DURACEF 500 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Duracef 500 mg Hard Capsules

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 that belongs to a group called cephalosporins.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as flu or 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 finishing the 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 you take Duracef

Do not take Duracef

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

- in children aged 6 years 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 do not work properly or if you are undergoing dialysis (due to kidney function problems). You can 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 samples that you are taking this medication.

Taking Duracef with other medications

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

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, 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 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 use machinery. If this occurs, do not drive or use machinery.

Duracef contains lactose

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

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 everything to you.

The following table will help you define the recommended dose:

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

With Duracef 500 mg capsules, an adequate dose for children aged 6 years or older with a weight of less than 40 kg cannot be achieved.

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

Children under 6 years of age

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

Renal insufficiency

Adults and adolescents (from 12 to less than 18 years of age) with a weight of 40 kg or more

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

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

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

Patients on 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 disappear.

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

If you take more Cefadroxil than you should

If you take more cefadroxil than prescribed, contact your doctor immediately or go to the hospital. The 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.

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

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

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

-yellowing of the eyes or skin, alterations in blood tests of renal 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, the 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 medication and contact a doctor or the nearest emergency service.

Other possible side effects:

Common(may affect 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 1 in 100 patients):

-thrush, vaginal thrush.

Rare(may affect 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 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 them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Duracef

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

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

This medication does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. 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 500 mg capsules

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

Appearance of the product and contents of the pack

Hard white capsules containing a white to pale yellow powder.

Each pack contains 28 capsules.

A clinical pack 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

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:July 2023

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