Zinnat

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Zinnat (Zinat ), 500 mg, film-coated tablets
Cefuroximum
Zinnat and Zinat are trade names of the same medicine written in Polish and Bulgarian.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

1. What Zinnat is and what it is 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 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 experienced a severe allergic reaction (hypersensitivity) to

any other type of beta-lactam antibiotics (penicillins, monobactams or
carbapenems);

• if the patient has ever developed severe skin rash, skin peeling, blisters and/or oral ulcers after treatment with cefuroxime or other cephalosporin antibiotics.
• If any of the above conditions apply to the patient, the patient must not take Zinnat without consulting a doctor.

Warnings and precautions
Severe skin adverse reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with cefuroxime.
If any of the symptoms associated with severe skin reactions described in section 4 occur, medical advice must be sought immediately.
Discuss this with your doctor or pharmacist before starting treatment with Zinnat.
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), and severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of complications. See “Symptoms to be aware of” 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, the patient should:

• inform the person taking the sample that Zinnat is being taken.

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 (blood thinners).
• If the patient is taking any of the above (or similar) medicines, the patient should inform the 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. If in doubt, consult a doctor.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 not feeling well.

Important information about certain ingredients of Zinnat

• Zinnat, coated tablets contain parabens, which may cause allergic reactions (delayed-type reactions possible).
• Zinnat 500 mg, 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 doctor to determine whether Zinnat is suitable for the patient.

3. How to use Zinnat

This medicine should always be taken as directed by a doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist again.
Zinnat is available in the following doses: 125 mg, 250 mg, 500 mg.
Zinnat should be taken after a meal. 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 children under 3 months of age, as the safety and efficacy of the medicine have not been established in this age group.

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

• Seek immediate medical advice or call emergency services. If possible, show the medicine package to the healthcare provider.

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 medical advice, even if the patient feels better. Shortening the recommended treatment period may lead to recurrence of the infection.

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 will experience them.
Conditions 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.
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a symptom of heart attack triggered by allergy (Kounis syndrome).
• Skin rash, which may develop into blisters and resemble target lesions (dark spot in the centre surrounded by a lighter ring and a dark ring at 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 conditions to be aware of while taking 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 prolonged period.
• 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 temperature (fever), chills, muscle and headache, and skin rash. This is known as 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 not 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 number of white blood cells (eosinophilia)
• increased liver enzyme activity.

Uncommon adverse reactions
May occur in not 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
• hepatitis.

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 this medicine.

5. How to store Zinnat

Keep this medicine 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Zinnat contains
The active substance is cefuroxime: each coated tablet contains 500 mg of cefuroxime in the form of cefuroxime axetil.
Other ingredients are:
Tablet core: microcrystalline cellulose, sodium croscarmellose (type A), sodium lauryl sulfate, hydrogenated vegetable oil, colloidal anhydrous silica;
Coating ingredients: 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 marked with "GX EG2" on the other.
The tablets are packed in aluminium foil blisters within a cardboard box. The packs contain either 10 or 50 coated tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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 Farmacevtska družba d. d. (Lek Pharmaceuticals d. d.)
Verovškova ulica 57, Ljubljana, 1526, Slovenia

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorisation number in Bulgaria, the country of export: 20020075
Parallel import authorisation number: 344/16

This medicinal product is authorised for sale in the following European Economic Area countries 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