Duracef

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Duracef

500 mg, hard capsules

Cefadroxil

Read the leaflet carefully before taking the 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Duracef and what is it used for
• 2. Important information before taking Duracef
• 3. How to take Duracef
• 4. Possible side effects
• 5. How to store Duracef
• 6. Contents of the pack and other information

1. What is Duracef and what is it used for

Duracef contains cefadroxil, an antibiotic belonging to the cephalosporin group, which acts bactericidally on many Gram-positive and Gram-negative bacteria. The mechanism of action involves inhibiting bacterial cell wall synthesis.
Cefadroxil is indicated for the treatment of the following infections, if they are caused by susceptible bacterial strains:

• upper and lower respiratory tract infections, particularly pharyngitis and tonsillitis caused by beta-hemolytic streptococci group A,
• urinary tract infections caused by E. coli, P. mirabilisand Klebsiella spp.,
• skin and soft tissue infections caused by staphylococci and (or) streptococci,
• osteomyelitis,
• bacterial arthritis.

(It has been shown that in the prevention of rheumatic fever, intramuscular administration of penicillin is effective. Duracef generally effectively eliminates streptococci from the oral cavity and throat. However, there are no data on the effectiveness of the drug in preventing recurrent rheumatic fever).

2. Important information before taking Duracef

When not to take Duracef

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

Warnings and precautions

Before taking Duracef, discuss it with your doctor or pharmacist.
If Duracef is to be taken by patients who are hypersensitive to penicillins, it should be considered that a person hypersensitive to one beta-lactam antibiotic may also be allergic to other antibiotics in this group (so-called cross-hypersensitivity). Such reactions may affect up to 10% of the patient population who have ever had a hypersensitivity reaction to penicillin.
In the event of an allergic reaction to Duracef, treatment should be discontinued. In the event of severe, acute symptoms of hypersensitivity, rapid administration of special treatment may be necessary.
Due to the use of most antibacterial drugs, including Duracef, there have been reports of diarrhea associated with Clostridium difficileinfection, which can range from mild diarrhea to life-threatening colitis. Therefore, if you experience diarrhea while taking Duracef or after its completion, inform your doctor. The doctor may decide to discontinue the use of the drug if diarrhea occurs during treatment and, if necessary, prescribe appropriate treatment.
Caution should be exercised when using Duracef in patients with impaired renal function.
In patients with suspected or confirmed renal impairment, careful observation and laboratory tests are necessary before and during the use of Duracef.
Prolonged use of Duracef may lead to the development of resistant bacterial flora. Close monitoring of the patient is necessary. If a secondary infection occurs during the use of Duracef, you should consult a doctor who will take appropriate measures.
During treatment with cephalosporin antibiotics, Coombs test results may be positive.
Results of hematological tests or antoglobulin tests and Coombs test, used for cross-matching in transfusiology, may be positive in newborns whose mothers were treated with cephalosporin antibiotics before delivery.
The drug should be used with caution in patients who have had gastrointestinal diseases, especially colitis.

Duracef and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Probenecid (used in gout) may increase the concentration of cefadroxil in the blood.

Duracef with food and drink

Duracef can be taken independently of meals, as food does not affect its bioavailability. Taking the drug during meals reduces nausea, without weakening absorption.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Animal studies have not shown harmful effects on fetal development, but there are no adequately documented and controlled studies in pregnant women, and therefore Duracef may only be used in pregnancy if absolutely necessary.
Cefadroxil passes into breast milk, so caution is necessary when administering Duracef to breastfeeding mothers.

Driving and using machines

Duracef has no effect on the ability to drive and use machines.

Duracef contains lactose monohydrate

This medicine contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Duracef

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Duracef is taken orally once or twice a day, depending on the type and severity of the infection. The drug should be taken for at least 48-72 hours after the disappearance of clinical symptoms or confirmation of the elimination of microorganisms. Treatment of infections caused by beta-hemolytic streptococci should last at least 10 days. In severe infections (e.g., osteomyelitis), it may be necessary to administer the drug for at least 4-6 weeks.
Duracef can be taken independently of meals, as food does not affect the absorption of the active substance.

