DURACEF 250 mg/5 ml ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

Duracef 250 mg/5 ml Powder for Oral Suspension

cefadroxil monohydrate

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.

Contents of the Package Leaflet

1.

1. What you need to know before you take Duracef
2. How to take Duracef
3. Possible side effects
4. Storage of Duracef
5. Contents of the pack and other information

1. What is Duracef and what is it used for

Duracef contains cefadroxil monohydrate, an antibiotic belonging to a group called cephalosporins.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is important to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

This medication is used to treat the following infections:

• Pharyngotonsillitis
• Uncomplicated skin and soft tissue infections.
• Uncomplicated urinary tract infections.

2. What you need to know before taking Duracef

Do not take Duracef

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• if you have had severe allergic reactions to any penicillin.
• in children over 6 years of age or weighing less than 40 kg with renal insufficiency or requiring hemodialysis.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Duracef

• if you have had an allergic reaction to an antibiotic or suffer from asthma,
• if you have been warned that your kidneys do not function properly or if you are undergoing dialysis (due to kidney function problems). You may take this medication, but your doctor will adjust the dose you should take,
• if you have ever had inflammation of the large intestine, called colitis, or any other disease that affects the intestine.

If you are being treated with this medication for a prolonged period, your doctor will perform periodic blood tests.

You should be monitored for the possibility of certain gastrointestinal disorders, such as diarrhea, while being treated with this medication. See section 4.

If you need a blood test

This medication may affect the results of urine sugar tests and a blood test called the Coombs test.

If you are going to have this test, tell the person taking the sample that you are taking this medication.

Other medications and Duracef

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Duracef may be affected by other medications that are eliminated by the kidneys.

Many medications have this effect, so you should consult your doctor or pharmacist before taking this medication.

You should consult your doctor or pharmacist if you are taking the following medications:

-anticoagulants (used to prevent blood clotting);

-probenecid (used for gout). It may delay the elimination of this medication from your body;

-cholestyramine (used to lower high cholesterol).

Never take this medication with the following medications:

-antibiotics called aminoglycosides (such as gentamicin), polymyxin B, and colistin;

-other antibiotics that stop bacterial growth (such as tetracyclines, erythromycin, sulfonamides, chloramphenicol).

-diuretics such as furosemide. It may be necessary to evaluate kidney function during treatment.

There should be an interval of 2 to 3 hours between taking Duracef and other medications.

Taking Duracef with food and drinks

Duracef (cefadroxil) is acid-stable and can be administered orally, with or without food. Moreover, administration with food helps to eliminate possible gastrointestinal disorders that may be associated with oral cephalosporin therapy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

While taking this medication, you may experience headache, dizziness, nervousness, insomnia, and fatigue. This may affect your ability to drive or operate machinery. If this occurs, do not drive or operate machinery.

Duracef contains sucrose

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 62 mg of sodium benzoate in each 60 ml dose unit.

Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Duracef

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The prescribed dose by your doctor will depend on the nature and severity of the infection. It will also depend on how well your kidneys work. Your doctor will explain all this to you.

Adults: Adolescents and adults who need treatment with cefadroxil usually take cefadroxil in tablets. The tablets have a separate package leaflet.

Use in children

• The daily amount is calculated based on the child's weight.
• In children, the dose may be increased up to 100 mg (2 ml)/kg/day.
• For children with kidney problems or on hemodialysis, Duracef should not be taken.

Elderly patients and patients with kidney problems or on hemodialysis:

The dose needs to be adjusted.

The exact dose will have been determined by the doctor.

The following table provides a guide to the usual doses in adults and adolescents weighing 40 kg or more with normal kidney function:

Instructions for the correct administration of the preparation

1. Shake vigorously to loosen the powder.
2. Add portions of water, shaking after each addition, taking care that the total volume reached does not exceed the mark indicated on the label (60 ml).
3. If necessary, add water again to reach the mark and shake well to achieve a uniform suspension. Shake well before use.

