Patient information leaflet Amoxicillin Axapharm®

Patient information leaflet
Please read this information leaflet carefully before you take or use the medicine. This medicine has been prescribed for your personal
use and you must not pass it on to anyone else. The medicine could be harmful to them even if they have the same symptoms as you.
Keep this information leaflet - you may wish to read it again later.
Amoxicillin Axapharm®
What is Amoxicillin Axapharm and when is it used?
Amoxicillin Axapharm is an antibiotic belonging to the penicillin
family. Its active substance, amoxicillin, destroys a number of bacteria
that are responsible for common infections.
Amoxicillin Axapharm is used exclusively on a doctor’s prescription
for the treatment of the following bacterial infections:
Infections of the nose, of the frontal and maxillary sinuses (sinuses
behind the forehead and in the jaw), of the throat, of the tonsils
and of the ears;
Infections of the airways (bronchi and lungs);
Infections of the kidneys, bladder and urinary tract;
Gastric and intestinal infections;
Infections of the genital organs (gonorrhoea, secretion of mucus),
gynaecological infections;
Infections of the skin and soft tissues (furuncles, abscesses, etc.);
Lyme disease (a tick bite causes reddening spreading out from a
centre [erysipelas migrans = migrant erysipelas] and is associated
with general physical symptoms such as headaches).
Amoxicillin Axapharm is also indicated for the prevention of bacterial
inflammation of the endocardium (the lining membrane of
the heart), in dental surgery (e.g. tooth extraction, scaling, fillings),
in endoscopic examinations (examinations of the internal surfaces
of hollow organs) and other operations which are frequently
accompanied by the risk of infection.
The single dose of 3 g of Amoxicillin Axapharm is recommended:
for the treatment of gonorrhoea and infections of what are known
as the lower urinary tract (inflammation of the urethra or of the
bladder).
for the prevention of bacterial inflammation of the endocardium,
in dental surgery and other operations which are frequently accompanied
by the risk of infection.
What else must I be aware of?
This medicine has been prescribed for you by your doctor for the
treatment of your present illness.
The antibiotic in Amoxicillin Axapharm is not effective against all
micro-organisms that cause infectious illnesses. Using the wrong
choice of antibiotic or incorrect dosage may cause complications.
So you must never decide of your own accord to use it to
treat other illnesses or other people. You must not use Amoxicillin
Axapharm either for other new infections later without consulting
a doctor again.
The signs of an illness often disappear before the infection has
been completely cured. So you must not stop the treatment too
soon, even if you feel better. In some circumstances, treatment
may take up to two weeks or longer, depending on your doctor’s
instructions.
When must Amoxicillin Axapharm not be used?
You should not take Amoxicillin Axapharm if you have previously
had an allergic reaction to penicillins or cephalosporins. An allergy
or hypersensitivity manifests itself in the form of symptoms such
as red patches on the skin, fever or a painful tongue.
Amoxicillin Axapharm must not be used if you have a known or
suspected hypersensitivity to one of the other ingredients of the
medicine.
You must not take Amoxicillin Axapharm if you are suffering from
glandular fever or lymphatic leukaemia.
In what circumstances is caution necessary when taking
Amoxicillin Axapharm?
This medicine may impair your reactions, your ability to drive or to
use tools or operate machinery.
Disturbed digestion is possible when taking Amoxicillin Axapharm.
If severe, persistent gastrointestinal disorders occur with vomiting
and diarrhoea, stop using the preparation and tell the doctor
immediately. A doctor or pharmacist must also be informed if skin
rashes or itching occur.
If diarrhoea occurs, no medicine that inhibits intestinal peristalsis
(intestinal motility) must be taken.
If you suffer from allergies such as asthma, hay fever or nettle
rash, particular caution must be exercised when using Amoxicillin
Axapharm due to possible hypersensitivity.
Patients who are having to take preparations containing allopurinol
(e.g. Zyloric®) at the same time are more inclined to develop
rashes.
If you are taking preparations containing digoxin, you must tell
your doctor or pharmacist.
The same applies if your are taking preparations to thin the blood
(anticoagulants).
