Label: information for the user

Duracef 250 mg/5 ml oral powder for suspension

cefadroxilo monohydrate

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Label contents

1.What Duracef is and for what it is used

2.What you need to know before starting to take Duracef

3.How to take Duracef

4.Possible adverse effects

5.Storage of Duracef

6.Contents of the package and additional information

Duracef contains cefadroxilo monohidrato, an antibiotic that belongs to a group called cefalosporins.

This medication is used to treat the following infections:

- Pharyngitis and tonsillitis

- Uncomplicated skin and soft tissue infections.

- Uncomplicated urinary tract infections.

Do not take Duracef

-if you are allergic to cefadroxil or any of the other ingredients of this medicine (listed in section 6).

-if you are allergic to cephalosporins.

-if you have had severe allergic reactions to any penicillin.

- in children 6 years of age or older 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 correctly or if you are undergoing dialysis (due to kidney function problems). You can take this medicine, but your doctor will adjust the dose you should take,

- if you have ever had an inflammation of the large intestine, known as colitis, or any other disease affecting the intestine.

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

You should monitor yourself for the possibility of certain gastrointestinal disorders, such as diarrhea, while being treated with this medicine. See section 4.

If you need a blood test

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

If you have to have this test, inform the person taking your samples that you are taking this medicine.

Other medicines and Duracef

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

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

Many medicines have this effect, so you should consult with your doctor or pharmacist before taking this medicine.

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

-anticoagulants (used to prevent blood clotting);

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

-colestiramine (used to lower high cholesterol).

Never take this medicine with the following medicines:

-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. You may need to have your renal function evaluated during treatment.

You should leave a gap of 2 to 3 hours between taking Duracef and other medicines.

Taking Duracef with food and drinks

Duracef (cefadroxil) is acid-stable and can be administered orally, with or without food. Furthermore, taking it with food helps to eliminate any possible gastrointestinal disorders associated with oral cephalosporin therapy.

Pregnancy and breastfeeding

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

Driving and operating machinery

While taking this medicine, you may experience headaches, 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 saccharose

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

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

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

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 your kidneys work. Your doctor will explain everything to you.

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

Use in children

• The daily dose 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.

Patients of advanced age 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 with weights of 40 kg or more with normal renal function:

Instructions for correct administration of the preparation

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

Duration of treatment

Treatment should be continued 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 Cefadroxilo Desgen 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Duracef

If you forgot to take your medication, continue with the normal dose recommended by your doctor.Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Duracef

It is essential that you take the medication as indicated by your doctor. Do not stop taking it without consulting your doctor.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If any of the following side effects appear, stop taking this medication and consult your doctor immediately or go to the nearest emergency service:

Severe side effects (anaphylactic reaction) requiring emergency care:

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

-sudden onset of hissing 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 an inflammation of the intestine called pseudomembranous colitis.

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

-yellowish eyes or skin, alterations in blood tests for kidney function;

-swelling of tongue and throat;

-decrease in the number of blood cells (symptoms may include fatigue, new infections, fever, sudden throat pain, 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 one of these signs, stop taking this medication and contact a doctor or the nearest emergency service.

Other possible side effects:

Frequent(may affect 1 in 10 patients):

-nausea or vomiting, stomach upset, abdominal pain, swelling of the tongue with redness, pain, and diarrhea;

-itching, rash, urticaria.

Occasional(may affect 1 in 100 patients):

-aphthae, vaginal aphthae.

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

-allergic reactions (which include skin rash, less severe allergic reactions mentioned earlier, urticaria, itching);

-kidney function impairment;

-joint pain;

-fever.

Very rare(may affect 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Once reconstituted, the suspension has a shelf life of 14 days in a refrigerator (4º to 8ºC).

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

Do not use this medication after the expiration date that appears on the packaging and blister, after “CAD”. The expiration date is the last day of the month indicated.

Store below 25ºC.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. In this way, you will help protect the environment.

Composition of Duracef 250 mg/5 ml oral powder for suspension

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

Appearance of the product and content of the container

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

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

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

Holder of the marketing authorization

Exeltis Healthcare, S.L.

Avda. de Miralcampo, 7

Polígono Industrial Miralcampo,

19200 Azuqueca de Henares, Guadalajara

Spain

Responsible for manufacturing

Laboratorios Atral S.A.

Rua Do Estacao, Ns 1 and 1A.

Castanheira Do Ribatejo,

2600-726, Portugal

Date of the last review of this leaflet:December 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.