AMOXYCILLIN 250MG CAPSULES BP

24 mm

AMOXICILLIN 250mg CAPSULES
AMOXICILLIN 500mg CAPSULES
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 only. Do not pass it on to
others. It may harm them, even if their symptoms 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.
In this leaflet:
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible Side Effects
5. How to store this medicine.
6. Contents of the pack and other information

1. What this medicine is and what it is used for
What Amoxicillin is
Amoxicillin is an antibiotic. The active ingredient is amoxicillin. This belongs
to a group of medicines called ‘penicillins’.
What Amoxicillin is used for
Amoxicillin is used to treat infections caused by bacteria in different parts of
the body. Amoxicillin may also be used in combination with other medicines
to treat stomach ulcers.

2. What you need to know before you take this medicine
Do not take this medicine if you:
8

SAME SIZE ARTWORK
360 x 120 mm
Front

- 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 or swelling of the face or throat.
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine 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 This is because
Amoxicillin can affect the results of these tests.
Other medicines and Amoxicillin
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, 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.
• 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 may
be less effective.
• If you are taking methotrexate (used for the treatment of cancer and severe
psoriasis) Amoxicillin may cause an increase in side effects.

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 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.
Important information about some of the ingredients of these
capsules
• The colours sunset yellow (E 110) and carmoisine (E 122) in the
capsule shell can cause allergic type reactions.
• This medicine also contains Methylparaben(E218) and Propylparaben
(E216) which may cause allergic reactions.

3.How to take this medicine
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
• Swallow with water without opening capsule.
• 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 the child’s body weight in kilograms.
• Your doctor will advise you how much Amoxicillin 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 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 antibiotics 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 than you should
If you have taken too much Amoxicillin, 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 the medicine to show the doctor.
If you forget to take Amoxicillin
• 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 for?
• Keep taking Amoxicillin 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 feel unwell you should go back to
see the doctor.
XXXXXX

PACKAGE LEAFLET: INFORMATION FOR THE USER

120 mm

8

SAME SIZE ARTWORK
360 x 120 mm
Back
Kaypee Design
Final 080415

•
•
•
•
•

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
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5. How to store this medicine
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
• Do not store above 25oC.
• Do not use this medicine if there are visible signs of deterioration.
• Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6. Contents of the pack and other information
What Amoxicillin Capsules contain:
• The active substance is Amoxicillin Trihydrate. The active substance in
each capsule is 250 mg or 500 mg amoxicillin.
• The other ingredient of the powder is magnesium stearate
• The capsule shell for both strengths contains gelatin, sunset yellow
(E 110), carmoisine (E 122), brilliant blue (E 133),quinoline yellow (E 104),
titanium dioxide (E171), Methyl hydroxybenzoate (E218) and Propyl
hydroxybenzoate (E216).
What Amoxicillin Capsules look like and contents of the pack:
• Amoxicillin 250mg Capsules -Red/buff coloured, hard gelatin capsule
containing a white to off white powder. Printed with ‘’AMOXY 250’’.
• Amoxicillin 500mg Capsules -Red/buff coloured, hard gelatin capsule
containing a white to off white powder. Printed with ‘’AMOXY 500’’
• Amoxicillin Capsules are supplied to your pharmacist in packs containing
21, 100, 250, 500 and 1000 capsules.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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 250mg Capsules; PL 17907/0006
Amoxicillin 500mg Capsules; PL 17907/0007
This leaflet was last revised in March 2016
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.
V8 05-03-2016 D0

120 mm

4. Possible Side Effects
Like all medicines, this medicine may sometimes cause side effects, although
not everybody gets them.
Stop taking Amoxicillin 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 reaction, the signs include: skin rash or itching, swelling of the
face, lips, tongue, body or breathing difficulties.These can be serious and
occasionally deaths have occured
• 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 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, 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 for Lyme disease and 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: o 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 (may affect up to
1 in 100 people).
If you have any of these talk to your doctor as Amoxicillin will need
to be stopped.
The other possible side effects are:
Common (may affect up to 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea.
Uncommon (may affect up to 1 in 100 people)
• being sick (vomiting).
Very rare (may affects 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

xxxxxxx

Thrush (a yeast infection of moist areas of the body which can cause
soreness, itching and white discharge) may develop if Amoxicillin is used
for a long time. If this occurs tell your doctor.
If you take Amoxicillin 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.