Duracef

Package Leaflet: Information for the User

DURACEF 500 mg Capsules

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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package 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 group of cephalosporins, which acts bactericidally 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, provided they are caused by susceptible bacterial strains:

• upper and lower respiratory tract infections, in particular pharyngitis and tonsillitis caused by beta-haemolytic 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, intramuscular administration of penicillin is effective. Duracef generally effectively eradicates 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 borne in mind that a person hypersensitive to one beta-lactam antibiotic may also be hypersensitive to other beta-lactam antibiotics (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.
Due to the use of most antibacterial drugs, including Duracef, there have been reports of the occurrence of diarrhea associated with Clostridium difficileinfection, which can range from mild diarrhea to colitis ending in death. Therefore, if the patient experiences diarrhea while taking Duracef or after its completion, 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 known or suspected renal impairment, careful monitoring and performance of appropriate laboratory tests are necessary before and during the use of 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 the use of 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 antglobulin tests and the Coombs' test, used to perform 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 administered independently of meals, as food does not affect its bioavailability.
Administration of the drug during meals 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 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 should be exercised when administering Duracef to breastfeeding mothers.

Driving and using machines

Duracef has no influence on the ability to drive and use machines.

Duracef contains lactose

This medicine contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Duracef

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Duracef is taken orally, 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 eradication of microorganisms. Treatment of infections caused by beta-haemolytic 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 administered independently of meals, as food does not affect the absorption of the active substance.

Adults and children over 12 years (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*.
Children with a body weight below 10 kg and those having difficulty swallowing capsules are given cefadroxil in the form of a suspension.

*Only in pharyngitis, tonsillitis, or scarlet fever

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 body surface area can be treated as patients with normal renal function.

Overdose of Duracef

No symptoms of overdose have been observed after taking cefadroxil at a dose of up to 250 mg/kg body weight (recommended is monitoring of the patient and possible symptomatic treatment). 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, 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 on the skin and mucous membranes, extensive necrosis, and exfoliation of the skin.
• Post-streptococcal disease characterized by fever, itching rash, joint pain, 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 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,
• urticaria, 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),
• decreased platelet count (thrombocytopenia),
• other hypersensitivity reactions, not described above,
• liver failure, bile flow problems (cholestasis), liver function disorders,
• joint pain,
• increased liver enzyme activity (aminotransferases).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell 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,
e-mail: ndl@urpl.gov.pl.
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 below 30°C.
Keep this medicine out of the sight and reach of children.
Do not use Duracef after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that 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 capsule contains 500 mg of cefadroxil.
• The other ingredients of the medicine are magnesium stearate, lactose, anhydrous colloidal silica; the capsule shell contains: gelatin, titanium dioxide.

What Duracef looks like and contents of the pack

Duracef capsules are opaque, containing a powder that is white to off-white in color.
They are available in PVC/PVDC/Al blisters in a cardboard box. The pack contains 12 capsules (1 blister) or 20 capsules (2 blisters of 10 capsules each).

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: