Zinnat

Leaflet accompanying the packaging: patient information

Zinnat, 125 mg/5 ml, granules for oral suspension

Cefuroxime

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Zinnat and what is it 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 packaging and other information

1. What is Zinnat and what is it used for

Zinnat is an antibiotic used in adults and children. The medicine 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
• of the sinuses
• of the middle ear
• of the lungs or chest
• of the urinary tract
• of the skin and soft tissues.

Zinnat may also be used:

• to treat early stages of Lyme disease (borreliosis - an infection transmitted by ticks).

Your doctor may test what type of bacteria caused the infection in the patient and check during treatment if the bacteria are sensitive to Zinnat.

2. Important information before taking Zinnat

When not to take Zinnat:

• if the patient is allergicto cefuroxime axetil, to any other cephalosporin antibioticsor to any of the other ingredients of Zinnat (listed in section 6);
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams, or carbapenems).
• if the patient has ever had a severe skin rash or skin peeling and blistering and (or) mouth sores after treatment with cefuroxime or other cephalosporin antibiotics. If the above circumstances apply to the patient, they should not take Zinnatwithout consulting a doctor.

Warnings and precautions

Severe skin reactions have occurred with cefuroxime treatment, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If any of the symptoms of severe skin reactions described in section 4 are noticed, medical advice should be sought immediately.
Before starting Zinnat, discuss it with your doctor or pharmacist.

Children

Zinnat is not recommended for use in children under 3 monthsbecause the safety and efficacy of the medicine in this age group are not known.
During treatment with Zinnat, attention should be paid to whether the following complaints occur: allergic reactions, fungal infections (e.g., thrush), and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See “Complaints to watch out for”in section 4.

Blood tests

Zinnat may affect the results of blood sugar tests and a blood test called the Coombs test. If the patient is to have blood tests, they should:
tell the person taking the blood samplethat they are taking Zinnat.

Zinnat and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might 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, they should tell their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Zinnat may cause dizzinessand other side effects that can impair the patient's alertness.
The patient should not drive or operate machineryif they do not feel well.

Important information about some ingredients of Zinnat

Zinnat oral suspension contains sugar (sucrose). This should be taken into account in patients with diabetes. If the doctor has told the patient that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.
Zinnat oral suspension also contains aspartame, which is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine builds up in the body because it is not excreted properly.
Zinnat oral suspension also contains benzyl alcohol (E1519), which may cause allergic reactions. The patient should consult their doctor or pharmacist if they have liver or kidney disease or if they are pregnant or breastfeeding (see also the section above - Pregnancy and breastfeeding, and fertility), as large amounts of benzyl alcohol may build up in the body, leading to side effects (metabolic acidosis). It should not be used for more than a week in small children (under 3 years), unless advised by a doctor or pharmacist.
5 ml of the prepared suspension contains 0.021 g of aspartame (E951).
5 ml of the prepared suspension contains 3.1 g of sucrose.
5 ml of the prepared suspension contains 6 mg of propylene glycol (E1520).
5 ml of the prepared suspension contains 4.5 mg of benzyl alcohol (E1519).
The patient should ask their doctorif Zinnat is suitable for them.

3. How to take Zinnat

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist again.
Zinnat should be taken after a meal. This will help increase the effectiveness of the treatment.
Before use, the bottle should be shaken.
The measured dose of Zinnat oral suspension can be diluted with cold fruit juice or a milk drink; it should be taken immediately after preparation.
Zinnat should not be mixed with hot liquids.
Detailed instructions for preparing Zinnat suspension can be found at the end of the leaflet (see Instructions for preparing the suspension).

Recommended dose

Adults and children with a body weight of 40 kg or more

The recommended dose of Zinnat is 250 mg to 500 mg twice a day, depending on the severity and type of infection.

Children with a body weight of less than 40 kg

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

• the severity and type of infection
• the child's body weight and age, not more than 500 mg per day.

Zinnat is not recommended for use in children under 3 months, as the safety and efficacy of the medicine in this age group are not known.
Depending on the disease and how the patient responds to treatment, the initial dose may be changed or more than one treatment cycle may be necessary.

Patients with kidney problems

If the patient has kidney problems, the doctor may change the dose of Zinnat.
If this applies to the patient, they should tell their doctor.

Taking more Zinnat than recommended

If the patient takes more Zinnat than recommended, they may experience neurological disorders, in particular, an increased risk of seizures (epileptic fits).
Seek medical help immediatelyor call the emergency services. If possible, show the Zinnat packaging.

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 advised by a doctor.

It is important not to shorten the prescribed treatment period. Do not stop treatment without the doctor's advice, even if the patient feels better. Shortening the recommended treatment period may lead to a relapse of the disease.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Zinnat can cause side effects, although not everybody gets them.

Complaints to watch out for

A small number of people taking Zinnat have reported an allergic reaction or a potentially severe skin reaction. Their symptoms may be:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which can make breathing difficult.
• Widespread rash, high fever, swollen lymph nodes(DRESS or hypersensitivity syndrome),
• Chest pain associated with an allergic reaction, which can be a sign of allergic myocardial infarction(Kounis syndrome).
• Skin rash, which can develop into blistersand look like small targets(a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
• Widespread skin changes with blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's disease).

Other complaints to watch out for while taking Zinnat

• Fungal infections. Medicines like Zinnat can cause an overgrowth of thrush (Candida) in the body, leading to a fungal infection (e.g., thrush). The risk of this side effect is higher if Zinnat is used for a long time.
• Severe diarrhea (pseudomembranous colitis). Medicines like Zinnat can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever.
• Jarisch-Herxheimer reaction. When taking Zinnat to treat Lyme disease (borreliosis), some patients may experience a high fever, chills, muscle and headache, and a rash on the skin. This is called a Jarisch-Herxheimer reaction. These symptoms usually last from a few hours to a day.

