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Dedoxil (Amoxicillin)
250 & 500 mg Caps

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PL No.:

33414/0157 & 0128

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All Packs


148 x 297 mm



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Arial Narrow
9 pt





Final Preparation Date For Submission: 14/07/2016

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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 or pharmacist.
- 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 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 the leaflet
1. What Dedoxil is and what it is used
2. What you need to know before you
take Dedoxil
3. How to take Dedoxil
4. Possible side effects
5. How to store Dedoxil
6. Contents of the pack and other

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
take Dedoxil
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 this leaflet).
 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
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
 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
feeling well.

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 not sure.
 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
hours apart.
Your doctor will decide your dose and length of
treatment, as it depends on your condition.
Adults, Elderly and Children weighing 40 kg or
 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
 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 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
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
10,000 people):
 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
your blood
 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
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 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)
 diarrhoea
 skin rash.
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
 dizziness
 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.
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 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 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 07/2016


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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.