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AMOXICILLIN CAPSULES 500MG
Active substance(s): AMOXYCILLIN TRIHYDRATE
250 mg & 500 mg
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
- This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as
- 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 the leaflet
1. What Dedoxil is and what it is used for
2. What you need to know before you take
3. How to take Dedoxil
4. Possible side effects
5. How to store Dedoxil
6. Contents of the pack and other information
1. What Dedoxil is and what it is used
The name of your medicine is Dedoxil. It contains the
active ingredient amoxicillin trihydrate. This belongs to a
group of antibiotics called penicillins.
Dedoxil can be used to treat bacterial infections of:
the respiratory tract (nose, throat and lungs)
the skin and soft tissue
the urinary system (bladder and kidneys)
the female reproductive system
the ear, nose and throat
the gums and teeth
the blood and abdomen
Dedoxil can also be used in combination with other
medicines to treat stomach ulcers.
2. What you need to know before you
Do not take Dedoxil
If you are allergic to amoxicillin or to any of the other
ingredients in Dedoxil capsules (listed in section 6 of
If you are allergic to other penicillin products or to
antibiotics known as cephalosporins.
The signs of an allergic reaction can include a rash,
itching, shortness of breath or swelling of the face or
Do not take this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist
before taking Dedoxil.
Warnings and Precautions
Tell your doctor or pharmacist before you take this
medicine if you:
have kidney problems: your doctor may have to
lower your dose.
are not passing urine regularly.
have glandular fever or leukaemia: you may have a
higher risk of skin reactions.
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking Dedoxil.
Blood and urine tests
If you are having blood tests or urine tests to check your
sugar levels, tell the doctor that you are taking Dedoxil
as it may interfere with the results.
Oestriol tests (used during pregnancy to check the baby
is developing normally).
Other medicines and Dedoxil
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
bought without a prescription. This is because Dedoxil
can affect the way some medicines work. Also some
medicines can affect the way Dedoxil works.
In particular, tell your doctor or pharmacist if you are
taking any of the following:
Probenecid to treat gout: the levels of amoxicillin
may be increased in your blood
Allopurinol to prevent gout: you may have a higher
risk of skin reactions
Anticoagulants (to prevent blood clotting) such as
Warfarin: the tendency to bleed may be increased
Contraceptive pills: there is a risk of contraceptive
pills not working to their greatest effect. An additional
form of contraception should be used, such as
If you are taking methotrexate (used for the
treatment of cancer and severe psoriasis) Dedoxil
may cause an increase in side effects
If you are taking other antibiotics (such as tetracycline) Dedoxil may be less effective
Taking Dedoxil with food and drink
It is recommended that you take Dedoxil at the start of
meals to reduce any possible digestive discomfort.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are
breast-feeding, ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Dedoxil 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
3. How to take Dedoxil
Always take Dedoxil capsules exactly as your doctor has
told you. check with your doctor or pharmacist if you are
Swallow the capsules whole with a glass of water
without opening capsule at the start of the meal.
Space the doses evenly during the day, at least 4
Your doctor will decide your dose and length of
treatment, as it depends on your condition.
Adults, Elderly and Children weighing 40 kg or over:
Standard dose: 250 mg three times a day
Severe infections: 500 mg three times a day
Severe or recurrent chest infection: 3000 mg twice a
Urinary tract infection: 3000 mg twice, with 10-12
hours between the two doses
Dental infection: 3000 mg twice, with 8 hours
between the two doses
Gonorrhoea: 3000 mg once
Stomach ulcers: 750-1000 mg twice a day for 7 days
with other antibiotics
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
Children weighing less than 40 kg:
Your doctor will advise you how much Dedoxil you
should give your child depending on the child’s
bodyweight. The usual dose is 40-90 mg/kg/day, given
in two or three divided doses.
The maximum recommended dose is 100 mg for each
kilogram of body weight a day.
Oral suspensions containing amoxicillin are
recommended for infants, as well as children who
cannot swallow capsules.
People with kidney problems:
Your doctor may have to lower your dose.
If you take more Dedoxil than you should
If you take more Dedoxil than you should, talk to a
doctor or go to a hospital straight away. Take the
medicine pack with you so the doctor knows what you
have taken. Signs of an overdose may include feeling
sick, being sick, diarrhoea or crystals in the urine, which
may be seen as cloudy urine, or difficulty in passing
If you forget to take Dedoxil
If you forget to take a dose, take it as soon as you
remember. However, if it is nearly time for the next dose,
skip the missed dose. Do not take a double dose (two
doses at the same time) to make up for a forgotten dose.
