Zinnat

Package leaflet: Information for the user

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

• Keep this leaflet, as you may need to read it again.
• 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. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions 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 the following infections:

• 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 investigate which type of bacteria caused the patient's 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 peeling skin, blisters and/or oral mucosal ulcers after treatment with cefuroxime or other cephalosporin antibiotics. If any of the above conditions apply to the patient, the patient should not take Zinnat without consulting a doctor.

Warnings and precautions
Severe skin adverse reactions, including:
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 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, monitor for possible adverse effects such as allergic reactions, fungal infections (e.g. candidiasis), and severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of complications. See "Side effects to watch for" in section 4.

Blood tests
Zinnat may affect the results of blood glucose tests and blood tests known as the Coombs test. If the patient is to undergo blood testing, they should:
inform the person taking the sample that they are taking Zinnat.

Zinnat and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• 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, 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. In case of 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 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 in Zinnat

• Zinnat, coated tablets contain methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (including delayed-type reactions).
• 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 per tablet, i.e. the medicine is considered "sodium-free".

Consult a doctor to determine whether Zinnat is an appropriate medicine for the patient.

3. How to take Zinnat

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you
are unsure, you should contact 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 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:

• 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 illness 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 you, you should inform your doctor.

Taking more than the recommended dose of Zinnat
If a patient takes more than the recommended dose of Zinnat, neurological disturbances may occur, particularly an increased risk of seizures (epileptic fits).
Seek immediate medical attention or call emergency services. If possible, show the Zinnat packaging to the healthcare provider.

If you miss 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 treatment. Do not discontinue treatment without consulting your doctor, even if you start to feel 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.
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 body temperature 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 caused by allergy (Kounis syndrome).
• Skin rash , which may develop into blisters and appear as target-like lesions (a dark spot in the center surrounded by a lighter ring and a dark ring 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 be aware of during treatment with Zinnat

• Fungal infections. Medicines such as Zinnat may cause overgrowth of yeast ( Candida ) in the body, which may lead 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. During treatment with Zinnat for Lyme disease, some patients may experience high temperature (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 in a patient, 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 test results:

• increased number of white blood cells (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 test results:

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

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 test results:

• excessive breakdown of red blood cells (haemolytic anaemia)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a 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 this medicine out of 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 (EXP) stated on the packaging. The expiry date refers to the last day of the stated month. The code 'Lot' on the packaging indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These 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 (as cefuroxime axetil).
The other ingredients are: microcrystalline cellulose, sodium lauryl sulphate, sodium croscarmellose (type A), hydrogenated vegetable oil, colloidal anhydrous silica, coating: hypromellose, propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), 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 500 mg coated tablets are white, capsule-shaped, smooth on one side and engraved with "GX EG2" on the other. The tablets are packed in aluminium/aluminium blisters and placed in a cardboard carton. The pack contains 14 coated tablets.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Greece, the country of export:
GlaxoSmithKline Monoprosopi A.E.B.E
Leof. Kifisias 266
152 32 Chalandri
Greece

Manufacturer:
Glaxo Wellcome Operations
Bernard Castle
United Kingdom
GlaxoSmithKline Manufacturing SpA
Verona
Italy

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing Authorisation number in Greece, the country of export: 41698/5-11-2009
Parallel Import Authorisation number: 66/24

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
coated tablets 500 mg
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