Zinnat

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Zinnat, 500 mg, Film-Coated Tablets

Cefuroxime

Before taking the medicine, carefully read the contents of this leaflet, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, 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 their symptoms are the same.
• If the patient experiences any side effects, including any 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
• 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).

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 antibiotics, or 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 above applies to the patient, they should not take Zinnatwithout consulting a doctor.

Warnings and precautions

Before starting to take Zinnat, discuss it with your doctor or pharmacist.

Children

Zinnat is not recommended for children under 3 monthsbecause the safety and efficacy of the medicine in this age group are not known.
During treatment with Zinnat, pay attention to whether the following complaints occur: allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This reduces the risk of complications. See "Complaints 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 the patient is to have blood tests, they should:

• tell the person taking the blood samplethat they are taking Zinnat.

Zinnat and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking now or has 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.

Oral contraceptives

Zinnat may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while taking Zinnat, they should also use mechanical methods of preventing pregnancy(e.g., condoms). If in doubt, consult a doctor.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, 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 ingredients of Zinnat

• Zinnat film-coated tablets contain parabens, 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, i.e., the medicine is considered "sodium-free".
• Consult a doctorto see if Zinnat is a suitable medicine for the patient.

3. How to take Zinnat

This medicine should always be taken as directed 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 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

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

Children

The recommended dose of Zinnat is 10 mg/kg body weight (not more than 125 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 monthsbecause 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 dosage of Zinnat.

• If this applies to the patient, they should tell their doctor.

Taking more Zinnat than recommended

If the patient takes more Zinnat than recommended, they may experience neurological disorders, in particular, the risk of seizures (epileptic fits) increases.

• Consult a doctor or call emergency services immediately.If possible, show the Zinnat packaging.

Missing a 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 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 prescribed treatment period may lead to a relapse of the disease.
If you have any further doubts about taking this medicine, consult your 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

In a small number of people taking Zinnat, an allergic reaction or potentially severe skin reaction has been reported. The symptoms may be:

• Severe allergic reaction.Symptoms include: raised, itchy rash, swelling,sometimes of the face or lips, which may make breathing difficult.
• Rash on the skinthat 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 temperature (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 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 tests:
• 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 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 temperature (fever)
• yellowing of the whites of the eyes or skin
• inflammation of the liver. Side effects that may be seen in blood tests:
• rapid breakdown of red blood cells (hemolytic anemia).

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product 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.
Reporting side effects will help gather 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 in a temperature below 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. 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 500 mg of cefuroxime in the form of cefuroxime axetil.
The other ingredients are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal anhydrous silica; coating: hypromellose, propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), Opaspray white M-1-7120 J (titanium dioxide (E 171), sodium benzoate (E 211)).

What Zinnat looks like and contents of the pack

Zinnat 500 mg film-coated tablets are white, capsule-shaped, smooth on one side, and with the inscription "GX EG2" on the other.
The tablets are packaged in Al/Al blisters, in a cardboard box. The packs contain 10, 14, or 50 film-coated tablets.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus
Dublin 24
Ireland

Manufacturer:

Glaxo Wellcome Operations, Barnard Castle, United Kingdom
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24
Ireland

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:15/061/88-C/C
Parallel import authorization number:2/18

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, United Kingdom – Zinnat
Germany – Elobact
Greece – Zinadol
Italy – Oraxim
Portugal – Zipos
Portugal – Zoref
Date of leaflet approval: 29.09.2022
[Information about the trademark]