ZINNAT 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zinnat 500 mg Film-Coated Tablets

cefuroxime

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Zinnat and what is it used for
2. What you need to know before you take Zinnat
3. How to take Zinnat
4. Possible side effects
   1. Storage of Zinnat

1. Contents of the pack and further information

1. What is Zinnat and what is it 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 infections of:

• throat
• nasal sinuses
• middle ear
• lungs or chest
• urinary tract
• skin and soft tissues.

Zinnat can also be used to:

• treat Lyme disease (an infection transmitted by ticks).

Your doctor may analyze the type of bacteria that cause your infection and check if the bacteria are sensitive to Zinnat during treatment.

2. What you need to know before you take Zinnat

Do not take Zinnat:

• if you are allergicto cefuroxime axetil or to any other cephalosporin antibioticor to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenem derivatives)
• if you have ever developed a severe skin rash or skin peeling and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

If you think this applies to you, do not take Zinnatuntil you have consulted your doctor.

Be cautious with Zinnat:

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxime treatment. Seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zinnat.

Children

Zinnat is not recommended for children under 3 months, as safety and efficacy for this age group are unknown.

You should be aware of certain symptoms such as allergic reactions, fungal infections (like Candida), and severe diarrhea (pseudomembranous colitis) while taking Zinnat. This will reduce the risk of possible complications. See “Symptoms to be aware of” in section 4.

If you need a blood test

Zinnat may affect the results of blood sugar tests or the Coombs test. If you need a blood test:

• Tell the person doing the testthat you are taking Zinnat.

Other medicines and Zinnat

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicines used to reduce stomach acidity(e.g., antacidsfor treating heartburn) may affect the action of Zinnat.

Probenecid

Oral anticoagulants

Tell your doctor or pharmacistif you are taking any of these medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Zinnat may cause dizzinessand other side effects that can make you lose your ability to be alert.

Do not drive or use machinesif you do not feel well.

Zinnat 500 mg film-coated tablets contain sodium benzoate (E 211).

This medicine contains 0.00506 mg of sodium benzoate (E 211) per tablet.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

Check with your doctor that Zinnat is suitable for you.

3. How to take Zinnat

Follow exactly the administration instructionsof this medicinegiven by your doctoror pharmacist. If in doubt, consult your doctor or pharmacist again.

Take Zinnat after meals.This will help the treatment be more effective.

Swallow the Zinnat tablets whole with water.

Do not chew, crush, or split the tablets— this can make the treatment less effective.

The recommended dose is

Adultsand children weighing 40 kg and over

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

Childrenweighing less than 40 kg

The recommended dose of Zinnat is 10 mg/kg of the child's weight (up to a maximum of 250 mg) to 15 mg/kg of the child's weight (up to a maximum of 250 mg) twice a day, depending on:

• the severity and type of infection.

Zinnat is not recommended for children under 3 months, as safety and efficacy for this age group are unknown.

Depending on the disease and how you or your child respond to treatment, the initial dose may be adjusted or it may be necessary to administer more than one treatment cycle.

Patients with kidney problems

If you have kidney problems, your doctor may change your dose.

Consult your doctorif you are affected by this problem.

If you take more Zinnat than you should

If you take too much Zinnat, you may experience neurological disorders, in particular, you may have a higher probability of having seizures (convulsions).

Do not delay.Contact your doctor immediatelyor go to the emergency department of the nearest hospital. If possible, show them the Zinnat packaging.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Zinnat

Do not take a double dose to make up for forgotten doses.Simply continue with the next dose as usual.

If you stop taking Zinnat

Do not stop taking Zinnat without prior advice.

It is important that you complete the entire Zinnat treatment.Do not stop it unless your doctor tells you to, even if you have started to feel better. If you do not complete the treatment cycle, the infection may recur.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Symptoms to be aware of

A small number of people who took Zinnat experienced a severe allergic reaction or a potentially severe skin reaction. The symptoms of these reactions include:

• severe allergic reaction.The signs include skin rash with itching, swelling,sometimes of the face or mouth, causing difficulty breathing
• widespread rash, high body temperatureand enlarged lymph nodes(DRESS or drug hypersensitivity syndrome)
• chest painin the context of allergic reactions, which can be a symptom of allergy-induced heart attack(Kounis syndrome)
• skin rash,which can cause blisters,resembling small targets(dark spot in the center surrounded by a lighter area, with a dark ring around the edge)
• widespread skin rashwith blisters and skin peeling.(These can be symptoms of Stevens-Johnson syndromeor toxic epidermal necrolysis)

Other symptoms to be aware of while taking Zinnat:

• fungal infections.Medicines like Zinnat can cause an increase in fungal growth (Candida) in the body, which can lead to fungal infections (such as thrush). This side effect is more likely to occur if you have taken Zinnat for a long time
• severe diarrhea (pseudomembranous colitis).Medicines like Zinnat can cause inflammation of the colon (large intestine), which produces severe diarrhea, usually accompanied by blood and mucus, stomach pain, and fever
• Jarisch-Herxheimer reaction. Some patients may experience an increase in body temperature (fever), chills, headache, muscle pain, and skin rash while taking Zinnat to treat Lyme disease. This is known as a Jarisch-Herxheimer reaction. The symptoms usually last from a few hours to a day.

• Contact a doctor or nurse immediately if you experience any of these symptoms.

Common side effects

May affect up to 1 in 10 people:

• fungal infection (such as Candida)
• headache
• dizziness
• diarrhea
• nausea
• stomach pain.

Common side effects that may appear in blood tests:

• increase in the count of a type of white blood cell (eosinophilia)
• increase in liver enzyme levels.

Uncommon side effects

May affect up to 1 in 100 people:

• vomiting
• skin rashes.

Uncommon side effects that may appear in blood tests:

• decrease in the number of platelets in the blood (cells that help blood clot)
• decrease in the number of white blood cells
• positive Coombs test.

Other side effects

Other side effects have occurred in a very small number of people, but their exact frequency is unknown:

• severe diarrhea (pseudomembranous colitis)
• allergic reactions
• skin rashes (which can be severe)
• high fever
• yellowing of the whites of the eyes or skin
• inflammation of the liver (hepatitis).

Side effects that may appear in blood tests:

• rapid destruction of red blood cells (hemolytic anemia).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zinnat

Keep this medicine out of the sight and reach of children.

Store in the original packaging. Do not store above 30°C.

Do not take Zinnat if the tablets are cracked or you notice other visible signs of deterioration.

Do not use this medicine after the expiry date which is stated on the packaging after the letters CAD/EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to the pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Zinnat

• The active substance in each tablet is 500 mg of cefuroxime (as cefuroxime axetil).
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose type A, sodium lauryl sulfate, hydrogenated vegetable oil, anhydrous colloidal silica, hypromellose, propylene glycol, and Opaspray white M-1-7120J [which contains sodium benzoate (E 211) and titanium dioxide (E 171)].

Appearance of the product and packaging

Zinnat 500 mg film-coated tablets are white, capsule-shaped, smooth on one side, and engraved with “GX-EG2” on the other. They are packaged in aluminum blisters, contained in a box. Each box contains 6, 10, 12, 14, 16, 20, 24, and 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

D24 YK11

Ireland

or

Lek farmacevtska družba d. d. (Lek Pharmaceuticals d. d.),

Verovškova ulica 57

Ljubljana, 1526

Slovenia

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

Date of last revision of this leaflet:September 2023.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es