If the patient experiences any of these symptoms, they should contact their doctor or nurse immediately.

Common side effects

May occur in up to 1 in 10 patients:

• fungal infections (e.g., thrush)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain

Common side effects that may be seen in blood test results:

• increased white blood cell count (eosinophilia)
• increased liver enzyme activity

Uncommon side effects

May occur in up to 1 in 100 patients:

• vomiting
• skin rashes

Uncommon side effects that may be seen in blood test results:

• decreased platelet count (thrombocytopenia)
• decreased white blood cell count (leukopenia)
• positive Coombs test result

Other side effects

Other side effects occur in a very small number of patients, but the exact frequency is unknown:

• severe diarrhea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high fever
• jaundice
• liver inflammation

Side effects that may be seen in blood test results:

• rapid breakdown of red blood cells (hemolytic anemia)

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Zinnat

The medicine should be stored out of sight and reach of children.
The granules (medicine before adding water) should be stored in the original packaging at a temperature not exceeding 30°C.

WARNING! The prepared suspension in the bottle (medicine after adding water) should be stored in the refrigerator (at a temperature between 2°C and 8°C) at all times, for no longer than 10 days.

Do not freeze.

Do not use Zinnat if there are signs of spoilage.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month stated. The abbreviation “Lot” on the packaging means batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Zinnat contains

• The active substance of Zinnat is cefuroxime: 5 ml of the prepared suspension contains 125 mg of cefuroxime in the form of cefuroxime axetil.
• The other ingredients of Zinnat are: aspartame (E951), xanthan gum, acesulfame potassium (E950), povidone K30, stearic acid, sucrose, Tutti Frutti fruit flavor (containing, among others, propylene glycol (E1520) and benzyl alcohol (E1519)). For other important information about some ingredients of Zinnat, see section 2.

What Zinnat looks like and what the packaging contains

Zinnat is a granule for oral suspension supplied in orange glass bottles in a cardboard box. Each packaging includes a measuring cup for water and a plastic measuring spoon or dosing syringe for measuring and administering the medicine. To prepare the suspension, water and the original granules supplied in the bottle should be used. After adding water, the bottle contains 40 ml, 50 ml, 60 ml, 70 ml, 80 ml, or 100 ml of suspension.
The packaging contains an excess of medicine, allowing for the removal of the required amount of doses.

*
The final suspension volume, including the excess.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer:

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana, 1526
Slovenia
To obtain more detailed information about this medicine, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00

This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Bulgaria, Czech Republic, Estonia, France, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, United Kingdom (Northern Ireland) - Zinnat
Germany - Cefuroxim 125 mg/5 ml - 1 A Pharma Granulat zur Herstellung einer Suspension zum Einnehmen
Italy - Oraxim
Portugal - Zipos
Portugal - Zoref
Date of last revision of the leaflet:09/2023
(logo of the marketing authorization holder)
---------------------------------------------------------------------------------------------------------------------------

Instructions for preparing the suspension Remember that preparing the Zinnat suspension before administering the first dose will take over an hour. This includes the time for the suspension to settle in the refrigerator.

When preparing and storing the Zinnat suspension for a child, it is essential to follow the instructions below carefully.
Shake the bottlewith the medicine to loosen the contents.
All the granules in the bottle should be loose.
Remove the cap and protective foil. If the foil is damaged or missing, the product should be returned to the pharmacist.

Fill the measuring cup provided with the packaging to the mark with

cold water. Previously boiled water must be cooled to room temperature before adding it to the granules. Do not mix Zinnat granules for oral suspension with hot or warm liquids. Use cold water to prevent the suspension from becoming too thick.

Pour the entire measured volume of cold water from the measuring cup

into the bottle with the granules. Close the bottle.
Leave the bottle upright, allowing all the granules to absorb the water; this should take about 1 minute.

Turn the bottle upside down and shake it vigorously(for at least 15 seconds) until all the granules are mixed with the water.

Turn the bottle upright, cap up, and shake it vigorously againfor at least 1 minute, until all the granules are mixed with the water.
Place the prepared suspension in the refrigerator at a temperature between 2°C and 8°C (do not freeze) and leave it there for at least 1 hour before administering the first dose.

The prepared suspension should be stored in the refrigerator at all times; the prepared suspension can be stored for up to 10 days if it is in the refrigerator at a temperature between 2°C and 8°C.
Always shake the bottle well before taking the medicine.
Zinnat packaging may be provided with a dosing syringe for administering the medicine to children who cannot use a measuring spoon. The dosing syringe is intended for accurate measurement and oral administration of the medicine.

• 1. Remove the cap.Leave it in a safe place.
• 2. Holding the bottle firmly, press the connector into the neck of the bottle.
• 3. Place the tip of the syringe firmlyin the recess of the connector.
• 4. Turn the bottle upside down.
• 5. Pull the syringe plunger downto draw up the first full dose of medicine prescribed by the doctor.
• 6. Turn the bottle upright (neck up) and remove the syringefrom the connector.
• 7.

The syringe should be carefully placed in the child's mouth, with the tip at the

inner side of the cheek. Then, slowly press the plunger, carefully administering the suspension, giving the child time to swallow it. Do notpress the syringe plunger too hard or administer the suspension to the back of the throat, as this may cause choking.

• 8. Repeat the steps described in points 3 to 7 until the full dose of medicine prescribed by the doctor has been administered to the child.
• 9. After use, remove the syringe from the bottle and rinse it thoroughlywith clean water. Leave it to dry completely before the next use.
• 10. Close the bottle tightly with the cap. Leave the connector in the neck of the bottle; do not remove it.