Zamur 250

Package leaflet: Information for the patient

Zamur 250
250 mg, film-coated tablets
Cefuroximum
Please read all of this leaflet carefully before taking this medicine, because it contains important
information for you.

• Keep this leaflet, as you may need to read it again. 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.
• It may harm other people, even if their symptoms are the same.
• If any of the side effects worsens or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Zamur 250 is and what it is used for
2. What you need to know before taking Zamur 250
3. How to take Zamur 250
4. Possible side effects
5. How to store Zamur 250
6. Contents of the pack and other information

1. What Zamur 250 is and what it is used for

Zamur 250 is an antibiotic used in adults and children. The medicine works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Zamur 250 is used to treat infections of the:

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

Zamur 250 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 caused your infection and may check during treatment whether the bacteria are sensitive to Zamur 250.

2. Important information before using Zamur 250

When not to use Zamur 250

• if the patient is allergic to cephalosporin antibiotics or to any of the other ingredients of Zamur 250;
• 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 patient has ever developed severe skin rash, peeling of the skin, blisters, and/or oral mucosal ulcers after treatment with cefuroxime or other cephalosporin antibiotics.

If any of the above conditions apply to the patient, the patient should not take Zamur 250 without consulting a doctor.
Warnings and precautions
Before starting treatment with Zamur 250, discuss this with a doctor or pharmacist.
Severe skin adverse reactions have been reported during treatment with cefuroxime, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms related to severe skin reactions described in section 4 occur, medical advice should be sought immediately.
Children
Zamur 250 is not recommended for use in children under 3 months of age, as the safety and efficacy of the drug in this age group have not been established.
While taking Zamur 250, the patient should be vigilant for symptoms such as allergic reactions, fungal infections (e.g. candidiasis), and severe diarrhea (pseudomembranous colitis). This will help reduce the risk of complications. See “Symptoms to be aware of” in section 4.
Blood tests
Zamur 250 may affect the results of blood glucose tests and the blood test known as the Coombs test. If the patient is due to have blood tests, they should:

• inform the person taking the sample that they are taking Zamur 250.

Other medicines and Zamur 250
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.

• Medicines reducing stomach acid (e.g. antacids used to treat heartburn) may affect the action of Zamur 250.
• Probenecid.
• Oral anticoagulant medicines (anticoagulants).
• If the patient is taking any of the above (or similar) medicines, they should inform the doctor or pharmacist.

Oral contraceptives
Zamur 250 may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives during treatment with Zamur 250, 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 a doctor or pharmacist before using this medicine.
Driving and operating machinery
Zamur 250 may cause dizziness and other adverse effects that may impair the patient's alertness.

• The patient should not drive or operate machinery if they do not feel well.

Zamur 250 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".
Zamur 250 contains castor oil
Castor oil may irritate the stomach and cause diarrhea.
Ask a doctor whether it is safe to use Zamur 250.

3. How to use Zamur 250

Zamur 250 should always be used as directed by a doctor or pharmacist. If in doubt, contact your doctor or pharmacist again.
Zamur 250 should be taken after a meal. This will help increase the effectiveness of treatment.
Zamur 250 tablets should be swallowed whole with water.
Do not chew, crush, or divide the tablets – this may reduce the effectiveness of treatment.

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

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

• severity and type of infection.

Zamur 250 is not recommended for use in 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 impairment
If the patient has impaired kidney function, the doctor may adjust the dosage of the drug.

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

Taking more than the recommended dose of Zamur 250
If a patient takes more than the recommended dose of Zamur 250, neurological disturbances may occur, particularly an increased risk of seizures (epileptic fits).

• Seek immediate medical attention or call emergency services. If possible, show the packaging of Zamur 250 to the healthcare provider.

Missing a dose of Zamur 250
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping treatment with Zamur 250
Do not stop taking Zamur 250 unless instructed by a doctor.
It is important not to shorten the prescribed duration of treatment with Zamur 250. Do not discontinue treatment without consulting a doctor, 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 all medicines, Zamur 250 may cause adverse reactions, although not everyone experiences them.

Symptoms to be aware of

A small number of people taking Zamur 250 have experienced an allergic reaction or potentially severe skin reaction. Symptoms may include:

• 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 blisters and look like small rings (a dark spot in the center surrounded by a lighter ring, with a dark edge).
• Widespread skin lesions with blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis – Lyell's syndrome).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

Other symptoms to be aware of during treatment with Zamur 250

• Fungal infections. Medicines such as Zamur 250 may lead to overgrowth of yeast (Candida) in the body, which may result in fungal infection (e.g. candidiasis). The risk of this adverse reaction is higher if Zamur 250 is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Zamur 250 may cause inflammation of the colon (large intestine), leading to severe diarrhoea, usually with blood and mucus, abdominal pain, and fever.
• Jarisch-Herxheimer reaction. During treatment with Zamur 250 for Lyme disease (borreliosis), some patients may experience high fever, chills, muscle and joint pain, headache, 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, 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 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 symptoms occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions may also be reported to the marketing authorization holder.

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

5. How to store Zamur 250

Keep this medicine 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 specified month.
The abbreviation "Lot" on the packaging refers to the batch number.
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 required. This will help protect the environment.

6. Contents of the pack and other information

What Zamur 250 contains
The active substance is cefuroxime.
Each film-coated tablet contains 250 mg of cefuroxime (equivalent to 300.72 mg of cefuroxime axetil).
Other ingredients of the medicinal product:
Tablet core: sodium croscarmellose; crosspovidone; sodium lauryl sulfate; hydrogenated castor oil; methylcellulose; precipitated silica.
Coating: hypromellose 6cP; microcrystalline cellulose; polyglycolised glycerides (macrogol stearate); talc; titanium dioxide (E171).
See section 2. Zamur 250 contains sodium and Zamur 250 contains castor oil.

What Zamur 250 looks like and contents of the pack
Zamur 250 is a white, round, film-coated tablet with a breakline on one side.
Film-coated tablets 250 mg are packed in blisters of 10 and 14 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5,
2031 GA Haarlem,
The Netherlands

Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
Teva Operations Poland Sp. z o.o
ul. Mogilska 80
31-546 Kraków
Poland
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

For further information, contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
tel. +48 22 345 93 00

This medicinal product is authorised in the European Economic Area under the following names:
CEFUDOC 250 mg film-coated tablets, Denmark
Cefuroxima ratiopharm 250 mg comprimidos revestidos, Portugal
Zamur 250, film-coated tablets, Poland