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CEFADROXIL 500 MG CAPSULES HARD

Active substance(s): CEFADROXIL MONOHYDRATE

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Package leaflet: Information for the user

Cefadroxil 500 mg capsules, hard
cefadroxil

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.
What is in this leaflet
1. What Cefadroxil is and what it is used for
2. What you need to know before you take Cefadroxil
3. How to take Cefadroxil
4. Possible side effects
5. How to store Cefadroxil
6. Contents of the pack and other information


1. What Cefadroxil is and what it is used for

Cefadroxil is an antibiotic. It belongs to a group of antibiotics
called cephalosporins. These antibiotics are similar to
penicillin.
Cefadroxil kills bacteria and can be used against various types
of infections. Like all antibiotics, cefadroxil is only effective
against certain types of bacteria. It is therefore appropriate
to treat certain types of infections. Cefadroxil can be used to
treat:
- infections of the throat;
- uncomplicated infections of the bladder and kidneys;
- uncomplicated infections of the skin and soft tissue.

Other medicines and Cefadroxil
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Cefadroxil may be affected by other medicines which are
excreted by the kidneys. Many medicines have this effect, so
you should consult your doctor or pharmacist before taking
Cefadroxil.
In particular, tell your doctor or pharmacist if you are taking the
following medicines:
- oral contraceptives (“the pill”). Their effectiveness can
be compromised during your treatment with Cefadroxil.
Therefore, you must use other methods of contraception
while taking this medicine;
- anticoagulants (used to thin the blood);
- probenecid (used for gout). It may delay the elimination of
cefadroxil from your body;
- cholestyramine (used to reduce high cholesterol).
Never take Cefadroxil together with the following
medicines:
- antibiotics called aminoglycosides (such as gentamicin),
polymyxin B and colistin;
- other antibiotics that stop the growth of bacteria (such as
tetracycline);
- water pills (diuretics) such as furosemide. It may be
necessary to frequently check your kidney function during
treatment. This can be done through blood and urine tests.
You should allow two to three hours to pass between taking
Cefadroxil and any of the above medicines.
Cefadroxil with food and drink
Cefadroxil can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
You may suffer from headaches, dizziness, nervousness,
insomnia and fatigue while taking this medication. This can
affect your ability to drive or use machines. If this happens, do
not drive or use machines.
Cefadroxil contains brilliant black BN (E151)
This medicine contains brilliant black BN (E151), which may
cause allergic reactions.

2. What you need to know before you take Cefadroxil

3. How to take Cefadroxil

Do not take Cefadroxil:
- if you are allergic to cefadroxil or any of the other ingredients
of this medicine (listed in section 6);
- if you are allergic to any other cephalosporin antibiotic;
- if you have had a severe allergic reaction to any penicillin
antibiotic.
Not all people allergic to penicillin are allergic to cephalosporins.
However, you should not take this medicine if you have ever
had a severe allergic reaction to any penicillin, as you may
also be allergic to this medicine (a cross-allergy).

The dose prescribed by your doctor depends on the nature
and severity of the infection. It also depends on how well your
kidneys are working. Your doctor will explain this.
The following table helps to define the usual doses:

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Cefadroxil:
- if you have ever had an allergic reaction to an antibiotic or
suffer from asthma;
- if you have been told that your kidneys are not working well
or if you are undergoing dialysis (due to problems with the
way your kidneys work). You can take cefadroxil, but your
doctor will adjust the dose for you;
- if you have ever had an inflammation of the large bowel,
called colitis, or any other serious disease that affects the
intestines.
If you are being treated with Cefadroxil for an extended period,
the doctor will perform regular blood tests.
You must look out for certain symptoms of gastrointestinal
disorders such as diarrhoea while you are taking cefadroxil.
See Serious adverse events in section 4.
If you need a blood or urine test
Cefadroxil can affect the results of urine tests for sugar and a
blood test known as the Coombs test.
If you are having test:
Tell the person taking the sample that you are taking
cefadroxil.

Always take this medicine exactly as described in this leaflet
or as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

Indications

Uncomplicated
infections of
the bladder and
kidneys
Uncomplicated
infections of the
skin and soft
tissue
Infections of the
throat

Adults and
adolescents
weighing more
than 40 kg with
normal kidney
function

Children
weighing less
than 40 kg, with
normal kidney
function

1000 mg twice
daily

30-50 mg/kg/day
divided into two
daily doses

1000 mg once a
day for at least 10
days

30 mg/kg/day
once a day over
at least 10 days

Use in children:
- for children older than 6 years of age who weigh less than
40 kg, the usual dose will be 500 mg (1 capsule) twice a day;
- for children younger than 6 years of age the doctor will
prescribe a more appropriate pharmaceutical form,
Cefadroxil granules for oral suspension;
- children should not take Cefadroxil if they weigh less
than 40 kg and have kidney problems or are undergoing
hemodialysis (a procedure to remove waste from the
blood).

