Denvar 400 mg capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Denvar 400 mg hard capsules

cefixime

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Denvar is and what it is 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 influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Denvar is used to treat:

1.- Otorhinolaryngological (ORL) 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 taking Denvar

Do not take Denvar

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Denvar:

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

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 immediate discontinuation of treatment.

• if you have asthma or a predisposition to allergic reactions.

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

• if you have drug-induced hemolytic anemia or a history of hemolytic anemias associated with this type of medicine.

• if your treatment with cefixime is prolonged, you may be more prone to fungal or resistant bacterial superinfections. If this occurs, your doctor will assess whether treatment interruption is necessary.

• if you develop severe diarrhea, or notice blood, mucus, or pus in your stools. Inform your doctor if this happens.

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

• if you are taking diuretic medicines and/or medicines that may be harmful to the kidneys. Your doctor may perform tests to monitor kidney function during treatment.

• if you have severe renal impairment. Your doctor will adjust the dose and monitor you closely.

• if you develop acute kidney failure. If this occurs, stop taking this medicine and contact your doctor immediately.

Treatment with cefixime may increase the risk of developing drug-resistant bacteria.

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

Children

Administration is not recommended in premature infants, newborns, and infants up to 6 months of age.

Other medicines and Denvar

Taking cefixime together with any of the following medicines may alter the effect of both cefixime and the other medicine:

• diuretic medicines (such as ethacrynic acid or furosemide) or medicines that may be harmful to the kidneys (certain antibiotics, colistin, polymyxin, chloramphenicol)
• medicines acting on blood vessels (such as nifedipine)
• medicines used to control blood clotting (coumarins)

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

Interference with laboratory tests:

Denvar may cause false positive results in urine tests for ketones and glucose, and false positive results in the direct Coombs test (a diagnostic test for certain types of anemia).

Use of Denvar with food and drinks

Denvar may be taken with food.

Pregnancy and breastfeeding

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

Due to insufficient information on the potential adverse effects of Denvar during pregnancy, Denvar is recommended during pregnancy only if prescribed by your doctor after evaluating the benefit-risk ratio.

It has not been detected that cefixime passes into breast milk.

Treatment with Denvar during breastfeeding is not recommended unless prescribed by your doctor after evaluating the benefit-risk ratio. Your doctor will decide whether to continue breastfeeding and cefixime treatment.

Driving and using machines

Based on current experience, Denvar has no effect on the ability to drive or operate machinery. However, some adverse effects may affect concentration and reaction ability; therefore, this should be taken into account in situations where concentration and reaction ability are important, such as when driving or operating machinery.

3. How to take Denvar

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The recommended daily dose for adults and children over 12 years of age is 1 capsule of 400 mg/24 hours, for 10 days.

Denvar is administered orally. The capsules must be swallowed whole, without chewing, and taken with some liquid.

Patients with renal problems

In case of renal impairment with a creatinine clearance ≥20 ml/min, dose adjustment is not necessary; if the clearance is lower, the dose should be reduced by half. In hemodialysis patients, the cefixime dosage should not exceed 200 mg/day either.

Patients with hepatic problems

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

Elderly patients

Dose adjustment is not necessary for elderly patients if kidney function is normal.

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

If you take more Denvar than you should

Contact your doctor or pharmacist immediately.

Due to the low toxicity of cefixime, accidental massive ingestion is not expected to result in intoxication. If it occurs, gastric lavage and symptomatic treatment are recommended. In case of severe allergic reactions, symptomatic treatment should be administered: adrenaline, corticosteroids, antihistamines.

In case of overdose or accidental ingestion, call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Denvar

Do not take a double dose to make up for missed doses. Wait until the next scheduled dose and continue treatment as usual.

If you stop taking Denvar

Your doctor will advise you on the duration of your treatment with Denvar. Do not stop treatment early, as your previous symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If they occur, the following may be observed:

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):
Loss of appetite, flatulence, itching, mucosal inflammation, dizziness, fever, hypersensitivity reactions such as flushing, palpitations, difficulty breathing, decreased blood pressure, facial swelling, transient increase in blood urea concentration, pathogen resistance, 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):
Inflammation of the large intestine, toxic skin disorders (Stevens-Johnson syndrome, erythema multiforme), blood disorders (leukopenia, agranulocytosis, pancytopenia, thrombocytopenia, coagulation disorders, anemia and other blood count changes), transient hyperactivity, allergic shock, serum sickness-like reactions (e.g. joint pain and swelling, 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 cells), increased bilirubin in blood (which may 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 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Denvar

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

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

Store below 30ºC. Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Denvar

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

Appearance of the product and contents of the pack

Denvar is presented as orange-colored hard capsules. Each pack contains 10 hard capsules.

Marketing Authorization Holder

Merck, S.L.

María de Molina, 40

28006 Madrid

Spain

Manufacturer

Merck, S.L.

Polígono Merck

08100 Mollet del Vallés (Barcelona)

Spain

Date of the most recent review of this leaflet: 06/2022

Detailed and up-to-date 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