ZINNAT 500 mg ORAL SUSPENSION GRANULES

2. What you need to know before you take Zinnat

Do not take Zinnat:

• if you are allergicto cefuroxime (as axetil) or toany 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, 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:

• Tell 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 mechanism of 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 cause other side effects that may impair your ability to be alert.

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

Zinnat 500 mg granules for oral suspension contain aspartame (E951), sucrose, propylene glycol (E1520), and benzyl alcohol (E1519).

This medicine contains 12.2 g of sucrose in each sachet, which should be taken into account in patients with diabetes mellitus. If your doctor has told you that you have an intolerance to some 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 0.084 g of aspartame(E951) in each sachet. Aspartame is a source of phenylalanine, which may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains 18 mg of benzyl alcohol (E1519) in each sachet.

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.

This medicine contains 24 mg of propylene glycol (E1520) in each sachet.

Check with your doctorthat Zinnat is suitable for you.

3. How to take Zinnat

Follow exactly the administration instructions of this medicine as 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.

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

The recommended doseis

Adultsand children with a weight of 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.

Children under 40 kg

Children under 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 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 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 other 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 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 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, talk to your doctor or pharmacist, even if they are 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.

The reconstituted suspension should be taken immediately.

Do not take Zinnat if it shows any 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 indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to 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. Contents of the pack and other information

Composition of Zinnat

• The active substance is 500 mg of cefuroxime (as cefuroxime axetil) per sachet.
• The other ingredients are: aspartame (E951), xanthan gum, acesulfame potassium (E950), povidone K30, stearic acid, sucrose, tutti-frutti flavoring, (contains propylene glycol (E1520) and benzyl alcohol (E1519)) and purified water.

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

Appearance of the product and packaging contents

Zinnat 500 mg granules for oral suspension are supplied in sachets. The sachets are inside a cardboard box.

Not all 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

Date of last revision of this leaflet:September 2023.

Detailed information on this medicine 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 from the sachets

1. Empty the granule contents of the sachet into a glass.
2. Add a small amount of cold water.
3. Shake well and drink immediately.

• Do not mix the suspension or granules with hot beverages.