Zinnat

Leaflet accompanying the packaging: patient information

WARNING: Keep the leaflet, the information on the immediate packaging is in a foreign language.

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 packaging 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). -

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

2. Important information before taking Zinnat

When not to take Zinnat:

• to 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 the above circumstances apply to you, you should not take Zinnatwithout consulting a doctor.

Warnings and precautions

You should discuss taking Zinnat with your doctor or pharmacist before starting treatment.

Children

Zinnat is not recommended for use in children under 3 monthsbecause the safety and efficacy of the medicine in this age group are not known. During treatment with Zinnat, you 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 “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

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about 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.

Oral contraceptives

Zinnat may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while taking Zinnat, you should also use mechanical methods of contraception(e.g. condoms). If you have any doubts, you should consult your doctor.

Pregnancy, breastfeeding and fertility

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

Driving and using machines

Zinnat may cause dizzinessand other side effects that can impair your alertness. You should not drive or operate machineryif you 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”. You should consult your doctorto see if Zinnat is a suitable medicine for you to take.

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. 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

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 use in 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 you have kidney problems, your doctor may change the dose of Zinnat. If this applies to you, you should tell your doctor.

Taking more than the recommended dose of Zinnat

If you have taken more than the recommended dose of Zinnat, you may experience neurological disorders, in particular an increased risk of seizures(epileptic fits).

You should contact a doctor or call an emergency immediately.

If possible, you should show 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 treatment with Zinnat

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.

Symptoms to watch out for

In a small number of people taking Zinnat, an allergic reaction or potentially serious 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 skin, which may develop into blisteringand 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. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - a condition that can be life-threatening.) -

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 greater 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 you experience any of these symptoms, you should contact a 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 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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 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 (EXP) 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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, 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 (E 171) and sodium benzoate (E 211)).

What Zinnat looks like and what the pack contains

Zinnat, 500 mg, film-coated tablets are available in blisters containing 10 or 50 tablets. The tablets are white, capsule-shaped, smooth on one side and with the inscription “GXEG2” on the other. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

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

Manufacturer:

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Harmire Road, Barnard Castle, County Durham, DL12 8DT, United Kingdom

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw Chemiczno-Farmaceutyczna Spółdzielnia Pracy „ESPEFA”, ul. Juliusza Lea 208, 30-133 Kraków LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław Authorization number in Romania, the country of export: 2018/2009/01 Parallel import authorization number: 352/12

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, France, 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: 01.06.2022[Information about the trademark]