Package leaflet: information for the user

CEFADROXIL

250 mg/5 ml granules for oral suspension

cefadroxil

Read all of this leaflet carefully before you start using 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 use Cefadroxil

3.    How to use 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 use cefadroxil

Do not use 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).

Cefadroxil 250 mg/5 ml granules for oral suspension contains soy-Lecithin.

If you are allergic to peanut or soya, do not use this medicinal product.

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.

Infants

Cefadroxil should be used with caution in premature and newborn infants, since their enzyme system is not fully developed.

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 250 mg/5 ml granules for oral suspension contains sucrose

This medicine contains 2.780 g of sucrose per 5 ml reconstituted suspension. This should be taken into account by patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars (fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency), contact your doctor before taking this medicinal product.

Cefadroxil 250 mg/5 ml granules for oral suspension contains sodium benzoate.

Mildly irritant to the skin, eyes and mucous membranes.

3. how to use cefadroxil

Always use 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. Your doctor will calculate the exact dose.

Cefadroxil granules for oral suspension is intended for use in children s 5 kg.

It may also be used in adults and older children who have difficulty swallowing capsules.

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

Adults

For adults and adolescents the doctor may prescribe a more appropriate pharmaceutical form, Cefadroxil capsules.

use in children

The daily dose is calculated according to the weight of the child. Your doctor will calculate the exact dose.

Body weight (kg)	General dosing recommendations based on 30-50 mg/kg/day administered twice daily	General dosing recommendations for pharyngitis and tonsillitis based on 30 mg/kg/day administered once daily
5-6	2.5 to 3.75 ml twice daily	3.75 ml once daily
7-8	2.5 to 5 ml twice daily	5 ml once daily
9-10	3.75 to 5 ml twice daily	6.25 ml once daily
11-12	3.75 to 6.25 ml twice daily	7.5 ml once daily
13-14	5 to 7.5 ml twice daily	8.75 ml once daily
15-16	5 to 8.75 ml twice daily	10 ml once daily
17-18	6.25 to 10 ml twice daily	11.25 ml once daily
19-20	6.25 to 10 ml twice daily	12.5 ml once daily
21-22	7.5 to 11.25 ml twice daily	13.75 ml once daily
23-25	7.5 to 12.5 ml twice daily	15 ml once daily
26-27	8.75 to 13.75 ml twice daily	16.25 ml once daily
28-29	8.75 to 15 ml twice daily	17.5 ml once daily
30-31	10 to 16.25 ml twice daily	18.75 ml once daily
32-33	10 to 17.5 ml twice daily	20 ml once daily
34-35	11.25 to 17.5 ml twice daily	20 ml once daily*
36-37	11.25 to 18.75 ml twice daily	20 ml once daily*
38-40	12.5 to 20 ml twice daily	20 ml once daily*

*The single dose should not exceed 1000 mg.

- Children should not use 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.

Instructions for reconstitution

Directions for making up the suspension using a graduated plastic measuring cup Warning:

•    A graduated plastic measuring cup is provided; this serves only to measure the amount of water needed to prepare the suspension.

•    After preparing the suspension, throw away the plastic measuring cup.

•    Never use the graduated plastic measuring cup to give the medicine.

1.    Shake the bottle to loosen the granules and remove the cap.

2.    Add 60 ml purified water to the bottle, using the plastic measuring cup, and replace the cap. Shake well the bottle to obtain a uniform suspension. The reconstituted suspension is a light lemon yellow viscous liquid with pleasant orange odour.

3.    The reconstituted suspension may be stored for 7 days below 30°C or 21 days in a refrigerator (5°C ± 3°C).

Method of administration

Use the plastic graduated oral syringe provided to measure the dose needed. The plastic oral syringe is graduated on 1.25 ml, 2.5 ml, 3.75 ml and 5 ml.

1.    Shake the bottle before use and remove the bottle cap.

2.    Check how much medicine needs to be taken.

3.    Remove cap from the syringe.

4.    While the bottle is sitting on a firm, flat surface, insert the syringe into the bottle.

5.    Slowly pull back the plunger of the syringe up to the graduation mark on the syringe corresponding to the quantity in milliliters (ml) prescribed by the doctor.

6.    Remove the syringe from the bottle.

7.    Make sure your child is supported in an upright position.

8.    Put the tip of the syringe carefully into your child's mouth. Point the tip of the syringe towards the inside of your child's cheek.

9.    Slowly push down the plunger of the syringe: Do not squirt it out quickly.

The medicine will trickle into your child's mouth.

10.    Allow your child some time to swallow the medicine.

11.    Repeat steps 4-10 in the same way until the whole dose has been given.

12.    Replace the cap on the bottle. Wash the syringe as instructed below.

Cleaning and storing the syringe

1.    Pull the plunger out of the syringe and wash both parts thoroughly in fresh drinking water.

2.    Allow the plunger and the barrel to dry naturally. Push the plunger back into the syringe. Keep it in a clean safe place with the medicine.

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 use more Cefadroxil than you should

If you use 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 use Cefadroxil

If you forget to use 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 using 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.

Unreconstituted product should be stored below 25°C.

The reconstituted suspension may be stored for 7 days below 30°C or 21 days in a refrigerator (5°C ± 3°C).

Do not use this medicine after the expiry date which is stated on the carton, bottle after {EXP}. The expiry date refers to the last day of that month.

Do not keep the product after the end of treatment.

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.

5 ml oral suspension contains 250 mg cefadroxil, corresponding to 262.39 mg cefadroxil monohydrate.

1 ml oral suspension contains 50 mg cefadroxil, corresponding to 52.478 mg cefadroxil monohydrate

-    The other ingredients are: microcrystalline cellulose and carmellose sodium, sucrose, xantan gum E415, sodium benzoate E211, citric acid monohydrate, sodium citrate dihydrate, polysorbate 80, flavour powder orange (flavouring ingredients, maltodextrin, sucrose, soy-lecithin E322, silicon dioxide E551), quinoline yellow al.lake E104.

What Cefadroxil looks like and contents of the pack

Cefadroxil granules for oral suspension are light yellow granules with visible dark yellow granules and pleasant-orange odour.

The granules for oral suspension are packed in a 150 ml brown neutral glass bottle, supplied with an aluminium cap with a polyethylene seal.

Cardboard box contains one (1) bottle, one plastic measuring cup graduated on 60 ml for reconstitution only, one plastic oral 5 ml syringe for dosing graduated on 1.25 ml, 2.5 ml, 3.75 ml and 5 ml, and an instruction leaflet. Each bottle contains 65 g granules for preparation of 100 ml oral suspension.

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

Austria Bulgaria Czech Republic Germany France Poland Romania Slovak Republic Slovenia

PL34088/0033

This leaflet was last revised in 03/2014.

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.

Cefadroxil_susp_UK_mock up_3a_297x420mm.indd 2 12/03/2014 09:51:31