CEFALEXIN REIWA HEALTHCARE 500 mg HARD CAPSULES

2. What you need to know before taking Cefalexina Reiwa Healthcare

Do not take Cefalexina Reiwa Healthcare

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cefalexina Reiwa Healthcare:

• if you have ever had an allergic reaction to cefalexina, cephalosporins, 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 cefalexina is administered for a long time, an infection with microorganisms (bacteria) insensitive to cefalexina may occur. Your doctor will carefully check and initiate appropriate treatment.
• if you have ever developed a severe skin rash, scaling, blisters, and/or sores in the mouth after taking cefalexina or other antibacterials.

Acute generalized exanthematous pustulosis (AGEP) has been reported with the use of cefalexina. 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 cefalexina and contact your doctor or seek immediate medical attention.

Other medications and Cefalexina Reiwa Healthcare

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 cefalexina.

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

• probenecid(medication used in the treatment of gout). Probenecid may increase the amount of cefalexina in the blood, so you may need a lower dose if you are also taking probenecid.
• metformin(medications used in the treatment of diabetes), as cefalexina may increase the amount of metformin in your blood.
• aminoglycosides, vancomycin, and other cephalosporins(medications used in the treatment of infections)
• furosemide(medication used to increase urine production).

Effects on laboratory tests

Tell your doctor if you are taking Cefalexina Reiwa Healthcare and are undergoing blood or urine tests, as cefalexina may interfere with the results of these tests.

Use of Cefalexina Reiwa Healthcare with food and beverages

Cefalexina Reiwa Healthcare 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

Cefalexina Reiwa Healthcare may cause dizziness, agitation, hallucinations, or confusion, so you should be cautious when driving or operating machines.

Cefalexina Reiwa Healthcare contains Allura Red (E129)

This medication may cause allergic reactions because it contains Allura Red (E129). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Cefalexina Reiwa Healthcare

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

Dose

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 years)

Cefalexina Reiwa Healthcare 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/min), a dose reduction is necessary.

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 Cefalexina Reiwa Healthcare than you should

If you have taken more capsules than you should have 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 Cefalexina Reiwa Healthcare

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 Cefalexina Reiwa Healthcare

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

Method of administration

Cefalexina Reiwa Healthcare is administered orally. The capsules should be swallowed whole with a full glass of water.

If you have any further 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 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, scaling, 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, hives, 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 cefalexina 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Cefalexina Reiwa Healthcare

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

Do not use this medication after the expiration date, which appears on the blister pack and carton after "EXP". The expiration date is the last day of the month indicated.

Store in the original packaging. Keep the blister pack in the outer packaging to protect it from light.

Do not use this medication if you notice visible signs of deterioration.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Cefalexina Reiwa Healthcare

• The active ingredient is cefalexina. Each hard gelatin capsule contains 500 mg of cefalexina (as cefalexina monohydrate).
• The other ingredients are: microcrystalline cellulose and magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171), potassium and aluminum silicate (E555), brilliant blue FCF (E133), Allura Red (E129).

Printing ink: shellac, potassium hydroxide, black iron oxide (E172).

Appearance of the product and package contents

Cefalexina Reiwa Healthcare is presented in hard gelatin capsules, with the body and cap of the capsule opaque, light blue and dark blue in color, respectively, and with the symbol.

Cefalexina Reiwa Healthcare is available in packages of 28 hard capsules, presented in blister packs (4 blister packs with 7 hard capsules per blister pack).

Marketing authorization holder

Reiwa Healthcare S.L.

Fuencarral Road, 22,

28108 Alcobendas (Madrid),

Spain

Manufacturer

Netpharmalab Consulting Services S.L.

Fuencarral Road, 22,

28108 Alcobendas (Madrid),

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Germany Cefalexin Reiwa Healthcare 500 mg Hartkapseln

Hungary Cefalexin Reiwa Healthcare 500 mg Kemény kapszula

Date of the last revision of this leaflet:April 2020

Other sources of information

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