Valechlor

PACKAGE LEAFLET

VALECLOR 250 mg/5 ml GRANULES FOR ORAL SUSPENSION

Cefaclor
PHARMOTHERAPEUTIC CATEGORY
Oral antibiotic (cephalosporins).
THERAPEUTIC INDICATIONS
Treatment of the following infections caused by susceptible organisms:

• Respiratory tract infections, such as pneumonia, bronchitis, acute exacerbations of chronic bronchitis, pharyngitis and tonsillitis.
• Otitis media (bacterial inflammatory processes affecting the middle ear).
• Skin and soft tissue infections.
• Urinary tract infections, including pyelonephritis and cystitis.
• Sinusitis.
• Gonococcal urethritis.

CONTRAINDICATIONS
Cefaclor is contraindicated in patients with known hypersensitivity to cephalosporins and to any of the other components of the product. The granules for oral suspension contain sucrose; therefore, if your doctor has diagnosed you with an intolerance to certain sugars, you should contact him/her before taking this medicine.

PRECAUTIONS FOR USE
Before starting therapy with cefaclor, it is recommended to investigate any previous history of hypersensitivity reactions to cephalosporins and penicillins. If allergic reactions occur, administration of the drug must be discontinued and the patient appropriately treated.
Severe reactions (including anaphylaxis) have been reported in patients receiving penicillins or cephalosporins, including Cefaclor. These IgE-mediated reactions usually manifest at 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 in breathing or swallowing, generalized pruritus especially on the soles of the feet and palms of the hands, urticaria with or without angioedema (swollen, itchy skin areas most commonly located on extremities, external genitalia, and face, particularly around the eyes and lips), skin redness especially around the ears, cyanosis, profuse sweating, nausea, vomiting, cramp-like abdominal pain, diarrhea.
Pseudomembranous colitis may occur during treatment with broad-spectrum antibiotics (including macrolides, semisynthetic penicillins, and cephalosporins); therefore, its development should be considered during treatment with these drugs.
Cefaclor should be administered with caution in patients with severely impaired renal function. In such cases, dosage should be lower than that generally recommended.
Broad-spectrum antibiotics should be administered with caution in patients with a history of intestinal disorders due to the possibility of developing antibiotic-associated colitis.
Prolonged use of cefaclor may lead to overgrowth of non-susceptible organisms; if bacterial superinfection occurs during cefaclor therapy, it should be appropriately managed.
Use in neonates
The efficacy and tolerability of cefaclor in neonates under one month of age have not been established.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
There is evidence of partial cross-allergenicity between penicillins and cephalosporins.
After administration of cefaclor, false positive results for urinary glucose may occur when using Benedict's or Fehling's solutions or Clinitest, but not with Tes-Tape (urine glucose test strip, Lilly). Positive Coombs test results (sometimes false positives) have been reported during treatment with cephalosporins. Renal excretion of cefaclor is inhibited by probenecid (an antigout drug that promotes uric acid excretion).

SPECIAL WARNINGS
Cefaclor has no effect on the ability to drive or use machinery.

Use during pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
The tolerability of Cefaclor during pregnancy has not been sufficiently proven.
In pregnant women, the drug should be used only if clearly needed and under direct medical supervision.
Small amounts of Cefaclor have been found in breast milk after single 500 mg doses. Caution is recommended when administering this drug during breastfeeding.

Keep out of the reach of children.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Cefaclor is administered orally and may be taken independently of meals.
Adults: 250 mg every 8 hours; higher doses may be required in more severe infections. The maximum recommended dose is 2 g per day.
For the treatment of acute gonococcal urethritis in both sexes, a single dose of 3 g of cefaclor is recommended, possibly in combination with 1 g of probenecid.
Children: 20 mg/kg/day in divided doses every 8 hours; in more severe infections (such as otitis media), a dosage of 40 mg/kg/day is recommended, up to a maximum daily dose of 1 g.
Alternative dosing: In otitis media and pharyngitis, the total daily dose may be administered in divided doses every 12 hours.

Instructions for use

In pharyngitis and otitis media, the total daily dose may be administered in divided doses every 12 hours. For example, the following scheme refers to a daily dose of 40 mg/kg:

The tables refer to the maximum daily dosage of 40 mg/kg; doses of 20 mg/kg per day correspond to half of the values reported above.
Instructions for use of VALECLOR 250 mg/5 ml GRANULES FOR ORAL SUSPENSION:

• shake the bottle well before adding water to facilitate dispersion of the granules;
• then add water up to the level indicated by the arrow on the label;
• close the bottle and shake well until the suspension becomes homogeneous; the volume will decrease below the level indicated by the arrow;
• add water again to bring the volume back up to the level indicated by the arrow on the label;
• shake well until a uniform suspension is obtained.

If prepared according to these instructions, 5 ml of the suspension will contain 250 mg of cefaclor.
Shake the suspension well before each administration.

OVERDOSE
In case of accidental ingestion/overdose of VALECLOR, contact your doctor immediately or go to the nearest hospital.

