Performer

Package Leaflet

PERFORMER 250mg/5ml GRANULES FOR ORAL SUSPENSION

cefaclor (monohydrate)

Package Leaflet

PERFORMER 750 mg MODIFIED-RELEASE TABLETS

cefaclor (monohydrate)
THERAPEUTIC PHARMACOLOGICAL CATEGORY
Oral antibiotic belonging to the cephalosporin class.
THERAPEUTIC INDICATIONS
PERFORMER 750 mg modified-release tablets are indicated for the treatment of severe forms of the following infections:

• Acute bronchitis and acute exacerbation of chronic bronchitis;
• Pharyngitis and tonsillitis;
• Skin and soft tissue infections;
• Uncomplicated lower urinary tract infections.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients, or to other cephalosporins or penicillins.
PRECAUTIONS FOR USE
Before initiating therapy with PERFORMER, careful investigation should be carried out to determine whether the patient has a history of hypersensitivity reactions to cephalosporins, penicillins, or other drugs.
Severe reactions (including anaphylaxis) have occurred in patients following administration of penicillins or cephalosporins, including Cefaclor. These IgE-mediated reactions usually manifest at the cutaneous, gastrointestinal, respiratory, and cardiovascular levels.
Symptoms may include: severe and sudden hypotension, tachycardia or bradycardia, unusual fatigue or weakness, anxiety, restlessness, dizziness, loss of consciousness, difficulty breathing or swallowing, generalized pruritus—especially on the soles of the feet and palms of the hands—urticaria with or without angioedema (swollen and itchy skin areas, most frequently located on extremities, external genitalia, and face, particularly around eyes and lips), skin redness especially around the ears, cyanosis, profuse sweating, nausea, vomiting, cramp-like abdominal pain, and diarrhea.
If an allergic reaction to PERFORMER occurs, discontinue administration of the drug.
Broad-spectrum antibiotic therapy, including PERFORMER, alters the normal colonic flora and may lead to overgrowth of Clostridia.
Multiple studies have demonstrated that a toxin produced by Clostridium difficile is the primary cause of severe antibiotic-associated diarrhea, including pseudomembranous colitis.
Therefore, this diagnosis should be considered in patients who develop diarrhea during therapy with these antibiotics.
As with other antibiotics, during treatment with PERFORMER, the possible emergence of resistant microorganisms should be taken into account, which may lead to superinfection requiring appropriate management.
Use in neonates
Efficacy and tolerability in children have not been well established.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those not requiring a prescription.
The extent of absorption of PERFORMER decreases if antacids containing magnesium or aluminum hydroxide are administered within one hour of taking the antibiotic. H₂-receptor antagonists do not alter the rate or extent of PERFORMER absorption.
After administration of Cefaclor, false-positive urinary glucose tests may occur when using Benedict's or Fehling's solutions or Clinitest, but not with Tes-Tape (urine glucose test strip, Lilly).
Like other beta-lactams, renal excretion of PERFORMER is inhibited by probenecid. No other clinically significant drug interactions have been observed in clinical studies.
SPECIAL WARNINGS
Use during pregnancy and breastfeeding
There are no specific, well-controlled studies in pregnant women, and since animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly necessary.
The use of PERFORMER 750 during labor and delivery has not been studied; therefore, the drug should be administered only if clearly needed.
Small amounts of Cefaclor have been detected in breast milk after single 500 mg doses. Caution is recommended when administering this drug during breastfeeding.
Effects on ability to drive and use machines
PERFORMER has no effect on the ability to drive or operate machinery.
DOSAGE, ADMINISTRATION, AND DURATION
PERFORMER is administered orally and may be taken regardless of meals. However, concomitant food intake increases the absorption of PERFORMER. Tablets must be swallowed whole and should not be split, crushed, or chewed.
The following dosage regimens are recommended:

• Pharyngitis, tonsillitis, and skin and soft tissue infections: 750 mg twice daily.
• Uncomplicated lower urinary tract infections: 750 mg twice daily.
• Bronchitis: 750 mg twice daily. In the treatment of infections caused by S. pyogenes (group A streptococci), therapy with PERFORMER should continue for 10 days.

