Zinnat

Leaflet accompanying the packaging: patient information

Zinnat, 125 mg, film-coated tablets

Zinnat, 250 mg, film-coated tablets

Zinnat, 500 mg, film-coated tablets

Cefuroxime

You should carefully 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 you need to.
• If you have any doubts, you should consult a doctor or pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Zinnat and what is it used for
• 2. Important information 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 is Zinnat and what is it used for

Zinnat 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.

Zinnat 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.

Zinnat may also be used:

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

The doctor may check what type of bacteria caused the patient's infection, and also check during treatment whether the bacteria are sensitive to Zinnat.

2. Important information before taking Zinnat

When not to take Zinnat:

• if the patient is allergicto cefuroxime axetil, to any of the cephalosporin antibioticsor to any of the other ingredients of Zinnat (listed in section 6);
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams or carbapenems).
• if the patient has ever had a severe skin rash or peeling of the skin, blisters and (or) ulcers of the mouth after treatment with cefuroxime or other cephalosporin antibiotics. ➔ If the above circumstances apply to the patient, they should not take Zinnatwithout consulting a doctor.

Warnings and precautions

Severe skin reactions have occurred 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 are noticed, medical advice should be sought immediately.
Before starting treatment with Zinnat, the patient should discuss it with their doctor or pharmacist.

Children

Zinnat is not recommended for use in children under 3 months, as the safety and efficacy of the medicine in this age group are not known.
During treatment with Zinnat, attention should be paid to whether the following complaints occur: allergic reactions, fungal infections (e.g. thrush) and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See “Complaints to watch out for”in section 4.

Blood tests

Zinnat may affect the results of blood sugar tests and a blood test called the Coombs test. If the patient is to have blood tests, they should:
➔
tell the person taking the blood samplethat they are taking Zinnat.

Zinnat and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Medicines that reduce stomach acid(e.g. antacids used to treat heartburn) may affect the action of Zinnat.
• Probenecid.
• Oral anticoagulants (blood thinners). ➔ If the patient is taking any of the above (or similar) medicines, they should tell their doctor or pharmacist.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or are planning to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Zinnat may cause dizzinessand other side effects that may impair the patient's alertness.
➔
The patient should not drive or operate machineryif they do not feel well.

Important information about some of the ingredients of Zinnat

• Zinnat, 125 mg, film-coated tablets contain 0.00152 mg of sodium benzoate in each tablet.
• Zinnat, 250 mg, film-coated tablets contain 0.00203 mg of sodium benzoate in each tablet.
• Zinnat, 500 mg, film-coated tablets contain 0.00506 mg of sodium benzoate in each tablet.
• The medicine contains less than 1 mmol (23 mg) of sodium in each tablet, which means the medicine is considered “sodium-free”.

➔ The patient should contact their doctorto see if Zinnat is a suitable medicine for them to take.

3. How to take Zinnat

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the patient should contact their doctor or pharmacist again.
Zinnat should be taken after a meal.This will help increase the effectiveness of the treatment.
Zinnat tablets should be swallowed whole with water.
The tablets should not be chewed, crushed or divided- this may reduce the effectiveness of the treatment.

Recommended dose

Adults and children with a body weight of 40 kg or more

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

Children weighing less than 40 kg

Children under 40 kg should be treated with Zinnat in the form of an oral suspension.
The recommended dose of Zinnat is 10 mg/kg body weight (not more than 250 mg) to 15 mg/kg body weight (not more than 250 mg) twice a day, depending on:

• the severity and type of infection.

Zinnat is not recommended for use in children under 3 months, 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 the patient has kidney problems, the doctor may change the dose of Zinnat.
➔
If this applies to the patient, they should tell their doctor.

Taking a higher dose of Zinnat than recommended

If the patient takes a higher dose of Zinnat than recommended, they may experience neurological disorders, in particular an increased risk of seizures(epileptic fits).
➔
The patient should contact their doctor or call an emergency immediately.If possible, they should show the packaging of Zinnat.

