MEDOCLOR Hard capsule, Granules for oral suspension Ref.[28300] Active ingredients: Cefaclor

• Medoclor is not suitable for the empiric treatment of respiratory infections because of the limited sensitivity of key-causing microorganisms.
• Before starting the treatment with cefaclor, the patient should be checked for a history of hypersensitivity reactions occurring on cephalosporins or βlactam antibiotics such as penicillins.
• Cephalosporin C derivatives should be administered with caution in patients who are hypersensitive to penicillin, since there are reports of a partial crossreactivity between penicillins and cephalosporins. Severe reactions (including anaphylaxis) have been observed with the combination. If a hypersensitivity reaction occurs with Medoclor, the administration of the drug should be discontinued and appropriate therapeutic measures should be taken. In case of peripheral corneal edema, the inflammatory reaction can be controlled by local treatment with corticosteroids.
• Prolonged treatment with Medoclor may lead to an excessive development of non-susceptible organism; therefore it is therefore very important to accurately monitor the state of the patient. If superinfection occurs during therapy, appropriate therapeutic measures should be taken.
• As for any medicine that is excreted by the kidney, there are theoretical arguments based on animal tests to check the kidney function on concomitant use of potentially nephrotoxic drugs such as strong diuretics furosemide and ethacrynic acid or aminoglycosides.
• Pseudomembranous colitis may occur during use of the antibiotics. It is therefore important to consider this diagnosis in patients who develop diarrhea during treatment with these medicines. In that case, appropriate measures should be taken.
• Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
• The safety and efficacy of cefaclor has not been established for children less than 1 month (see section 4.3).

• Treatment with cefaclor can prevent a false positive response to glucose in the urine with the use of copper reagents (e.g., Benedict or Fehling) and Clinitest tablets, but not with enzyme-based testing (Tes-Tape).
• A positive Coombs test can occur during treatment with cephalosporins. During blood tests or in the study of blood group compatibility in the case of blood transfusion (crossmatching with the anti-globulin) or when a Coombs 'test is carried out at a neonate which the mother before giving birth was treated with cephalosporins, this should be taken into account.
• In patients receiving cefaclor and warfarin there are reports of prolonged prothrombin time with or without clinical bleeding
• As with other beta.-lactam antibiotics, the renal excretion of cefaclor is inhibited by probenecid; as a result, there is a high concentration of antibiotic in the blood plasma.
• Oral contraceptives: Cefaclor may affect the efficacy of hormonal contraceptives. Therefore, it is advisable to supplementary use non-hormonal contraceptives.
• The absorption of cefaclor can be reduced by antacids.

Pregnancy

Extensive experience with the use of cefaclor in human pregnancy does not indicate an increased incidence of birth defects. There is no evidence of harm in animal experiments.

If cefaclor is indicated, it can be used during pregnancy.

Breast-feeding

Cefaclor is excreted in low concentrations in human milk. Cefaclor can be used while breastfeeding.

There are no data on the effect of cefaclor on the drive and the ability to operate machines.

The following side effects may occur with the use of cefaclor. Adverse reactions are ranked according to MedDRA system/organ classification. The frequency of each updating is displayed, using the following category classification:, 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 (can not be estimated from the available data/ post-marketing experience).

Infections and infestations

Uncommon: Moniliasis

Rare: Pseudomembranous colitis (see section 4.4)

Blood and lymphatic system disorders

Common: Eosinophilia

Uncommon: Neutropenia

Rare: agranulocytosis; hemolytic anemia; aplastic anemia; thrombocytopenia;

Unknown: leukopenia, lymphadenopathy; edema; vasodilatation

Immune system disorders

Common: Hypersensitivity reactions

Rare: Anaphylactic reaction; serum sickness (or serum sickness-like reactions, erythema multiforme in combination with arthralgia/arthritis and fever)

Nervous system disorders

Rare: Reversible hyperactivity; nervousness; insomnia; confusion; hypertonia; dizziness; hallucinations; sleep disorders; asthenia; syncope

Respiratory, thoracic and mediastinal disorders

Rare: Dyspnea; rhinitis

Gastrointestinal disorders

Common: Diarrhoea (the most common side effect, rarely severe enough to discontinue treatment); nausea

Uncommon: vomiting

Hepatobiliary disorders

Rare: cholestatic jaundice

Unknown: slight increase in AST, ALT and alkaline phosphatase values

Skin and subcutaneous tissue disorders

Common: (morbilliform) rash (this reaction usually disappears after discontinuation the treatment),

Uncommon: itching; urticaria (this reaction usually disappears after discontinuation of treatment)

Rare: Erythema multiforme; Stevens-Johnson syndrome; toxic epidermal necrolysis; angioedema; genital pruritus; vaginitis; vaginal moniliasis

Musculoskeletal and connective tissue disorders

Rare: Arthralgia; arthritis

Renal and urinary disorders

Rare: Reversible interstitial nephritis

Very rare: Presence of protein in the urine

General disorders and administration site conditions

Uncommon: Fever

Investigations

Common: Abnormal liver function tests (slight increase in SGOT and SGPT)

Uncommon: Abnormal renal function tests

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.

None known.