If your kidney function or liver function are inadequate,
Amoxicillin Axapharm must be used with caution.
If you are taking an oral contraceptive (the pill), please be aware
that its effectiveness may be reduced during treatment with
Amoxicillin Axapharm. Therefore additional measures to prevent
contraception should be taken during treatment with Amoxicillin
Axapharm.
Inform your doctor or pharmacist if you are suffering from any
other illnesses, have any allergies or are using medicines taken
orally or applied externally (including those you may have bought
yourself!).
Can Amoxicillin Axapharm be taken during pregnancy
or when breast-feeding?
Pregnancy
During pregnancy, the decision to take medicines or any sort must
be taken with the greatest caution and only after consulting your
doctor or pharmacist.
Breast-feeding
As Amoxicillin Axapharm passes into the mother’s milk in small
quantities, there is a possibility of babies suffering a hypersensitivity
reaction (with symptoms such as reddening of the skin and

fever) or diarrhoea. For this reason, Amoxicillin Axapharm should
not be taken during the period of lactation or breast-feeding
should be stopped.
In any case, tell your doctor or pharmacist if you are pregnant or
want to breast-feed. They are the only people who can decide if
you may taken Amoxicillin Axapharm during this period.
How do you take Amoxicillin Axapharm?
Amoxicillin Axapharm can be taken during or after meals with no
loss of effect; doing so also reduces the risk of side-effects.
Amoxicillin Axapharm tablets are swallowed whole with a little liquid.
The dosage depends on your age, bodyweight, kidney function
and on the severity of the infection and the sensitivity of the germ
concerned.
Unless otherwise prescribed by the doctor, the following dosage
applies:
Adults and children over 40 kg in weight
Mild to moderately severe infections: 3× 375 mg-750 mg
Amoxicillin Axapharm a day.
Urinary tract infections: 4× 750 mg (3 g), taken as a single dose.
Lyme disease: 3-4× 750 mg a day when there is a bright red, slowly
growing ring with a pale centre (= migrant erysipelas). The dosage
is continued for 12 days.
Children up to and including 40 kg bodyweight
The doctor uses your child’s normal bodyweight and the severity
of the infection to determine the appropriate dosage.
Amoxicillin Axapharm 5% Suspension is suitable for the treatment
of infections in children.
General guidance:
25-75 mg/kg bodyweight per day, divided into 3-4 single doses, or
up to 2 years old:
3-4 x 100 mg (½ a measuring spoonful) a day;
from 2 to 12 years old:
3-4 x 200 mg (1 measuring spoonful) a day;
over 12 years old:
3-4 x 375 mg a day.
Lyme disease: 50 mg/kg bodyweight every 24 hours when migrant
erysipelas is present.
Prevention of inflammation of the endocardium
Adults and children over 10 years old: 4× 750 mg (3 g) taken as a single
dose approximately 1 hour before the operation which might
result in a bacterial infection.
Children up to 10 years old: half the adult dose.
Special dosage instructions
Renal insufficiency (= poor functioning of the kidneys):
You must tell your doctor if this situation applies to you. He or she
will prescribe a dosage for you appropriate to your individual case,
and it may differ from the dosage scheme described above.
Once started, antibiotic treatment should be continued for as long
as the doctor has prescribed.
Symptoms of illness often disappear before the infection has
been completely cured. Not using the medicine for long enough
or stopping the treatment too soon can lead to the illness flaring
up again.
Do not change the prescribed dosage or length of time of treatment
yourself without asking a doctor or pharmacist. If you believe
that the medicine is not powerful enough or is too strong,
talk to your doctor or pharmacist.
Preparing the suspension
Each bottle of Amoxicillin Axapharm Suspension should be prepared
freshly immediately before it is needed.
The suspension is normally prepared by the pharmacist. If the suspension
has not been prepared, add the granulate to ordinary tap
water as follows:
Tap the bottle to loosen the powder.
To prepare 80 ml of suspension, add exactly 57 ml of tap water, or
fill the bottle carefully with tap water up to the mark (ring) on the
glass bottle.
Shake thoroughly and leave to stand for a short while.
If necessary, add more tap water to bring the level to the mark.
