Zinnat

Leaflet attached to the packaging: patient information

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

Zinnat (Зинат), 500 mg, coated tablets

Cefuroxime
Zinnat and Зинат are trade names for the same medicine written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before using 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 their symptoms 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 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).

The doctor may check what type of bacteria caused the patient's infection and also check during treatment whether the bacteria are sensitive to Zinnat.

2. Important information before taking Zinnat

When not to take Zinnat:

• if the patient is allergicto cefuroxime axetil, to any of the cephalosporin antibioticsor 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 antibiotic (penicillins, monobactams or carbapenems);

• if the patient has 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 the above circumstances apply to the patient, they should not take Zinnatwithout consulting a 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 any of the symptoms associated with severe skin reactions are noticed, as described in section 4, medical advice should be sought immediately.
Before starting Zinnat, the patient should discuss it with their 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, the patient should be aware of the possibility of allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See “Adverse reactions to watch for”in section 4.

Blood tests

Zinnat may affect the results of blood tests for sugar and 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

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or 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 contraception(e.g., condoms). If in doubt, they should consult their doctor.

Pregnancy, breastfeeding, and fertility

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

• Zinnat, coated tablets, contains parabens, which may cause allergic reactions (possible late reactions).
• Zinnat, 500 mg, 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”.
• The patient should consult their doctorto determine if Zinnat is suitable for them.

3. How to take Zinnat

This medicine should always be taken exactly as advised by the doctor or pharmacist. If in doubt, the patient should consult their 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 patient should swallow Zinnat tablets 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 daily, 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 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 the patient's response 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 dose of Zinnat.

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

Taking more than the recommended dose of Zinnat

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

• The patient should immediately consult a doctor or call an emergency number.If possible, they should show the packaging of Zinnat.

Missing a dose of Zinnat

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

Stopping treatment with Zinnat

The patient should not stop taking Zinnat unless their doctor advises them to do so.

It is important not to shorten the prescribed treatment period with Zinnat.The patient should not stop treatment without their doctor's advice, even if they feel better. Shortening the recommended treatment period may lead to a recurrence of the disease.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Adverse reactions to watch 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 mouth, which may make breathing difficult.
• Widespread rash, high fever, swollen 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 adverse reactions to watch for while taking Zinnat

• Fungal infections.Medicines like Zinnat may 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 used for a long time.
• Severe diarrhea (pseudomembranous colitis).Medicines like Zinnat may cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever.
• Jarisch-Herxheimer reaction.When Zinnat is used to treat Lyme disease (borreliosis), some patients may experience a high fever, chills, muscle and headache, and skin rash. This is known as 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 immediately consult their 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 (thrombocytopenia)
• decreased white blood cell count (leukopenia)
• positive Coombs test.

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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 to gather 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.
Do not store above 30°C.
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. The patient should ask their 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 coated tablet contains 500 mg of cefuroxime in the form of cefuroxime axetil.
The other ingredients of Zinnat are:
tablet core: microcrystalline cellulose, sodium croscarmellose (type A), sodium lauryl sulfate, hydrogenated vegetable oil, colloidal silicon dioxide;
coating: hypromellose, propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), Opaspray white M-1-7120J (containing, among others: titanium dioxide (E 171), sodium benzoate (E 211)).

What Zinnat looks like and contents of the pack

Zinnat, 500 mg, 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 foil blisters, in a cardboard box. The packs contain 10 or 50 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Sandoz d. d., Verovškova ulica 57, 1000 Ljubljana, Slovenia

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 Bulgaria, the country of export:20020075
Parallel import authorization number:344/16

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 approval of the leaflet: 13.02.2024

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