Duracef

Package Leaflet: Information for the User

DURACEF 250 mg/5 ml Powder for Oral Suspension

DURACEF 500 mg/5 ml Powder for Oral Suspension

Cefadroxil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 those not listed in this leaflet, please inform your doctor or pharmacist. 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, a bactericidal antibiotic of the cephalosporin group, effective against 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. mirabilis, and 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 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 occur in up to 10% of the patient population who have previously experienced hypersensitivity to penicillin.
In the event of an allergic reaction to Duracef, treatment should be discontinued.
In the event of severe, acute hypersensitivity reactions, rapid administration of special treatment may be necessary.
Due to the use of most antibacterial drugs, including Duracef, reports have been made of the occurrence of diarrhea associated with Clostridium difficileinfection, which can range from mild diarrhea to colitis ending in death. Therefore, if a patient experiences diarrhea during or after treatment with Duracef, they should inform their 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 renal impairment.
In patients with suspected or confirmed renal impairment, careful observation and 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 necessary. If a secondary 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.
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, or have recently taken, and about the 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Animal studies have not shown any harmful effects on the fetus, but there are no adequately documented and controlled studies in pregnant women, and therefore Duracef may only be used during pregnancy if absolutely necessary.
Cefadroxil passes into breast milk, so caution is necessary when administering Duracef to breastfeeding mothers.

Driving and using machines

Duracef does not affect the ability to drive and use machines.

Duracef contains sucrose.

Duracef 250mg/5ml contains 2433.7 mg of sucrose in each 5ml. Duracef 500mg/5ml contains 2185.75 mg of sucrose in each 5ml. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the medicine.

Duracef contains sodium benzoate (E 211).

Duracef 250 mg/5 ml contains 4.5 mg of sodium benzoate in each 5 ml, which corresponds to 0.9 mg/ml.
Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life).
Duracef 500 mg/5 ml contains 4 mg of sodium benzoate in each 5 ml, which corresponds to 0.8 mg/ml.
Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life).

Duracef contains sodium.

Duracef 250 mg/5 ml contains 0.72 mg of sodium (0.03 mmol) in each 5 ml.
Duracef 250 mg/5 ml contains less than 1 mmol (23 mg) of sodium per 5 ml, which means the drug is considered "sodium-free".
Duracef 500 mg/5 ml contains 0.64 mg of sodium (0.028 mmol) in each 5 ml.
Duracef 500 mg/5 ml contains less than 1 mmol (23 mg) of sodium per 5 ml, which means the drug is considered "sodium-free".

3. How to take Duracef

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist.
Duracef is taken 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 adolescents over 12 years (with a body weight over 40 kg)

*Measuring spoon with a capacity of 5 ml

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**.

*Measuring spoon with a capacity of 5 ml
In the treatment of infections caused by beta-hemolytic streptococci, therapeutic doses of Duracef should be taken for at least 10 days.

Patients with impaired renal function

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

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

Method of preparation of oral suspension from powder for oral suspension

Duracef (60 ml and 100 ml bottles)

Shake the bottle to loosen the powder.
Then add water in two portions (shake after adding the first portion of water; fill with the second portion of water to the level marked on the label). After each addition of water, turn the bottle upside down and shake the contents well.
5 ml of the prepared suspension contains, depending on the drug, 250 mg or 500 mg of cefadroxil in the form of cefadroxil monohydrate.
The prepared oral suspension is stable at room temperature for 7 days and in the refrigerator for 14 days.
Before use, shake the bottle contents well. The bottle should be tightly closed.
After 7 days of storage at room temperature or 14 days of storage in the refrigerator, the unused suspension is not suitable for use.

Overdose of Duracef

No symptoms of overdose have been observed after taking cefadroxil in a dose of up to 250 mg/kg body weight (the recommended dose is observed and, if necessary, symptomatic treatment is performed). In the event of taking cefadroxil in a dose exceeding 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.
The 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 can 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 polymorphic erythema, toxic epidermal necrolysis, Stevens-Johnson syndrome, characterized by widespread skin lesions with blisters, extensive necrosis, and exfoliation of the skin.
• Serum sickness-like reaction characterized by fever, itching rash, joint pain, and lymphadenopathy.
• Severe, persistent diarrhea, sometimes with blood or mucus, which may be accompanied by fever and abdominal pain (pseudomembranous colitis).

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

Common (occurring in less than 1 in 10 people):

• fever,
• diarrhea, nausea, vomiting.

Rare (occurring in less than 1 in 1000 people):

• vaginal infection,
• hives, rash, itching,

Unknown (frequency cannot be determined from available data):

• genital fungal infections,
• genital itching,
• agranulocytosis, neutropenia (significant decrease in the number of white blood cells called granulocytes),
• low 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 those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: 22 49-21-301,
Fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov..
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Duracef

Store in a temperature below 25°C.
The prepared suspension can be stored for 7 days at a temperature below 25°C or 14 days in the refrigerator, i.e., at a temperature between 2°C and 8°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP). 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. Powder for oral suspension, 250 mg/5 ml: 5 ml of the prepared suspension contains 250 mg of cefadroxil in the form of cefadroxil monohydrate. Powder for oral suspension, 500 mg/5 ml: 5 ml of the prepared suspension contains 500 mg of cefadroxil in the form of cefadroxil monohydrate.
• The other ingredients of the medicine are: sodium benzoate (E 211), sucrose, titanium dioxide, xanthan gum, Tween 40 (1% mixture with sucrose), lemon flavor, strawberry flavor, raspberry flavor, Refrachissment flavor.

What Duracef looks like and contents of the pack

The medicine is available in the form of a powder for oral suspension in HDPE bottles with a polyethylene cap, with a powder for preparing 60 ml or 100 ml of suspension, in a cardboard box with a measuring spoon.

Marketing authorization holder:

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

Date of last revision of the leaflet: