Prospect: information for the user

Duracef 500 mg hard capsules

cefadroxilo monohydrate

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must 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 prospect. See section 4.

Content of the prospect

1.What is Duracef 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 monohydrate, an antibiotic that belongs to a group called cephalosporins.

This medication is used for the treatment of the following infections:

- Pharyngotonsillitis.

- 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 that affects 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 known as the Coombs test.

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

Taking Duracef with other medicines

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;

- cholestyramine (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. It may be necessary to evaluate kidney function during treatment.

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

Taking Duracef with food

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 lactose

This medicine contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

The following table will help you define the recommended dose:

Use in children 6 years of age or older with a body weight of less than 40 kg:

Cefadroxil 500 mg capsules cannot provide an adequate dose for children 6 years of age or older with a body weight of less than 40 kg.

Cefadroxil capsules are not suitable for the treatment of children and adolescents who cannot swallow the capsules. There are other available oral liquid forms (Cefadroxil 250 mg/5 ml oral powder for suspension).

Children under 6 years of age

Cefadroxil 500 mg capsules are not recommended for children under 6 years of age. For children under 6 years of age, there are available oral liquid forms (Cefadroxil 250 mg/5 ml oral powder for suspension).

Renal insufficiency

Adults and adolescents (12 years of age or less) with a body weight of 40 kg or more

The dose should be adjusted according to creatinine clearance rates to avoid cefadroxil accumulation.

Children 6 years of age or older with a body weight of less than 40 kg with renal insufficiency

The doctor may adjust the dosing interval according to creatinine clearance rates.

Patients undergoing hemodialysis

The doctor may adjust the dose during hemodialysis. Patients undergoing hemodialysis will be treated with an additional dose of 500 to 1,000 mg of cefadroxil at the end of hemodialysis.

Hepatic insufficiency

No dose adjustment is necessary.

Method of administration

The capsules should be swallowed whole with a little water. Do not chew the capsules.

Duration of treatment

Treatment should be continued for at least 2-3 days after the acute symptoms have disappeared.

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

If you take more Cefadroxil 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 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 compensate for the missed doses.

If you interrupt the treatment with Duracef

It is essential to 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 medicines, this medicine may cause side effects, although not everyone will experience them.

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If any of the following side effects appear, stop taking this medicine 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 yellowish 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 medicine and contact a doctor or the nearest emergency service.

Other possible side effects:

Frequent(may affect 1 in 10 patients):

-nausea or feeling sick, 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 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 medicine.

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 in the blister, after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special preservation conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Duracef 500 mg capsules

• The active ingredient is cefadroxil monohydrate. Each capsule contains 500 mg.
• The other components are lactose, aerosil, and magnesium stearate.

Appearance of the product and contents of the packaging

Hard white capsules containing a white to pale yellow powder.

Each package contains 28 capsules.

A clinical package of 500 capsules is available.

Marketing Authorization Holder

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

Last review date of this leaflet:July 2023

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.