KEFLORIDINA FORTE 500 mg HARD CAPSULES

Introduction

Leaflet: Information for the user

Kefloridina Forte 500 mg hard capsules

Cefalexin monohydrate

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Kefloridina Forte is and what it is used for
2. What you need to know before taking Kefloridina Forte
3. How to take Kefloridina Forte
4. Possible side effects
5. Storage of Kefloridina Forte
6. Package contents and additional information

1. What Kefloridina Forte is and what it is used for

Kefloridina Forte is a semi-synthetic antibiotic of the cephalosporin family, for oral administration.

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 to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

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

Cefalexin works by eliminating certain types of bacteria that can cause various infections in people. Like all antibiotics, cefalexin can only eliminate certain types of bacteria, so it is only suitable for treating certain types of infections.

Cefalexin can be used to treat the following infections:

• bacterial infection of the ears (otitis media)
• bacterial infections of the pharynx
• infections of the lungs and respiratory tract
• uncomplicated urinary bladder infection (cystitis)
• uncomplicated kidney and prostate infections
• dental infections
• uncomplicated skin infections

2. What you need to know before taking Kefloridina Forte

Do not take Kefloridina Forte:

• if you are allergic to cefalexin or any of the other components of this medication (listed in section 6).
• if you are allergic (hypersensitive) to the group of antibiotics known as cephalosporins.
• if you have had previous severe and immediate hypersensitivity reactions to penicillin or any other type of beta-lactam antibiotic.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Kefloridina Forte:

• if you have ever had an allergic reaction to cefalexin, cephalosporins, penicillins, or any other medication.
• if you develop diarrhea while using an antibiotic
• if you have kidney disease (you may need a reduced dose)
• when cefalexin is administered for a long time, an infection with microorganisms (bacteria) insensitive to cefalexin may occur. Your doctor will carefully check and initiate appropriate treatment.
• if you have ever developed a severe skin rash, peeling, or blisters in the mouth after taking cefalexin or other antibacterial medications.

Acute generalized exanthematous pustulosis (AGEP) has been reported with the use of cefalexin. AGEP appears at the start of treatment as a red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever. The most common location is mainly in skin folds, trunk, and upper limbs. The highest risk of this severe skin reaction occurs during the first week of treatment. If you develop a severe rash or any of these skin symptoms, stop taking cefalexin and contact your doctor or seek immediate medical attention.

Other medications and Kefloridina Forte

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including medications obtained without a prescription. This is because they may interact with cefalexin.

In particular, consult your doctor or pharmacist if you are using any of the following medications:

• probenecid(medication used to treat gout). Probenecid may increase the amount of cefalexin in the blood, so you may need a lower dose if you are also taking probenecid.

• metformin(medications used to treat diabetes), as cefalexin may increase the amount of metformin in your blood.
• aminoglycosides, vancomycin, and other cephalosporins(medications used to treat infections)
• furosemide(medication used to increase urine production).

Effects on laboratory tests

Tell your doctor if you are taking Kefloridina Forte and are undergoing blood or urine tests, as cefalexin may interfere with the results of these tests.

Use of Kefloridina Forte with food and beverages

Kefloridina Forte can be taken with a full or empty stomach.

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. Ask your doctor or pharmacist for advice before taking any medication.

Driving and using machines

Kefloridina Forte may cause dizziness, agitation, hallucinations, or confusion, so you should be cautious when driving or operating machines.

Kefloridina Forte contains sodium

Kefloridina Forte contains less than 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free".

Kefloridina Forte contains Patent Blue V (E131)

This medication may cause allergic reactions because it contains Patent Blue V (E131). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Kefloridina Forte

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

Method of administration

Kefloridina Forte is administered orally. The capsules should be swallowed whole with a full glass of water.

Use in adults (≥ 18 years)

The usual dose ranges from 1 to 4 g per day in divided doses, and most infections respond to a dose of 500 mg every 8 hours.

