Zinnat

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Zinnat
250 mg/5 ml, granules for oral suspension
Cefuroximum
Please read all of this leaflet carefully before taking this medicine, because 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 effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

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
• 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 (Lyme 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, skin peeling, blisters, and/or oral ulcers after treatment with cefuroxime or other cephalosporin antibiotics. → If any of the above apply, the patient should not take Zinnat without consulting a doctor.

Warnings and precautions
Severe skin adverse reactions have been reported during treatment with cefuroxime, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and
systemic symptoms (DRESS). If any of the symptoms associated with severe skin reactions described in
section 4 occur, seek immediate medical advice.
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 tests for glucose and the 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 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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, 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 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 alertness.
→ The patient should not drive or operate machinery if they do not feel well.

Important information about some ingredients of Zinnat oral suspension
Zinnat oral suspension contains sugar (sucrose). This should be considered in patients with diabetes. If the doctor has diagnosed the patient with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Zinnat oral suspension also contains aspartame (E 951), which is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

Zinnat oral suspension also contains benzyl alcohol (E 1519), which may cause allergic reactions. Consult a doctor or pharmacist if the patient has liver or kidney disease, or if the patient is pregnant or breastfeeding (see also section above – Pregnancy, breastfeeding and fertility), as benzyl alcohol may accumulate in the body and cause adverse effects (so-called metabolic acidosis). It should not be used for longer than one week in young children (under 3 years of age) unless otherwise directed by a doctor or pharmacist.

5 ml of prepared suspension contains 0.045 g of aspartame (E 951).
5 ml of prepared suspension contains 2.3 g of sucrose.
5 ml of prepared suspension contains 4.6 mg of benzyl alcohol (E 1519).
→ Ask your doctor whether Zinnat is suitable for the patient.

3. How to use Zinnat

This medicine should always be used exactly as directed by a doctor or pharmacist. If you
have any doubts, please contact your doctor or pharmacist again.
Zinnat should be taken after a meal. This will help increase the effectiveness of treatment.
Shake the bottle well before use.
The measured dose of Zinnat suspension may be diluted with cold fruit juice or a milk drink; it should be taken immediately after preparation.
Zinnat must not be mixed with hot liquids.
Detailed instructions for preparing the Zinnat suspension are provided at the end of this leaflet (see Instructions for preparing the suspension).

Recommended dose
Adults and children with body weight of 40 kg or more
The recommended dose of Zinnat is 250 mg to 500 mg twice daily, depending on the severity and type of infection.

Children with body weight below 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
• the child's body weight and age, not exceeding 500 mg per day.

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.
→ 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).
→ Contact a doctor immediately or call 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 instructed by a doctor.
It is important not to shorten the prescribed duration of treatment. Do not discontinue 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, please consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 symptom of heart attack triggered by allergy (Kounis syndrome).
• Skin rash, which may develop into blisters and look like target lesions (a dark spot in the center surrounded by a lighter ring and a dark outer ring).
• 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 symptoms to be aware of while taking Zinnat

• Fungal infections. Medicines such as Zinnat may cause overgrowth of yeast (Candida) in the body, which may lead 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), leading to 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 the patient, 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 adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can 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
Adverse effects can also be reported to the marketing authorisation holder or parallel importer.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Zinnat

Keep this medicine out of sight and reach of children.
The granules (medicine before adding water) should not be stored at temperatures above 30°C.
Store in the original packaging.
WARNING! The reconstituted suspension in the bottle (medicine after adding water) must be
stored in the refrigerator at all times (at a temperature between 2°C and 8°C) and used within 10 days.
Do not freeze.
Do not use Zinnat if signs of spoilage are visible.
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. This will help protect the environment.

