Zinoxx

Package leaflet: Information for the patient

Zinoxx 250 mg coated tablets
Zinoxx 500 mg coated tablets
Cefuroximum
Please read carefully all the information in this leaflet before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Zinoxx is and what it is used for
2. What you need to know 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 Zinoxx is and what it is used for

Zinoxx is an antibiotic used in adults and children. It 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,
• the sinuses,
• the middle ear,
• the lungs or chest,
• the urinary tract,
• the skin and soft tissues.

Zinoxx may also be used:

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

2. Important information before using Zinoxx

When not to use Zinoxx:

• if the patient is allergic (hypersensitive) to cephalosporin antibiotics or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems),
• if the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral mucosal ulcers after treatment with cefuroxime or other cephalosporin antibiotics.

If any of the above situations apply, the patient should not take Zinoxx without first consulting a doctor.

Warnings and precautions

Before starting treatment with Zinoxx, discuss this 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 have not been established.

During treatment with Zinoxx, be alert for symptoms such as allergic reactions, fungal infections (e.g. candidiasis), or severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of complications. See "Symptoms which require attention" in section 4.

Severe skin reactions have occurred during treatment with cefuroxime, including: Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms associated with severe skin reactions described in section 4 occur, seek immediate medical advice.

Blood tests

Zinoxx may affect the results of blood glucose tests and of a 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 Zinoxx.

Zinoxx and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained 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-thinning medicines). If the patient is taking any of the above (or similar) medicines, they should inform their doctor.

Oral contraceptives

Zinoxx may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while using Zinoxx, 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.

The doctor will assess whether the benefits of using Zinoxx during pregnancy or breastfeeding outweigh any potential risks to the child.

Driving and operating machinery

Zinoxx may cause dizziness and other adverse effects that may impair alertness.

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

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

The medicine contains propylene glycol (E 1520).

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

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

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Zinoxx

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Zinoxx should be taken after a meal. This will help increase the effectiveness of treatment.
Zinoxx tablets should be swallowed whole with water.
Do not chew, crush or divide the tablets – this may reduce the effectiveness of treatment.
Zinoxx coated tablets should not be crushed and are therefore not suitable for use in patients who cannot swallow tablets. In children, cefuroxime may be administered as an oral suspension.

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

Children
The usual dose of Zinoxx 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.
Zinoxx is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine 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 medicine.
If this applies to the patient, they should inform their doctor.

Use of a higher than recommended dose of Zinoxx
If the patient takes a higher than recommended dose of Zinoxx, neurological disturbances may occur, particularly an increased risk of seizures (epileptic fits).
Seek immediate medical attention or call emergency services. If possible, show the Zinoxx packaging to the healthcare provider.

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

Stopping Zinoxx treatment
It is important not to shorten the prescribed duration of Zinoxx treatment. Do not stop treatment without medical advice, even if the patient feels better. Prematurely stopping the recommended course of treatment may lead to recurrence of the illness.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Serious adverse reactions
Symptoms to be aware of
In a small number of people taking Zinoxx, an allergic reaction or potentially serious skin reaction has been reported. Symptoms may include the following:

• Severe allergic reaction. Symptoms include raised, itchy rash, swelling, sometimes of the face or mouth, which may make breathing difficult.
• Chest pain associated with an allergic reaction, which may be a sign of heart attack triggered by allergy (Kounis syndrome).
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Skin rash, which may develop into blisters and look like small rings (a dark spot in the centre surrounded by a lighter ring with a dark 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 disease).
• Fungal infections. Medicines such as Zinoxx may cause excessive growth of yeast ( Candida ) in the body, which may lead to fungal infection (e.g. candidiasis). The risk of this adverse reaction is higher if Zinoxx is used for a long period of time.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Zinoxx may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, abdominal pain and fever.
• Jarisch-Herxheimer reaction. When Zinoxx is used to treat Lyme disease (borreliosis), some patients may experience high temperature (fever), chills, muscle and headache, and skin rash. This is known as a Jarisch-Herxheimer reaction. These symptoms usually last from several hours to one day.

If any of the symptoms listed above occur in a patient, contact a doctor or nurse immediately.
Other adverse reactions
Common adverse reactions (may occur in up to 1 in 10 patients):

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

Common adverse reactions that may be revealed in blood test results:

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

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• vomiting,
• skin rashes.

Uncommon adverse reactions that may be revealed in blood test results:

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

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 test results:

• excessive breakdown of red blood cells (haemolytic anaemia).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Zinoxx

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the cardboard packaging
and blister after "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the package and other information

What the medicine Zinoxx contains

• The active substance is cefuroxime. Each coated tablet of Zinoxx contains 250 mg or 500 mg of cefuroxime in the form of cefuroxime axetil.
• The other components (excipients) are: microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, 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), sodium croscarmellose 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, capsule-shaped tablets, embossed with
"ZNX 250" on one side and smooth on the other side.
Zinoxx 500 mg – white or almost white, film-coated, capsule-shaped tablets, embossed with
"ZNX 500" on one side and a division line on the other side.
Zinoxx 250 mg – tablets are packed in blisters containing 10 tablets, in a cardboard box containing 1 blister.
Zinoxx 500 mg – tablets are packed in blisters containing 14 tablets, in a cardboard box containing 2 blisters, or containing 10 tablets, in a cardboard box containing 1 blister.
Marketing Authorisation 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]
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Polfarmex S.A., ul. Józefów 9, 99-300 Kutno
Tel.: (24) 357 44 44