DENVAR 400 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Denvar 400 mg Hard Capsules

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 package leaflet:

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 further 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 important that you follow the instructions regarding dosage, administration interval, and treatment duration as 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 via wastewater or trash.

Denvar is used to treat:

1.- Ear, nose, and throat infections: acute sinusitis.

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

3.- Urinary tract infections: uncomplicated acute pyelonephritis.

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 components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Denvar:

In case of allergy to other beta-lactam antibiotics (e.g., penicillin), a possible cross-allergic reaction with cefixime should be considered. Special caution 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 antibiotic-resistant bacteria.

Some cephalosporin antibiotics can 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 infants under 6 months.

Other medications and Denvar

Taking cefixime with some of the following medications may alter the effect of both cefixime and the other medication:

• diuretic medications (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 are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 assessing 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 assessing the benefit-risk ratio. Your doctor will decide whether to continue breastfeeding and treatment with cefixime.

Driving and using machines

Based on current experience, Denvar does not affect the ability to drive and use machines. However, some side effects may affect concentration and reaction, so this should be taken into account in situations where concentration and reaction are important, such as driving and using machines.

3. How to take Denvar

Follow the instructions for administration of 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 is 1 capsule of 400 mg/24 hours, for 10 days.

Denvar is administered orally. The capsules should be swallowed without chewing and with a little liquid.

Patients 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 dosage of cefixime should not exceed 200 mg/day.

Patients with liver problems

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

Patients 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 effect of Denvar is too strong or too weak, tell your doctor or pharmacist.

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 this 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 continue treatment as usual.

If you stop taking Denvar

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

Common (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, mucosal inflammation, 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 prolonged administration, blood disorders (eosinophilia, increase in a type of blood cell).

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

Colitis, toxic skin disorders (Stevens-Johnson syndrome, erythema multiforme), blood disorders (leukopenia, agranulocytosis, pancytopenia, thrombocytopenia, coagulation disorders, anemia, and other changes in blood count), transient hyperactivity, anaphylactic shock, serum sickness-like reactions (e.g., joint pain and inflammation, muscle pain, urticaria, etc.), hepatitis, yellowing of the skin, kidney disorders.

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

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

An increased predisposition to seizures cannot be ruled out.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide 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 expiry date which is stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Store below 30°C. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Denvar

• The active substance is cefixime. Each hard capsule contains 400 mg of cefixime (as trihydrate).
• The other ingredients are calcium carboxymethylcellulose, magnesium stearate, anhydrous colloidal silica, and polyoxyl 40 stearate. Capsule components: gelatin, quinoline yellow (E 104), titanium dioxide (E 171), erythrosine (E 127), and gray printing ink (containing Shellac, titanium dioxide (E 171), black iron oxide (E 172), propylene glycol, ammonium hydroxide, and simethicone).

Appearance of the product and pack contents

Denvar is presented in the form of hard orange capsules. Each pack contains 10 hard capsules.

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 last revision of this leaflet:06/2022

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