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CEFADROXIL 500 MG CAPSULES

Active substance(s): CEFADROXIL MONOHYDRATE

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500000/PL1a

Cefadroxil 500 mg Capsules
Patient Information Leaflet
The name of your medicine is Cefadroxil 500 mg capsules.
Throughout this leaflet it will be referred to as Cefadroxil
Capsules.
Read all of this leaflet carefully before you start
taking this medicine.
- 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. 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 gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1) What Cefadroxil Capsules are and what they are used
for
2) Before you take Cefadroxil Capsules
3) How to take Cefadroxil Capsules
4) Possible side effects
5) How to store Cefadroxil Capsules
6) Further information
1. WHAT CEFADROXIL CAPSULES ARE AND WHAT
THEY ARE USED FOR
Cefadroxil is an antibiotic. It belongs to a group of antibiotics
that are called cephalosporins. These types of antibiotics are
similar to penicillin.
Cefadroxil kills bacteria and it can be used against various
sorts of infections.
Like all antibiotics, Cefadroxil is only effective against some
types of bacteria. So, it is only suitable for treating some types
of infection.
Cefadroxil can be used to treat:
• throat infections
• chest infections such as bronchitis and some types of
pneumonia
• uncomplicated infections of the bladder and kidneys
• infections in the skin and the layers just under the skin
2. BEFORE YOU TAKE CEFADROXIL CAPSULES
Do not take Cefadroxil
• You are allergic (hypersensitive) to Cefadroxil or to any
of the other ingredients of this medicine (See Further
Information in Section 6).
• You are allergic (hypersensitive) to any other
cephalosporin type of antibiotic
• You have ever had a severe allergic reaction to any
sort of penicillin antibiotic
Not all people who are allergic to penicillins are also allergic to
cephalosporins. However, you should not take this medicine if
you have ever had a severe allergic reaction to any penicillin.
This is because you might also be allergic to this medicine
(cross-allergy).
If you are not sure about anything, ask your doctor or
pharmacist.
Take special care with this medicine if:
• You have ever had an allergic reaction to any antibiotic
or asthma, tell your doctor or pharmacist before you
take this medicine.
• You have ever been told that your kidneys do not work
very well. Also, if you are having any sort of treatment
(like dialysis) for kidney failure. You may take
cefadroxil but you may need a lower dose.
• If you have ever had inflammation of your bowel, called
colitis or any other severe disease affecting your gut.
• If you are being treated with cefadroxil for a prolonged
period. The attending physician must check your blood
regularly. Infections due to cefadroxil-resistant microorganisms (bacteria or germs) may develop.
• This medicine can alter the results of some blood tests
(such as cross-matching blood and the Coombs' test).
It is important to tell the doctor that you are taking this
medicine if you have to have any of these tests.
• This medicine can also alter the results of urine tests
for sugar (such as Benedict's or Fehling's tests). If you
have diabetes and routinely test your urine, tell your
doctor. This is because other tests may have to be
used to monitor your diabetes while you are having this
medicine.
Talk to your doctor or pharmacist if any of the above apply to
you.
Taking other medicines Please tell your doctor or
pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a
prescription.
This medicine can be affected by other medicines that are
removed by the kidneys. This is especially so if these other
medicines also affect how well kidneys work. There are many
medicines that can do this, so check with your doctor or
pharmacist before taking this medicine.

In particular, tell your doctor or pharmacist if you are taking:
• Oral contraceptives (the Pill). These may not work
while you are getting Cefadroxil. You must use another
type of contraception while you are receiving this
medicine.
• Anticoagulants (medicines for blood-thinning)
• Probenecid (for gout). This can delay the time it takes
for cefadroxil to leave your body.
• Cholestyramine
(medicine
to
lower
elevated
cholesterol levels)
Do not take Cefadroxil at the same time as:
• Antibiotics
called
aminoglycosides
(such
as
gentamycin), polymyxin B and colistin
• Other antibiotics that inhibit growth of bacteria (such as
tetracycline)
• Water tablets or injections (diuretics) such as
furosemide. It might be necessary to check your
kidneys often during treatment. This can be done with
blood and urine tests.
Leave two or three hours after taking this medicine before
taking any of these other medicines.
Taking Cefadroxil with food and drink
Cefadroxil may be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
If you are pregnant or breast-feeding do not take Cefadroxil
before consulting your doctor.
Driving and using machines You may get headache,
dizziness, nervousness, sleeplessness and exhaustion when
taking this medicine. This may affect your ability to drive or
operate machinery. If this happens, do not drive or use
machines.
3. HOW TO TAKE CEFADROXIL CAPSULES
Always take this medicine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
The dispensing label will tell you how much of this medicine
you should take and how often you should take. Please read it
carefully. The dose your doctor prescribes depends on the
type of infection and how bad the infection is. It also depends
on how well the kidneys are working. Your doctor will explain
this to you.
Children:
• Children who weigh below 40 kg and need treatment
with cefadroxil are usually given liquid oral
formulations.
• In children the dose may be increased up to 100
mg/kg/day
• For children who weigh below 40 kg and have kidney
problems or haemodialysis Cefadroxil must not be
taken.
Elderly and patients with kidney problems or on
haemodialysis
Adjustment of the dosage is necessary.
Patients with haemodialysis
Patients with haemodialysis are treated with 500 mg to 1000
mg cefadroxil at the end of haemodialysis.
The exact dose will have been worked out by the doctor and
shown on the label.
The following table provides a guide to usual doses:
Indications

