Meiact 400 mg film-coated tablets: detailed information

Brand name Meiact 400 mg film-coated tablets

Form tablets, film-coated

Active substance / Dosage

CEFDITOREN PIVOXIL · 490,2 mg

Prescription type Prescription Only Medicine

ATC code

J01D J01DD J01DD16

Registration number 65975

Manufacturer Meiji Pharma Spain S.A.

Table of Contents

Package leaflet: Information for the user
Introduction
1. What MEIACT 400 mg film-coated tablets is and what it is used for
2. What you need to know before starting to take MEIACT 400 mg film-coated tablets
3. How to take MEIACT 400 mg film-coated tablets
4. Possible adverse effects
5. Storage of MEIACT 400 mg film-coated tablets
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

MEIACT 400 mg film-coated tablets

cefditoren

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What MEIACT 400 mg film-coated tablets are and what they are used for
What you need to know before taking MEIACT 400 mg film-coated tablets
How to take MEIACT 400 mg film-coated tablets
Possible side effects
How to store MEIACT 400 mg film-coated tablets

Contents of the pack and other information

1. What MEIACT 400 mg film-coated tablets is and what it is used for

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not keep or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via wastewater or household waste.

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

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

Do not take MEIACT

if you are allergic to antibiotics, particularly penicillins or other types of β-lactam antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to casein, you should be aware that this medicine contains sodium caseinate.
if you have a condition called primary carnitine deficiency.

Warnings and precautions

Talk to 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 disorders, particularly colitis
if you are simultaneously receiving treatment with nephrotoxic active substances such as aminoglycoside antibiotics or potent diuretics (such as furosemide), as these combinations may have undesirable effects on kidney function and have been associated with ototoxicity.

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

if you develop any allergic reaction characterized by symptoms such as itching, redness, skin rash, swelling, or difficulty breathing
if you develop diarrhea while taking this medicine or after treatment has ended

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

You may develop signs and symptoms of serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. Stop using MEIACT and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

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

Direct Coombs test
Urine glucose testing

And false negatives in:

Blood or plasma glucose testing.

Other medicines and MEIACT

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

A period of at least two hours is recommended between administration of antacids and MEIACT.

Concomitant administration of MEIACT with probenecid increases blood levels of cefditoren.

Concomitant administration of MEIACT with intravenous famotidine is not recommended, as it may impair achieving the necessary blood concentration.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Taking MEIACT shortly before delivery may interfere with the results of neonatal screening tests for metabolic disorders. You must inform the healthcare professional performing the test if you have taken this medicine shortly before delivery.

MEIACT is not recommended during pregnancy or breastfeeding.

Driving and using machines

MEIACT may cause dizziness and drowsiness, which may impair your ability to drive or operate tools or machinery.

MEIACT 400 mg film-coated tablets contain sodium

This medicine contains 26.2 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 1.3% of the maximum daily sodium intake recommended for an adult.

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

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine. Your doctor will tell you how long to continue treatment with MEIACT.

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

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

Adults and adolescents (over 12 years of age)

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

Use in children under 12 years of age

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

Elderly patients

In elderly patients, dose adjustments are not required except in cases of advanced impairment of hepatic and/or renal function.

Patients with renal insufficiency

Dosage adjustment is not required in patients with mild renal impairment. In patients with moderate renal insufficiency, the dose should not exceed 200 mg of cefditoren (MEIACT 200 mg) every 12 hours. In patients with severe renal impairment, a single daily dose of 200 mg of cefditoren (MEIACT 200 mg) is recommended. The appropriate dose has not been determined in patients undergoing dialysis.

Patients with hepatic insufficiency

In mild or moderate hepatic impairment, it is not necessary to modify the treatment regimen. In cases of severe hepatic impairment, there are no available data to allow 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 at telephone number 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the medication's packaging and leaflet to the healthcare professional.

If you forget to take MEIACT

If you have missed a dose, take it as soon as possible and then continue with your regular dosing schedule. Do not take a double dose to make up for missed doses.

If you stop taking MEIACT

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following symptoms, as you may require urgent medical treatment:

Severe skin reactions (frequency not known, cannot be estimated from available data)

Stevens-Johnson syndrome (blisters and erosion of the skin and mucous membranes)
widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis)

Adverse 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, 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, burping, dry mouth, and loss of taste
alteration of liver function
skin rash, itching, and urticaria
vaginal inflammation and vaginal discharge
fever, weakness, and sweating
changes in blood cell counts (leucopenia and thrombocytosis), liver function test abnormalities (elevation of ALT)

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

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

Frequency not known:

pneumonia
redness of the skin
toxic epidermal necrolysis (a severe form of Stevens-Johnson syndrome followed by skin pain and shedding of the upper layer of skin)
acute kidney failure
anaphylactic shock
serum sickness reaction (delayed allergic skin reaction)
reduction in blood cells (agranulocytosis)
decreased levels of carnitine in the blood
cholestasis (obstruction of bile flow from the liver)
aplastic anemia (reduction in blood cells)
liver damage
hepatitis
inflammation of the large intestine (colon). Symptoms include diarrhea, usually with blood and mucus, stomach pain, and fever
inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of MEIACT 400 mg film-coated tablets

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

Store in the original packaging.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of MEIACT 400 mg film-coated tablets

The active substance is cefditoren. Each tablet contains 400 mg of cefditoren (as cefditoren pivoxil).
- The 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.

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

Appearance of the product and contents of the pack

MEIACT 400 mg is presented as film-coated tablets. Each pack contains 10 tablets.

Meiact 400 mg film-coated tablets