CEFALEXIN REIWA HEALTHCARE 250 mg ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

Cefalexina Reiwa Healthcare 250 mg Powder for Oral Suspension EFG

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 Cefalexina Reiwa Healthcare and what is it used for
2. What you need to know before you take Cefalexina Reiwa Healthcare
3. How to take Cefalexina Reiwa Healthcare
4. Possible side effects
5. Storage of Cefalexina Reiwa Healthcare
6. Contents of the pack and other information

1. What is Cefalexina Reiwa Healthcare and what is it used for

Cefalexina is an antibiotic. It belongs to a group of antibiotics called cephalosporins.

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

Cefalexina can be used to treat the following infections in adults:

• 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
• uncomplicated skin infections
• dental infections

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

Do not take Cefalexina Reiwa Healthcare

• if you are allergic to cefalexina or any of the other ingredients of this medicine (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 medicine.
• if you develop severe or prolonged diarrhea while taking cefalexina.
• if you have any kidney disease (you may need a reduced dose)
• if you have ever developed a severe skin rash, scaling, or blisters and ulcers in the mouth after taking cefalexina or other antibacterial agents.

Tell your doctor if you are going to have blood or urine tests. Cefalexina may interfere with these tests.

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 widespread 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 greatest 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 medicines and Cefalexina Reiwa Healthcare

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those 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 medicines:

• probenecid(a medicine used to treat 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(medicines used to treat diabetes), as cefalexina may increase the amount of metformin in your blood.
• aminoglycosides, vancomycin, and other cephalosporins(medicines used to treat infections)
• furosemide(a medicine used to increase urine production).
• medicines used to treat leukemia.

Effects on laboratory tests

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

Cefalexina Reiwa Healthcare should only be used during pregnancy after a benefit/risk assessment by the doctor, especially during the first trimester.

Driving and using machines

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

Cefalexina Reiwa Healthcare contains lactose

This medicine contains 1161.1 mg of lactose monohydrate per sachet. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Cefalexina Reiwa Healthcare contains tartrazine

It may cause allergic-type reactions.

Cefalexina Reiwa Healthcare contains aspartame

This medicine contains 10 mg of aspartame in each sachet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Cefalexina Reiwa Healthcare contains sulfites

It may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Cefalexina Reiwa Healthcare

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

First, invert the sachet and gently tap to loosen the powder, pour into a glass, then add 5 ml of water, shaking until it is suspended. Take the 5 ml of suspension with about 150 ml of water.

The reconstituted suspension is stable for 60 minutes. The reconstituted suspension is yellow in color.

Dose

Use in adults and elderly:

The recommended total daily dose is 1 to 4 g orally, in divided doses.

Most infections can be treated with 500 mg every 8 hours. For skin and soft tissue infections, sore throat (streptococcal pharyngitis), and mild and uncomplicated urinary tract infections (e.g., cystitis), the recommended dose is 250 mg every 6 hours or 500 mg every 12 hours.

For more severe infections, higher doses may be needed. A reduced dose is needed for patients with severe kidney disorders.

If you take more Cefalexina Reiwa Healthcare than you should

If you have taken more Cefalexina Reiwa Healthcare than you should, consult your doctor or pharmacist or go to a hospital immediately.

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 medicine and the amount ingested.

If you forget to take Cefalexina Reiwa Healthcare

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

If you stop taking Cefalexina Reiwa Healthcare

Take all the sachets that your doctor has prescribed for you. Do not stop taking them, even if you feel better.

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

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking this medicine and tell your doctor immediately or go to the emergency department of your nearest hospital:

• Swelling of the face, lips, tongue, or throat (angioedema). (rare side effect - may affect up to 1 in 1,000 people)
• A sudden allergic reaction, with difficulty breathing, rash, wheezing, and low blood pressure. (rare side effect)
• Itchy spots or rash on the arms and legs, or severe skin rash, widespread and with blisters (erythema multiforme, Stevens-Johnson syndrome) (rare side effect).
• Fever, sore throat, and joint pain accompanied by severe blisters, scaling, and a red rash (toxic epidermal necrolysis) (rare side effect).
• Severe or prolonged diarrhea. This could be a symptom of a more serious illness (pseudomembranous colitis) (rare side effect).

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.
• Headache, dizziness.
• Abdominal pain, vomiting, indigestion.
• Kidney inflammation.
• Genital and anal itching and vaginal inflammation (vaginitis).
• Fatigue.
• Liver inflammation and yellowing of the skin and eyes (jaundice).

Frequency not known(frequency cannot be estimated from the 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).
• 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 exanthematous pustulosis). Stop taking 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 of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefalexina Reiwa Healthcare

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

This medicine does not require any special storage temperature.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Place the sachets and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of sachets and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefalexina Reiwa Healthcare

• The active substance is cefalexina. Each sachet contains 250 mg of cefalexina (equivalent to 263 mg of cefalexina monohydrate).

• The other ingredients are:

Lactose monohydrate

Hypromellose 2910

Yellow powder 5 of FD&C (tartrazine E102)

Strawberry flavor

Raspberry flavor

Tutti Frutti flavor

Aspartame

Colloidal anhydrous silica 200

Talc

Appearance of the product and contents of the pack

Cefalexina Reiwa Healthcare is a dry, flavored powder with a white to yellowish color.

The powder is packaged in paper and aluminum sachets. Each carton contains 12 sachets.

Marketing authorization holder

Reiwa Healthcare S.L

Carretera de Fuencarral, 22

28108 – Alcobendas

Madrid

Spain

Manufacturer

Netpharmalab Consulting Services S.L

Carretera de Fuencarral, 22

28108 – Alcobendas

Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary: Cefalexin Reiwa Healthcare 250 mg por belsoleges szuszpenzióhoz

Germany: Cefalexin Reiwa Healthcare 250 mg Pulver zur Herstellung einer Suspension zum Einnehmen

Spain: Cefalexina Reiwa Healthcare 250 mg polvo para suspensión oral EFG

Date of last revision of this leaflet: March 2022

Other sources of information

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