Zinoxx

Package Leaflet: Information for the Patient

Zinoxx 250 mg Film-Coated Tablets

Zinoxx 500 mg Film-Coated Tablets

Cefuroxime

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 experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Zinoxx and what is it used for

Zinoxx 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.

Zinoxx is used to treat infections of:

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

Zinoxx may also be used:

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

2. Important information before taking Zinoxx

When not to take Zinoxx:

• if you are allergic (hypersensitive) to cephalosporin antibiotics or any of the other ingredients of this medicine (listed in section 6),
• 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 blistering of the skin, or peeling and (or) mouth sores after taking cefuroxime or other cephalosporin antibiotics.

If any of the above applies to you, do not take Zinoxx without consulting your doctor.

Warnings and precautions

Before taking Zinoxx, discuss it with your doctor or pharmacist.

Zinoxx is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group are not known.

During treatment with Zinoxx, pay attention to whether you experience any symptoms such as allergic reactions, fungal infections (e.g. thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See "Symptoms to watch for" in section 4.

Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxime treatment. If you notice any symptoms related to severe skin reactions described in section 4, seek medical attention immediately.

Blood tests

Zinoxx 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, tell the person taking the sample that you are taking Zinoxx.

Zinoxx and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take. This includes medicines that are available without a prescription.

• Medicines that reduce stomach acid (e.g. antacids used to treat heartburn) may affect the action of Zinoxx.
• Probenecid.
• Oral anticoagulants (blood thinners). If you are taking any of these medicines (or similar ones), tell your doctor.

Oral contraceptives

Zinoxx may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while taking Zinoxx, use additional mechanical methods of contraception (e.g. condoms). If in doubt, consult your doctor.

Pregnancy, breastfeeding, and fertility

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

Your doctor will assess whether the benefits of taking Zinoxx during pregnancy and breastfeeding outweigh the risks to the baby.

Driving and using machines

Zinoxx may cause dizziness and other side effects that can impair your attention.

Do not drive or operate machinery if you do not feel well.

Zinoxx contains propylene glycol (E 1520), croscarmellose sodium, and sodium lauryl sulfate (excipients), which are sources of sodium.

The medicine contains propylene glycol (E 1520).

Zinoxx 250 mg contains 0.71 mg of propylene glycol in one film-coated tablet.

Zinoxx 500 mg contains 1.43 mg of propylene glycol in one film-coated tablet.

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is considered "sodium-free".

3. How to take Zinoxx

Always take this medicine exactly as your doctor has told you.

If you are unsure, ask your doctor or pharmacist.

Take Zinoxx after a meal. This will help increase the effectiveness of the treatment.

Swallow the Zinoxx tablets whole with water.

Do not chew, crush, or divide the tablets - this may reduce the effectiveness of the treatment.

Zinoxx film-coated tablets should not be crushed and are therefore not suitable for patients who have difficulty swallowing tablets. In children, cefuroxime can be given in the form of an oral suspension.

Recommended dose

Adults

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

Children

The recommended dose of Zinoxx 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.

Zinoxx is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group are not known.

Depending on the disease and how the patient responds 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 Zinoxx.

If this applies to you, tell your doctor.

Taking more than the recommended dose of Zinoxx

If you take more than the recommended dose of Zinoxx, you may experience neurological disorders, in particular, the risk of seizures (epileptic fits) increases.

Contact your doctor or call the emergency services immediately. If possible, show them the Zinoxx packaging.

Missing a dose of Zinoxx

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

Stopping treatment with Zinoxx

It is important not to shorten the prescribed treatment period with Zinoxx. Do 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 disease.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects

Symptoms to watch for

In a small number of people taking Zinoxx, an allergic reaction or potentially severe skin reaction has been reported. The symptoms may be:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which can make breathing difficult.
• Chest pain associated with an allergic reaction, which can be a sign of an allergic myocardial infarction (Kounis syndrome).
• Widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Skin rash that can develop into blisters and look like small rings (a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
• Widespread skin lesions with blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's disease).
• Fungal infections. Medicines like Zinoxx 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 Zinoxx is taken for a long time.
• Severe diarrhea (pseudomembranous colitis). Medicines like Zinoxx 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 Zinoxx for Lyme disease (borreliosis), some patients may experience 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 the above symptoms, contact your doctor or nurse immediately.

Other side effects

Common side effects(may affect up to 1 in 10 people):

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

Common side effects that may be seen in blood tests:

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

Uncommon side effects(may affect up to 1 in 100 people):

• vomiting,
• skin rashes.

Uncommon side effects that may be seen 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 ones),
• high fever,
• yellowing of the whites of the eyes or skin,
• inflammation of the liver.

Side effects that may be seen in blood tests:

• rapid breakdown of red blood cells (hemolytic anemia).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist, or nurse. 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

Website: https://smz.ezdrowie.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 Zinoxx

Keep the medicine out of the sight and reach of children.

Store in a temperature below 30°C.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the 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 Zinoxx contains

• The active substance is cefuroxime. Each Zinoxx film-coated tablet contains 250 mg or 500 mg of cefuroxime in the form of cefuroxime axetil.
• The other ingredients (excipients) are: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, hydrogenated vegetable oil; tablet coating: hypromellose, propylene glycol (E 1520), macrogol 4000, titanium dioxide (E 171), talc.

Zinoxx contains propylene glycol (E 1520), croscarmellose sodium, and sodium lauryl sulfate (excipients) - see section 2.

What Zinoxx looks like and contents of the pack

Zinoxx 250 mg - white or almost white film-coated tablets in the shape of a capsule, with the inscription ZNX 250 on one side and smooth on the other.

Zinoxx 500 mg - white or almost white film-coated tablets in the shape of a capsule, with the inscription ZNX 500 on one side and a dividing line on the other.

Zinoxx 250 mg - tablets are packaged in blisters containing 10 tablets, in a carton containing 1 blister.

Zinoxx 500 mg - tablets are packaged in blisters containing 14 tablets, in a carton containing 2 blisters or containing 10 tablets, in a carton containing 1 blister.

Marketing authorization holder and manufacturer

Polfarmex S.A.

ul. Józefów 9

99-300 Kutno

Poland

Tel.: (24) 357 44 44

Fax: (24) 357 45 45

e-mail: [email protected]

To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:

Polfarmex S.A., ul. Józefów 9, 99-300 Kutno

Tel.: (24) 357 44 44

Date of last revision of the package leaflet: