Package leaflet: Information for the user

Amoxicillin 250 mg and 500 mg Capsules

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 Capsules are and what are they are used for
2. What you need to know before you take Amoxicillin Capsules
3. How to take Amoxicillin Capsules
4. Possible side effects
5. How to store Amoxicillin Capsules
6. Contents of the pack and other Information

1. What Amoxicillin Capsules are and what they are used for

The name of your medicine is Amoxicillin 250 mg or 500 mg Capsules (referred to as

Amoxicillin Capsules in this leaflet).

Amoxicillin Capsules contain the active substance, amoxicillin (as the trihydrate).
Amoxicillin is an antibiotic and belongs to a group of medicines called ‘penicillins’.

Amoxicillin Capsules are used to treat infections caused by bacteria in different parts
of the body. They are also used in combination with other medicines to treat stomach
ulcers.

2. What you need to know before you take Amoxicillin Capsules

Do not take Amoxicillin Capsules

• 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.

Do not take Amoxicillin Capsules if any of the above apply. If you are not sure, talk to
your doctor or pharmacist before taking Amoxicillin Capsules.

Warnings and precautions

Talk to your doctor or pharmacist before you take Amoxicillin Capsules if you:
• have glandular fever (fever, sore throat, swollen glands and extreme
tiredness)
 • have kidney problems
• are not urinating properly.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before taking Amoxicillin Capsules.

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 Capsules. This is
because Amoxicillin Capsules can affect the results of these tests.

Other medicines and Amoxicillin Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained with a prescription.

• If you are taking oral contraceptives.

• If you are taking allopurinol (used for gout) with Amoxicillin Capsules, 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 Capsules.
• 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 Capsules
may be less effective.
• If you are taking methotrexate (used for the treatment of cancer and severe
psoriasis) Amoxicillin Capsules 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 Capsules can have side effects and the symptoms (such as allergic
reactions, dizziness and convulsions) may make you unfit to drive. Do not operate
machinery unless you are feeling well.

Amoxicillin Capsules contain Carmoisine E122, Sunset Yellow E110 and

Tartrazine E102
Which may cause allergic reactions in some people.

3. How to take Amoxicillin Capsules

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 the 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 Capsules 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 Capsules 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 Capsules than you should

If you have taken too much Amoxicillin Capsules, 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 Capsules

• 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 Capsules for?

• Keep taking Amoxicillin Capsules 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 Capsules are used for a long
time. If this occurs tell your doctor.

If you take Amoxicillin Capsules 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 Capsules 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 having
Amoxicillin Capsules, 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
• flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test
results (including increased white blood cells (eosinophilia) and liver
enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms
(DRESS)).
• 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 Capsules 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
o blisters, redness or bruising of the skin
o darker urine or paler stools
o 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
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 Capsules 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
• 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 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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Amoxicillin Capsules

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.
Keep this medicine in a dry place below 25°C. Keep it in the pack in which it was
given to you. Do not transfer your medicine to another container.

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 ingredient in this medicine is amoxicillin trihydrate.
• The capsules also contain magnesium stearate.
The shell of the capsule contains gelatin, sodium lauryl sulphate and purified water.
It is coloured with brilliant blue (E133), tartrazine (E102), sunset yellow (E110),
carmoisine (E122) and titanium dioxide (E171). The ink on the capsule contains
shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol,
purified water, strong ammonia, potassium hydroxide, black iron oxide (E172)

What Amoxicillin Capsules look like and the contents of the pack
Amoxicillin Capsules are available in plastic bottles of 100, 250, 500 and 1000 and
blister packs of 21 capsules.

The Marketing Authorisation Holder and manufacturer

Marketing Authorisation holder
Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR.

Manufacturer
Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR.

This leaflet was last revised in October 2017

PL 06464/1418 Amoxicillin 250 mg Capsules
PL 06464/1419 Amoxicillin 500 mg Capsules

To request a copy of this leaflet in Braille, large print or audio

format, contact the licence holder at the above address or
telephone: 01268 535200 (select option Medical Information) /
e-mail: info@waymade.co.uk

General advice regarding the use of antibiotics

Antibiotics are used to treat infections caused by bacteria.

They have no effect against infections caused by viruses.

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.

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.

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.