Zinnat

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Zinnat (Zinadol), 500 mg, film-coated tablets
Cefuroximum
Zinnat and Zinadol are different brand names of the same medicine.
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, 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.
• 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 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 bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Zinnat is used to treat infections of:

• the throat
• the sinuses
• the middle ear
• the lungs or chest
• the urinary tract
• the 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 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 cephalosporin antibiotics.
• If any of the above situations 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 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 have not been established in this age group.
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 due to have 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 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.

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 which 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 contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)

• parabens, which may cause allergic reactions (delayed-type reactions possible).

Zinnat contains 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 your doctor to determine whether Zinnat is suitable for the patient.

3. How to use Zinnat

This medicine should always be used exactly as directed by your doctor or pharmacist. If you
have any doubts, 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 divide 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:

• 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 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 the 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, bring the Zinnat 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 treatment with Zinnat. Do not stop treatment without consulting your doctor, even if you feel better. Shortening the prescribed 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 effects

Like all medicines, this medicine can cause adverse effects, 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 cause difficulty in breathing.
• 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 symptom of heart attack induced 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 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 syndrome).
Other conditions to be aware of during treatment with Zinnat

• Fungal infections. Medicines such as Zinnat may cause overgrowth of yeasts (Candida) in the body, leading to fungal infection (e.g. candidiasis). 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 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, contact a doctor or nurse immediately.

Common adverse effects
May occur in not more than 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 not more than 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.

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 temperature (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 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 effects helps 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 if tablets are chipped 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package 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 (type A), sodium lauryl sulphate, 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 and sodium benzoate).

What Zinnat looks like and contents of the pack
The tablets are white, elongated, biconvex, smooth on one side and engraved with "GXEG2" on the other. The tablets are packed in Al blisters within a cardboard box. The pack contains 14 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
Athens, Greece

Manufacturer:
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, D24 YK11
Dublin, Ireland

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation number in Greece, the country of export: 41698/5-11-2009
Parallel import authorisation number: 408/19

This medicinal product is authorised for sale in the European Economic Area member states 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 (Northern Ireland) – Zinnat
Germany – Elobact
Greece – Zinadol
Italy – Oraxim
Portugal – Zipos
Portugal – Zoref