Skip to Content

CEFADROXIL 500 MG CAPSULES HARD

Active substance(s): CEFADROXIL MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the patient

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

1. What Cefadroxil capsules are and what are they
used for

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

2. What you need to know before you take Cefadroxil
capsules
Do not take Cefadroxil capsules:
- 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).
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 capsules:
- 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 capsules 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 side effects in section 4.
If you need a blood or urine test
Cefadroxil capsules 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.
Other medicines and Cefadroxil capsules
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 capsules.

In particular, tell your doctor or pharmacist if you are taking the
following medicines:
- 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 capsules 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 capsules with food, drink and alcohol
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 capsules contain brilliant black BN (E151)
This medicine contains brilliant black BN (E151), which may
cause allergic reactions.

3. How to take Cefadroxil capsules

Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
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 recommended doses:
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

1000 mg twice daily

1000 mg once a day for at least
10 days

Use in children:
Indications

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

Children weighing less
than 40 kg, with normal
kidney function
30-50 mg/kg/day divided into
two daily doses
30 mg/kg/day once a day
over at least 10 days

- 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 capsules 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
The dosage should be adjusted.
Patients undergoing hemodialysis
The doctor may adjust the dose during hemodialysis.
Patients undergoing hemodialysis are treated with one
additional dose of 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 capsules than you should
If you take more Cefadroxil capsules 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 capsules
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 capsules
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 side effects, that require emergency care:
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.
Rare (may affect up to 1 in 1,000 users):
- yellowing of the eyes or skin, changes in blood tests for liver
function;
- swelling of the face, tongue and throat;
- decrease in the number of different types of blood cells
(symptoms may include fatigue, new infections, fever, sudden
sore throat and mouth ulcers), 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.
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.
Other possible side effects:
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.
Uncommon (may affect up to 1 in 100 users):
- thrush, vaginal thrush.
Rare (may affect up to 1 in 1,000 users):
- alergic reactions (which include skin rash, allergic reactions
less severe than those mentioned above, hives, itching);
- changes in the way your kidneys work;
- 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.
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 Yellow Card
Scheme, website: 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 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 ”Expiry date:”. 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 capsules contain
- 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 capsules look 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
Austria
Bulgaria
Czech Republic
Germany
France
Poland
Romania
Slovak Republic
Slovenia


PL 34088/0032

Cefadroxil 500 mg capsules, hard
Valdocef 500 mg Hartkapseln
Valdocef 500 mg capsules, hard
Valdocef 500 mg tvrdé tobolky
Valdiocef 500 mg Hartkapseln
Cefadroxil Alkaloid-INT 500 mg, gélule
Valdocef
Valdocef 500 mg capsule
Valdocef, 500 mg tvrdé kapsuly
Valdiocef 500 mg trde kapsule

This leaflet was last revised in 9/2016
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.
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.

Expand view ⇕

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.

Hide