Duration of treatment

Treatment should continue for at least 2-3 days after the disappearance of acute symptoms.

In the case of streptococcal infections, the minimum duration of treatment should be 10 days.

If you take more Duracef than you should

If you take more cefadroxil than prescribed, contact your doctor immediately or go to the hospital. Symptoms of overdose include: nausea, hallucinations, increased reflexes, decreased consciousness, and even coma.

If you have taken more cefadroxil than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Duracef

If you forget to take your medication, continue with the normal dose recommended by your doctor. Do not take a double dose to make up for forgotten doses.

If you stop taking Duracef

It is important to take the medication as indicated by your doctor. Do not stop taking it without consulting your doctor.

If you have any other questions about the use of this product, 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 effects occur, stop taking this medicine and consult your doctor immediately or go to the nearest emergency department:

Severe side effects (anaphylactic reaction) that require emergency care:

Very rare(may affect up to 1 in 10,000 patients):

-sudden onset of wheezing and chest tightness;

-swelling of eyelids, face, or lips;

-loss of consciousness (fainting);

-severe rash associated with blisters, in eyes, mouth, and throat, or genitals (Stevens-Johnson syndrome).

-severe diarrhea or bleeding in stools, indicating a condition called pseudomembranous colitis.

Rare(may affect up to 1 in 1,000 patients):

-yellowing of the eyes or skin, alterations in blood tests of kidney function;

-swelling of the tongue and throat;

-decrease in the number of blood cells (symptoms may include fatigue, new infections, fever, sudden sore throat, and mouth ulcers), increase in the number of certain types of white blood cells, decrease in the number of blood cells necessary for coagulation may cause bruising or bleeding.

If you think you have any of these signs, stop taking this medicine and contact a doctor or the nearest emergency department.

Other possible side effects:

Common(may affect up to 1 in 10 patients):

-feeling sick, stomach upset, abdominal pain, swelling of the tongue with redness, pain, and diarrhea;

-itching, rash, hives.

Uncommon(may affect up to 1 in 100 patients):

-mouth ulcers, vaginal ulcers.

Rare(may affect up to 1 in 1,000 patients):

-allergic reactions (which include skin rash, less severe allergic reactions than those mentioned above, hives, itching);

-alteration in kidney function;

-joint pain;

-fever.

Very rare(may affect up to 1 in 10,000 patients):

-a type of anemia that can be severe caused by the rupture of red blood cells;

-headache, numbness, dizziness, nervousness;

-insomnia, fatigue;

-abnormal blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Duracef

Once the suspension is reconstituted, it has a shelf life of 14 days in the refrigerator (between 4°C and 8°C).

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging and blister, after "EXP". The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and other information

Composition of Duracef 250 mg/5 ml Powder for Oral Suspension

• The active ingredient is cefadroxil monohydrate equivalent to 250 mg per 5 ml.
• The other ingredients are: sodium benzoate (E 211), microcrystalline cellulose (E460), lemon flavor, raspberry flavor, strawberry flavor, polysorbate 40, tragacanth gum (E413), and sucrose.

Appearance of the product and contents of the pack

White to pale yellow granular powder with a characteristic fruit odor.

After reconstitution with water, 60 ml of suspension is obtained.

Duracef 250 mg/5 ml Powder for Oral Suspension is presented in packs with powder to prepare 60 ml of suspension. The packs include a syringe and a spoon, to facilitate the administration of the product.

Marketing Authorization Holder

Exeltis Healthcare, S.L.

Avda. de Miralcampo, 7

Polígono Industrial Miralcampo,

19200 Azuqueca de Henares, Guadalajara

Spain

Manufacturer

Laboratorios Atral S.A.

Rua Do Estacao, Ns 1 and 1A.

Castanheira Do Ribatejo,

2600-726, Portugal

Date of the last revision of this leaflet:December 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.