Zinnat

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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 need to 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 the following infections:

• Throat
• Sinuses
• Middle ear
• Lungs or chest
• Urinary tract
• Skin and soft tissues

Zinnat may also be used:

• To treat 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 or skin peeling, blisters and (or) mouth ulcers after treatment with cefuroxime or other antibiotics from the cephalosporin group.
• If any of the above circumstances apply to the patient, the patient should 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 occurred during treatment with cefuroxime. If any of the symptoms associated with severe skin reactions described in section 4 occur, medical advice should be sought immediately.
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), and severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of complications. See “Symptoms which require 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 testing, the patient should:

• inform the person taking the sample that the patient is taking Zinnat.

Zinnat and other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken, or might take any other medicines.

• Medicines reducing 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, the patient should inform the doctor or pharmacist.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and using machines
Zinnat may cause dizziness and other adverse effects which may impair the patient's alertness.

• The patient should not drive or operate machinery if he/she does not feel well.

Important information about some of the ingredients of Zinnat

• Zinnat 250 mg film-coated tablets contain 0.00203 mg of sodium benzoate (E 211) per tablet.
• The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".
• Consult your doctor to determine whether Zinnat is the appropriate medicine for the patient.

3. How to use Zinnat

This medicine should always be used exactly as directed 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 and children with body weight equal to or greater than 40 kg
The recommended dose of Zinnat is 250 mg to 500 mg twice daily, depending on the
severity and type of infection.

Children weighing less than 40 kg
Children with body weight below 40 kg should preferably be treated with Zinnat oral suspension.
The recommended dose of Zinnat is 10 mg/kg body weight (not exceeding 250 mg) to 15 mg/kg body weight (not exceeding 250 mg) twice daily, depending on:

• 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 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 course of treatment 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 packaging of Zinnat.

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 stop treatment without medical advice, 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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.
• 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 sign of heart attack triggered by allergy (Kounis syndrome).
• Skin rash, which may develop into blisters and appear as target-like lesions (dark spot in the center surrounded by a lighter ring and a dark rim at the edge).

Widespread skin lesions with blisters and peeling of the outer layer of skin. This may be a sign of
Stevens-Johnson syndrome or toxic epidermal necrolysis – Lyell's disease.
Other symptoms to be aware of 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 effect 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. During treatment with Zinnat for 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 your doctor or nurse immediately.

Common adverse effects
May occur in up to 1 in 10 patients:

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

Common adverse effects that may be revealed in blood tests:

• increased number of white blood cells (eosinophilia)
• increased liver enzyme activity

Uncommon adverse effects
May occur in up to 1 in 100 patients:

• vomiting
• skin rashes

Uncommon adverse effects that may be revealed in blood tests:

• decreased number of platelets (cells involved in blood clotting)
• decreased number of white blood cells (leukopenia)
• positive Coombs test result

Other adverse effects
Other adverse effects 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 fever
• yellowing of the whites of the eyes or skin
• hepatitis

Adverse effects that may be revealed in blood tests:

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

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

5. How to store Zinnat

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Zinnat contains
The active substance is cefuroxime: each film-coated tablet contains 250 mg of cefuroxime (as
cefuroxime axetil).
Other ingredients are: microcrystalline cellulose, sodium lauryl sulfate, sodium croscarmellose,
hydrogenated vegetable oil, colloidal anhydrous silica; coating: hypromellose, propylene glycol, Opaspray white M-1-7120J (containing, among others, titanium dioxide (E 171) and sodium benzoate (E 211)).

What Zinnat looks like and contents of the pack
Zinnat 250 mg film-coated tablets are white, capsule-shaped, smooth on one side and marked with the imprint “GX ES7” on the other. The tablets are packed in aluminium/aluminium blisters, contained in a cardboard box. The pack contains 6, 12, or 24 tablets.

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

Marketing Authorisation Holder in Greece, the country of export:
Sandoz Pharmaceuticals d.d.
Verovškova 57
SI-1000 Ljubljana
Slovenia

Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
D24 YK11 Dublin
Ireland
Lek Pharmaceuticals d.d.
Verovškova 57
SI-1526 Ljubljana
Slovenia

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

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

Marketing Authorisation Number in Greece, the country of export: 41696/5-11-2009
Parallel Import Licence Number: 193/25

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following trade names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland) – Zinnat
Germany – Elobact
Greece – Zinadol
Italy – Oraxim
Portugal – Zipos
Portugal – Zoref