Duracef

Leaflet attached to the packaging: 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 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 only. 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 tell 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, an antibiotic belonging to the cephalosporin group with a bactericidal effect on many Gram-positive and Gram-negative bacteria. The mechanism of action involves inhibiting the synthesis of the bacterial cell wall. Cefadroxil is indicated for the treatment of the following infections, if they are caused by susceptible bacterial strains:

• upper and lower respiratory tract infections, in particular 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, penicillin administered intramuscularly 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 recurrence of 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 symptoms of hypersensitivity, rapid administration of special treatment may be necessary. In connection with the use of most antibacterial drugs, including Duracef, the occurrence of diarrhea associated with Clostridium difficileinfection has been reported, which can range from mild diarrhea to colitis ending in death. Therefore, if the 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 monitoring 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 an 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. The results of hematological tests or antoglobulin tests and the 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, 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 a meal reduces nausea and does not weaken 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 sufficiently 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 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 the oral suspension from the 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 medicine, 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.

Use of a higher than recommended dose 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 observation of the patient and possible symptomatic treatment). 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, this medicine 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 on the skin and mucous membranes, extensive necrosis, and exfoliation of the skin.
• Serum sickness-like reaction characterized by fever, itchy rash, joint pain, lymph node enlargement.
• 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 determined based on available data). In addition, during clinical trials and after the marketing of the drug, 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 based on 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 any not listed in this leaflet, please tell 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, Tel.: 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. 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. 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. The medicine should be stored out of 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 given 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 the preparation of 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: