Store in the original pack below 25°C.
• Do not use Amoxil if there are visible signs of
deterioration.
• 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
What Amoxil contains
• The active substance in each capsule is 250 mg
or 500 mg amoxicillin.
• The other ingredients are magnesium stearate
(E572), erythrosine (E127), indigo carmine (E132),
titanium dioxide (E171), yellow iron oxide (E172)
and gelatin.

What Amoxil looks like and contents of the pack
Amoxil Capsules are maroon and gold capsules
overprinted ‘GS LEX’ for the 250 mg capsule or ‘GS JVL’
for the 500 mg capsule. They are packaged in blister
packs, enclosed in a carton. Each pack contains
21 capsules.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK, Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer:
Glaxo Welcome Production, Terras 2, Zone Industrielle
de la Peyenniere, 53100 Mayenne, France

Other formats
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:

Product name

Amoxil Capsules 250 mg
Amoxil Capsules 500 mg

Reference number 00038/0103
This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: November 2013
Amoxil and the maroon and gold capsules are
registered trademarks of the GlaxoSmithKline
group of companies
© 2013 GlaxoSmithKline group of companies

5127783020

V3

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.

Hide
(web1)