Zinnat

Leaflet attached to the packaging: patient information

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

Zinnat (Zinadol), 500 mg, film-coated tablets

Cefuroxime
Zinnat and Zinadol are different trade names for the same medicine.

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 necessary.
• In case of 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, 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).

Your doctor may check what type of bacteria caused 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 antibiotics, or 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 peeling of the skin, blisters, and (or) ulcers of the mouth after treatment with cefuroxime or other cephalosporin antibiotics.
• If any of the above applies to you, you should not take Zinnatwithout consulting your doctor.

Warnings and precautions

Severe skin side effects have been reported with cefuroxime, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice any of the symptoms related to severe skin reactions described in section 4, you should seek medical advice immediately.
Before taking Zinnat, you should discuss it 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 in this age group are not known.
During treatment with Zinnat, you should be aware of the possibility of side effects such as allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See "Side effects to look out for" 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 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

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you 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 you are taking any of the above (or similar) medicines, you should tell your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist 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 contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)

• parabens, which may cause allergic reactions (possible late reactions).

Zinnat contains 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".

• You should consult your doctorto see if Zinnat is suitable for you.

3. How to take Zinnat

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your 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.
Zinnat tablets should be swallowed whole with water.
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 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 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 you have kidney problems, your doctor may change the dose of Zinnat.

• If this applies to you, you should tell your doctor.

Taking more Zinnat than prescribed

If you take more Zinnat than prescribed, you may experience neurological disorders, in particular, the risk of seizures (epileptic fits) increases.

• You should contact your doctor or call emergency services immediately. If possible, you should show them the packaging of Zinnat.

Missing a dose of Zinnat

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

Stopping Zinnat treatment

You should not stop taking Zinnat unless your doctor advises you to do so.

It is important not to shorten the prescribed treatment period with Zinnat. You should 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 doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

Side effects to look 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 may make breathing difficult.
• 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).
• Rash on the skin, 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(may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's disease).

Other side effects to look 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. During treatment with Zinnat for 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 you experience any of these symptoms, you should 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 (cells involved in blood clotting)
• decreased white blood cell count (leukopenia)
• positive Coombs test result.

Other 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
• 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 side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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
By reporting side effects, you can help provide more information on the safety of this 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 crushed or damaged in any way.
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. You should 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 of Zinnat is cefuroxime: each film-coated tablet contains 500 mg of cefuroxime in the form of cefuroxime axetil.
The other ingredients of Zinnat are: microcrystalline cellulose, sodium croscarmellose (type A), sodium lauryl sulfate, hydrogenated vegetable oil, anhydrous colloidal silica; coating: hypromellose, propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E

• 216), Opaspray white M-1-7120J (containing, among others, titanium dioxide and sodium benzoate).

What Zinnat looks like and contents of the pack

The tablets are white, oblong, biconvex, smooth on one side, and with the inscription "GXEG2" on the other. The tablets are packaged in Al/Al blisters, in a cardboard box. The pack contains 14 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

GlaxoSmithKline Monoprosopi A.E.B.E.
Leof. Kifisias 266
152 32 Chalandri
Athens, Greece

Manufacturer:

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, D24 YK11
Dublin, Ireland

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
Marketing authorization number in Greece, the country of export: 41698/5-11-2009

Parallel import authorization number: 408/19

This medicine is authorized in the Member States of the European Economic Area 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:24.10.2024
[Information about the trademark]