For some infections, such as those of the skin and underlying tissues, throat pain, and cystitis, the recommended dose is 250 mg, if available, every 6 hours or 500 mg every 12 hours. If you have a more severe infection, you may need a higher dose.

Use in children (<18 years)< strong>

Kefloridina Forte 500 mg hard capsules are not suitable for the recommended dosing regimens in the pediatric population.

Use in patients with renal insufficiency

If you have severe kidney problems (glomerular filtration rate <10ml>

Use in elderly patients

The recommended dose is the same as for adults. However, for patients with renal insufficiency, a lower dose may be necessary.

If you take more Kefloridina Forte than you should

If you have taken more capsules than you should have taken or if someone else has swallowed some of your capsules, contact your doctor, pharmacist, or the hospital emergency department immediately. Symptoms of overdose may include nausea, vomiting, abdominal pain, diarrhea, and blood in the urine.

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 medication and the amount ingested.

If you forget to take Kefloridina Forte

If you forget to take a dose, take it as soon as you remember. However, if you are due to take another dose soon, skip the missed dose and continue your treatment as before.

Do not take a double dose to make up for missed doses.

If you stop taking Kefloridina Forte

Use all the capsules that your doctor has prescribed. Do not stop taking them, even if you feel better.

If you have any other doubts 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 will experience them.

If you think you are experiencing any of the following serious side effects, stop taking this medication and inform your doctor immediately or go to the nearest hospital emergency department:

• Swelling of the face, lips, tongue, or throat (angioedema)
• A sudden allergic reaction, with difficulty breathing, rash, wheezing, and low blood pressure.
• Itchy spots or rash on the arms and legs, or severe skin rash, widespread and with blisters (erythema multiforme, Stevens-Johnson syndrome)
• Fever, sore throat, and joint pain accompanied by severe blisters, peeling, and rash (toxic epidermal necrolysis).
• Severe or prolonged diarrhea. This could be a symptom of a more serious disease (pseudomembranous colitis).

The following side effects have also been reported:

Common side effects(may affect up to 1 in 10 people)

• Nausea and diarrhea.

Uncommon side effects(may affect up to 1 in 100 people)

• Changes in blood tests that check how your liver is working
• Increased levels of certain types of white blood cells.
• Rash, urticaria, and itching

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

• Blood disorders: decrease in the number of different cells in the blood (symptoms may include new infections and easy bruising or bleeding), including the small cells needed for blood clotting; hemolytic anemia, a type of anemia that can be severe and is caused by the rupture of red blood cells.
• Headaches, dizziness
• Abdominal pain, vomiting, indigestion
• Kidney inflammation
• Genital and anal problems: vaginal itching and inflammation (vaginitis)
• Fatigue
• Liver inflammation and yellowing of the skin and eyes (jaundice).

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

• Urinalysis results for sugar and the Coombs test may be affected
• Pain or inflammation of the joints
• Infections caused by other germs (e.g., vaginal candidiasis may occur)
• Fever
• Hallucinations, agitation, confusion.
• Red, scaly, and generalized rash with bumps under the skin and blisters accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using cefalexin if you develop these symptoms and contact your doctor or seek immediate medical attention. See also section 2.

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.

Reporting side effects

If you experience any type of side effect, 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 Medicines and Healthcare Products Agency's (AEMPS) online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Kefloridina Forte

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Kefloridina Forte

• The active ingredient is cefalexin monohydrate. Each capsule contains 500 mg of cefalexin monohydrate.
• The other ingredients are magnesium stearate, dimeticone, and sodium croscarmellose. Capsule: Patent Blue V, quinoline yellow (E104), titanium dioxide (E171), gelatin.

Appearance of the product and package contents

Kefloridina Forte hard capsules have a dark green opaque cap and a light green opaque body.

They are available in packs of 28 and 500 (clinical pack) hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 - Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

ACS DOBFAR S.P.A.

Via Laurentina, Km 24,

00040 Pomezia (Rome)

Italy

Date of the last revision of this leaflet:September 2021

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/