MEIACT 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

MEIACT 400 mg film-coated tablets

cefditoren

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, 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 not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What MEIACT 400 mg film-coated tablets are and what they are used for
2. What you need to know before taking MEIACT 400 mg film-coated tablets
3. How to take MEIACT 400 mg film-coated tablets
4. Possible side effects
5. Storage of MEIACT 400 mg film-coated tablets

Contents of the pack and additional information

1. What MEIACT 400 mg film-coated tablets are and what they are used for

MEIACT belongs to a group of antibiotics called cephalosporins, which work by inhibiting the synthesis of the bacterial cell wall.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or 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 completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

MEIACT is used in adult patients for the treatment of moderate community-acquired pneumonia.

2. What you need to know before taking MEIACT 400 mg film-coated tablets

Do not take MEIACT

• if you are allergic to antibiotics, particularly penicillin or other beta-lactam antibiotics, or to any of the other components of this medication (listed in section 6).
• if you have a casein allergy, you should be aware that this medication contains sodium caseinate.
• if you have a condition called primary carnitine deficiency.

Warnings and precautions

Consult your doctor or pharmacist before starting to take MEIACT

• if you have liver and/or kidney disease
• if you are receiving anticoagulant therapy
• if you have a history of gastrointestinal disease, particularly colitis
• if you are receiving treatment with nephrotoxic agents such as aminoglycoside antibiotics or potent diuretics (such as furosemide), as these combinations may have undesirable effects on renal function and have been associated with ototoxicity.

Consult your doctor if you experience any of the following effects during treatment:

• if you experience an allergic reaction characterized by symptoms such as itching, redness, skin rash, swelling, or difficulty breathing during treatment
• if you experience diarrhea while taking this medication or after completing treatment

As with other antibiotics, prolonged treatment with MEIACT may lead to an overgrowth of non-susceptible microorganisms, requiring discontinuation of treatment and institution of appropriate therapy.

Treatment with MEIACT may interfere with the results of some laboratory tests, potentially leading to false positives in:

• Direct Coombs test
• Urinary glucose determination

And false negatives in:

• Blood or plasma glucose determination

Other medications and MEIACT

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

A minimum period of 2 hours should be allowed between the administration of antacids and MEIACT.

Concomitant administration of MEIACT with probenecid increases the amount of cefditoren in the blood.

Concomitant administration of MEIACT with intravenous famotidine is not recommended, as it may hinder the achievement of the necessary amount in the blood.

Pregnancy and lactation

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.

MEIACT is not recommended during pregnancy or breastfeeding.

Driving and using machines

MEIACT may cause dizziness and drowsiness, which may affect your ability to drive or operate any tool or machine.

MEIACT 400 mg film-coated tablets contain sodium

This medication contains 26.2 mg of sodium (main component of table salt) per tablet. This is equivalent to 1.3% of the maximum recommended daily sodium intake for an adult.

3. How to take MEIACT 400 mg film-coated tablets

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to take your medication. Your doctor will indicate the duration of treatment with MEIACT.

Swallow the tablets whole, with a sufficient amount of liquid (a glass of water), during meals.

The recommended dose of the medication and the frequency of administration are as follows:

Adults and adolescents (over 12 years)

1 tablet (400 mg of cefditoren) every 12 hours for 14 days is recommended.

Use in children under 12 years

The use of MEIACT has not been studied in patients under 12 years, and therefore, its administration is not recommended.

Elderly patients

No dose adjustments are necessary in elderly patients, except in cases of advanced hepatic and/or renal impairment.

Patients with renal impairment

No dose adjustment is necessary in patients with mild renal impairment. In patients with moderate renal impairment, do not exceed the dose of 200 mg of cefditoren (MEIACT 200 mg) every 12 hours. In patients with severe renal impairment, a single dose of 200 mg of cefditoren (MEIACT 200 mg) per day is recommended. The appropriate dose has not been determined in patients undergoing dialysis.

Patients with hepatic impairment

In mild or moderate hepatic impairment, it is not necessary to modify the treatment regimen. In cases of severe hepatic impairment, there are no data available to make a dose recommendation.

If you take more MEIACT than you should

If you have taken more MEIACT than recommended, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to take the packaging and package leaflet of the medication to the healthcare professional.

