Zinnat 500 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zinnat 500 mg film-coated tablets

cefuroxime

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

   1. Storage of Zinnat

5. Contents of the pack and other information

1. What Zinnat is and what it is used for

Zinnat is an antibiotic used in both 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:

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

Zinnat may also be used to:

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

Your doctor may identify the type of bacteria causing your infection and monitor whether the bacteria are sensitive to Zinnat during treatment.

2. What you need to know before starting to take Zinnat

Do not take Zinnat:

• if you are allergic to cefuroxime axetil or to any cephalosporin antibiotic, or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had a severe allergic (hypersensitivity) reaction 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, blisters and/or mouth ulcers after treatment with cefuroxime or any other cephalosporin antibiotic.

? If you think any of the above apply to you, do not take Zinnat until you have consulted your doctor.

Take special care with Zinnat:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Zinnat.

Children

Zinnat is not recommended for children under 3 months of age, as safety and efficacy have not been established in this age group.

Be alert for certain symptoms such as allergic reactions, fungal infections (such as candida), and severe diarrhoea (pseudomembranous colitis) while taking Zinnat. This will help reduce the risk of possible complications. See “Symptoms you need to watch out for” in section 4.

If you need a blood test

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

• Inform the person performing the test that you are taking Zinnat.

Other medicines and Zinnat

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

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

Probenecid

Oral anticoagulants

? Inform your doctor or pharmacist if you are taking any medicine of this type.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Zinnat may cause dizziness and other adverse effects that could impair your ability to remain alert.

? Do not drive or operate machinery if 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; essentially “sodium-free”.

?Check with your doctor that Zinnat is suitable for you.

3. How to take Zinnat

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Swallow the Zinnat tablets whole with water.

Do not chew, crush, or divide the tablets — this may make the treatment less effective.

Recommended dose

Adults and children weighing 40 kg and above

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

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

• the severity and type of infection.

Zinnat is not recommended in children under 3 months of age, as the safety and efficacy in this patient group are unknown.

Depending on the illness and how you or your child responds to treatment, the initial dose may be adjusted or it may be necessary to administer more than one course of treatment.

Patients with kidney problems

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

? Consult your doctor if you are affected by this condition.

If you take more Zinnat than you should

If you take too much Zinnat, you may experience neurological disturbances, in particular you may have an increased risk of epileptic seizures (convulsions).

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 treatment with Zinnat without prior advice.

It is important that you complete the full course of Zinnat treatment. Do not stop unless instructed by your doctor, even if you start to feel better. If you do not complete the treatment course, the infection may recur.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Symptoms to watch for

A small number of people who took Zinnat experienced an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:

• Severe allergic reaction. Signs include skin rash with itching, swelling, sometimes of the face or mouth, causing difficulty breathing
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
• Chest pain in the context of allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome)
• Skin rash, which may cause blisters, appearing as small targets (a dark spot in the center surrounded by a lighter area, with a dark ring around the edge)
• Widespread skin rash with blisters and peeling of the skin. (These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis)

Other symptoms to watch for while taking Zinnat:

• Fungal infections. Medicines like Zinnat may cause increased growth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if Zinnat has been taken for a prolonged period

• Severe diarrhoea (pseudomembranous colitis). Medicines like Zinnat may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, 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 Jarisch-Herxheimer reaction. Symptoms usually last from a few hours to one day.

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

Common adverse effects

May affect up to 1 in 10 people:

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

Common adverse effects that may appear in blood tests:

• increase in the count of a type of white blood cells (eosinophilia)
• increased levels of liver enzymes

Uncommon adverse effects

May affect up to 1 in 100 people:

• vomiting
• skin rashes

Uncommon adverse effects that may appear in blood tests:

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

Other adverse effects

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

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

Adverse effects that may appear in blood tests:

• rapid destruction of red blood cells (haemolytic anaemia)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 if you notice any other visible signs of deterioration.

Do not use this medicine after the expiry date stated on the packaging after the letters CAD/EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zinnat

• The active substance in each tablet is 500 mg of cefuroxime (as cefuroxime axetil).
• The other components 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 [containing sodium benzoate (E 211) and titanium dioxide (E 171)].

Nature of the product and pack contents

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised 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 the most recent revision of this leaflet: September 2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es