If you stop taking Dedoxil
Keep taking this medicine until the course is finished,
even if you feel better. If you stop taking this medicine
too soon, the infection may come back
Thrush (a yeast infection of moist areas of the body
which can cause soreness, itching and white discharge)
may develop if Dedoxil is used for a long time. If this
occurs tell your doctor.
If you take Dedoxil 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, Dedoxil can cause side effects,
although not everybody gets them.
If you notice any of the following serious side
effects, STOP TAKING Dedoxil and see a doctor or
go to a hospital straight away:
The following are very rare (affects less than 1 in
allergic reactions, which may cause an itchy skin
rash, swelling of the face, lips, tongue or throat,
difficulty in breathing. These can be serious and
occasionally deaths have occurred
flat red spots under the skin surface or bruising of
the skin. This is due to an allergic reaction caused by
inflammation of blood vessel walls. It can be
associated with joint pain (arthritis) and kidney
a delayed allergic reaction which can occur 7 to 12
days after taking this medicine. The signs may
include rashes, fever, joint pain or swollen lymph
nodes especially under arms
itchy reddish purple patches on the skin especially
on the palms of the hands or soles of the feet
other severe skin reactions causing small
pus-containing blisters, changes in skin colour, flaky
skin, peeling, redness or blistering of the skin,
mouth, eyes or genitals. These may be associated
with fever, headaches and body aches
blood disorders, which may cause fever, chills, sore
throat, ulcers in the mouth or throat, unexplained
bleeding or bruising. Your doctor may wish to test
the Jarisch-Herxheimer reaction which occurs during
treatment with dedoxil for Lyme disease and causes
fever ,chills, headache, muscle pain and skin rash.
inflammation of the large intestine (colitis), which
may cause aches and pain in the stomach area,
diarrhoea, blood in the stools, tiredness, fever, joint
pain or weight loss
kidney problems, which may cause a change in the
amount of urine passed, blood in the urine, swollen
ankles, feeling or being sick, or confusion
liver problems, which may cause yellowing of the
skin or whites of the eyes (jaundice), or darker urine
or paler stools. These may happen several weeks
after you stop taking this medicine
Sometimes you may get less severe skin reactions
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 get any of the following side effects, talk to
your doctor as soon as possible:
Common (affects less than 1 in 10 people):
feeling sick (nausea)
Uncommon (affects less than 1 in 100 people):
being sick (vomiting)
Very rare (affects less than 1 in 10,000 people):
abnormal breakdown of red blood cells (haemolytic
anaemia), which can make the skin pale yellow and
cause tiredness, weakness or breathlessness
bleeding for longer than usual. You may notice this if
you have a nosebleed or cut yourself
changes in the colour of your teeth. This is usually
removed by brushing
a black “hairy” tongue
fits (convulsions), seen in patients on high doses or
with kidney problems
feeling unusually excitable (hyperactivity)
crystals in the urine (crystalluria), which may be seen
as cloudy urine, or difficulty in passing urine. Make
sure you drink plenty of fluids to reduce the chance
of getting these symptoms
vaginal itching, soreness and discharge due to yeast
infections (thrush). Your doctor or pharmacist can
give you treatment for thrush
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
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:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Dedoxil
Keep out of the reach and sight of children.
Store below 25°C in a dry place. Store in the original
package or container and keep the container tightly
Do not use this medicine after the expiry date, which is
stated on the package or container. The expiry date
refers to the last day of that month.
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. Contents of the pack and other
What Dedoxil Capsules contain
The active substance (the ingredient that makes the
capsules work) is amoxicillin trihydrate. The other
ingredients are magnesium stearate, gelatin, titanium
dioxide (E171) and red and yellow iron oxides (E172).
What Dedoxil Capsules look like and contents of the
Dedoxil capsules are maroon and flesh coloured
capsules with ‘DEDOXIL 250’ or ‘DEDOXIL 500’ printed
on them in black ink.
Both strengths come in blister packs and containers of
7, 14, 15, 21, 28, 30, 56, 60, 100 and 500 capsules. Not
all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London SW5 9JQ
For more information about this product, please contact
the Marketing Authorisation Holder.
This leaflet was last revised in 09/2017