SPECTRACEF 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

SPECTRACEF 400 mg film-coated tablets

Cefditoren

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 pack

1. What SPECTRACEF 400 mg film-coated tablets are and what they are used for
2. What you need to know before you take SPECTRACEF 400 mg film-coated tablets
3. How to take SPECTRACEF 400 mg film-coated tablets
4. Possible side effects
5. Storage of SPECTRACEF 400 mg film-coated tablets
6. Contents of the pack and other information

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

SPECTRACEF 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 do not work for viral infections such as the flu or the common cold.

It is important that you follow the instructions regarding dosage, administration interval, and treatment duration as 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 via wastewater or trash.

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

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

Do not take SPECTRACEF

• 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 SPECTRACEF

• 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 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 present diarrhea while taking this medication or once treatment is finished.

As with other antibiotics, prolonged treatment with SPECTRACEF may lead to an overgrowth of non-susceptible microorganisms, which requires the interruption of treatment and the establishment of suitable therapy.

Treatment with SPECTRACEF may interfere with the results of some analytical tests, which may lead 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 SPECTRACEF

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

Between the administration of antacids and SPECTRACEF, it is recommended to wait at least two hours.

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

Concomitant administration of SPECTRACEF with intravenous famotidine is not recommended because it may hinder the achievement of the necessary amount in the blood.

Pregnancy and breastfeeding

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.

SPECTRACEF is not recommended during pregnancy or breastfeeding.

Driving and using machines

SPECTRACEF may cause dizziness and drowsiness, which can interfere with your ability to drive or operate any tool or machine.

SPECTRACEF 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 SPECTRACEF 400 mg film-coated tablets

Follow exactly the administration instructions of 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 indicate the duration of treatment with SPECTRACEF.

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 is as follows:

Adults and adolescents (over 12 years)

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

Use in children

The use of SPECTRACEF has not been studied in patients under 12 years of age, 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 200 mg of cefditoren (SPECTRACEF 200 mg) every 12 hours. In patients with severe renal insufficiency, a single dose of 200 mg of cefditoren (SPECTRACEF 200 mg) 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 is no data available to make a dose recommendation.

If you take more SPECTRACEF than you should

If you have taken more SPECTRACEF 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 ingested. It is recommended to bring the packaging and leaflet of the medication to the healthcare professional.

If you forget to take SPECTRACEF

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 SPECTRACEF

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 medicines, this medicine can cause side effects, although not everybody gets them. Side effects can 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 alteration
• skin rash, itching, and urticaria
• vaginal inflammation and vaginal discharge
• fever, weakness, and sweating
• alterations in blood cell count (leukopenia and thrombocytosis), liver function test disorders (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, visual acuity loss, eye pain, and eyelid inflammation
• tinnitus
• heart rhythm alterations, 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 count (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 (cannot be estimated from the available data):

• 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 peeling of the upper layer of the skin)
• acute kidney failure
• anaphylactic shock

• serum sickness-like reaction (late allergic skin reaction)

• decrease in blood cells (agranulocytosis)
• decrease in carnitine values in the blood
• cholestasis (the flow of bile from the liver is obstructed)
• aplastic anemia (decrease in the number of blood cells)
• liver damage
• hepatitis.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of SPECTRACEF 400 mg film-coated tablets

Keep this medication out of sight and reach of children.

Store in the original packaging.

Do not store above 30°C.

Do not use SPECTRACEF after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place 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 other information

Composition of SPECTRACEF 400 mg film-coated tablets

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

core: sodium caseinate, sodium croscarmellose, mannitol E421, sodium tripolyphosphate, and magnesium stearate.

coating: opadry Y-1-7000 (hypromellose, titanium dioxide E171, macrogol 400) and carnauba wax.

printing ink Opacode S-1-20986 blue: shellac, brilliant blue lacquer, titanium dioxide E171, propylene glycol, and concentrated ammonia solution.

Appearance of the product and contents of the pack

SPECTRACEF 400 mg is presented in the form of film-coated tablets. Each pack contains 10 tablets. Other presentations:

SPECTRACEF 200 mg film-coated tablets: pack with 16 or 20 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 leaflet:November 2020.

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