AMBEN Capsule, hard Ref.[28105] Active ingredients: Cefadroxil

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

In patients with a history of penicillin allergy, Amben should be used with caution. There is evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Should an allergic reaction to Amben occur, the drug should be discontinued and the patient treated with the usual agents (pressor amines, corticosteroids and/or antihistamines), depending on the severity of the reaction.

As experience in premature infants and neonates is limited, the use of Amben in these patients should only be undertaken with caution.

As with all antibiotics, prolonged use may result in overgrowth of non-susceptible organisms.

As with other broad spectrum antibiotics, pseudomembranous colitis has been reported. It is important to consider its diagnosis in patients who develop diarrhoea in association with Amben therapy.

Amben contains azorubine which may cause allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction

There are not sufficient data available to indicate whether the concurrent use of Amben and potential nephrotoxic agents such as aminoglycosides causes any alteration in their nephrotoxic effects.

The concomitant administration of probenecid reduces the renal elimination of cefadroxil; therefore, plasma concentrations of cefadroxil may be increased when given in combination with probenecid.

A false-positive Coombs' reaction may occur in some patients receiving Amben.

Urine from patients treated with Amben may give a false-positive glycosuria reaction when tested with Benedict’s or Fehling’s solutions. This does not occur with enzyme based tests.

4.6. Pregnancy and lactation

Pregnancy

Although animal studies and clinical experience have not shown any evidence of teratogenicity, the safe use of cefadroxil during pregnancy has not been established.

Breast-feeding

Amben is excreted in breast milk and should be used with caution in lactating mothers.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

The adverse events are ranked under headings of frequency, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Infections and infestations

Not known: genital moniliasis

Blood and lymphatic system disorders

Rare: Reversible neutropenia, leucopenia, thrombocytopenia, agranulocytosis

Immune system disorders

Common: hypersensitivity phenomena.

Rare: serum sickness, anaphylaxis.

Nervous system disorders

Not known: dizziness, headache

Gastrointestinal disorders

Common: The most commonly reported side-effects are gastrointestinal disturbances.

Rare: pseudo-membraneous colitis.

Not known: nausea, vomiting, diarrhoea, dyspepsia, abdominal discomfort, colitis

Hepatobiliary disorders

Rare: and minor elevations in serum transaminase

Skin and soft tissue infections

Rare: Rash, pruritus, urticaria, angioneurotic oedema, erythema multiforme, Stevens-Johnson syndrome.

Muskuloskeletal and connective tissue disorders

Not known: arthralgia

General disorders and administration site conditions

Not known: fever

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

6.2. Incompatibilities

None known.

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