Label: information for the user

Denvar 100 mg/5 ml oral powder for suspension

Cefixima

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 questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What Denvar is and for what it is used

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

3. How to take Denvar

4. Possible adverse effects

5. Storage of Denvar

6. Contents of the package and additional information

Denvar contains a substance called cefixime, which belongs to the group of antibiotics known as “cephalosporins” and is used to treat infections caused by bacteria.

Denvar is used to treat:

1.- Upper respiratory tract infections: pharyngitis and tonsillitis.

2.- Lower respiratory tract infections: acute bronchitis, exacerbations of chronic bronchitis, and pneumonia.

3.- Ear, nose, and throat infections: otitis media.

4.- Uncomplicated urinary tract infections.

Do not take Denvar

- If you are allergic to cefixime, other cephalosporins or cephamycins, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Denvar:

- if you have previously experienced any type of allergic reaction to cephalosporins, penicillins, or any other medication.

In case of allergy to other beta-lactam antibiotics (for example, penicillin), a possible cross-reaction with cefixime should be considered. Special care should be taken in patients who have experienced anaphylactic reactions to penicillins. The appearance of any allergic manifestation requires suspension of treatment.

- if you have asthma and predisposition to allergic manifestations.

- if you present severe skin reactions while taking this medication, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, or the syndrome known as DRESS (severe drug reaction with eosinophilia and systemic symptoms). If this occurs, stop taking this medication and contact your doctor immediately.

- if you present hemolytic anemia induced by treatment or have a history of hemolytic anemias associated with this type of medication.

- if your treatment with cefixime is prolonged, it may increase the predisposition to overinfections by fungi or resistant bacteria. If this occurs, your doctor will assess whether treatment interruption is necessary.

- if important diarrhea appears, or blood, mucus, or pus is observed in the stools. If this occurs, inform your doctor.

- if you have severe gastrointestinal problems with nausea and vomiting.

- if you are taking diuretics and/or medications that can be harmful to the kidneys at the same time.Your doctor may perform a test to measure kidney function during treatment.

- if you have severe renal insufficiency. Your doctor will adjust the dose and closely monitor you.

• if acute renal failure occurs. If this occurs, stop taking this medication and contact your doctor immediately.

The treatment with cefixime may increase the risk of developing resistant bacteria.

Some cephalosporin antibiotics may cause convulsions, especially in patients with renal insufficiency when the dose has not been reduced. If convulsions occur, stop taking this medication and contact your doctor immediately.

Children

Denvar is not recommended for premature, newborn, and lactating infants until 6 months.

Other medications and Denvar

The concomitant administration of cefixime with any of the following medications may modify the effect of both cefixime and the medication in question:

• diuretics (such as etacrynic acid or furosemide) or medications that can be harmful to the kidneys (certain antibiotics, colistin, polymyxin, chloramphenicol)

- medications that act on blood vessels (such as nifedipine)

- medications for controlling blood coagulation (coumarins)

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

Interference with laboratory tests:

Denvar may give false positive reactions in tests for ketones and glucose in urine, and false positive reaction in the direct Coombs test (diagnostic test for some types of anemia).

Use of Denvar with food and beverages

Denvar can be taken with food.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to the lack of sufficient information on the possible negative effects of Denvar during pregnancy, Denvar should only be taken during pregnancy if your doctor prescribes it after evaluating the benefit-risk ratio.

Cefixime has not been detected in breast milk.

Treatment with Denvar during lactation is not recommended, unless your doctor prescribes it, after evaluating the benefit-risk ratio.Your doctor will decide whether to continue or discontinue breastfeeding and cefixime treatment.

Driving and operating machinery

With current experience, Denvar does not have effects on the ability to drive and operate machinery. However, some adverse effects may affect concentration and reaction, so it should be taken into account in situations where concentration and reaction are important, such as driving and operating machinery.

Denvar contains saccharose and sodium benzoate

This medication contains saccharose. If your doctor has indicated that you have intolerance to certain sugars, consult with him before taking this medication.

Patients with diabetes mellitus should be aware that this medication contains approximately 2.5 g of saccharose per 5 ml of reconstituted suspension.

This medication contains 2.5 mg of sodium benzoate per 5 ml of reconstituted suspension.

This medication contains less than 1 mmol of sodium (23 mg) per 5 ml of reconstituted suspension; it is essentially "sodium-free".

Denvar contains glucose and wheat starch

This medication contains glucose (from wheat-derived maltodextrin). If your doctor has indicated that you have intolerance to certain sugars, consult with him before taking this medication.

This medication contains very low levels of gluten (from wheat starch)and it is very unlikely to cause problems if you have celiac disease. 5 ml of suspension does not contain more than 20 ppm of gluten.

If you have wheat allergy (other than celiac disease), do not take this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Unless your doctor has given you different instructions, follow the following instructions:

The recommended daily dose for adults and children over 12 years old is 200 mg every 12 hours (10 ml of reconstituted suspension) or 400 mg once a day (20 ml of reconstituted suspension).