If you forget to take MEIACT

In case you have forgotten a dose, take another as soon as possible and continue with the usual schedule. Do not take a double dose to make up for forgotten doses.

If you stop treatment with MEIACT

Do not stop treatment before the duration indicated by your doctor, as there is a risk of relapse of the disease.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. Side effects may occur mainly of a gastrointestinal nature.

Very common (more than 1 in 10 people):

• diarrhea

Common (1 to 10 in 100 people):

• headache, nausea, abdominal pain, feeling of indigestion, and vaginal infection

Uncommon (1 to 10 in 1,000 people):

• fungal infection
• anorexia
• nervousness, dizziness, and sleep disorders
• pharyngitis, rhinitis, and sinusitis
• constipation, flatulence, vomiting, oral candidiasis, eructation, dry mouth, and loss of taste
• liver function alterations
• skin rash, itching, and urticaria
• vaginal inflammation and vaginal discharge
• fever, weakness, and sweating
• alterations in blood cell counts (leukopenia and thrombocytosis), liver function test disorders (elevated ALT)

Rare (1 to 10 in 10,000 people):

• hemolytic anemia and lymph node alterations
• dehydration
• dementia, depersonalization, emotional weakness, euphoria, hallucinations, and increased libido
• memory loss, discoordination, increased muscle tone, meningitis, and tremor
• photosensitivity, visual acuity loss, eye pain, and eyelid inflammation
• tinnitus
• heart rhythm disorders, heart failure, and fainting
• low blood pressure
• asthma
• oral ulcers, stomatitis, hemorrhagic colitis, ulcerative colitis, gastrointestinal bleeding, hiccups, tongue inflammation and discoloration, diarrhea associated with Clostridium difficile
• acne, hair loss, eczema, exfoliative dermatitis (cracked and scaly skin), and herpes simplex
• muscle pain
• urination pain, kidney inflammation, alterations in urination frequency, incontinence, and urinary tract infection
• breast pain, menstrual disorders, and erectile dysfunction
• body odor and chills
• alterations in blood cell counts (eosinophilia, neutropenia, thrombocytopenia), coagulation disorders (prolonged coagulation time, decreased thromboplastin time, platelet alterations), liver function test disorders (elevated AST, alkaline phosphatase), alterations in certain blood components (hyperglycemia, hypokalemia, bilirubinemia, elevated LDH, hypoproteinemia, elevated creatinine), or urine (albuminuria)

Frequency not known:

• pneumonia
• Stevens-Johnson syndrome (blisters and erosion of the skin and mucous membranes)
• skin redness
• toxic epidermal necrolysis (severe form of Stevens-Johnson syndrome followed by skin pain and shedding of the upper layer of the skin)
• acute kidney failure
• anaphylactic shock
• serum sickness-like reaction (late allergic reaction of the skin)
• decrease in blood cell counts (agranulocytosis)
• decrease in carnitine levels in the blood
• cholestasis (obstruction of bile flow from the liver)
• aplastic anemia (decrease in blood cell counts)
• liver damage
• hepatitis

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of MEIACT 400 mg film-coated tablets

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

Store in the original packaging.

Do not store above 30°C.

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 medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and additional information

Composition of MEIACT 400 mg film-coated tablets

• The active ingredient is cefditoren. Each tablet contains 400 mg of cefditoren (as cefditoren pivoxil).
• Other components are:

core: sodium caseinate, sodium croscarmellose, mannitol E-421, sodium tripolyphosphate, and magnesium stearate.

coating: Opadry Y-1-7000 (hypromellose, titanium dioxide E-171, macrogol 400) and carnauba wax.

Opacode S-1-20986 blue printing ink: shellac, brilliant blue lake, titanium dioxide E-171, propylene glycol, and concentrated ammonia solution.

Appearance of the product and pack contents

MEIACT 400 mg is presented in the form of film-coated tablets. Each pack contains 10 tablets.

Other presentations

MEIACT 200 mg film-coated tablets: each pack contains 16 or 20 tablets.

Marketing authorization holder and manufacturer:

Meiji Pharma Spain, S.A.

Avenida de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the last revision of this package leaflet: November 2020

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