Duracef

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Duracef

500 mg, hard capsules

Cefadroxil

You should carefully read the contents of the leaflet before using the medicine because it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, which has 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, 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 eliminates streptococci from the oral cavity and pharynx. However, there are no data on the effectiveness of the medicine in preventing recurrence of rheumatic fever).

2. Important information before taking Duracef

When not to take 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, the patient should discuss it with their doctor or pharmacist.
If Duracef is to be used in 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 antibiotics in this group (so-called cross-hypersensitivity). Such reactions may affect up to 10% of the patient population who have ever 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.
Due to the use of most antibacterial medicines, including Duracef, reports have been made of the occurrence of diarrhea associated with Clostridium difficileinfection, which can range from mild diarrhea to life-threatening colitis. Therefore, if the patient experiences diarrhea during or after taking Duracef, they should inform their doctor. The doctor may decide to discontinue the use of the medicine 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 laboratory tests are necessary before and during treatment with Duracef.
Prolonged use of Duracef may lead to the development of resistant bacterial flora. The patient should be closely monitored. If a secondary infection occurs during treatment with Duracef, the patient should consult their doctor, who will take appropriate measures.
During treatment with cephalosporin antibiotics, Coombs' test results may be positive.
The results of haematological or antiglobulin tests and the Coombs' test, used for cross-matching in transfusion medicine, may be positive in newborns whose mothers were treated with cephalosporin antibiotics before delivery.
The medicine should be used with caution in patients who have had gastrointestinal diseases, especially colitis.

Duracef and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they 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 medicine with food reduces nausea and does not impair absorption.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their 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 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 or operate machinery.

Duracef contains lactose monohydrate

This medicine contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Duracef

This medicine should always be taken exactly as advised by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Duracef is taken once or twice a day orally, depending on the type and severity of the infection. The medicine 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-haemolytic streptococci should last at least 10 days. In severe infections (e.g. osteomyelitis), it may be necessary to administer the medicine 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 (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 creatinine clearance.

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

Use of a higher than recommended dose of Duracef

No symptoms of overdose have been observed after taking cefadroxil at a dose of up to 250 mg/kg body weight (the patient should be monitored and treated symptomatically if necessary). If cefadroxil is taken 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 they may not occur in every patient.
The side effects observed after taking cefadroxil are similar to those observed after taking other cephalosporins.

If any of the following side effects occur, the patient should stop taking the medicine and contact their 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 polymorphic erythema, toxic epidermal necrolysis, Stevens-Johnson syndrome, characterized by widespread skin lesions with blisters and mucous membrane involvement, extensive necrosis and exfoliation of the skin.
• Serum sickness-like reaction characterized by fever, itching 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).
Additionally, during clinical trials and after the medicine 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 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
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 25°C.
The medicine should be stored out of sight and reach of children.
Do not use Duracef after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 hard capsule contains 500 mg of cefadroxil in the form of cefadroxil monohydrate.
• The other ingredients of the medicine are magnesium stearate, lactose monohydrate, colloidal silica anhydrous; the capsule shell contains: gelatin, titanium dioxide; the ink contains: shellac, iron oxide black (E 172), propylene glycol (E 1520), ammonium hydroxide (E 527).

What Duracef looks like and contents of the pack

Duracef is a white, opaque hard capsule with the inscription "7244", containing a white powder.
The hard capsules are available in PVC/PVDC/Aluminum blisters in a cardboard box.
The pack contains 12 hard capsules (1 blister).
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Latvia, the country of export:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:98-0089

Parallel import authorization number: 334/24

Date of leaflet approval: 02.09.2024

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