For children under 12 years old, the recommended daily dose is 8 mg/kg/day, which can be administered in a single dose or in doses of 4 mg/kg every 12 hours. The following table may serve as a guide:

The maximum recommended dose should not exceed 12 mg/kg/day.

For women with uncomplicated acute cystitis, a dose of 400 mg per day in a single dose for 3 days is recommended.

Patients with renal problems

In the case of renal insufficiency with a creatinine clearance ≥20 ml/minute, no dose adjustment is necessary; if the clearance is lower, the dose should be reduced to half. In hemodialyzed patients, the cefixime dosage should not exceed 200 mg/day.

Patients with hepatic problems

In patients with liver insufficiency, the fact that cefixime is not metabolized in the liver allows for the administration of the medication without the need to modify the dose.

Patients of advanced age

No dose adjustment is necessary for patients of advanced age, if kidney function is normal.

If you estimate that the action of Denvar is too strong or too weak, inform your doctor or pharmacist.

INSTRUCTIONS FOR THE CORRECT ADMINISTRATION OF THE MEDICATION

The package contains:

A.A bottle with granules to prepare the oral suspension, with a safety cap.

B.A syringe.

Preparation of the suspension

Administration of the dose

Shake before use

If you take more Denvar than you should

Consult your doctor or pharmacist immediately.

Given the low toxicity of cefixime, it is not predictable that accidental massive ingestion will lead to a poisoning syndrome. If it occurs, gastric lavage and symptomatic treatment are recommended. In case of important allergic manifestations, symptomatic treatment is required: adrenaline, corticosteroids, antihistamines.

In case of overdose or accidental ingestion, call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Denvar

Do not take a double dose to compensate for the missed doses, wait for the next dose and follow the normal treatment.

If you interrupt the treatment with Denvar

Your doctor will indicate the duration of your treatment with Denvar. Do not stop treatment before, as you will feel the symptoms you had before treatment again.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

If they occur, the following may be detected:

Frequent (may affect up to 1 in 10 people):

Diarrhea, soft stools.

Less frequent (may affect up to 1 in 100 people):

Nausea, vomiting, indigestion, abdominal pain, urticaria, skin redness, rash, exanthema, headache, reversible increases in liver enzymes in blood.

Rare (may affect up to 1 in 1,000 people):

Loss of appetite, flatulence, itching, mucous membrane inflammation, dizziness, fever, hypersensitivity reactions such as flushing, palpitations, difficulty breathing, decreased blood pressure, facial edema, transient increase in blood urea concentration, resistance to pathogens, predisposition to overinfections by fungi and antibiotic-resistant bacteria in case of continuous administration,blood abnormalities (eosinophilia, increase in a type of blood cell).

Very rare (may affect up to 1 in 10,000 people):

Colitis, toxic skin alterations (Stevens-Johnson syndrome, exanthematous multiforme), blood abnormalities (leucopenia, agranulocytosis, pancitopenia, thrombocytopenia, coagulation disorders, anemia, and other blood count changes),transient hyperactivity, anaphylactic shock, reactions similar to serum disease (e.g., joint pain and inflammation, muscle pain, urticaria, etc.), hepatitis, yellow skin discoloration, renal alterations.

Unknown frequency(cannot be estimated from available data):

DRESS syndrome (drug reaction with abnormally high eosinophilic white blood cell counts and systemic symptoms), granulocytopenia (reduction of granulocyte type white blood cells), increased bilirubin in blood (which may cause yellow skin discoloration), acute renal failure including tubulointerstitial nephritis (a type of kidney inflammation).

Cannot rule out an increased predisposition to seizures.

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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse 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.

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

Before reconstitution, store below 25°C.

Once reconstituted, store in the refrigerator (between 2°C and 8°C). The shelf life of the reconstituted suspension is 14 days. Discard any remaining product after that time. Note the day and month of the reconstituted suspension in the box provided for this purpose.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Denvar

- The active principle is cefixima.Cada 5 ml of the reconstituted suspension contains 100 mg of

cefixima (as trihydrate).

- The other components (excipients) are sacarosa, xanthan gum, strawberry flavor (contains maltodextrin from wheat), (see section 2), sodium benzoate (E 211).

Appearance of the product and contents of the packaging

Denvar is presented in packaging with a granulate to prepare an oral suspension.

There are 2 packaging: packaging with 1 g of cefixima to prepare 50 ml of oral suspension and packaging with 2 g of cefixima to prepare 100 ml of oral suspension.

The packaging also contains a graduated syringe for the administration of the reconstituted medication.

Holder of the marketing authorization

Merck, S.L.

María de Molina, 40

28006 Madrid

Spain

Responsible for manufacturing

Merck, S.L.

Polígono Merck

08100 Mollet del Vallés (Barcelona)

Spain

Last review date of this leaflet:06/2022

The detailed and updated information of this medication is available on the webpage of the

Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es