Zinnat

Patient Information Leaflet

Keep this leaflet! Information on the immediate packaging is in a foreign language.
Zinnat 500 mg, film-coated tablets
Cefuroximum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Zinnat is and what it is used for
2. What you should know 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 Zinnat is and what it is used for

Zinnat is an antibiotic used in adults and children. It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Zinnat is used to treat infections of:

• throat
• sinuses
• middle ear
• lungs or chest
• urinary tract
• skin and soft tissues

Zinnat may also be used:

• in the treatment of early-stage Lyme disease (borreliosis – an infection transmitted by ticks).

Your doctor may test which type of bacteria caused your infection and may check during treatment whether the bacteria are sensitive to Zinnat.

2. Important information before using Zinnat

When not to use Zinnat:

• if the patient is allergic to cefuroxime axetil, to any of the 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 any of the above apply to the patient, the patient must not take Zinnat without consulting a doctor.

Warnings and precautions
Before starting treatment with Zinnat, discuss this 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 have not been established.
During treatment with Zinnat, be alert for symptoms such as allergic reactions, fungal infections (e.g. candidiasis), or severe diarrhoea (pseudomembranous colitis). This may help reduce the risk of complications. See "Symptoms which need attention" in section 4.
Blood tests
Zinnat may affect the results of blood glucose tests and a blood test known as the Coombs test. If the patient is to undergo blood tests, they should:

• inform the person taking the sample that they are taking Zinnat.

Zinnat with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or might take in the future.

• Medicines that reduce stomach acid (e.g. antacids used to treat heartburn) may affect the action of Zinnat.
• Probenecid.
• Oral anticoagulants.
• If the patient is taking any of the above (or similar) medicines, they should inform their doctor or pharmacist.

Oral contraceptives
Zinnat may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives during treatment with Zinnat, additional mechanical methods of contraception (e.g. condoms) should be used. Consult a doctor if in doubt.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Zinnat may cause dizziness and other adverse effects that may impair the patient's alertness.

• The patient should not drive or operate machinery if they do not feel well.

Important information about certain ingredients of Zinnat

• Zinnat film-coated tablets contain parabens, which may cause allergic reactions (delayed-type reactions possible).
• 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 your doctor to determine whether Zinnat is suitable for the patient.

3. How to use Zinnat

This medicine should always be taken exactly as prescribed 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 food. This will help increase the effectiveness of treatment.
Zinnat tablets should be swallowed whole with water.
Do not chew, crush, or split the tablets – this may reduce the effectiveness of 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 exceeding 125 mg) to 15 mg/kg body weight (not exceeding 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 have not been established.

Depending on the disease and the patient's response to treatment, the initial dose may be adjusted or more than one treatment course may be required.

Patients with kidney problems
If the patient has impaired kidney function, the doctor may adjust the dosage of the medicine.

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

Taking more Zinnat than prescribed
If the patient takes more Zinnat than prescribed, neurological disturbances may occur, particularly an increased risk of seizures (epileptic fits).

• Seek immediate medical attention or call emergency services. If possible, bring the medicine packaging with you.

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 instructed by your doctor.
It is important not to shorten the prescribed duration of Zinnat treatment. Do not discontinue treatment without consulting your doctor, even if the patient feels better. Shortening the recommended treatment period may lead to recurrence of the illness.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Symptoms to be aware of
In a small number of people taking Zinnat, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
• Skin rash that may develop into blisters and look like target lesions (a dark spot in the centre surrounded by a lighter ring with a dark rim around the edge).
• Widespread skin lesions 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 for during treatment with Zinnat

• Fungal infections. Medicines such as Zinnat may cause overgrowth of yeast ( Candida ) in the body, leading to fungal infection (e.g. thrush). The risk of this adverse reaction is higher if Zinnat is used for a long time.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Zinnat may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, 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 high fever, chills, muscle and headache, and skin rash. This is known as the Jarisch-Herxheimer reaction. These symptoms usually last from several hours to one day.
• If any of these symptoms occur, contact a doctor or nurse immediately.

Common adverse reactions
May occur in no more than 1 in 10 patients:

• fungal infections (e.g. candidiasis)
• headache
• dizziness
• diarrhoea
• nausea
• stomach pain.

Common adverse reactions that may be revealed in blood tests:

• increased white blood cell count (eosinophilia)
• increased liver enzyme activity.

Uncommon adverse reactions
May occur in no more than 1 in 100 patients:

• vomiting
• skin rashes.

Uncommon adverse reactions that may be revealed in blood tests:

• decreased platelet count (cells involved in blood clotting)
• decreased white blood cell count (leukopenia)
• positive Coombs test.

Other adverse reactions
Other adverse reactions occur in a very small number of patients, but the exact frequency is unknown:

• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• liver inflammation.

Adverse reactions that may be revealed in blood tests:

• excessive breakdown of red blood cells (haemolytic anaemia).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zinnat

Keep the medicine out of the sight and reach of children.
Store below 30°C in the original packaging.
Do not use if the tablets are broken or otherwise damaged.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps 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.
Other components are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil, anhydrous colloidal silicon dioxide; coating: hypromellose, propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), Opaspray White M-1-7120 J (containing, among others, titanium dioxide (E 171) and 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 marked with "GX EG2" on the other.
The tablets are packed in PA/Al/PVC//Al blisters in cardboard boxes. The packs contain 10, 20 or 50 film-coated tablets.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Croatia, the country of export:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Manufacturer:
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 Warszawa
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Poland

Marketing Authorisation Number in Croatia, the country of export: HR-H-565616124-01
Parallel Import Authorisation Number: 6/23

This medicinal product is authorised in the European Economic Area countries 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