Missing a dose of Zinnat

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

Stopping treatment with Zinnat

The patient should not stop taking Zinnat unless their doctor tells them to.

It is important not to shorten the prescribed treatment period with Zinnat.The patient should not stop treatment without their doctor's advice, even if they feel better. Shortening the recommended treatment period may lead to a recurrence of the disease.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Complaints to watch out for

A small number of people taking Zinnat have reported an allergic reaction or a potentially severe skin reaction. The symptoms may be:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which can make breathing difficult.
• Widespread rash, high fever, swollen lymph nodes(DRESS syndrome or hypersensitivity syndrome),
• Chest pain associated with an allergic reaction, which can be a sign of an allergic heart attack(Kounis syndrome).
• Rash on the skin, which can develop into blistersand look like small targets(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 - Lyell's disease

Other complaints to watch out for while taking Zinnat

• Fungal infections.Medicines like Zinnat 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 Zinnat is taken for a long time.
• Severe diarrhea (pseudomembranous colitis).Medicines like Zinnat can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain and fever.
• Jarisch-Herxheimer reaction.When taking Zinnat to treat Lyme disease (borreliosis), some patients may experience a high fever, chills, muscle and headache, and a rash on the skin. This is known as a Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day.

➔ If the patient experiences any of these symptoms, they should contact their doctor or nurse immediately.

Common side effects

May occur in up to 1 in 10 patients:

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

Common side effects that may be seen in blood test results:

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

Uncommon side effects

May occur in up to 1 in 100 patients:

• vomiting
• skin rashes

Uncommon side effects that may be seen in blood test results:

• decreased platelet count (cells involved in blood clotting)
• decreased white blood cell count (leukopenia)
• positive Coombs test result

Rare 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
• inflammation of the liver

Side effects that may be seen in blood test results:

• rapid breakdown of red blood cells (hemolytic anemia)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Drug Monitoring, 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
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 Zinnat

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use if the tablets are broken or damaged in any way.
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 batch number (Lot) is stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zinnat contains

The active substance of the medicine is cefuroxime: each film-coated tablet contains 125 mg, 250 mg or 500 mg of cefuroxime (as axetil).
The other ingredients of the medicine are: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hydrogenated vegetable oil, colloidal anhydrous silica, coating: hypromellose, propylene glycol, Opaspray white M-1-7120J (containing, among others, titanium dioxide (E171) and sodium benzoate (E211))

What Zinnat looks like and contents of the pack

Zinnat, 125 mg, film-coated tablets are white, capsule-shaped, smooth on one side and with the imprint “GX ES5” on the other. The tablets are packaged in aluminum/aluminum blisters in a cardboard box. The pack contains 6, 10, 12, 14, 16, 20, 24 or 50 tablets.
Zinnat, 250 mg, film-coated tablets are white, capsule-shaped, smooth on one side and with the imprint “GX ES7” on the other. The tablets are packaged in aluminum/aluminum blisters in a cardboard box. The pack contains 6, 10, 12, 14, 16, 20, 24 or 50 tablets.
Zinnat, 500 mg, film-coated tablets are white, capsule-shaped, smooth on one side and with the imprint “GX EG2” on the other. The tablets are packaged in aluminum/aluminum blisters in a cardboard box. The pack contains 6, 10, 12, 14, 16, 20, 24 or 50 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer:

Sandoz GmbH
Kundl (AICO FDF Kundl)
Biochemiestrasse 10
6250 Kundl
Austria
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
Slovenia
To obtain more detailed information about this medicine, the patient should contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

film-coated tablets 125 mg
Czech Republic, Denmark, France, Hungary, Ireland, Lithuania, Netherlands, Poland, Romania, Slovakia, United Kingdom (Northern Ireland) – Zinnat
Germany – Elobact
film-coated tablets 250 mg
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland) – Zinnat
Germany – Elobact
Greece – Zinadol
Italy – Oraxim
Portugal – Zipos
Portugal – Zoref
film-coated tablets 500 mg
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
Date of last revision of the leaflet:04/2024
(logo of the marketing authorization holder)