Spectracef 200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

SPECTRACEF 200 mg film-coated tablets

Cefditoren

Read the entire leaflet carefully before you start taking this medicine, because 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 you must not give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What SPECTRACEF 200 mg film-coated tablets is and what it is used for
2. What you need to know before taking SPECTRACEF 200 mg film-coated tablets
3. How to take SPECTRACEF 200 mg film-coated tablets
4. Possible adverse effects
5. How to store SPECTRACEF 200 mg film-coated tablets
6. Contents of the pack and other information

1. What SPECTRACEF 200 mg film-coated tablets is and what it is used for

SPECTRACEF belongs to a group of antibiotics called 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 influenza or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

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

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

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

2. What you need to know before starting to take SPECTRACEF 200 mg film-coated tablets

Do not take SPECTRACEF

• if you are allergic to antibiotics, particularly penicillin or other 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

Consult your doctor or pharmacist before starting to take SPECTRACEF

• 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 effects 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 SPECTRACEF 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 generalized exanthematous pustulosis. Stop using SPECTRACEF and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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

• The direct Coombs test.
• Urine glucose testing.

And false negatives in:

• Blood or plasma glucose testing.

Other medicines and SPECTRACEF

Tell 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 should elapse between administration of antacids and SPECTRACEF.

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

Concomitant administration of SPECTRACEF with intravenous famotidine is not recommended, as it may hinder 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 SPECTRACEF 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.

Administration of SPECTRACEF during pregnancy or breastfeeding is not recommended.

Driving and use of machinery

SPECTRACEF may cause dizziness and drowsiness, which could affect your ability to drive or operate any tools or machinery.

SPECTRACEF 200 mg film-coated tablets contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., essentially "sodium-free".

3. How to take SPECTRACEF 200 mg film-coated tablets

Follow exactly the instructions for use of this medicine as 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 take SPECTRACEF.

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

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

Adults and adolescents (over 12 years of age)

• 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:

  • In mild cases: 1 tablet (200 mg of cefditoren) every 12 hours for 14 days.
  • In 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 of age

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

Elderly patients

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

Patients with renal impairment

No dose adjustment is necessary in patients with mild renal dysfunction. In patients with moderate renal impairment, the dose should not exceed 1 tablet (200 mg of cefditoren) every 12 hours. In patients with severe renal impairment, a once-daily dose of 1 tablet (200 mg of cefditoren) is recommended. The appropriate dose has not been established in patients undergoing dialysis.

Patients with hepatic impairment

In mild or moderate hepatic impairment, no modification of the dosing regimen is necessary. In cases of severe hepatic impairment, there are no data available to allow a dosing recommendation.

If you take more SPECTRACEF than you should

If you have taken more SPECTRACEF than recommended, contact 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 medicine package and leaflet to the healthcare professional.

If you forget to take SPECTRACEF

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

If you stop taking SPECTRACEF

Do not discontinue treatment before completing the duration prescribed by your doctor, as there is a risk of disease relapse.

4. Possible adverse effects

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

Contact 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 occur 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, belching, dry mouth, and loss of taste
• Liver function abnormalities
• Skin rash, itching, and urticaria
• Vaginal inflammation and vaginal discharge
• Fever, weakness, and sweating
• Changes in blood cell counts (leukopenia and thrombocytosis), liver function test abnormalities (elevated ALT)

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

• Hemolytic anemia and lymph node abnormalities
• 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, inflammation and discoloration of the tongue, Clostridium difficile-associated diarrhea
• Acne, hair loss, eczema, exfoliative dermatitis (cracked and scaly skin), and herpes simplex
• 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 prothrombin time, platelet dysfunction), liver function test abnormalities (increased AST, alkaline phosphatase), changes in certain blood components (hyperglycemia, hypokalemia, bilirubinemia, elevated LDH, hypoproteinemia, elevated creatinine), or urine (albuminuria)

Frequency not known (cannot be estimated from available data):

• Pneumonia
• Skin redness
• Toxic epidermal necrolysis (a severe form of Stevens-Johnson syndrome followed by skin pain and peeling of the upper layer of skin)
• Acute kidney failure
• Anaphylactic shock
• Serum sickness reaction (delayed allergic skin reaction)
• Decrease in blood cells (agranulocytosis)
• Decreased blood carnitine levels
• Cholestasis (obstruction of bile flow from the liver)
• Aplastic anemia (reduction in blood cell counts)
• Liver damage
• Hepatitis
• Inflammation of the large intestine (colon). Symptoms include diarrhea, usually with blood and mucus, stomach pain, and fever.
• Kidney inflammation (tubulointerstitial nephritis)

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 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 SPECTRACEF 200 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 SPECTRACEF after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of SPECTRACEF 200 mg film-coated tablets

• The active substance is cefditoren. Each tablet contains 200 mg of cefditoren (as cefditoren pivoxil).

• The 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 lake, titanium dioxide E171, propylene glycol and concentrated ammonia solution.

Appearance of the product and contents of the pack

SPECTRACEF 200 mg is presented as film-coated tablets. Each pack contains 16 or 20 tablets.

Only certain pack sizes may be marketed.

Other presentations:

SPECTRACEF 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 most recent review of this leaflet: March 2026.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es