Label: information for the user

Zinnat 250mg/5 ml oral powder for suspension

cefuroxima

Read this label carefully before starting to take this medication,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 medication has been prescribedonlyto you, and you must not give it to others even iftheyhave the same symptomsas you,as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist or nurse,evenifthey are not listed in this label. See section 4.

1. Contents of the package and additional information

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:

• the throat
• the nasal 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 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 think this applies to you,do not take Zinnatuntil you have consulted 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 reported 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 (colitis pseudomembranosa) 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 the Coombs test. If you need a blood test:

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

Other medicines and Zinnat

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

Medicines 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 of these medicines.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machines

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

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

Zinnat 250 mg/5 ml oral suspension contains aspartame (E951), sucrose, and benzyl alcohol (E1519).

This medicine contains 2.3 g of sucrose in each 5 ml of reconstituted suspension, which should be taken into account in patients with diabetes mellitus. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Patients with hereditary fructose intolerance, glucose absorption problems, or saccharase-isomaltase deficiency should not take this medicine.

This medicine contains 0.045 g ofaspartame(E951) in each 5 ml of reconstituted suspension. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medicine contains 4.6 mg of benzyl alcohol (E1519) in each 5 ml of reconstituted suspension.

Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease, are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (metabolic acidosis).

This product should not be used for more than one week in children under 3 years of age unless instructed by your doctor or pharmacist.

?Check with your doctorthatZinnat 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.

Shake the bottle before using.

Once reconstituted, you can dilute Zinnat suspension in cold fruit juices or milk beverages, but you must take it immediately.

Do not mix Zinnat with hot liquids.

To prepare Zinnat suspension, follow the step-by-step instructions inInstructions for reconstitution,at the end of this leaflet.

The recommended dose is

Adultsand 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.

Childrenunder 40 kg

Children under 40 kg should preferably be treated with Zinnat granulated for oral suspension in a bottle orin sachets.

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:

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 disorders, particularly you may have a higher probability of havingseizures (epileptic attacks).

• 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 forget 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 treatment with Zinnat

Do not interrupt 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 the growth of fungi (Candida) in the body that can lead to fungal infections (such as thrush). 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, 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 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.

Common side effects

May affectup to 1 in 10people:

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

Common side effects that may appear in blood tests:

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

Uncommon side effects

May affectup to 1 in 100people:

• Vomiting
• Skin rash.

Uncommon 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 white 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.Once reconstituted, store the suspension in the refrigerator at all times, when not taking the medication.

Do not freeze. It can be stored in the refrigerator for a maximum of 10 days.

Do not take Zinnat if it shows any 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. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Zinnat

• The active ingredient is 250 mg of cefuroxime (as cefuroxime axetil) per 5 ml of reconstituted solution.
• The other components are: aspartame (E951), xanthan gum, potassium acesulfame (E950), povidone K30, stearic acid, sucrose, tutti-frutti flavoring (contains benzyl alcohol (E1519)) and purified water.

See section 2 for important information about some of the components of Zinnat.

Appearance of the product and contents of the pack

Zinnat250mg/5 ml oral suspension granules are supplied in amber glass multidose vials. The vial contains 50 ml, 60 ml, 70 ml or 100 ml of the suspension. This medicine must be prepared with water using the original granules supplied in the bottle. The vial is contained in a cardboard carton.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublín 24

D24 YK11

Ireland

or

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)with the following names:

Bélgica, Bulgaria, Chipre, Irlanda, Italia, Luxemburgo, Malta, Polonia, Eslovaquia, Eslovenia, España, Reino Unido (Irlanda del Norte) – Zinnat

Grecia – Zinadol

Italia – Oraxim

Portugal - Zipos

Portugal - Zoref

Last update of this leaflet:September 2023.

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

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Instructions for reconstitution

Instructions for preparing the suspension

Important: The time required to prepare the Zinnat suspension before the first dose will be more than one hour. This includes the time for the suspension to settle in the refrigerator.

Follow the instructions below carefully when preparing and storing the Zinnat suspension for your child.

The reconstituted suspension should be refrigerated at all times; when refrigerated between 2 and 8°C, the reconstituted suspension can be stored for up to 10 days.

Always shake the vial well before taking the medicine.

For children who cannot take Zinnat using a spoon, a 5 ml graduated dosing syringe may be included in the pack. If supplied, use this dosing syringe to measure the dose accurately:

1.Remove the vial cap.Keep it in a safe place.

2.Hold the vial firmly.Press the plastic adapter onto the vial neck.

3.Insert the syringefirmly into the adapter.

4.Turn the vial upside down.

5.Pull the plunger of the syringeuntil the syringe contains the first part of the child's complete dose.

6.Turn the vial to its original vertical position.Remove the syringefrom the adapter.

7.Place the syringe in the child's mouth,depositing the tip of the syringe into the inner cheek.Press the plunger slowly,allowing time to swallow.Do notpress forcefully to avoid directing a jet of liquid towards the back of the child's throat, which could cause choking.

8.Repeat steps 3 to 7in the same way until the child has taken the entire dose.

9.Remove the syringe from the vialandrinse itthoroughly with clean water. Allow the syringe to dry completely before reusing it.

10.Close the vial tightlywith the cap, leaving the adapter in place.