Zinnat

Patient Information Leaflet

Important! Keep this leaflet! Information on the outer packaging is in a foreign language.
Zinnat, 500 mg, film-coated tablets
Cefuroximum
Please read all of 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 doubts, 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 someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell 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:

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

Your doctor may identify the type of bacteria causing your infection and may also 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 any of the above circumstances apply to the patient, Zinnat must not be taken 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), and severe diarrhoea (pseudomembranous colitis). This will help reduce the risk of complications. See "Side effects that 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 tests, he or she 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 or has recently taken, as well as any medicines the patient plans 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, he or she 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. 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 side effects that may impair the patient's alertness.

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

Important information about certain ingredients of Zinnat

• Zinnat, coated tablets contain parabens, 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, i.e. the medicine is considered "sodium-free".
• Consult your doctor whether Zinnat is an appropriate medicine for the patient.

3. How to use Zinnat

This medicine should always be used as directed by a doctor or pharmacist. If in
doubt, contact 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 divide 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 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 Zinnat packaging to the healthcare provider.

Missed 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
Do not stop taking Zinnat unless instructed by your doctor.
It is important not to shorten the prescribed duration of treatment with Zinnat. Do not discontinue treatment without a doctor's instruction, 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 will experience them.
Symptoms that require attention
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 mouth, which may make breathing difficult.
• Skin rash that may develop into blisters and look like target 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 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 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 a 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 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 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 tests:

• decreased number of platelets (cells involved in blood clotting)
• decreased number of white blood cells (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 for Monitoring of Adverse Reactions to Medicinal Products at 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 provide more information on the safety of this medicine.

5. How to store Zinnat

Keep the medicine out of the sight and reach of children.
Store below 30°C.
Do not use if 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 should not be disposed of via wastewater or household waste. Ask your 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 is cefuroxime: each coated tablet contains 500 mg of cefuroxime
in the form of cefuroxime axetil.
Other components of the medicine are: microcrystalline cellulose, sodium croscarmellose,
sodium lauryl sulfate, hydrogenated vegetable oil, colloidal anhydrous silica; coating: hypromellose,
propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216),
Opaspray White M-1-7120 J (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 Al/Al blisters, contained in a cardboard box. The packs contain 10, 14 or 50
coated tablets.

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

Marketing Authorisation Holder in the Czech Republic, the country of export:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus
Dublin 24
Ireland

Manufacturer:
Glaxo Wellcome Operations, Barnard Castle, United Kingdom
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 Warsaw
Poland

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

Marketing Authorisation number in the Czech Republic, the country of export: 15/061/88-C/C
Parallel import authorisation number: 2/18

This medicinal product is authorised for sale 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