Kefloridina forte 500 mg capsulas duras

Package Insert: Information for the User

Kefloridina Forte 500 mg Hard Capsules

Cefalexina monohidrato

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given 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 package insert. See section 4.

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

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 ear infection (otitis media)
• Throat bacterial infections
• Lung and respiratory tract infections
• Uncomplicated urinary tract infection (cystitis)
• Uncomplicated kidney and prostate infections
• Dental infections
• Uncomplicated skin infections

Do not take Kefloridina Forte:

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

Warnings and precautions

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

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

Generalized Acute Pustular Exanthema (PEGA) has been reported with the use of cefalexin. PEGA appears at the beginning of treatment as a red, scaly, and generalized rash with subcutaneous nodules and blisters accompanied by fever. The most common location is mainly located in the 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 other skin symptoms, stop taking cefalexin and contact your doctor or seek immediate medical attention.

Other medications and Kefloridina Forte

Inform your doctor or pharmacist if you are taking, have taken recently, 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(a medication used in the treatment of gout). Probenecid may increase the amount of cefalexin in the blood, so you may need a lower dose if you also take probenecid.

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

Effects on laboratory tests

Inform your doctor if you are taking Kefloridina Forte and 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Ask your doctor or pharmacist for advice before taking any medication.

Driving and operating machinery

Kefloridina Forte may cause dizziness, agitation, hallucinations, or confusion, so you should exercise caution when driving or operating machinery.

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 Red Patent Blue V (E131)

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

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

Administration Form

Kefloridina Forte is administered orally. The capsules must 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 skin and underlying tissue infections, sore throat, 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)

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 ratio <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's emergency service 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 Toxicological 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 must take another dose soon, leave the missed dose completely and continue your treatment as before.

Do not take a double dose to compensate for the missed doses.

If You Interrupt Treatment with Kefloridina Forte

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

If you have any other questions 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 you consider that you are experiencing any of the following serious side effects, stop taking this medicine and inform your doctor immediately or go to the nearest hospital emergency service:

• Swelling of the face, lips, tongue, or throat (angioedema)
• A sudden allergic reaction, with difficulty breathing, rash, wheezing, and decreased blood pressure.
• Rash with itching or eruption on the arms and legs, or severe, extensive, and blistering skin eruption (erythema multiforme, Stevens-Johnson syndrome)
• Fever, sore throat, and joint pain accompanied by severe blisters, peeling, and red 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:

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

• Nausea and diarrhea.

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

• Changes in blood tests that check how your liver is functioning
• 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 ease of bruising or bleeding), including 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 and skin inflammation, and yellowing of the eyes and skin (jaundice).

Unknown frequency(frequency cannot be estimated from available data)

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

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not included 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side 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.

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Kefloridina Forte

• The active ingredient is cefalexina monohydrate. Each capsule contains 500 mg of cefalexina monohydrate.
• The other components are magnesium stearate, dimethicone, and sodium croscarmellose. Capsule: patent blue V, quinoline yellow (E104), titanium dioxide (E171), gelatin.

Appearance of the product and contents of the packaging

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

It is presented in packaging of 28 and 500 (clinical packaging) hard capsules.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 - Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

ACS DOBFAR S.P.A.

Vía Laurentina, Km 24,

730 Pomezia (Roma)

Italy

Last review date of this leaflet:September 2021

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