6. Contents of the pack and other information

What Zinnat contains

• The active substance is cefuroxime: 5 ml of prepared suspension contains 250 mg cefuroxime in the form of cefuroxime axetil.
• Other components of the medicine are: aspartame (E 951), xanthan gum, acesulfame potassium (E 950), povidone K 30, stearic acid, sucrose, Tutti Frutti flavour (containing, among others, benzyl alcohol (E 1519)). For further important information on some of the excipients of Zinnat, see section 2.

What Zinnat looks like and contents of the pack
Zinnat is a granulate for oral suspension, supplied in amber glass bottles (type III) with a heat-sealed membrane and a cap, packed in a cardboard box. Each pack includes a measuring scoop 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 50 ml of suspension.
The table below shows the volume of water to be added to prepare the suspension.
The pack contains an excess of medicine, allowing for the required number of doses to be withdrawn.

* Final volume of the suspension, including overfill.
For more detailed information, please contact the marketing
authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, country of export:
Bexal Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer:
Lek farmacevtska družba d. d.
(Lek Pharmaceuticals d. d.)
Verovškova ulica 57
Ljubljana, 1526
Slovenia
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Spain, country of export: 728788.9
Parallel import authorisation number: 47/26
This medicinal product is authorised for marketing in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium, Bulgaria, Cyprus, Ireland, Italy, Luxembourg, Malta, Poland, Slovakia, Slovenia, Spain,
United Kingdom (Northern Ireland) – Zinnat
Greece – Zinadol
Italy – Oraxim
Portugal – Zipos
Portugalia – Zoref
Instructions for preparing the suspension
Please note that preparation of Zinnat suspension before administration of the first dose will take
more than one hour, including the time required for the suspension to settle in the refrigerator.
When preparing and storing Zinnat for oral suspension for children, the instructions below must be followed
exactly.

Shake the bottle to loosen the contents. All granules in the bottle should be free-flowing.
Remove the cap and the protective foil seal. If the foil seal is damaged or missing, return the product
to the pharmacist.
Fill the measuring device provided in the package to the mark with cool water. Previously boiled water
must be cooled to room temperature before adding to the granules. Do not mix Zinnat granules for oral suspension
with hot or warm liquids. Use cool water to prevent excessive thickening of the suspension.

Pour the entire measured volume of cool water from the measuring device into the bottle with
the granules. Close the bottle tightly. Leave the bottle in an upright position to allow all granules
to absorb the water; this should take about 1 minute.
Turn the bottle upside down and shake vigorously (for at least 15 seconds) until all granules are mixed with water.
Turn the bottle back to an upright position , cap up, and shake vigorously again
for at least 1 minute until all granules are completely mixed with water. Immediately place the prepared suspension
in the refrigerator at 2°C to 8°C (do not freeze) and leave it there for at least 1 hour before administering the first dose.
The prepared suspension must be stored in the refrigerator at all times. The suspension may be stored in the refrigerator
at 2°C to 8°C for up to 10 days. Always shake the bottle well before administering the medicine.
The Zinnat packaging may include an oral dosing syringe intended for administering the medicine to children who cannot use
the measuring spoon. The dosing syringe is designed for accurate measurement and oral administration of the medicine.

1. Remove the cap. Keep it in a safe place.
2. Firmly holding the bottle, press the adapter into the neck of the bottle.
3. Firmly place the tip of the syringe into the depression of the adapter.
4. Turn the bottle upside down.
5. Pull the plunger of the syringe down until the first portion of the full prescribed dose is drawn.
6. Turn the bottle upright (neck up) and remove the syringe from the adapter.
7. Carefully insert the syringe into the child's mouth, placing the tip against the inside of the cheek. Then, slowly press the plunger to administer the suspension, allowing the child time to swallow. Do not press the plunger too forcefully or administer the suspension at the back of the throat to avoid choking.
8. Repeat steps 3 to 7 until the child has received the full prescribed dose.
9. After use, remove the syringe from the bottle and rinse it thoroughly with clean water. Allow it to dry completely before next use.
10. Close the bottle tightly with the cap. Leave the adapter in the bottle neck; do not remove it.