Signs and symptoms: may include nausea, vomiting, epigastric disturbances, and diarrhea, the severity of which is related to the dose ingested. If other symptoms are present, they are likely secondary to a pre-existing condition, an allergic reaction, or another toxic state.

Treatment: always consider the possibility that overdose may be caused by multiple drugs, drug interactions, or the patient's particular pharmacokinetics.
Gastric lavage is not necessary when the patient has not ingested a dose of cefaclor five times higher than the recommended dose.
The patient should be closely monitored, with particular attention paid to airway patency, ensuring adequate ventilation and perfusion, vital signs (heart rate and blood pressure), blood gas analysis, serum electrolytes, etc.
Intestinal absorption may be reduced by administering activated charcoal, which in many cases is more effective than induced emesis or gastric lavage; therefore, consider activated charcoal as an alternative or additional treatment to gastric emptying. Repeated administration of activated charcoal may enhance the elimination of other drugs that may have been ingested. Carefully monitor the patient's airway during gastric emptying and when using activated charcoal.
It is not known whether forced diuresis, peritoneal dialysis, hemodialysis, or hemoperfusion with charcoal are beneficial to the patient.

UNDESIRABLE EFFECTS
Like all medicines, VALECLOR can cause undesirable effects, although not everyone experiences them.

Adverse reactions considered related to cefaclor treatment include:

Allergic manifestations: hypersensitivity reactions (1.5%) have been observed, including morbilliform rashes (1%); pruritus, urticaria, and positive Coombs test occur in fewer than 1 in 200 treated patients.
Generalized reactions known as "serum sickness-like" diseases have also been reported, characterized by the presence of erythema multiforme, skin eruptions, and other skin manifestations, accompanied by arthritis and/or arthralgia (inflammatory or painful joint disorders), with or without fever. "Serum sickness-like" reactions occur more frequently during and after a course of treatment with cefaclor, and more often in children than in adults.
Signs and symptoms appear a few days after starting therapy and resolve a few days after its completion. Antihistamines and corticosteroids promote recovery. No severe complications have been observed.
More severe hypersensitivity reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis) have been observed rarely.

Gastrointestinal manifestations: may occur in approximately 2.5% of patients, sometimes with the onset of diarrhea.
Pseudomembranous colitis may be observed during and after antibiotic treatment.
Nausea and vomiting are rarely observed. With some penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have rarely been observed.

Other manifestations: angioedema (abnormal fluid retention in tissues of allergic origin), eosinophilia, genital pruritus, vaginal moniliasis, vaginitis, and, rarely, thrombocytopenia and reversible interstitial nephritis.
Cases of hemolytic anemia have been reported following treatment with cephalosporins.

Effects for which a definite relationship to treatment is uncertain.

Central nervous system: rarely reversible hyperactivity, restlessness, insomnia, mental confusion, hypertonia (increased muscle tone), hallucinations, dizziness and unsteadiness, somnolence.

Digestive system: mild increases in transaminase values (SGOT and SGPT) or alkaline phosphatase.

Hemolymphatic system: transient lymphocytosis, leukopenia, and, rarely, aplastic anemia, agranulocytosis, and reversible neutropenia. There have been rare reports of increased prothrombin time, with or without clinical consequences (e.g., bleeding), in patients receiving cefaclor and sodium warfarin (antithrombotic drug) concomitantly.

Genitourinary system: mild increases in blood urea nitrogen, serum creatinine, and changes in urine analysis.

Following the instructions contained in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsen, or if you notice any undesirable effect not listed in this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE
EXPIRY DATE: SEE THE EXPIRY DATE ON THE PACKAGING.
THE EXPIRY DATE APPLIES TO THE PRODUCT IN UNOPENED PACKAGING,
PROPERLY STORED.
WARNING: DO NOT USE THE MEDICINE AFTER THE EXPIRY DATE STATED ON THE PACKAGING.
Once prepared, the suspension must be stored in the refrigerator between 2°C and 8°C and used within 14 days.

MEDICINES MUST NOT BE DISPOSED OF VIA SEWAGE OR HOUSEHOLD WASTE. ASK YOUR PHARMACIST HOW TO DISPOSE OF MEDICINES YOU NO LONGER USE. THIS WILL HELP PROTECT THE ENVIRONMENT.

KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.

COMPOSITION
VALECLOR 250 mg/5 ml GRANULES FOR ORAL SUSPENSION
5 ml of suspension contain:
Active substance:
Cefaclor monohydrate equivalent to Cefaclor: 250 mg
Excipients:
dimethicone 350, xanthan gum, pregelatinized starch, black cherry flavor, sodium lauryl sulfate, methylcellulose 15, sucrose.

PHARMACEUTICAL FORM AND CONTENT
Granules for oral suspension. 100 ml bottle

MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Siar Pharma S.r.l.
Via Verdi, 33
Bussero (Milan)
Manufacturer
ACS DOBFAR S.p.A.
Via Laurentina KM. 24.730
00071 Pomezia (RM)
Italy

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY: .