Instructions for use
PERFORMER is administered orally and may be taken regardless of meals. Tablets must be swallowed whole and should not be split, crushed, or chewed.
OVERDOSAGE
Signs and symptoms:
Toxic symptoms following PERFORMER overdose may include nausea, vomiting, gastric disturbances, and diarrhea.
Treatment:
In addition to general supportive measures, intestinal absorption may be reduced by inducing emesis, gastric lavage, or administering activated charcoal.
Forced diuresis, peritoneal dialysis, hemodialysis, or hemoperfusion have not proven beneficial in accelerating PERFORMER elimination.
In case of accidental ingestion or overdose of PERFORMER, contact your doctor immediately or go to the nearest hospital.
ADVERSE REACTIONS
Like all medicines, PERFORMER can cause adverse reactions, although not everyone experiences them.
Following oral administration of PERFORMER in clinical trials, few adverse effects have been reported (with incidence generally less than 1%), most of which were mild and transient.
Gastrointestinal manifestations: diarrhea, nausea, vomiting, dyspepsia.
Allergic manifestations: skin rash, urticaria, and pruritus have been reported. In controlled clinical trials involving 3,272 patients treated with PERFORMER, a serum-sickness-like reaction (0.03%) was observed, characterized by the appearance of erythema multiforme, skin rash, and other cutaneous manifestations associated with arthritis/ararthralgia, with or without fever. These manifestations typically occur during or after a course of Cefaclor therapy and have been observed more frequently in children than in adults. Signs and symptoms usually appear a few days after starting treatment and resolve a few days after discontinuation. Antihistamines and corticosteroids may aid recovery. No serious complications have been reported.
Lymphatic and circulatory system: eosinophilia.
Genitourinary system: vaginal candidiasis and vaginitis.
The following adverse events, whose causal relationship to the drug is uncertain, have been observed in patients treated with PERFORMER: headache, dizziness, somnolence, transient increases in transaminases and alkaline phosphatase, transient increases in blood urea nitrogen and creatinine, transient thrombocytopenia, leukopenia, lymphocytosis, neutropenia, and urinary abnormalities.
In patients treated with Cefaclor, the following have occasionally been observed: erythema multiforme, fever, anaphylaxis (more frequent in patients with a history of penicillin allergy), Stevens-Johnson syndrome, positive direct Coombs test, genital pruritus, toxic epidermal necrolysis, reversible interstitial nephritis, impaired liver function including cholestasis, prolonged prothrombin time in patients concurrently receiving Cefaclor and Warfarin, reversible hyperactivity, nervousness, insomnia, confusion, hypertonia, aplastic anemia, agranulocytosis, and hemolytic anemia.
Antibiotic therapy with broad-spectrum agents may alter intestinal bacterial flora, occasionally leading to pseudomembranous colitis.
Anaphylactoid reactions may present as isolated manifestations, including angioedema, asthenia, edema (facial or limb), dyspnea, paresthesia, syncope, and vasodilation.
Following the instructions in the package leaflet reduces the risk of adverse reactions.
If any of the listed adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product stored in unopened, properly preserved packaging.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
COMPOSITION
Each tablet contains:
Active substance: Cefaclor monohydrate equivalent to Cefaclor 750 mg
Excipients: Hypromellose, mannitol, povidone, magnesium stearate, colloidal silicon dioxide, propylene glycol, titanium dioxide.
PHARMACEUTICAL FORM AND CONTENT
Modified-release tablets in boxes of 6 and 12 tablets.
MARKETING AUTHORIZATION HOLDER
PIAM Farmaceutici S.p.A. – Via Padre G. Semeria, 5 – 16131 Genoa
MANUFACTURER
FACTA Farmaceutici S.p.A. – Via Laurentina Km 24.730 – Pomezia (ROME)
April 2012