Adults and children over 12 years (with a body weight over 40 kg)

Use in children

Children are usually given a daily dose of 25 to 50 mg/kg body weight (in osteomyelitis and bacterial arthritis - 50 mg/kg body weight per day) in two equal doses (every 12 hours), and in pharyngitis, tonsillitis, and scarlet fever - in a single daily dose*.
Children with a body weight below 10 kg and those having difficulty swallowing capsules are given cefadroxil in the form of a suspension.

*Only in pharyngitis, tonsillitis, or scarlet fever

Patients with impaired renal function

In patients with renal impairment, the doctor will determine the dosage of Duracef based on creatinine clearance.

Patients with a creatinine clearance of more than 50 ml/min/1.73 m2 body surface area can be treated as patients with normal renal function.

Overdose of Duracef

No symptoms of overdose have been observed after taking cefadroxil at a dose of up to 250 mg/kg body weight (recommended observation of the patient and possible symptomatic treatment). In the event of taking cefadroxil at a dose above 250 mg/kg body weight, it is recommended to empty the stomach (induce vomiting or gastric lavage).

4. Possible side effects

Like all medicines, Duracef can cause side effects, although not everybody gets them.
Side effects observed after taking cefadroxil are similar to those observed after taking other cephalosporins.

If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately:

• Allergic reaction with localized swelling of the face, lips, mouth, tongue, and (or) throat (angioedema). This may cause a feeling of constriction in the throat, difficulty swallowing, and breathing.
• Sudden, life-threatening allergic reactions affecting the whole body (anaphylactic reactions).
• Severe skin reactions, such as erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, characterized by widespread skin lesions with blisters and mucosal involvement, extensive necrosis, and exfoliation of the skin.
• Serum sickness-like reaction characterized by fever, itching rash, joint pain, lymphadenopathy.
• Severe, persistent diarrhea, sometimes with blood or mucus, and abdominal pain (pseudomembranous colitis).

The frequency of the above-mentioned severe side effects is unknown (cannot be estimated from the available data).
In addition, during clinical trials and after the drug was placed on the market, the following side effects have been reported:

Common (affecting less than 1 in 10 people):

• fever,
• diarrhea, nausea, vomiting.

Rare (affecting less than 1 in 1000 people):

• vaginal infection,
• urticaria, rash, itching.

Unknown (frequency cannot be estimated from the available data):

• genital fungal infections,
• genital itching,
• agranulocytosis, neutropenia (significant decrease in the number of white blood cells called granulocytes),
• decreased platelet count (thrombocytopenia),
• other hypersensitivity reactions not described above,
• liver failure, bile flow problems (cholestasis), liver function disorders,
• joint pain,
• increased activity of liver enzymes (aminotransferases).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Duracef

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use Duracef after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Duracef contains

• The active substance of the medicine is cefadroxil in the form of cefadroxil monohydrate. 1 hard capsule contains 500 mg of cefadroxil in the form of cefadroxil monohydrate.
• The other ingredients of the medicine are magnesium stearate, lactose monohydrate, colloidal silica anhydrous; the capsule shell contains: gelatin, titanium dioxide (E 171); the ink contains: shellac, iron oxide black (E 172), propylene glycol (E 1520), ammonium hydroxide (E 527).

What Duracef looks like and contents of the pack

Duracef hard capsules are opaque, containing a powder with a color from white to off-white.
They are available in PVC/PVDC/Al blisters, in a cardboard box. The pack contains 12 hard capsules (1 blister).
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

PenCef Pharma GmbH
Schützenanger 9
37081 Göttingen
Lower Saxony
Germany

Parallel importer:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing authorization number in Bulgaria, the country of export:20030299

Parallel import authorization number: 212/25

Date of leaflet approval: 20.06.2025

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