Label: information for the user

Zinnat 250 mg film-coated tablets

cefuroxime

Read this label carefully before starting to take this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacistor nurse.
• This medicine has been prescribedonlyfor you, and you must not give it to others even iftheyhave the same symptomsas you,as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist or nurse,evenifthey are not listed in this label. See section 4.

Zinnat is an antibiotic used in both adults and children. It works by eliminating the bacteria that cause infections. It belongs to a group of medications calledcephalosporins.

Zinnat is used to treat infections of:

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

Zinnat may also be used to:

• treat Lyme disease (infection transmitted by ticks).

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

Do not take Zinnat:

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

• if you consider this applies to you,do not take Zinnatuntil you have consulted with your doctor.

Be especially careful with Zinnat:

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been associated with cefuroxime treatment. Seek medical attention immediately if you notice any of the 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 the safety and efficacy for this age group are unknown.

You should be aware of certain symptoms such as allergic reactions, fungal infections (such ascandida) 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 levels in blood tests, or theCoombs test. If you need a blood test:

• Inform the person performing the testthat you are taking Zinnat.

Other medications and Zinnat

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Medications used toreduce stomach acid(e.g.,antacidsto treatheartburn) may affect the mechanism of action of Zinnat.

Probenecid

Oral anticoagulants

• Inform your doctor or pharmacistif you are taking any medication of this type.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consultyour doctor or pharmacist before using this medication.

Driving and operating machinery

Zinnatmay cause dizzinessand other adverse effects that may impair your ability to be alert.

• Do not drive or operate machineryif you are not feeling well.

Zinnat 250 mg film-coated tablets contain sodium benzoate (E 211).

This medication contains 0.00203 mg ofsodium benzoate (E 211) per tablet.

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

?Check with your doctor thatZinnat is suitable for you.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of 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.

The recommended dose is

Adults and children with a 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 weight of 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,since the safety and efficacy for this group of patients is unknown.

Depending on the disease 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 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 disturbances, particularly you may have a higher probability of having a seizure (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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Zinnat

Do not take a double dose to compensate for the missed doses.Simply continue with the next dose as usual.

If you interrupt the treatment with Zinnat

Do not interrupt the treatment with Zinnat without prior advice.

It is essential that you complete the entire Zinnat treatment.Do not interrupt 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 other doubts about the use of this medication, ask your doctor or pharmacist.

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

Symptoms to be aware of

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

• Severe allergic reaction.The signs includeskin rash with itching, swelling,sometimes on the face or mouth, causingdifficulty breathing
• Generalized rash, high body temperatureandenlarged lymph nodes(DRESS syndrome or drug hypersensitivity syndrome)
• Chest painin the context of allergic reactions, which can be a symptom ofallergic-induced heart attack(Kounis syndrome)
• Skin rash,which can causeblistering,which appear likesmall dots(dark spot in the center surrounded by a lighter area, with a dark ring around the edge)
• Widespread skin rashwithblistering and skin peeling.(These can be symptoms ofStevens-Johnson syndromeortoxic 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 that can lead to fungal infections (such as mouth ulcers). This side effect is more likely to occur if Zinnat has been taken for a prolonged period
• 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, abdominal 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 asJarisch-Herxheimer reaction. The symptoms usually last for a few hours to a day.

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

Frequent side effects

May affectup to 1 in 10people:

• Fungal infection (such asCandida)
• Headache
• Dizziness
• Diarrhea
• Nausea
• Abdominal pain.

Frequent side effects that may appear in blood tests:

• Increased count of a type of white blood cell (eosinophilia)
• Increased levels of liver enzymes.

Rare side effects

May affectup to 1 in 100people:

• Vomiting
• Skin rash.

Rare side effects that may appear in blood tests:

• Decreased number of platelets in the blood (cells that help blood to clot)
• Decreased 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 rash (which can be severe)
• High fever
• Yellowing of the whites of the eyes or skin
• Liver inflammation (hepatitis).

Side effects that may appear in blood tests:

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

Do not use this medication after the expiration date that appears on the packaging after the letters CAD/EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zinnat

• The active ingredient in each tablet is 250 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 [which contains sodium benzoate (E 211) and titanium dioxide (E 171)].

Appearance of the product and contents of the packaging

Zinnat 250 mg are white-coated tablets with a capsule shape, smooth on one side and engraved with “GX ES7” 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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) with the following names:

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland) – Zinnat

Germany – Elobact

Greece – Zinadol

Italy – Oraxim

Portugal – Zipos

Portugal – Zoref

Date of the last review of this leaflet: September 2023.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es