Prospect: Information for the User

MEIACT 400 mg Film-Coated Tablets

Cefditoren

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Contents of the pack and additional information

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

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

Do not take MEIACT

• if you are allergic to antibiotics, particularly penicillin or other types of antibiotics?-lactámicos, or to any of the other components of this medication (listed in section 6).
• if you have an allergy to casein, 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 any 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 active principles 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 experience 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 treatment has been completed

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

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

• The direct Coombs test
• Glucose determination in urine

And false negatives in:

• Glucose determination in blood or plasma.

Other medications and MEIACT

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

A minimum period of two hours is recommended 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 necessary amount in the blood.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The administration of MEIACT is not recommended during pregnancy or lactation.

Driving and operating machinery

MEIACT may cause dizziness and somnolence, which may interfere with the 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/for cooking) in each tablet. This is equivalent to 1.3% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Remember to take your medication. Your doctor will inform you of the duration of treatment withMEIACT.

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

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

Adults and adolescents (over 12 years)

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

Use in children under 12 years

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

Older patientsa

In older patients, no dose adjustments are required except in cases of advanced deterioration of liver and/or renal function.

Patients with renal insufficiency

No dose adjustment is required in patients with mild renal function impairment. In patients with moderate renal insufficiency, do not exceed a dose of 200 mg of cefditoren (MEIACT 200 mg) every 12 hours. In patients with severe renal insufficiency, 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 liver insufficiency

In cases of mild or moderate liver insufficiency, no treatment adjustments are required. In cases of severe liver insufficiency, there is no data 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and medication leaflet to the healthcare professional.

If you forget to take MEIACT

If you have forgotten a dose, take another as soon as possible and continue with your usual schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with MEIACT

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Side effects may mainly occur of a gastrointestinal type.

Very common (more than 1 in 10 people):

• diarrhea.

Common (1 to 10 per 100 people):

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

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

• yeast infection
• loss of appetite
• nervousness, dizziness, and sleep disorders
• pharyngitis, rhinitis, and sinusitis
• constipation, flatulence, vomiting, oral candidiasis, belching, dry mouth, and loss of taste
• liver function alteration
• skin rash, itching, and urticaria
• vaginal inflammation and vaginal discharge
• fever, weakness, and sweating
• alterations in the number of blood cells (leucopenia and thrombocytosis), disorders of liver function tests (elevation of ALT)

Rare (1 to 10 per 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 conjunctival inflammation
• tinnitus in the ears
• cardiac rhythm alterations, heart failure, and fainting
• hypotension
• asthma
• oral ulcers, stomatitis, hemorrhagic colitis, ulcerative colitis, gastrointestinal hemorrhage, hiccups, inflammation, and discoloration of the tongue, diarrhea associated withClostridium difficile
• acne, hair loss, eczema, dermatitis exfoliativa (scaly and cracked skin) and herpes simplex
• muscle pain
• urinary pain, kidney inflammation, alterations in urination frequency, incontinence, and urinary tract infection
• breast pain, menstrual disorders, and erectile dysfunction
• body odor and chills
• alteration in the number of blood cells (eosinophilia, neutropenia, thrombocytopenia), disorders of coagulation (prolongation of coagulation time, decrease in thromboplastin time, platelet alteration), disorders of liver function tests (increase in AST, alkaline phosphatase), alterations in the values of certain blood components (hyperglycemia, hypokalemia, bilirubinemia, increase in LDH, hypoproteinemia, increase in creatinine), or urine (albuminuria)

Unknown frequency:

• 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 detachment of the upper layer of the skin)
• acute renal failure
• anaphylactic shock
• serum disease reaction (late allergic skin reaction)
• agranulocytosis (decrease in blood cells)
• decrease in blood carnitine values
• bile duct obstruction (cholestasis)
• aplastic anemia (decrease in the number of blood cells)
• hepatic damage
• hepatitis

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging.

Do not store above30°C.

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging andthe medicines you no longer need at the SIGREcollection point at the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and the medicines you no longer need. By doing so, you will help protect the environment.

Composition of MEIACT 400 mg film-coated tablets

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

• The other components are:

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

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

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

Appearance of the product and contents of the packaging

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

Other presentations

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

Holder of the marketing authorization and responsible for manufacturing:

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the last review of this leaflet: November 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /