Zinnat

Leaflet attached to the packaging: patient information

Zinnat, 125 mg, film-coated tablets

Zinnat, 250 mg, film-coated tablets

Zinnat, 500 mg, film-coated tablets

Cefuroxime

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 any not listed in this leaflet, tell your 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:

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

Zinnat may also be used:

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

Your doctor may check what type of bacteria is causing your infection and check if the bacteria are sensitive to Zinnat during treatment.

2. Important information before taking Zinnat

When not to take Zinnat:

• if you are allergicto cefuroxime axetil, to any other cephalosporin antibioticsor to any of the other ingredients of Zinnat (listed in section 6);
• if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams, or carbapenems).
• if you have ever had a severe skin rash or skin peeling, blisters, and (or) ulcers of the mouth after treatment with cefuroxime or other cephalosporin antibiotics. ➔ If any of the above applies to you, do not take Zinnatwithout consulting your 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 you notice any symptoms related to severe skin reactions described in section 4, seek medical attention immediately. Before taking Zinnat, discuss this with your 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, pay attention to whether the following symptoms occur: allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See “Symptoms to watch out for”in section 4.

Blood tests

Zinnat 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, you should:

➔ tell the person taking the blood samplethat you are taking Zinnat.

Zinnat and other medicines

Tell your doctor or pharmacist about all medicines you 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 you are taking any of the above (or similar) medicines, tell your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Zinnat may cause dizzinessand other side effects that may impair your alertness. ➔ You should not drive or operate machineryif you do not feel well.

Important information about some 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 it is considered ‘sodium-free’.

➔ Consult your doctorto see if Zinnat is suitable for you.

3. How to take Zinnat

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Zinnat should be taken after a meal. This will help increase the effectiveness of the treatment. Swallow the Zinnat tablets whole with water. Do not chew, crush, or break the tablets- 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 daily, 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 daily, 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 you have kidney problems, your doctor may change the dose of Zinnat. ➔ If this applies to you, tell your doctor.

Taking more Zinnat than prescribed

If you take more Zinnat than prescribed, you may experience neurological disorders, in particular, an increased risk of seizures(epileptic fits). ➔ Contact a doctor or call an emergency immediately. If possible, show the Zinnat packaging.

Missing a dose of Zinnat

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

Stopping Zinnat treatment

Do not stop taking Zinnat unless your doctor tells you to.

It is important not to shorten the prescribed treatment period with Zinnat. 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Symptoms to watch out for

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

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which may cause difficulty breathing.
• Widespread rash, high fever, swollen lymph nodes(DRESS or hypersensitivity syndrome),
• Chest pain associated with an allergic reaction, which may be a sign of allergic myocardial infarction(Kounis syndrome).
• Skin rash, which may 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 symptoms 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 used 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 skin rash. This is called a Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day.

➔ If you experience any of these symptoms, contact your 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

Rare side effects

Other side effects occur in a very small number of patients, but the frequency is unknown:

• severe diarrhea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high fever
• yellowing of the whites of the eyes or skin
• liver inflammation

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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects 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 Zinnat

Keep the medicine out of the sight and reach of children. Do not store above 30°C. Do not use if the tablets are crushed 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 stated. The batch number (Lot) is stated on the packaging. 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 Zinnat contains

The active substance is cefuroxime: each film-coated tablet contains 125 mg, 250 mg, or 500 mg of cefuroxime (as axetil). The other ingredients 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. (Lek Pharmaceuticals d.d.) Verovškova ulica 57 1526 Ljubljana Slovenia For more information about this medicine, contact: Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warszawa 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 (marketing authorization holder’s logo)