FELEXIN Powder for oral suspension (2018)

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Περιεχόμενα

1. Name of the medicinal product

Felexin 125 mg/5 ml powder for oral suspension. Felexin 250 mg/5 ml powder for oral suspension.

2. Qualitative and quantitative composition

Felexin 125 mg/5 ml powder for oral suspension: Each 5 ml of oral suspension contains cefalexin monohydrate equivalent to 125 mg cefalexin. Felexin 250 mg/5 ml powder for oral suspension: Each 5 ml of ...

3. Pharmaceutical form

Powder for oral suspension. Felexin 125 mg/5 ml powder for oral suspension: White powder that after reconstitution gives a pink, flavoured suspension. Felexin 250 mg/5 ml powder for oral suspension: ...

4.1. Therapeutic indications

Felexin is indicated in the treatment of the following infections: Respiratory tract infections Otitis media Skin and soft tissue infections Bone and joint infections Genito-urinary tract infections, including ...

4.2. Posology and method of administration

Posology Adults The adult dosage ranges from 1-4 g daily in divided doses; most infections will respond to a dosage of 500 mg every 8 hours. For skin and soft tissue infections, streptococcal pharyngitis, ...

4.3. Contraindications

Felexin is contra-indicated in patients with known allergy to the cephalosporin group of antibiotics.

4.4. Special warnings and precautions for use

Before instituting therapy with cefalexin, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to the cephalosporins, penicillins, or other drugs. Cefalexin ...

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

As with other beta-lactam drugs, renal excretion of cefalexin is inhibited by probenecid. In a single study of 12 healthy subjects given single 500 mg doses of cefalexin and metformin, plasma metformin ...

4.6. Pregnancy and lactation

Pregnancy Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing Felexin in pregnant women. Breast-feeding The excretion of cefalexin ...

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Gastro-intestinal Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Nausea and vomiting have been reported rarely. The most frequent side-effect has been diarrhoea. ...

4.9. Overdose

Symptoms of oral overdosage may include nausea, vomiting, diarrhoea, epigastric distress and haematuria. In the event of severe overdosage, general supportive care is recommended, including close clinical ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use; Other beta-lactam antibacterials ATC code: J01DB01 In vitro tests demonstrate that cephalosporins are bactericidal because ...

5.2. Pharmacokinetic properties

Cefalexin is acid stable and may be given without regard to meals. Cefalexin is almost completely absorbed from the gastro-intestinal tract, and 75-100% is rapidly excreted in active form in the urine. ...

5.3. Preclinical safety data

The daily oral administration of cefalexin to rats in doses of 250 or 500 mg/Kg prior to and during pregnancy, or to rats and mice during the period of organogenesis only had no adverse effects on fertility, ...

6.1. List of excipients

Felexin 125 mg/5 ml powder for oral suspension: Sodium Benzoate Disodium Edetate Xanthan Gum Silica, colloidal anhydrous Apricot flavour liquid Carmoisine azorubine E122 Sucrose Povidone Felexin ...

6.2. Incompatibilities

None known.

6.3. Shelf life

3 years. Shelf life after reconstitution: store the reconstituted suspension up to 14 days in a refrigerator.

6.4. Special precautions for storage

Store below 25°C. Protect from light and moisture.

6.5. Nature and contents of container

Amber glass bottles with aluminium closure. A measuring spoon of 5 ml (graduated every 2.5 ml) is supplied with this pack. Pack-size of 100 ml oral suspension.

6.6. Special precautions for disposal and other handling

Directions for reconstitution: Check that the bottles cap is intact before use. Shake to loosen powder. Add water up to the bottle line, invert the bottle, tap until the powder falls in the water ...

7. Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

Felexin 125 mg/5 ml powder for oral suspension: 19757 Felexin 250 mg/5 ml powder for oral suspension: 8572

9. Date of first authorization / renewal of the authorization

Felexin 125 mg/5 ml powder for oral suspension: Date of first authorization: 8 December 2005 Date of latest renewal: 12 September 2011 Felexin 250 mg/5 ml powder for oral suspension: Date ...

10. Date of revision of the text

04/06/2018

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