Zinnat

Patient Information Leaflet

Warning! Keep this leaflet, information on the immediate packaging is in a foreign language!
Zinnat
500 mg, film-coated tablets
Cefuroximum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of Contents

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

1. What Zinnat is and what it is used for

Zinnat 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.
Zinnat is used to treat infections of:

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

Zinnat 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 the infection and may monitor during treatment whether the bacteria are sensitive to Zinnat.

2. Important information before using Zinnat

When not to use Zinnat:

• if the patient is allergic to cefuroxime axetil, to any of the cephalosporin antibiotics, or to any of the other ingredients of Zinnat (listed in section 6);
• 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, skin peeling, 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 Zinnat without consulting a doctor.

Warnings and precautions
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 associated with severe skin reactions described in
section 4 occur, medical advice should be sought immediately.
Before starting treatment with Zinnat, discuss this with your doctor or pharmacist.

Children
Zinnat 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.

During treatment with Zinnat, be alert 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 be aware of” in section 4.

Blood tests
Zinnat may affect test results for blood glucose detection and blood tests known as the Coombs test. If the patient is to undergo blood tests, they should:
➔ inform the person taking the sample that they are taking Zinnat.

Zinnat and other medicines
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 Zinnat.
• Probenecid.
• Oral anticoagulants. ➔ If the patient is taking any of the above (or similar) medicines, they should inform their doctor or pharmacist.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, 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
Zinnat 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.

Important information about certain ingredients of Zinnat

• The medicine contains 0.00506 mg of sodium benzoate (E 211) in each tablet.
• The medicine contains less than 1 mmol (23 mg) of sodium, meaning the medicine is considered "sodium-free".

➔ Consult your doctor to determine whether Zinnat is an appropriate medicine for the patient.

3. How to use Zinnat

This medicine should always be used exactly as advised by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist again.
Zinnat is available in the following strengths: 125 mg, 250 mg, 500 mg.
Zinnat should be taken after food. This will help increase the effectiveness of treatment.
Zinnat 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 and children with body weight of 40 kg and above
The recommended dose of Zinnat is 250 mg to 500 mg twice daily, depending on the
severity and type of infection.

Children weighing less than 40 kg
Children weighing below 40 kg should preferably be treated with Zinnat oral suspension.
The recommended dose of Zinnat is 10 mg/kg body weight (not exceeding 250 mg) to 15 mg/kg body weight (not exceeding 250 mg) twice daily, depending on:

• severity and type of infection.

Zinnat 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.
Depending on the illness and the patient's response to treatment, the initial dose may be adjusted or more than one course of treatment may be required.

Patients with kidney problems
If the patient has impaired kidney function, the doctor may adjust the dosage of the medicine.
➔ If this applies to the patient, he/she should inform the doctor.

Taking more Zinnat than recommended
If a patient takes more Zinnat than recommended, neurological disturbances may occur, particularly an increased risk of seizures (epileptic fits).
➔ Seek immediate medical advice or call an ambulance. If possible, show the Zinnat packaging to the healthcare provider.

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

Stopping Zinnat treatment
Do not stop taking Zinnat unless instructed by your doctor.
It is important not to shorten the prescribed duration of Zinnat treatment. Do not stop treatment without consulting your doctor, even if the patient feels better. Shortening the recommended treatment period 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.
Symptoms to be aware of
In a small number of people taking Zinnat, 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.
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome),
• Chest pain associated with an allergic reaction, which may be a symptom of allergy-induced heart attack (Kounis syndrome).
• Skin rash, which may develop into blisters and appear as target-like lesions (a dark spot in the centre surrounded by a lighter ring and a dark edge). Widespread skin lesions with blisters and peeling of the outer skin layer. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's disease).

Other symptoms to watch for during treatment with Zinnat

• Fungal infections. Medicines such as Zinnat may lead to overgrowth of yeast ( Candida ) in the body, which may result in fungal infection (e.g. thrush). The risk of this adverse reaction is higher if Zinnat is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines like Zinnat 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 Zinnat for Lyme disease, some patients may experience high temperature (fever), chills, muscle and 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 in a patient, contact a doctor or nurse immediately.
Common adverse reactions
May occur in no 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 white blood cell count (eosinophilia)
• increased liver enzyme activity

Uncommon adverse reactions
May occur in no more than 1 in 100 patients :

• vomiting
• skin rashes

Uncommon adverse reactions that may be revealed in blood tests:

• reduced platelet count (cells involved in blood clotting)
• reduced white blood cell count (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 symptoms occur, including any 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.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Zinnat

Keep the medicine out of the sight and reach of children.
Store below 30°C, in the original packaging.
Do not use if the tablets are broken or otherwise damaged.
Do not use this medicine after the expiry date stated on the packaging. 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Zinnat contains
The active substance is cefuroxime: each coated tablet contains 500 mg of cefuroxime (as cefuroxime axetil).
Other components are: microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose, hydrogenated vegetable oil, anhydrous colloidal silicon dioxide, coating: hypromellose, propylene glycol, Opaspray white M-1-7120J (containing, among others, titanium dioxide (E 171) and sodium benzoate (E 211)).

What Zinnat looks like and contents of the pack
Zinnat coated tablets are white, capsule-shaped, smooth on one side and marked with "GX EG2" on the other. The coated tablets are packed in OPA-Al-PVC/Al blisters in a cardboard box. The pack contains 10 coated tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Romania, the country of export:
Sandoz Pharmaceuticals S.R.L.
Calea Floreasca, nr. 169A
Clădirea A, etaj 1, sector 1, 014459
Bucharest, Romania

Manufacturer:
Sandoz GmbH
Kundl (AICO FDF Kundl)
Biochemiestraße 10
6250 Kundl, Austria
Lek Farmacevtska družba d. d.
(Lek Pharmaceuticals d. d.)
Verovškova ulica 57
Ljubljana, 1526, Slovenia

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź, Poland

Marketing authorisation number in Romania, the country of export: 2018/2009/01
Parallel import authorisation number: 20/21

This medicinal product is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland) – Zinnat
Germany – Elobact
Greece – Zinadol
Italy – Oraxim
Portugal – Zipos
Portugal – Zoref