Duracef

Patient Information Leaflet

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

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

Table of contents:

1. What Duracef is and what it is used for
2. What you need to know 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, provided they are caused by susceptible bacterial strains:

• upper and lower respiratory tract infections, particularly pharyngitis and tonsillitis caused by beta-hemolytic 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 shown that intramuscular penicillin is effective in preventing rheumatic fever. Duracef is generally effective in eliminating streptococci from the oral cavity and throat. However, there is no data on the effectiveness of Duracef in preventing recurrences of rheumatic fever.)

2. 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, discuss it with your 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-hypersensitivity). Such reactions may occur in up to 10% of patients who have ever experienced hypersensitivity to penicillin.
In case of an allergic reaction to Duracef, treatment should be discontinued. If severe, acute symptoms of hypersensitivity occur, prompt specific treatment may be necessary.
Cases of Clostridium difficile-associated diarrhoea have been reported with the use of most antibacterial agents, including Duracef, which may range from mild diarrhoea to fatal colitis. Therefore, if diarrhoea develops during or after treatment with Duracef, the patient should inform the doctor. The doctor may decide to discontinue the drug if diarrhoea occurs during treatment and, if necessary, initiate appropriate therapy.
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 necessary 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 required. If additional infection occurs during treatment with Duracef, medical advice should be sought so that appropriate measures can be taken.
During treatment with cephalosporin antibiotics, Coombs' test results may be positive.
Hematological tests, antiglobulin tests, and Coombs' test used in cross-matching procedures in transfusion medicine may yield positive results 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 your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Probenecid (used in gout) may increase serum concentrations of cefadroxil.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Animal studies have not shown harmful effects on fetal development; however, there are no adequately documented and 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 nursing mothers.

Driving and using machines
Duracef has no influence on the ability to drive 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 consult their doctor before taking this medicine.

3. How to use Duracef

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Duracef should be administered once or twice daily by oral route, 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.
osteomyelitis), administration of the medicine may need to continue for at least 4–6 weeks.
Duracef can 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 above 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) divided into two equal doses (every 12 hours), and in cases of
pharyngitis, tonsillitis, and impetigo – as a single daily dose*.
For children weighing less than 10 kg and for those who have difficulty swallowing capsules,
cefadroxil should be administered in the form of a suspension.
*

*Only in throat, tonsil, or skin infections
Patients with impaired kidney function
For patients with renal impairment, 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.
Administration 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. (Patient observation 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 localized in 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 extensive rash with blisters on the skin and mucous membranes, extensive necrosis and peeling of the epidermis.
• Serum sickness-like illness presenting with fever, itchy rash, joint pain, and enlarged lymph nodes.
• Severe, persistent diarrhoea, sometimes with blood or mucus, sometimes accompanied by fever and abdominal pain (pseudomembranous colitis).

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

• fever,
• diarrhoea, indigestion, nausea, vomiting.

Rare (affects less than 1 in 1000 people):

• vaginal infection,
• urticaria, rash, itching.

Unknown frequency (cannot be estimated from available data):

• fungal infections of the genital organs,
• genital itching,
• agranulocytosis, neutropenia (marked decrease in the number of white blood cells called granulocytes),
• decreased number of blood platelets (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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse reactions helps to collect 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. 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 monohydrate cefadroxil. One hard capsule contains 500 mg of cefadroxil in the form of cefadroxil monohydrate.
• Other components of the medicine are magnesium stearate, monohydrate lactose, anhydrous colloidal silicon dioxide; the capsule shell contains: gelatin, titanium dioxide (E 171); the printing 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 and contain powder ranging from white to off-white.
They are available in blisters made of PVC/PVDC/Al, packed in a cardboard box. The pack contains 12 hard capsules (1 blister).
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Bulgaria, the country of export: 20030299
Parallel Import Number: 212/25