Lower respiratory tract
infections
Urinary tract infections
Skin and soft tissue infections
Upper respiratory tract
infections (pharyngitis,
tonsillitis)

Adults and young people
who weigh more than 40 kg
and have normal renal
function

1000 mg twice a day
Dosage may be reduced to
1000 mg once a day over at
least 10 days

Method of administration
The capsules should be swallowed whole with a glass of
water.
Duration of treatment
The treatment should be continued for at least 2-3 days after
acute symptoms have disappeared.
In the case of streptococcal infections the minimum duration
of therapy should be 10 days.
If you take more of this medicine than you should
If you have taken too much of this medicine, contact your
doctor or hospital as soon as possible. Symptoms of
overdosage may be nausea, hallucinations, increased
reflexes, clouding of consciousness or even coma, disorders
of kidney function.
If you forget to take this medicine
If you forget to take this medicine, continue treatment
following the normal dosage, recommended by your doctor.
Do not take a double dose to make up for a forgotten dose.
Continued overleaf

If you stop taking this medicine
It is important that you take your medicine in accordance with
the doctor’s instructions. Do not suddenly stop using this
medicine without discussing it first with your doctor. Otherwise
symptoms may return.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Serious side effects
If any of the following happens, stop taking this medicine and
tell your doctor immediately or go to the casualty department
at your nearest hospital:
Very rare serious side effects (affects less than 1 patient in
10,000):
Severe allergic reactions (anaphylactic shock) to this
medicine are. These can include:
• Sudden wheeziness and tightness of chest
• Swelling of eyelids, face or lips
• Severe skin rashes that can blister and may involve
the eyes, mouth and throat and genitals.
• Loss of consciousness (fainting).
All of these allergic reactions need urgent medical attention. If
you think you are having any of these types of reaction, stop
taking this medicine and contact your doctor or your nearest
hospital accident and emergency department.

6. FURTHER INFORMATION
What Cefadroxil Capsules contain
• Each capsule contains 500 mg cefadroxil (as
monohydrate).
• The other ingredients are: magnesium stearate,
sodium dodecyl sulfate, microcrystalline cellulose,
titanium dioxide (E171), gelatine.
What Cefadroxil Capsules looks like and contents of the
pack
Capsules, hard, white, opaque capsule containing white to
slightly yellowish powder.
Each pack contains 20 Capsules in polyvinylchloride/
polyvinylidene (PVC/PVDC)-Aluminium-blister strips.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria.
Cefadroxil 500 mg Capsules
PL No: 18067/0470

POM
th

This leaflet was last revised on 26 August 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

Other possible side effects:
Common side effects (affects 1 to 10 patients in 100)
include:
• nausea, vomiting, stomach discomfort, abdominal pain,
diarrhoea and swollen, red, sore tongue; If you have
severe diarrhoea or if you see blood in your diarrhoea
you should stop taking this medicine and talk to your
doctor immediately.
• itching, itchy rash;
Uncommon side effects (affects 1 to 10 patients in 1,000)
include: Having a course of cefadroxil can temporarily
increase the chance that you can get infections caused by
other sorts of germs. For example, thrush may occur.
Possible side effects 4
Rare side effects (affects 1 to 10 patients in 10,000) include:
• anaemia, drops in the numbers of different cells in the
blood (symptoms can include tiredness, new
infections, fever and easy bruising or bleeding),
increases in some types of white blood cells,
decreases in the numbers of small cells that are
needed for clotting of the blood;
• hypersensitivity reactions (These are skin rashes that
are less severe allergic reactions than mentioned
above, lumpy rash (hives), itching);
• yellow eyes or skin, changes in blood tests that check
how your liver is working;
• changes in kidney function; • joint problem;
• fever, feeling or being sick, weakness and a feeling of
generally being unwell;
Very rare side effects (affects less than 1 patient in 10,000)
include:
• anaphylactic reactions (e.g. bronchospasms, purpura
and edema of the face and extremities);
• a type of anaemia that can be severe and is caused by
red blood cells breaking up; If you are having a blood
test for any reason, tell the person who is taking your
blood sample that you are taking this medicine as it
may affect your result.
• headaches, sleeplessness, dizziness, nervousness;
• inflammation of the gut called pseudomembranous
colitis;
• rash, red skin, blistering of the lips, eyes or mouth, skin
peeling, fever;
• abnormal blood tests;
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE CEFADROXIL CAPSULES
• Keep out of the sight and reach of children.
• Do not use Cefadroxil Capsules after the expiry date
which is stated on the label after EXP. The expiry date
refers to the last day of that month.
• Store in the original package.
This medicinal product does not require any special
temperature storage conditions.
• Do not use Cefadroxil Capsules if you notice any
visible sign of deterioration.
• Medicines should be 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.
• If you notice any signs of discolouration or
deterioration of your medicine, please tell you
pharmacist immediately.

500000/PL1a

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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.

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