This gives you 80 ml of suspension ready for use.
Shake the suspension again before each use.
If you wish, the doctor or pharmacist will be happy to prepare a
suspension ready for use.
What side-effects may Amoxicillin Axapharm have?
The following side-effects may occur when taking Amoxicillin
Axapharm:
Disturbed digestion such as stomach problems, nausea or diarrhoea.
Reactions such as vomiting, abdominal pains, loss of appetite,
wind and inflammation of the tongue and mucous membranes
of the mouth may also occur. The gastrointestinal problems are less
frequent if Amoxicillin Axapharm is taken at the beginning of meals.
Skin rashes, reddening of the skin, itching and urticaria (nettle
rash) may occur.
Fungal infections of the skin / mucous membranes have been observed
in very rare cases.
Agitation, anxiety, sleeplessness, confusion, behavioural changes,
a dazed state, headaches and changes in sensation may occur in
rare cases.
Dizziness, convulsions and hyperkinesia (hyperactivity) have been
observed in very rare cases.
After taking the suspension, superficial changes in the colour of
the teeth have been described. This phenomenon usually disappears
again when the teeth are cleaned.
A dark coating on the tongue has been observed in very rare cases.
When amoxicillin is administered to babies between the ages of
0 and 9 months, damage to the enamel of the mature incisors
(e.g. white striping, discolouration) cannot be ruled out.
Allergic reactions such as those described below are common
with Amoxicillin Axapharm, as with all medicines in the penicillin
family. Jaundice has been reported in rare cases.
Consult your doctor immediately if the following occur:
urticaria, a skin rash over large areas; reddening of the skin;
yellowish colour of the skin or of the whites of the eyes;
sudden onset of abdominal pains or vomiting;
severe, bloody or persistent diarrhoea;
breathing problems in the form of asthma attacks and hay fever.
If you notice any side-effects that are not described here, you
should tell your doctor or pharmacist.
What else must I be aware of?
Information for diabetics
If you are diabetic, please note that Amoxicillin Axapharm 5% Suspension
is not suitable for diabetics:
1 measuring spoonful containing 4 ml of Amoxicillin Axapharm
5% Suspension contains 1.68 g of sugar (saccharose).
Other information
Amoxicillin Axapharm must be kept in the sealed original pack,
out of the reach of children, at a temperature not above 25°C.
Shelf-life
The medicine must not be used after the date shown on the pack
beside the letters “EXP”.
The suspension once prepared will keep for 12 days at room temperature
(15-25°C).
When you have completed the treatment, take any medicine left
over back to your dispensary (doctor or pharmacist) to be disposed
of properly.
Your doctor or pharmacist can give you further information. They
have detailed information for specialists.
What does Amoxicillin Axapharm contain?

Amoxicillin Axapharm Tablets contain the active substance amoxicillin
anhydrate (as amoxicillin trihydrate) in strengths of 375, 500,
750 and 1000 mg of amoxicillin, plus non-active ingredients.
Amoxicillin Axapharm 5% contains:
80 ml of suspension: bottle containing 40 g of granulate (equivalent
to 4 g of amoxicillin) for the preparation of 80 ml of suspension.
Active substance: 1 measuring spoonful (= 4 ml) contains 200 mg
amoxicillin anhydrate (as amoxicillin trihydrate), plus 1.68 g of saccharose,
flavourings, vanilla and other non-active ingredients.
Authorisation numbers
59430, 59429 (Swissmedic)
Where can Amoxicillin Axapharm be obtained?
What pack sizes are available?
In pharmacies when prescribed by a doctor, for the dispensing of
one prescription only.
Tablets:
375 mg tablets: Packs of 16 tablets.
500 mg tablets: Packs of 16 tablets.
750 mg tablets: Packs of 4 and 20 tablets.
1000 mg tablets: Packs of 10 tablets.
Suspension 5%
80 ml of suspension: Packs of 1 bottle containing 40 g granulate
(equivalent to 4 g of amoxicillin) for the preparation of 80 ml of
suspension.
Authorisation holder
Axapharm AG, 6340 Baar
This information leaflet was last examined by the medicines authority
(Swissmedic) in January 2007.