Package leaflet: Information for the user

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.

2.    What you need to know before you 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).

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.

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.

3. How to take 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.

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:

Indications	Adults and adolescents weighing more than 40 kg with normal kidney function	Children weighing less than 40 kg, with normal kidney function
Uncomplicated infections of the bladder and kidneys	1000 mg twice daily	30-50 mg/kg/day divided into two daily doses
Uncomplicated infections of the skin and soft tissue
Infections of the throat	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.

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.

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):

-    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.

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, N^o 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.

Slandrova ulica 4, 1231 Ljubljana - Crnuce, 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 tvrde tobolky
Germany	Valdiocef 500 mg Hartkapseln
France	Cefadroxil Alkaloid-INT 500 mg, gelule
Poland	Valdocef
Romania	Valdocef 500 mg capsule
Slovak Republic	Valdocef, 500 mg tvrde kapsuly
Slovenia	Valdiocef 500 mg trde kapsule

PL 34088/0032

This leaflet was last revised in 05/2013.

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.

ALKALOID