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AMOXICILLIN 250 MG CAPSULES

Active substance(s): AMOXICILLIN TRIHYDRATE

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PACKAGE LEAFLET

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Package leaflet: Information for the patient
Amoxicillin 250 mg Capsules
Amoxicillin 500 mg Capsules
(amoxicillin)
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, ask your doctor or pharmacist.
This medicine has been prescribed for you (or 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 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

What Amoxicillin is
Amoxicillin capsules contain the active substance amoxicillin, a broad-spectrum antibiotic belonging 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 Amoxicillin

Do not take Amoxicillin:

if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in
section 6).

you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the
face or throat.
Do not take this medicine if any of the above apply. If you are not sure, talk to your doctor or pharmacist
before taking Amoxicillin.
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

have epilepsy or have ever had a seizure (fit)
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
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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.
3.

How to take Amoxicillin

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 the capsules whole with a glass of water
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.

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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 medicine, 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 Mylan for?

Keep taking this medicine 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.
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.
4.

Possible side effects

Like all medicines, this medicine can 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 (may affect up to 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 taking 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 feel
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.

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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:
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 happens 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 the 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 your treatment 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 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.

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 white of the
eyes

the blood may take longer to clot than it normally would. You may notice this if you have a nose bleed
or cut yourself.

an increase in levels of some liver enzymes in the blood, which would be seen in a blood test
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.

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5.

How to store Amoxicillin

Keep this medicine out of the sight and reach of children.
Store in a dry place below 25°C and protect from light.
Do not use Amoxicillin after the expiry date which is stated on the carton after EXP. The expiry date refers
to the last day of that month. Do not use Amoxicillin 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 any medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Amoxicillin contains:
The active substance is amoxicillin trihydrate.
The other ingredients are talc, magnesium stearate, sodium starch glycollate with microcrystalline cellulose
in the 250 mg product only and colloidal silicon dioxide in the 500 mg product only. The capsule shell
contains erythrosine (E127), quinoline yellow (E104), titanium dioxide (E171), red iron oxide (E172) and
gelatine. The printing ink contains black iron oxide (E172), shellac, isopropyl alcohol, n-butyl alcohol,
propylene glycol and ammonium hydroxide.
What Amoxicillin looks like and contents of the pack:
Your medicine comes as a hard capsule with a yellow body and a red cap. The 250 mg capsule is marked
‘AX250’ and ‘G’. The 500 mg capsule is marked ‘AX500’ and ‘G’
Amoxicillin Capsules are available in blisters or bottles of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90,
100, 250 and 500 capsules. The 250 mg capsules are also available in blisters or bottles of 50 capsules.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Generics [UK] Ltd., Potters Bar, Herts., EN6 1TL, United Kingdom.
This leaflet was last revised in: November 2015

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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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