DENVAR 100 MG/5 ML ORAL SUSPENSION GRANULES

Introduction

Package Leaflet: Information for the User

Denvar 100 mg/5 ml Granules for Oral Suspension

cefixime

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
  If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Denvar and what is it used for
2. What you need to know before you take Denvar
3. How to take Denvar
4. Possible side effects
5. Storage of Denvar
6. Contents of the pack and other information

1. What is Denvar and what is it used for

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.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential that you follow the dosage, administration interval, and treatment duration instructions indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

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 (ENT) infections: otitis media.

4. Uncomplicated urinary tract infections.

2. What you need to know before you take Denvar

Do not take Denvar

• If you are allergic to cefixime, other cephalosporins, or cefamicins, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Denvar:

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

Treatment with cefixime may increase the risk of developing bacteria resistant to medications.

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

Children

It is not recommended to administer to premature infants, newborns, and breastfed babies until 6 months of age.

Other medications and Denvar

Taking cefixime with any of the following medications may modify the effect of both cefixime and the other medication:

• 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 to control blood coagulation (coumarins)

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

Interference with laboratory tests:

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

Using Denvar with food and drinks

Denvar can be taken with food.

Pregnancy and breastfeeding

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

Since there is not enough information about the possible negative effects of Denvar during pregnancy, it is only recommended to take Denvar 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 breastfeeding is not recommended unless your doctor prescribes it after evaluating the benefit-risk ratio. Your doctor will decide whether to continue breastfeeding and treatment with cefixime.

Driving and using machines

With current experience, Denvar does not affect the ability to drive or use machines. However, some side 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 using machines.

Denvar contains sucrose and sodium benzoate

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains approximately 2.5 g of sucrose per 5 ml of reconstituted suspension.

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

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

Denvar contains glucose and wheat starch

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

This medication contains very low levels of gluten (from wheat starch) and is 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 a wheat allergy (different from celiac disease), you should not take this medication.

3. How to take Denvar

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Unless your doctor has given you different instructions, follow these 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).

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

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

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

Patient with renal problems

In case of renal insufficiency with a creatinine clearance ≥ 20 ml/minute, it is not necessary to modify the dose; if the clearance is lower, the dose should be reduced by half. In patients undergoing hemodialysis, the cefixime dosage should not exceed 200 mg/day.

Patient with hepatic problems

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

Patient of advanced age

It is not necessary to change the dose for patients of advanced age if kidney function is normal.

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

INSTRUCTIONS FOR THE CORRECT ADMINISTRATION OF THE MEDICATION

The pack contains:

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

• 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 unlikely that accidental massive ingestion will lead to a poisoning syndrome. If it occurs, gastric lavage and symptomatic treatment are recommended. In case of significant allergic manifestations, treatment should be symptomatic: adrenaline, corticosteroids, antihistamines.

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

If you forget to take Denvar

Do not take a double dose to make up for forgotten doses, wait for the next dose and follow the normal treatment.

If you stop treatment with Denvar

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following may be detected if they occur:

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

Diarrhea, soft stools.

Uncommon (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):

Lack of appetite, flatulence, itching, inflammation of the mucous membranes, dizziness, fever, hypersensitivity reactions such as flushing, palpitations, difficulty breathing, decreased blood pressure, facial edema, transient increase in urea concentration in blood, resistance to pathogens, predisposition to superinfections by fungi and resistant bacteria in case of continued administration, blood alterations (eosinophilia, increase in a type of blood cell).

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

Inflammation of the large intestine, toxic skin alterations (Stevens-Johnson syndrome, multiform exudative erythema), blood alterations (leukopenia, agranulocytosis, pancytopenia, thrombocytopenia, alterations in coagulation, anemia, and other changes in blood count), transient hyperactivity, anaphylactic shock, reactions similar to serum sickness (e.g., joint pain and inflammation, muscle pain, urticaria, etc.), hepatitis, yellowing of the skin, renal alterations.

Frequency not known (cannot be estimated from available data):

DRESS syndrome (drug reaction with high levels of eosinophils and systemic symptoms), granulocytopenia (reduction of a type of white blood cell granulocyte), increase in bilirubin in blood (which can cause yellowing of the skin), acute renal failure including tubulointerstitial nephritis (a type of kidney inflammation).

An increased predisposition to seizures cannot be excluded.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Denvar

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

Do not use this medication after the expiration date stated 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 validity period of the reconstituted suspension is 14 days. Discard any leftover product after this time. Write the day and month of the reconstituted suspension in the box provided for this purpose.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Denvar

• The active ingredient is cefixime. Each 5 ml of the reconstituted suspension contains 100 mg of cefixime (as trihydrate).

The other ingredients (excipients) are sucrose, xanthan gum, strawberry flavor (contains maltodextrin derived from wheat), (see section 2), sodium benzoate (E 211).

Appearance of the product and contents of the pack

Denvar is presented in packs with granules to prepare an oral suspension.

There are 2 packs: a pack with 1 g of cefixime to prepare 50 ml of oral suspension and a pack with 2 g of cefixime to prepare 100 ml of oral suspension.

The packs also contain a graduated syringe for the administration of the reconstituted medication.

Marketing Authorization Holder

Merck, S.L.

María de Molina, 40

28006 Madrid

Spain

Manufacturer

Merck, S.L.

Merck Industrial Park

08100 Mollet del Vallés (Barcelona)

Spain

Date of the last revision of this leaflet:06/2022

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