MEIACT 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

MEIACT 200 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 200 mg film-coated tablets are and what they are used for
2. What you need to know before taking MEIACT 200 mg film-coated tablets
3. How to take MEIACT 200 mg film-coated tablets
4. Possible side effects
5. Storage of MEIACT 200 mg film-coated tablets

Contents of the pack and further information

1. What MEIACT 200 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.

MEIACT is used in adult patients for the treatment of the following infections:

• Acute pharyngotonsillitis.
• Acute maxillary sinusitis.

• Acute exacerbation of chronic bronchitis.
• Community-acquired pneumonia, mild to moderate.
• Uncomplicated skin and soft tissue infections, such as cellulitis, infected wounds, abscesses, folliculitis, impetigo, and furunculosis.

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2. What you need to know before taking MEIACT 200 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 during treatment you present any allergic reaction characterized by symptoms such as itching, redness, skin rash, swelling, or difficulty breathing.
• 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, which requires 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:

• The 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 period of at least two hours should be allowed between the administration of antacids and MEIACT.

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

The 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 somnolence, which may interfere with the ability to drive or operate any tool or machine.

MEIACT 200 mg film-coated tablets contain sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take MEIACT 200 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 this medication and the frequency of administration are as follows:

Adults and adolescents (over 12 years)

• Acute pharyngotonsillitis: 1 tablet (200 mg of cefditoren) every 12 hours for 10 days.
• Acute maxillary sinusitis: 1 tablet (200 mg of cefditoren) every 12 hours for 10 days.
• Acute exacerbation of chronic bronchitis: 1 tablet (200 mg of cefditoren) every 12 hours for 5 days.
• Community-acquired pneumonia:

• Mild cases: 1 tablet (200 mg of cefditoren) every 12 hours for 14 days.
• Moderate cases: 2 tablets (400 mg of cefditoren) every 12 hours for 14 days.

• Uncomplicated skin and soft tissue infections: 1 tablet (200 mg of cefditoren) every 12 hours for 10 days.

Use in children under 12 years

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

Elderly patients

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

Patients with renal insufficiency

No dose adjustment is necessary in patients with mild renal impairment. In patients with moderate renal insufficiency, do not exceed the dose of 1 tablet (200 mg of cefditoren) every 12 hours. In patients with severe renal insufficiency, a dose of 1 tablet (200 mg of cefditoren) per day is recommended. The appropriate dose has not been determined in patients undergoing dialysis.

Patients with hepatic insufficiency

In mild or moderate hepatic insufficiency, it is not necessary to modify the treatment regimen. In cases of severe hepatic insufficiency, 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 bring 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 discontinue 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
• alteration of liver function
• skin rash, itching, and urticaria
• vaginal inflammation and vaginal discharge
• fever, weakness, and sweating
• alterations in blood cell counts (leukopenia and thrombocytosis), disorders of liver function tests (elevation of ALT)

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

• hemolytic anemia and lymph node alteration
• dehydration
• dementia, depersonalization, emotional weakness, euphoria, hallucinations, and increased libido
• memory loss, discoordination, increased muscle tone, meningitis, and tremor
• photosensitivity, loss of visual acuity, eye pain, and eyelid inflammation
• tinnitus
• arrhythmias, heart failure, and fainting
• decreased blood pressure
• asthma
• oral ulcers, stomatitis, hemorrhagic colitis, ulcerative colitis, gastrointestinal bleeding, hiccups, inflammation, and discoloration of the tongue, diarrhea associated with Clostridium difficile
• acne, hair loss, eczema, exfoliative dermatitis (cracked and scaly skin), and herpes simplex
• muscle pain
• pain when urinating, 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 (prolongation of coagulation time, decrease in thromboplastin time, platelet alteration), liver function test disorders (increase in AST, alkaline phosphatase), alterations in certain blood components (hyperglycemia, hypokalemia, bilirubinemia, elevation of LDH, hypoproteinemia, elevation of creatinine), or urine (albuminuria)

Frequency not known:

• pneumonia
• Stevens-Johnson syndrome (blisters and erosion of the skin and mucous membranes)
• redness of the skin
• toxic epidermal necrolysis (severe form of Stevens-Johnson syndrome followed by skin pain and peeling of the top layer of the skin)
• acute renal failure
• anaphylactic shock
• serum sickness-like reaction (late allergic skin reaction)
• 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 count)
• liver damage
• hepatitis

Reporting of 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 package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of MEIACT 200 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 medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of MEIACT 200 mg film-coated tablets

• The active ingredient is cefditoren. Each tablet contains 200 mg of cefditoren (as cefditoren pivoxil).
• The other ingredients 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 lacquer, titanium dioxide E-171, propylene glycol, and concentrated ammonia solution.

Appearance of the product and contents of the pack

MEIACT 200 mg is presented in the form of film-coated tablets. Each pack contains 16 or 20 tablets.

Not all pack sizes may be marketed.

Other presentations

MEIACT 400 mg film-coated tablets: each pack contains 10 tablets.

Marketing authorization holder and manufacturer:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

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

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