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CEFADROXIL 500MG CAPSULES

Active substance(s): CEFADROXIL MONOHYDRATE

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Ref: LTT0189/091214/1/F

Cefadroxil 500mg Capsules
Patient Information Leaflet
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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Cefadroxil 500mg Capsules and will be referred to
as Cefadroxil Capsules throughout the rest of this leaflet.
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 Capsule 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 Capsules is only effective against some
types of bacteria. So, it is only suitable for treating some types of infection.
Cefadroxil Capsules 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

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 Capsules. 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 Capsules 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 Capsules with food and drink
Cefadroxil Capsules 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 Capsules
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.

Before you take Cefadroxil Capsules
3

Do not take Cefadroxil Capsules
* You are allergic (hypersensitive) to Cefadroxil Capsules 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 micro-organisms (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.

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 Capsules 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
capsules at the end of haemodialysis.
The exact dose will have been worked out by the doctor and shown on the
label.

Ref: LTT0189/091214/1/B

Cefadroxil 500mg Capsules
Patient Information Leaflet (continued)
The following table provides a guide to usual doses:

Indications

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

Lower respiratory tract
infections
Urinary tract infections

1000 mg twice a day

Skin and soft tissue
infections
Upper respiratory tract Dosage may be reduced to
infections (pharyngitis, 1000 mg once a day over at
least 10 days
tonsillitis)
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.
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.

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

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in the original package.
Do not take use Cefadroxil Capsules after the expiry date shown on the
carton and blister label. If your doctor tells you to stop taking this medicine,
take any remaining medicine back to the pharmacist for safe disposal.
Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.

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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.
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 Capsules can temporarily increase the chance
that you can get infections caused by other sorts of germs. For example,
thrush may occur.

How to store Cefadroxil Capsules

6

Further information

What Cefadroxil Capsules contains:
The active substance is cefadroxil. One capsule contains 500 mg cefadroxil
(as monohydrate).
The other ingredients are: magnesium stearate, sodium lauryl sulfate,
microcrystalline cellulose, titanium dioxide (E171), gelatine.
What Cefadroxil Capsules looks like and contents of the pack
Each capsule is white, opaque containing white to light yellow powder.
Avaliable in blister packs of 20 capsules.
Manufacturer and Licence Holder
This medicine is manufactured by Sandoz GmbH, Biochemiestrasse 10,
A-6250 Kundl, Austria and is procured from within the EU. Product Licence
Holder LTT Pharma Limited, B98 0RE and repackaged by Lexon (UK)
Limited Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 33723/0189

Cefadroxil 500mg Capsules

Revision date: 09/12/14

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Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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