Zamur 500

Leaflet accompanying the packaging: patient information

Zamur 500

500 mg, coated tablets
Cefuroxime

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• You should consult a doctor or pharmacist if you have any further doubts.
• 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 any of the side effects worsen or if you experience any side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

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

Zamur 500 is used to treat infections:

• of the throat
• of the sinuses
• of the middle ear
• of the lungs or chest
• of the urinary tract
• of the skin and soft tissues.

Zamur 500 can also be used:

• to treat early stages of Lyme disease (borreliosis - an infection transmitted by ticks).

Your doctor may check what type of bacteria caused your infection and check if the bacteria are sensitive to Zamur 500 during treatment.

2. Important information before taking Zamur 500

When not to take Zamur 500

• if you are allergic(hypersensitive) to cephalosporin antibioticsor any of the other ingredients of Zamur 500;
• if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams or carbapenems);
• if you have ever had a severe skin rash or skin peeling, blisters, and (or) ulcers of the mouth after treatment with cefuroxime or other cephalosporin antibiotics.

If any of the above applies to you, you should not takeZamur 500 without consulting your doctor.

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting to take Zamur 500. Severe skin reactions, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have occurred with cefuroxime treatment. If you notice any symptoms related to severe skin reactions described in section 4, you should seek medical advice immediately.

Children

Zamur 500 is not recommended for use in children under 3 monthsbecause the safety and efficacy of the medicine in this age group are not known.
During treatment with Zamur 500, you should be aware of the following conditions: allergic reactions, fungal infections (e.g. thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See “Conditions to watch out for”in section 4.

Blood tests

Zamur 500 may affect the results of blood tests for sugar and a blood test called the Coombs test. If you are going to have a blood test, you should:

• tell the person taking the blood samplethat you are taking Zamur 500.

Other medicines and Zamur 500

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan 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 you are taking any of the above (or similar) medicines, you should tell your doctor or pharmacist.

Oral contraceptives

Zamur 500 may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while taking Zamur 500, you should also use mechanical methods of contraception(e.g. condoms). If you are unsure, you should consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Zamur 500 may cause dizzinessand other side effects that may impair your alertness.

• You should not drive or operate machineryif you do not feel well.

Zamur 500 contains sodium

This medicine contains 23.61 mg of sodium (the main component of common salt) per coated tablet.
This corresponds to 1.2% of the maximum recommended daily intake of sodium in the diet for adults.

Zamur 500 contains castor oil

Castor oil may irritate the stomach and cause diarrhea.
You should ask your doctorif you can take Zamur 500.

3. How to take Zamur 500

Zamur 500 should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist again.
Zamur 500 should be taken after a meal.This will help increase the effectiveness of the treatment.
Zamur 500 tablets should be swallowed whole with water.
Tablets should not be chewed, crushed, or divided- this may reduce the effectiveness of the treatment.

Recommended dose

Adults

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

Children

The usual recommended dose of Zamur 500 is 10 mg/kg body weight (not more than 125 mg) to 15 mg/kg body weight (not more than 250 mg) twice a day, depending on:

• the severity and type of infection.

Zamur 500 is not recommended for use in children under 3 monthsbecause the safety and efficacy of the medicine in this age group are not known.
Depending on the disease and how you respond to treatment, the initial dose may be changed or more than one treatment cycle may be necessary.

Patients with kidney problems

If you have kidney problems, your doctor may change the dose of Zamur 500.

• If this applies to you, you should tell your doctor.

Taking more than the recommended dose of Zamur 500

If you have taken more than the recommended dose of Zamur 500, you may experience neurological disorders, in particular an increased risk of seizures (epileptic fits).

• You should contact your doctor or call emergency services immediately. If possible, you should show the packaging of Zamur 500.

Missing a dose of Zamur 500

You should not take a double dose to make up for a missed dose.You should take the next dose at the usual time.

Stopping treatment with Zamur 500

You should not stop taking Zamur 500 unless your doctor tells you to.

It is important not to shorten the prescribed treatment period with Zamur 500.You should not stop treatment without your doctor's advice, even if you feel better. Shortening the recommended treatment period may lead to a recurrence of the infection.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zamur 500 can cause side effects, although not everybody gets them.

Conditions to watch out for

A small number of people taking Zamur 500 have reported an allergic reaction or potentially severe skin reaction. Their symptoms may be:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which may make breathing difficult.
• Skin rash, which may develop into blistersand look like small rings(a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
• Widespread skin changes with blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - a condition known as Lyell's syndrome).
• Widespread rash, high fever, and swollen lymph nodes(DRESS syndrome or drug hypersensitivity syndrome).
• Chest painassociated with an allergic reaction, which may be a sign of an allergic myocardial infarction (Kounis syndrome).

Other conditions to watch out for while taking Zamur 500:

• Fungal infections. Medicines like Zamur 500 can cause an overgrowth of yeast (Candida) in the body, leading to a fungal infection (e.g. thrush). The risk of this side effect is higher if Zamur 500 is taken for a long time.
• Severe diarrhea (pseudomembranous colitis). Medicines like Zamur 500 can cause inflammation of the colon (large intestine), leading to severe diarrhea, 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 a high fever, chills, muscle and headache, and skin rash. This is known as the Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day.

If you experience any of these symptoms, you should contact your doctor or nurse immediately.

Common side effects:

May occur in more than 1 in 10 patients:

• fungal infections (e.g. thrush)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain

Common side effects that may be detected in blood tests:

• increased white blood cell count (eosinophilia)
• increased liver enzyme activity

Uncommon side effects:

May occur in more than 1 in 100 patients:

• vomiting
• skin rashes

Uncommon side effects that may be detected in blood tests:

• decreased platelet count (thrombocytopenia)
• decreased white blood cell count (leukopenia)
• positive Coombs test result

Other side effects

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

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

Side effects that may be detected in blood tests:

• rapid breakdown of red blood cells (hemolytic anemia)

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
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 Zamur 500

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
The abbreviation “Lot” on the packaging means batch number.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Zamur 500 contains

The active substance of the medicine is cefuroxime.
Each coated tablet contains 500 mg of cefuroxime (equivalent to 601.44 mg of cefuroxime axetil).
Other ingredients of the medicine:
Tablet core: sodium croscarmellose; crospovidone; sodium lauryl sulfate; hydrogenated castor oil; methylcellulose; silica colloidal.
Coating: hypromellose 6cP; microcrystalline cellulose; macrogol 8 stearate; talc; titanium dioxide (E171).
See section 2. Zamur 500 contains sodiumand Zamur 500 contains castor oil.

What Zamur 500 looks like and contents of the packaging

Zamur 500 is a white, oval, coated tablet.
Coated tablets 500 mg are packaged in blisters of 10 and 14 pieces.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V.
Swensweg 5,
2031 GA Haarlem,
Netherlands

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80
31-546 Kraków
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
tel. +48 22 345 93 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

CEFUDOC 500 mg film-coated tablets, Denmark
Cefuroxima ratiopharm 500 mg coated tablets, Portugal
Zamur 500, coated tablets, Poland
Date of last revision of the leaflet:May 2023