Duracef

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Duracef
500 mg, hard capsules
Cefadroxilum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Duracef is and what it is 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 Duracef is and what it is used for

Duracef contains cefadroxil – an antibiotic belonging to the cephalosporin group, which acts bactericidally against many Gram-positive and Gram-negative bacteria. Its mechanism of action involves inhibition of bacterial cell wall synthesis.
Cefadroxil is indicated for the treatment of the following infections, when caused by susceptible bacterial strains:

• Upper and lower respiratory tract infections, particularly pharyngitis and tonsillitis caused by beta-haemolytic streptococci of group A,
• Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella spp.,
• Skin and soft tissue infections caused by staphylococci and/or streptococci,
• Osteomyelitis,
• Bacterial arthritis.

(It has been demonstrated that intramuscular penicillin is effective in preventing rheumatic fever. Duracef is generally effective in eliminating streptococci from the oral cavity and throat. However, there are no data on the effectiveness of this drug in preventing recurrences of rheumatic fever.)

2. Important information before using Duracef

When not to use Duracef

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

Warnings and precautions
Before starting treatment with Duracef, consult a doctor or pharmacist.
If Duracef is to be used in patients hypersensitive to penicillins, it should be borne in mind that individuals hypersensitive to one beta-lactam antibiotic may also be allergic to other antibiotics in this group (so-called cross-sensitivity). Such reactions may occur in up to 10% of patients who have ever experienced hypersensitivity to penicillin.
If an allergic reaction to Duracef occurs, treatment should be discontinued.
In the event of severe, acute hypersensitivity symptoms, prompt administration of specific treatment may be necessary.
Due to the use of most antibacterial agents, including Duracef, cases of Clostridium difficile-associated diarrhea have been reported, which may range from mild diarrhea to fatal colitis. Therefore, if diarrhea occurs during or after treatment with Duracef, the patient should inform the doctor. The doctor may decide to discontinue treatment if diarrhea occurs during therapy and, if necessary, recommend appropriate treatment.
Caution is advised when administering Duracef to patients with renal impairment.
In patients with confirmed or suspected renal impairment, careful monitoring and appropriate laboratory tests are required before and during treatment with Duracef.
Prolonged use of Duracef may lead to the development of resistant bacterial flora. Close monitoring of the patient is necessary. If additional infection occurs during treatment with Duracef, medical advice should be sought and appropriate measures taken.
During treatment with cephalosporin antibiotics, Coombs test results may become positive.
Hematological test results, antihuman globulin tests, and Coombs test results used in cross-matching tests in transfusion medicine may be positive in newborns whose mothers were treated with cephalosporin antibiotics before delivery.
Duracef should be used with caution in patients with a history of gastrointestinal disorders, especially colitis.

Duracef and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Probenecid (used in gout) may increase cefadroxil plasma concentrations.

Duracef with food and drink
Duracef can be administered regardless of meals, as food does not affect its bioavailability. Administration during meals may reduce nausea without impairing absorption.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. Animal studies have not shown harmful effects on fetal development; however, there are no adequate and well-controlled studies in pregnant women. Therefore, Duracef should be used during pregnancy only if clearly necessary.
Cefadroxil passes into human milk; therefore, caution is required when administering Duracef to breastfeeding mothers.

Driving and operating machinery
Duracef has no influence on the ability to drive vehicles or operate machinery.

Duracef contains monohydrate lactose
This medicine contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to use Duracef

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Duracef should be taken once or twice daily by mouth, depending on the type and severity
of the infection. The medicine should be taken for at least 48–72 hours after clinical symptoms
have subsided or eradication of microorganisms has been confirmed. Treatment of infections caused by
beta-haemolytic streptococci should last for at least 10 days. In severe infections
(e.g. bone marrow), it may be necessary to administer the medicine for at least 4–6 weeks.
Duracef may be taken regardless of meals, as food does not affect the absorption
of the active substance.
Adults and children over 12 years of age (with body weight over 40 kg)

Use in children
Children are usually given a daily dose of 25 to 50 mg/kg b.w. (in osteomyelitis and bacterial
arthritis - 50 mg/kg b.w. per day) in two equal doses (every 12 hours), and in pharyngitis, tonsillitis, and impetigo - as a single daily dose*.
For children with body weight below 10 kg and for those who have difficulty swallowing capsules,
cefadroxil should be administered in the form of a suspension.

*Only in pharyngitis, tonsillitis, or impetigo
Patients with impaired renal function
In patients with renal insufficiency, the physician will determine the dosage of Duracef based on creatinine clearance.

Patients with a creatinine clearance above 50 ml/min/1.73 m² may be treated as patients with normal renal function.
Use of a higher than recommended dose of Duracef
Symptoms of overdose have not been observed after ingestion of cefadroxil at doses up to 250 mg/kg body weight. (Observation of the patient and, if necessary, symptomatic treatment are recommended.) In case of ingestion of cefadroxil at doses exceeding 250 mg/kg body weight, gastric emptying (induction of emesis or gastric lavage) is recommended.

4. Possible adverse reactions

Like all medicines, Duracef may cause adverse reactions, although not everyone experiences them.
Adverse reactions observed after administration of cefadroxil are similar to those observed with other cephalosporins.
If any of the following adverse reactions occur, stop taking the medicine immediately and contact your doctor without delay:

• Allergic reaction with swelling of the face, lips, mouth, tongue, and (or) throat (angioedema). This may cause a sensation of tightness in the throat, difficulty swallowing and breathing.
• Sudden, life-threatening systemic allergic reactions (anaphylactic reactions).
• Severe skin reactions such as erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, characterized by widespread rash with blisters on the skin and mucous membranes, extensive necrosis and detachment of the epidermis.
• Serum sickness-like reaction presenting with fever, itchy rash, joint pain, and enlarged lymph nodes.
• Severe, persistent diarrhea, sometimes with blood or mucus, sometimes accompanied by fever and abdominal pain (pseudomembranous colitis).

The frequency of the above-mentioned serious adverse reactions is unknown (cannot be estimated from the available data).
Additionally, during clinical trials and after marketing of the medicinal product, the following adverse reactions have been reported:
Common (affecting less than 1 in 10 people):

• fever,
• diarrhea, indigestion, nausea, vomiting.

Rare (affecting less than 1 in 1,000 people):

• vaginal infection,
• urticaria, rash, itching.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Duracef

Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Duracef contains

• The active substance is cefadroxil in the form of cefadroxil monohydrate. One hard capsule contains 500 mg of cefadroxil in the form of cefadroxil monohydrate.
• Other ingredients are magnesium stearate, lactose monohydrate, colloidal anhydrous silica; the capsule shell contains: gelatin, titanium dioxide; 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 is white, opaque hard capsules with the imprint “7244”, containing white powder.
The hard capsules are available in blisters made of PVC/PVDC/Aluminium, packed in a cardboard box.
The pack contains 12 hard capsules (1 blister).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Latvia, 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Latvia, country of export: 98-0089
Parallel import authorisation number: 334/24