Zamur 500

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Zamur 500 (Cefuroxima ratiopharm)
500 mg, film-coated tablets
Cefuroximum
Zamur 500 and Cefuroxima ratiopharm are different trade names for the same medicine.
Please read the entire leaflet before using the medicine, as it contains important information
for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsens or if any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Zamur 500 is and what it is used for
2. What you need to know before taking Zamur 500
3. How to take Zamur 500
4. Possible side effects
5. How to store Zamur 500
6. Contents of the pack and other information

1. What Zamur 500 is and what it is used for

Zamur 500 is an antibiotic used in adults and children. It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Zamur 500 is used to treat the following infections:

• Throat
• Sinuses
• Middle ear
• Lungs or chest
• Urinary tract
• Skin and soft tissues

Zamur 500 may also be used:

• In the treatment of early-stage Lyme disease (borreliosis – an infection transmitted by ticks).

Your doctor may test which type of bacteria is causing your infection and may check during treatment whether the bacteria are sensitive to Zamur 500.

2. Important information before using Zamur 500

When not to use Zamur 500

• if the patient is allergic (hypersensitive) to cephalosporin antibiotics or to any of the other components of Zamur 500; if the patient has ever experienced a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams, or carbapenems). If
  the above circumstances apply to the patient, he/she must not take Zamur 500 without
  consulting a doctor.
  Warnings and precautions
  Before starting treatment with Zamur 500, discuss this with your doctor or pharmacist.
  Children
  Zamur 500 is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group have not been established.
  During treatment with Zamur 500, the patient should be vigilant for symptoms such as allergic reactions, fungal infections (e.g. candidiasis), and severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of complications. See "Symptoms to watch for" in section 4.
  Blood tests
  Zamur 500 may affect the results of blood sugar tests and a blood test known as the Coombs test. If the patient is due to have blood tests, he/she should:

• inform the person taking the sample that he/she is taking Zamur 500.

Other medicines and Zamur 500
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Medicines that reduce stomach acid (e.g. antacids used to treat heartburn) may affect the action of Zamur 500.
• Probenecid.
• Oral anticoagulants (blood thinners).
• If the patient is taking any of the above (or similar) medicines, he/she should inform the doctor or pharmacist.

Oral contraceptives
Zamur 500 may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives during treatment with Zamur 500, additional mechanical methods of contraception (e.g. condoms) should be used. In case of doubt, consult a doctor.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Zamur 500 may cause dizziness and other adverse effects that may impair the patient's alertness.

• The patient should not drive or operate machinery if he/she does not feel well.

Zamur 500 contains sodium
This medicine contains 23.61 mg of sodium (the main component of table salt) in each coated tablet.
This corresponds to 1.2% of the maximum recommended daily dietary intake of sodium for adults.
Zamur 500 contains castor oil
Castor oil may irritate the stomach and cause diarrhoea.
Ask your doctor whether it is safe to use Zamur 500.

3. How to use Zamur 500

Zamur 500 must always be used as directed by a doctor or pharmacist. If in doubt, contact your doctor or pharmacist again.
Zamur 500 should be taken after a meal. This will help increase the effectiveness of treatment.
Zamur 500 tablets should be swallowed whole with water.
Do not chew, crush, or split the tablets – this may reduce the effectiveness of treatment.

Recommended dose
Adults
The usual recommended dose of Zamur 500 is 250 mg to 500 mg twice daily, depending on the severity and type of infection.

Children
The usual recommended dose of Zamur 500 is 10 mg/kg body weight (not exceeding 125 mg) to 15 mg/kg body weight (not exceeding 250 mg) twice daily, depending on:

• the severity and type of infection.

Zamur 500 is not recommended for children under 3 months of age, as the safety and efficacy of the drug have not been established in this age group.

Depending on the disease and the patient's response to treatment, the initial dose may be adjusted or more than one treatment cycle may be required.

Patients with kidney problems
If the patient has impaired kidney function, the doctor may adjust the dosage.

• If this applies to the patient, they should inform the doctor.

Taking more than the recommended dose of Zamur 500
If a patient takes more than the recommended dose of Zamur 500, neurological disturbances may occur, particularly an increased risk of seizures (epileptic seizures).

• Seek immediate medical attention or call emergency services. If possible, show the packaging of Zamur 500.

Missed dose of Zamur 500
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping Zamur 500 treatment
Do not stop taking Zamur 500 unless instructed by a doctor.
It is important not to shorten the prescribed duration of treatment with Zamur 500. Do not stop treatment without a doctor's instruction, even if the patient feels better. Shortening the recommended treatment period may lead to recurrence of infection.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Zamur 500 may cause adverse reactions, although not everyone experiences them.

Symptoms to be aware of

In a small number of people taking Zamur 500, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
• Skin rash, which may develop into blisters and look like small rings (a dark spot in the center surrounded by a lighter ring, with a dark ring around the edge).
• Widespread skin lesions with blisters and peeling of the outer layer of skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's syndrome).

Other symptoms to watch for during treatment with Zamur 500:

• Fungal infections. Medicines such as Zamur 500 may cause overgrowth of yeasts (Candida) in the body, leading to fungal infection (e.g. thrush). The risk of this adverse reaction is higher if Zamur 500 is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Zamur 500 may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, abdominal pain and fever.
• Jarisch-Herxheimer reaction. During treatment with Zamur 500 for Lyme disease (borreliosis), some patients may experience high fever, chills, muscle and joint pain, and skin rash. This is known as the Jarisch-Herxheimer reaction. These symptoms usually last from several hours to one day.

If any of these symptoms occur in a patient, contact a doctor or nurse immediately.

Common adverse reactions:
May occur in not more than 1 in 10 patients:

• fungal infections (e.g. candidiasis)
• headache
• dizziness
• diarrhoea
• nausea
• stomach pain

Common adverse reactions that may be revealed in blood tests:

• increased number of white blood cells (eosinophilia)
• increased liver enzyme activity

Uncommon adverse reactions:
May occur in not more than 1 in 100 patients:

• vomiting
• skin rashes

Uncommon adverse reactions that may be revealed in blood tests:

• decreased number of platelets (cells involved in blood clotting)
• decreased number of white blood cells (leukopenia)
• positive Coombs test

Other adverse reactions
Other adverse reactions occur in a very small number of patients, but the exact frequency is unknown:

• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• hepatitis

Adverse reactions that may be revealed in blood tests:

• excessive breakdown of red blood cells (haemolytic anaemia)

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zamur 500

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Zamur 500 contains
The active substance is cefuroxime.
Each coated tablet contains 500 mg of cefuroxime (equivalent to 601.44 mg of cefuroxime axetil).
Other components of the medicine:
Tablet core: sodium croscarmellose; crospovidone; sodium lauryl sulfate; hydrogenated castor oil; methylcellulose; colloidal anhydrous silica.
Coating: hypromellose; microcrystalline cellulose; polyglycol stearate 8000; talc; titanium dioxide (E 171).
See section 2. Zamur 500 contains sodium and Zamur 500 contains castor oil.

What Zamur 500 looks like and contents of the pack
Zamur 500 is white, oval, film-coated tablets.
500 mg film-coated tablets are packed in blisters containing 8 or 16 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
Lagoas Park, Edifício 5-A, Piso 2
2740 - 245 Porto Salvo
Portugal

Manufacturer:
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in Portugal, country of export: 5337282
Parallel Import Licence Number: 261/23

This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names:
CEFUDOC 500 mg film-coated tablets, Denmark
Cefuroxima ratiopharm 500 mg comprimidos revestidos, Portugal
Zamur 500, film-coated tablets, Poland