Duracef 500 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Duracef 500 mg hard capsules

cefadroxil monohydrate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

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Contents of the package leaflet

1. What Duracef is and what it is used for

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

1. What Duracef is and what it is used for

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

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

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

This medicine 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 starting to take Duracef

Do not take Duracef

• if you are allergic to cefadroxil or to 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 with a weight of 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 are not functioning properly or if you are undergoing dialysis (due to kidney function problems). You may take this medicine, 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 intestinal disorder.

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

You should monitor for the possibility of developing certain gastrointestinal disorders, such as diarrhea, while taking 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 these tests, inform the person taking the samples that you are taking this medicine.

Taking Duracef with other medicines

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

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

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

You should consult 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 together with the following medicines:

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

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

-diuretics such as furosemide. Renal function may need to be evaluated during treatment.

A gap of 2 to 3 hours should be left between taking Duracef and other medicines.

Taking Duracef with food

Duracef (cefadroxil) is acid-stable and may be administered orally, with or without food. Moreover, administration with food may help reduce possible gastrointestinal disturbances associated with oral cephalosporin therapy.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

While taking this medication, you may experience headache, dizziness, nervousness, insomnia, and fatigue. These effects may impair 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 informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Duracef

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in 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 well your kidneys are working. Your doctor will explain this to you.

The following table will help you determine the recommended dose:

Use in children 6 years of age and older weighing less than 40 kg:

Duracef 500 mg capsules cannot provide an appropriate dose for children aged 6 years or older weighing less than 40 kg.

Duracef capsules are not suitable for the treatment of children and adolescents who cannot swallow the capsules. Alternative liquid oral formulations are available (Duracef 250 mg/5 ml powder for oral suspension).

Children under 6 years of age

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

Renal impairment

Adults and adolescents (12 to less than 18 years of age) weighing 40 kg or more

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

Children aged 6 years or older weighing less than 40 kg with renal impairment

The physician may adjust the dosing interval based on creatinine clearance rates.

Patients undergoing hemodialysis

The physician may adjust the dose during hemodialysis. Patients undergoing hemodialysis should receive an additional dose of 500 to 1,000 mg of cefadroxil at the end of the dialysis session.

Hepatic impairment

Dose adjustment is not necessary.

Method of administration

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

Duration of treatment

Treatment should continue for at least 2–3 days after acute symptoms have resolved.

In the case of streptococcal infections, the minimum duration of treatment is 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 level of consciousness, and even coma.

If you have taken more cefadroxil than you should, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone number 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 next dose as prescribed by your doctor. Do not take a double dose to make up for missed doses.

If you stop taking Duracef

It is important to take the medicine exactly as prescribed by your doctor. Do not stop taking it without consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Severe adverse effects (anaphylactic reaction) requiring emergency care:

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

• sudden onset of wheezing and tightness in the chest;

• swelling of the eyelids, face, or lips;

• loss of consciousness (fainting);

• severe rash associated with blisters, in the eyes, mouth, throat, or genitals (Stevens-Johnson syndrome);

• severe diarrhoea or bleeding in stools, indicating inflammation of the intestine called pseudomembranous colitis.

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

• yellowing of the eyes or skin, changes in blood tests indicating kidney function abnormalities;

• 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 certain types of white blood cells; decrease in blood cells necessary for clotting, which may lead to bruising or bleeding.

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

Other possible adverse effects:

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

• feeling sick, stomach upset, abdominal pain, swelling of the tongue with redness and pain, diarrhoea;

• itching, rash, hives.

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

• mouth ulcers, vaginal thrush.

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

• allergic reactions (including skin rash, less severe allergic reactions than those mentioned above, hives, itching);

• impaired kidney function;

• joint pain;

• fever.

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

• a type of anaemia which can be serious, caused by the breakdown of red blood cells;

• headache, numbness, dizziness, nervousness;

• insomnia, fatigue;

• abnormal blood test results.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Duracef

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

Do not use this medicine after the expiry date stated on the packaging and blister, following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of Duracef 500 mg capsules

• The active substance 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 pack

Hard capsules, white in colour, containing a white to pale yellow powder.

Each pack contains 28 capsules.

A clinical pack containing 500 capsules is also available.

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 most recent review of this leaflet: July 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.