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250 mg & 500 mg
Read all of this leaflet carefully before you
start taking this medicine.
- Keep this leaflet. You may need to read it
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you.
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 become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

1. What Dedoxil is and what it is used for
2. Before you take Dedoxil
3. How to take Dedoxil
4. Possible side effects
5. How to store Dedoxil
6. Further information

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
 respiratory tract (nose, throat and lungs)
 skin and soft tissue
 urinary system (bladder and kidneys)
 female reproductive system
 ear, nose and throat
 gums and teeth
 blood and abdomen.
Dedoxil can also be used in combination with
other medicines to treat stomach ulcers, as well
as in patients with heart disease who need
protection from infection during dental treatment.
If you are not sure why you have been
prescribed this medicine then please ask your

Do not take Dedoxil and tell your doctor
if you:
 allergic to amoxicillin or to any of the
other ingredients in Dedoxil capsules (listed
in section 6 of this leaflet)
 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 throat.
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.
Take special care with Dedoxil
Tell your doctor before you take this medicine
if you:
 kidney problems: your doctor may have
to lower your dose
 not passing urine regularly
 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.

Having 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
Taking other medicines
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 condoms.
Taking Dedoxil with food and drink
It is recommended that you take Dedoxil at the
start of meals to reduce any possible digestive
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
Driving and using machines
Dedoxil should not affect your ability to drive or
operate machinery.

Always take Dedoxil capsules exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Swallow the capsules whole with a glass of water
at the start of a meal.
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 day
 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
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.
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 urine.
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
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

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 10, 000 people):
allergic reactions, which may cause an itchy
skin rash, swelling of the face, lips, tongue or
throat, difficulty in breathing, speaking or
swallowing, dizziness or collapse
 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
delayed allergic reaction which can occur
7 to 14 days after taking this medicine. The
signs may include rashes, fever, joint pain or
swollen lymph nodes
 reddish purple patches on the skin
especially on the palms of the hands or soles
of the feet
 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 your blood
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
 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.
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)
 rash.
Uncommon (affects less than 1 in 100
being sick (vomiting)
 itching or red and raised lumps (hives).

Very rare (affects less than 1 in 10,000
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
changes in the colour of your teeth. This is
usually removed by brushing
black "hairy" tongue
 (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
vaginal itching, soreness and discharge due
to yeast infections (thrush). Your doctor or
pharmacist can give you treatment for thrush.
If any of the side effects become serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

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 closed.
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.

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 pack
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
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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 approved in 11/2011

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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.