Label: Information for the User

SPECTRACEF 200 mg Film-Coated Tablets

Cefditoren

Read this label carefully before you start taking this medicine, because it contains important information for you.

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

• This medicine has been prescribed for you only, and you must not give it 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 label. See section 4.

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

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

• Acute pharyngoamigdalitis.
• 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.

Do not take SPECTRACEF

• If you are allergic to antibiotics, particularly penicillin or other types of antibiotics, 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 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 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 SPECTRACEF may lead to overgrowth of non-susceptible microorganisms, requiring interruption of treatment and initiation of appropriate therapy

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

• The direct Coombs test
• Urinary glucose determination

And false negatives in:

- Urinary glucose determination

Other medications and SPECTRACEF

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

A period of at least two hours is recommended between the administration of antacids and SPECTRACEF

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

The concomitant administration of SPECTRACEF with intravenous famotidine is not recommended, as it may make it difficult to achieve the necessary amount in the blood

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. SPECTRACEF is not recommended during pregnancy or breastfeeding

Driving and operating machinery

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

SPECTRACEF 200 mg film-coated tablets contain sodium

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

Follow exactly the administration instructions of this medication 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 whole tablets with a sufficient amount of liquid (a glass of water) during meals.

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

Adults and adolescents (over 12 years)

• Acute pharyngoamigdalitis: 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

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

Geriatric patients

No dose adjustments are required in elderly patients except in cases of advanced deterioration of hepatic and/or renal function.

Patients with renal insufficiency

No dose adjustment is required in patients with mild renal impairment. In patients with moderate renal insufficiency, do not exceed a dose of 1 tablet (200 mg of cefditoren) every 12 hours. In patients with severe renal insufficiency, a single 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, no treatment regimen modification is necessary. In cases of severe hepatic insufficiency, no dose recommendation is available.

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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet 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 compensate for the missed doses.

If you interrupt treatment with SPECTRACEF

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

Like all medicines, this medicine may 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 in every 100 people):

- Headache, nausea, abdominal pain, feeling of indigestion, and vaginal infection.

Uncommon (1 to 10 in every 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 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 in every 10,000 people):

• Hemolytic anemia and alteration of lymph nodes
• 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
• Alterations in heart rhythm, heart failure, and fainting
• Low blood pressure
• Asthma
• Mouth ulcers, stomatitis, hemorrhagic colitis, ulcerative colitis, gastrointestinal hemorrhage, hiccups, inflammation, and discoloration of the tongue, diarrhea associated with Clostridium difficile
• Acne, hair loss, eczema, dermatitis exfoliativa (scaly and cracked skin) and herpes simplex
• Muscle pain
• Painful urination, kidney inflammation, alterations in urination frequency, incontinence, and urinary tract infection
• Mastalgia, 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).

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

• 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 shedding of the upper layer of the skin)
• Acute renal failure
• Anaphylactic shock
• Serum disease reaction (late allergic skin reaction)
• Decrease in blood cells (agranulocytosis)
• Decrease in carnitine values in the blood
• Bile duct obstruction (cholestasis)
• Aplastic anemia (decrease in the number of blood cells)
• Liver damage
• Heptatitis.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side 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 above 30°C.

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

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines.By doing so, you will help protect the environment.

Composition of SPECTRACEF 200 mg film-coated tablets

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

• The other components are:

corecasein sodium, sodium croscarmellose, mannitol E421, tripolyphosphate sodium, and magnesium stearate.

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

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

Appearance of the product and contents of the packaging

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

Only some package sizes may be marketed.

Other presentations:

SPECTRACEF 400 mg film-coated tablets: each package contains 10 tablets.

Holder of the marketing authorization and responsible manufacturer:

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