Duracef

Package leaflet: Information for the user

DURACEF 1 g tablets for oral suspension
Cefadroxil
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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 or pharmacist. See section 4.

Contents of the leaflet

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, with bactericidal activity 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-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 shown that intramuscular penicillin is effective in preventing rheumatic fever. Duracef generally effectively eradicates streptococci from the oral cavity and throat. However, there are no data on the effectiveness of Duracef 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, discuss this with your doctor or pharmacist.
If Duracef is to be used in patients hypersensitive to penicillins, it should be borne in mind that
patients 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 case of severe, acute hypersensitivity symptoms, prompt administration of specific treatment may be necessary.
Due to the use of most antibacterial drugs, including Duracef, cases of Clostridioides difficile-associated diarrhea have been reported, which may range from mild diarrhea to fatal colitis. Therefore, if a patient develops diarrhea during or after treatment with Duracef, the doctor should be informed. The doctor may decide to discontinue the medication if diarrhea occurs during treatment and, if necessary, recommend appropriate treatment.
Caution should be exercised when using Duracef in patients with renal impairment.
In patients in whom renal impairment has been confirmed or is suspected, 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 patient monitoring is necessary. If additional infection occurs during treatment with Duracef, the patient should consult a doctor who will take appropriate measures.
During treatment with cephalosporin antibiotics, Coombs test results may be positive.
Hematological tests, antiglobulin tests, and Coombs test used in cross-matching in transfusion medicine may yield positive results in newborns whose mothers were treated with cephalosporin antibiotics before delivery.
The medicine 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 cefadroxil plasma concentrations.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may 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, and therefore Duracef should be used during pregnancy only if, in the opinion of the doctor, it is 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 propylene glycol and sucrose (ingredient of raspberry flavor and lemon flavor).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

Duracef contains sodium.
Duracef contains less than 1 mmol (23 mg) of sodium per 5 ml, meaning the medicine is considered "sodium-free".

3. How to use Duracef

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Duracef is administered orally once or twice daily, depending on the type and severity of the infection.
Treatment should continue for at least 48–72 hours after clinical symptoms have resolved or eradication
of microorganisms has been confirmed. Therapy for infections caused by beta-haemolytic streptococci
should last for at least 10 days. In severe infections (e.g. osteomyelitis), administration of the medicine
may be necessary 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 (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 for throat infections, tonsillitis, and impetigo, as a single daily dose.
Tablets 1 g are intended for children with body weight above 20 kg.
For children with lower body weight, the oral suspension or 500 mg capsules should be used.

*Only in pharyngitis, tonsillitis, or impetigo. In cases where it is necessary to use a twice-daily dosing regimen in this
patient group, the 500 mg suspension or capsules should be used.
For infections caused by beta-hemolytic streptococci, therapeutic doses of Duracef should be administered for at least 10 days.
Patients with impaired renal function
In patients with renal impairment, the physician will determine the Duracef dosage based on creatinine clearance.

Patients with creatinine clearance above 50 ml/min/1.73 m² may be treated as patients with normal renal function.

Preparation of oral suspension from Duracef tablets:

After removing the foil, place the tablet into 120 ml of water and wait 30-60 seconds for it to disintegrate. Then mix thoroughly and drink immediately. The suspension should be prepared immediately before administration.

Use of higher than recommended Duracef dose

No symptoms of overdose have been observed following 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 (induced emesis or gastric lavage) is recommended.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects observed with cefadroxil are similar to those observed with other cephalosporins.
If any of the following adverse effects 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 allergic reactions affecting the whole body (anaphylactic reactions).
• Severe skin reactions such as erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, characterised by widespread rash with blisters on the skin and mucous membranes, extensive necrosis and peeling of the epidermis.
• Serum sickness-like reaction characterised by 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 occurrence of the above-mentioned severe adverse effects is unknown (cannot be estimated from the available data).
In addition, the following adverse effects have been reported during clinical trials and after marketing of the medicine:
Common (affects less than 1 in 10 people):

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

Rare (affects 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 mentioned above,
• liver failure, problems with bile flow (cholestasis), liver function disorders,
• joint pain,
• increased liver enzyme activity (aminotransferases).

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

5. How to store Duracef

Store below 30 °C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Duracef contains

• The active substance is cefadroxil in the form of cefadroxil monohydrate. One tablet contains 1 g of cefadroxil.
• The other ingredients are microcrystalline cellulose, magnesium stearate, crospovidone, ammonium glycyrrhizinate, raspberry flavour (containing propylene glycol and sucrose), lemon flavour (containing sucrose), strawberry flavour, sodium saccharin (E 954), sodium gluconate (E 576), gluconolactone (E 575), guar gum.

What Duracef looks like and contents of the pack
The medicine in the form of tablets for oral suspension is available in blisters made of
OPA/Aluminium/HDPE/Aluminium, containing 10 tablets, packed in a cardboard box.
Marketing Authorisation Holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00
Manufacturer:
PenCef Pharma GmbH
Schützenanger 9
37081 Göttingen
Lower Saxony