Duracef

Package Leaflet: Information for the User

DURACEF 1 g Tablets for Oral Suspension

Cefadroxil

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

• Keep this package 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 those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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 bactericidal action against 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, 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 administration of penicillin is effective. Duracef generally effectively eliminates streptococci from the oral cavity and pharynx. However, there are no data on the effectiveness of the drug in preventing recurrences 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 ever had 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.
With the use of most antibacterial drugs, including Duracef, the occurrence of diarrhea associated with Clostridioides difficileinfection has been reported, which can range from mild diarrhea to life-threatening colitis. Therefore, if you experience diarrhea during or after taking Duracef, inform your 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 taking Duracef in patients with renal impairment.
In patients with known or suspected 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, you should consult a doctor who will take appropriate measures.
During treatment with cephalosporin antibiotics, Coombs' test results may be positive.
The results of hematological or antiglobulin 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 now or have taken recently, 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 plan to have a child, consult your doctor or pharmacist 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, in the doctor's opinion, it is necessary.
Cefadroxil passes into human 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 propylene glycol and sucrose (ingredients of the raspberry and lemon flavors).

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Duracef contains sodium.

Duracef 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 directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Duracef is taken once or twice a day orally, 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 children over 12 years old (with a 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 in pharyngitis, tonsillitis, and scarlet fever - in a single daily dose.
1 g tablets are intended for children with a body weight over 20 kg.
In children with a lower body weight, a suspension or 500 mg capsules are used.

*Only in pharyngitis, tonsillitis, or scarlet fever. In the case of the need to use a dosing regimen twice a day in this group of patients, a suspension or 500 mg capsules are used.
In the treatment of infections caused by beta-hemolytic streptococci, therapeutic doses of Duracef should be used 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 m^2 body surface area can be treated as patients with normal renal function.

Preparation of the oral suspension from Duracef tablets:

After removing the foil, throw the tablet into 120 ml of water, then wait 30-60 seconds for it to disintegrate.
Then stir the whole thing and drink. The suspension should be prepared immediately before consumption.

Overdose of Duracef

No symptoms of overdose have been observed after taking cefadroxil at a dose of up to 250 mg/kg body weight (observation of the patient and possible symptomatic treatment are recommended). In the event of taking cefadroxil at a dose above 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, oral cavity, 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 and mucosal lesions, 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, and abdominal pain (pseudomembranous colitis).

The frequency of the above-mentioned severe side effects is unknown (cannot be estimated from the 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,
• urticaria, rash, itching.

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

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Duracef

Store in a temperature below 30°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 and blister 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. 1 tablet contains 1 g of cefadroxil.
• The other ingredients are microcrystalline cellulose, magnesium stearate, crospovidone, ammonium glycyrrhizinate, raspberry flavor (contains propylene glycol and sucrose), lemon flavor (contains sucrose), strawberry flavor, sodium saccharin (E 954), sodium gluconate (E 576), gluconic acid lactone (E 575), guar gum.

What Duracef looks like and contents of the pack

The medicine is available in the form of tablets for oral suspension in OPA/Aluminum/HDPE/Aluminum blisters containing 10 tablets, in a cardboard box.

Marketing authorization 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

Date of last revision of the package leaflet: