ZINNAT 250 mg/5 ml ORAL SUSPENSION GRANULES

2. What you need to know before you take Zinnat

Do not take Zinnat:

• to cefuroxime axetil or toany cephalosporin antibioticor to any of the other components 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 peeling of the skin, blisters, 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 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 safety and efficacy for this age group are unknown.

You should be aware of certain symptoms such as allergic reactions, fungal infections (such as 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:

• Inform the person performing 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., antacidsto treat 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Zinnat may cause dizzinessand other side effects that may impair your ability to be alert.

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

Zinnat 250 mg/5 ml granules for 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 an intolerance to certain sugars, consult with them before taking this medicine.

Patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

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

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, if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (metabolic acidosis).

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

Check with your doctorthat Zinnat is suitable for you.

3. How to take Zinnat

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

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

Shake the bottle before use.

Once reconstituted, Zinnat suspension can be diluted in cold fruit juices or dairy drinks, but it must be taken immediately.

Do not mix Zinnat with hot liquids.

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

The recommended doseis

Adultsand children with weight 40 kg and above

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

Childrenwith weight below 40 kg

Children with weight below 40 kg should preferably be treated with Zinnat granules for oral suspension in a bottle or 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:

• the severity and type of infection
• the child's weight and age, up to a maximum of 500 mg per day.

Zinnat is not recommended in children under 3 months,as safety and efficacy for this patient 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 epileptic seizures(convulsions).

• Do not delay. Contact your doctor immediately or 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 treatment of Zinnat. 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 about 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 presented with 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 the growth of fungi (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 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 as 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 10people:

• 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 100people:

• 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, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them 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. Once reconstituted, store the suspension in the refrigerator at all times when not taking the medicine.

Do not freeze. It can be stored in the refrigerator for up to 10 days.

Do not take Zinnat if it shows any signs of deterioration.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Zinnat Composition

• 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, acesulfame potassium (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.

Product Appearance and Container Contents

Zinnat 250 mg/5 ml granules for oral suspension are supplied in amber glass multidose bottles. The bottle contains 50 ml, 60 ml, 70 ml, or 100 ml of the suspension. This medication should be prepared with water using the original granules supplied in the bottle. The bottle is inside a cardboard box.

Only some pack sizes may be marketed.

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 Pharmaceuticals d. d.

Verovškova ulica 57

Ljubljana, 1526

Slovenia

This medicinal product is authorized in the Member States of the European Economic Areaand 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

Portugal - Zoref

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

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

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Reconstitution Instructions

Instructions for preparing the suspension

Please note that the time required to prepare the Zinnat suspension before administering 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°C and 8°C, the reconstituted suspension can be stored for up to 10 days.

Always shake the bottle well before taking the medication.

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

1. Remove the bottle cap. Keep it in a safe place.
2. Hold the bottle firmly. Press the plastic adapter onto the neck of the bottle.
3. Insert the syringe firmly into the adapter.
4. Turn the bottle upside down.
5. Pull the syringe plunger until the syringe contains the first part of the child's complete dose.
6. Turn the bottle back to its original upright position. Remove the syringe from the adapter.
7. Place the syringe in the child's mouth, putting the tip of the syringe inside the cheek. Press the plunger slowly, allowing time to swallow. Do not press abruptly to avoid directing a stream of liquid towards the back of the child's throat, as they may choke.
8. Repeat steps 3 to 7 in the same way until the child has taken the entire dose.
9. Remove the syringe from the bottle and rinse it well with clean water. Let the syringe dry completely before reusing it.
10. Close the bottle tightly with the cap, leaving the adapter in place.