Elderly and patients with kidney problems or undergoing
hemodialysis
The dosage should be adjusted.
Patients undergoing hemodialysis are treated with 500 mg to
1000 mg of cefadroxil at the end of hemodialysis.
Method of administration
Capsules should be swallowed whole with a glass of water.
Do not chew these capsules.
Duration of treatment
Treatment should be continued for at least 2-3 days after the
acute symptoms disappear.
In case of streptococcal infections, the minimum duration of
treatment is 10 days.
If you take more Cefadroxil than you should
If you take more Cefadroxil then prescribed, immediately
contact your doctor or hospital. Symptoms of overdose
may include: nausea, hallucinations, increased reflexes,
decreased consciousness or even coma, problems with the
way your kidneys work.
If you forget to take Cefadroxil
If you forget to take this medicine, continue with your normal
dosage schedule recommended by your doctor. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Cefadroxil
It is important that you take the medicine as prescribed by your
doctor. Do not suddenly stop using this medication without first
talking to your doctor. Otherwise, the symptoms may return.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If any of the following occurs, stop taking this medicine and
consult your doctor immediately or go to the emergency
department of the nearest hospital:
Serious adverse events are very rare (may affect up to 1 in
10,000 users):
- severe allergic reactions (anaphylaxis) such as:
- sudden onset of wheezing and tightness in the chest
- swelling of eyelids, face or lips
- loss of consciousness (fainting).
- severe rash associated with blistering, involving eyes, mouth
and throat, or genitals (Stevens-Johnson syndrome);
- severe diarrhea, or if you have blood in your stool, which
is an indication of an inflammation of the intestines, called
pseudomembranous colitis.

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.

5. How to store Cefadroxil

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date which is stated
on the carton after {EXP}. The expiry date refers to the last
day of that month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What Cefadroxil contains
- The active substance is cefadroxil monohydrate.
Each hard capsule contains 500 mg cefadroxil, corresponding
to 524.78 mg cefadroxil monohydrate.
- The other ingredients are: cellulose, microcrystalline, sodium
lauryl sulfate, magnesium stearate, titanium dioxide (E171),
patent blue (E131), brilliant black BN (E151), gelatine.
What Cefadroxil looks like and contents of the pack
Cefadroxil capsules are hard gelatine capsules, No 0 (app.
21.70 x 7.65 mm), filled with homogenous light yellow powder.
Colour of the capsule body is light blue opaque, and colour of
the capsule cap is blue opaque.
16 capsules of 500 mg in blister package (2 blisters with 8
capsules) and an instruction leaflet, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
ALKALOID-INT d.o.o.
Šlandrova ulica 4, 1231 Ljubljana – Črnuče, Slovenia
tel.: 386 1 300 42 90; fax: 386 1 300 42 91
e-mail: info@alkaloid.si
This medicinal product is authorised in the Member
States of the EEA under the following names:
UK

Cefadroxil 500 mg capsules, hard

Austria

Valdocef 500 mg Hartkapseln

Bulgaria

Valdocef 500 mg capsules, hard

Czech Republic

Valdocef 500 mg tvrdé tobolky

Germany

Valdiocef 500 mg Hartkapseln

France

Cefadroxil Alkaloid-INT 500 mg, gélule

Poland

Valdocef

Romania

Valdocef 500 mg capsule

Slovak Republic

Valdocef, 500 mg tvrdé kapsuly

Slovenia

Valdiocef 500 mg trde kapsule

All the above require emergency care. If you think you have
any of these signs, stop taking this medicine and contact your
doctor or the emergency department of the nearest hospital.


PL 34088/0032

Other possible side effects:

This leaflet was last revised in 05/2013.

Common (may affect up to 1 in 10 users):
- feeling or being sick, upset stomach, abdominal pain,
swelling of the tongue with redness and pain and diarrhea;
- itching, rash, hives.

Advice/medical education
Antibiotics are used to cure infections caused by bacteria
(bacterial infections). They are ineffective against infections
caused by viruses (viral infections).
If your doctor has prescribed antibiotics, you need them
precisely for your current illness.
Despite antibiotics, some bacteria may survive or grow. This
phenomenon is called resistance: some antibiotic treatments
become ineffective.
Misuse of antibiotics increases resistance. You may even help
bacteria become resistant and therefore delay your cure or
decrease antibiotic efficacy if you do not respect appropriate:
- dosages;
- schedules;
- duration of treatment.

Uncommon (may affect up to 1 in 100 users):
- thrush, vaginal thrush.
Rare (may affect up to 1 in 1,000 users):
- decrease in the number of different types of blood cells
(symptoms may include fatigue, new infections and fever),
increased number of certain types of white blood cells,
decrease in the number of blood cells that are necessary for
blood clotting that may result in bruising or bleeding;
- hypersensitivity reactions (which include skin rash, allergic
reactions less severe than those mentioned above, hives,
itching);
- yellowing of the eyes or skin, changes in blood tests for liver
function;
- changes in the way your kidneys work;
- swelling of the face, tongue and throat;
- joint pain;
- fever.
Very rare (may affect up to 1 in 10,000 users):
- a type of anemia which can be severe and is caused by the
breakdown of red blood cells;
- headache, sleeplessness, dizziness, nervousness;
- tiredness;
- abnormal blood tests.

Consequently, to preserve the efficacy of this drug:
1. Use antibiotics only when prescribed by your doctor.
2. Strictly follow the prescription.
3. Do not re-use an antibiotic without medical prescription,
even if you want to treat a similar illness.
4. Never give your antibiotic to another person; maybe it is not
adapted to her/his illness.
5. After completion of treatment, return all unused medicines to
your pharmacist to ensure they will be correctly thrown away.

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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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