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

Read the Leaflet Carefully Before Taking the Medication, 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. It may harm them, even if their symptoms are the same as yours.
• 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 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 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 spread by ticks).

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

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 you have ever had a severe skin rash or blistering of the skin, or mouth sores after taking cefuroxime or other cephalosporin antibiotics.
• If any of these conditions apply to you, do not take Zinnatwithout consulting your doctor.

Warnings and Precautions

Severe skin reactions have been reported with cefuroxime, including:

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, as described in section 4, seek medical advice 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 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, 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 in doubt, consult your doctor.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and Using Machines

Zinnat may cause dizzinessand other side effects that can impair your attention.

• 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, contains 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 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, 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.

Do not chew, crush, or divide the tablets- 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 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 Than the Recommended Dose of Zinnat

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

• Immediately consult your doctor or call emergency services.If possible, show them 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 Treatment with Zinnat

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 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.

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 include:

• 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).
• Skin rash, 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 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, immediately consult your doctor or nurse.

Immediately consult your doctor or nurse.

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 not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, National Institute of Pharmacy, ul. Grójecka 81/83, 00-844 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Reporting side effects will help to 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, 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. Ask your pharmacist how to dispose of medicines no longer required. 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:

tablet core: microcrystalline cellulose, croscarmellose sodium (type A), sodium lauryl sulfate, hydrogenated vegetable oil, colloidal anhydrous silica;

coating: hypromellose, propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), Opaspray white M-1-7120J (hypromellose, titanium dioxide (E 171), sodium benzoate).

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 "GXEG2" on the other.

The tablets are packaged in OPA-Al-PVC/Al blisters, in a cardboard box. The packaging contains 10 film-coated tablets.

For more detailed information, consult the marketing authorization holder or 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

Lek Pharmaceuticals d.d.

Verovškova ulica 57, Ljubljana, 1526, Slovenia

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 Romania, the Country of Export:2018/2009/01

Parallel Import Authorization Number:64/11

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 Approval of the Leaflet: 08.02.2024

[Information about the Trademark]