Zinnat

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Zinnat

500 mg, film-coated tablets

Cefuroxime

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given 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, 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 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 check if the bacteria are sensitive to Zinnat during treatment.

2. Important information before taking Zinnat

When not to take Zinnat:

• if the patient is allergicto cefuroxime axetil, to any other 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 antibiotics (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 taking 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, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)have been reported with cefuroxime. If the patient notices any symptoms related to severe skin reactions described in section 4, they should seek medical advice immediately.
Before taking Zinnat, the patient should discuss it with their doctor or pharmacist.

Children

Zinnat is not recommended for children under 3 months of age, as the safety and efficacy of the medicine in this age group are not known.
During treatment with Zinnat, the patient should be aware of the following symptoms: allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See " Special warnings and precautions for use" in section 4.

Blood tests

Zinnat may affect the results of blood tests for sugar in the blood and a blood test called the Coombs test. If the patient is going to have a blood test, 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 taking, have recently taken, or might 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, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Zinnat may cause dizzinessand other side effects that may affect the patient's ability to drive or use machines.

• The patient should not drive or use machinesif they do not feel well.

Important information about some ingredients of Zinnat

• Zinnat 500 mg, film-coated tablets contain parabens (methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216)), which may cause allergic reactions (possible late reactions).
• 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 it is considered "sodium-free".
• The patient should consult their doctorto see if Zinnat is suitable for them.

3. How to take Zinnat

This medicine should always be taken as directed by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist again.
Zinnat is available in the following strengths: 125 mg, 250 mg, 500 mg.
Zinnat should be taken after a meal. This will help increase the effectiveness of the treatment.
The 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 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 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 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 more Zinnat than prescribed

If the patient takes more Zinnat than prescribed, they may experience neurological disorders, particularly an increased risk of seizures(epileptic fits).

• The patient should contact their doctor or call the emergency services 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 relapse 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.

Special warnings and precautions for use

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 may make breathing difficult.
• Widespread rash, high fever, enlarged lymph nodes(DRESS syndrome or hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a sign of allergic myocardial infarction(Kounis syndrome).
• Rash on the skin, which may develop into blistersand look like small targets(a dark spot in the center surrounded by a lighter ring with a dark ring around the edge).
• Widespread skin lesions with blisters and peeling skin(may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's disease).

Other special warnings and precautions for use during treatment with Zinnat

• Fungal infections. Medicines like Zinnat may 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 may 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 called 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 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.

Rare side effects

Affect a very small number of people, 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.

Rare side effects that may be seen in blood tests:

• 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 Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Zinnat

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C, in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 is cefuroxime: each film-coated tablet contains 500 mg of cefuroxime (as cefuroxime axetil).
• The other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose (type A), sodium lauryl sulfate, hydrogenated vegetable oil, colloidal anhydrous silica; coating: hypromellose, propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), 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 500 mg, film-coated tablets are white, capsule-shaped, smooth on one side, and have the imprint "GX EG2" on the other. The tablets are packaged in OPA-Al-PVC/Al blisters, in a cardboard box. The pack contains 10, 20, or 50 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Sandoz Pharmaceuticals S.R.L.
Calea Floreasca, no. 169A
Building A, 1st floor, sector 1
014459, Bucharest, Romania

Manufacturer:

GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland
Lek Pharmaceuticals d.d.
Verovškova ulica 57, Ljubljana 1526, Slovenia

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romanian marketing authorization number, country of export: 2018/2009/01

Parallel import authorization number: 346/11

This medicine is authorized in the Member States of 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
Date of revision of the leaflet:16.05.2025
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