Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3506 Limassol, Cyprus
Hypersensitivity to the active substance, to other penicillins or to any of the excipients is listed in section 6.1.
Cross allergy between penicillins and cephalosporins occurs. Diarrhoea/pseudomembranous colitis caused by Clostridium difficile occurs. Patients with diarrhoea should be carefully monitored.
Penopen 250 mg film-coated tablets contain sunset yellow FCF aluminium lake E110 which may cause allergic reactions.
The following combinations with Penopen may require dose adjustment: methotrexate.
A serious case with severe toxic reaction to methotrexate has been described in which the patient was treated with furosemide and penicillin V, organic acids that can inhibit the tubular secretion of methotrexate. A suspected interaction is also described by the combination of methotrexate and mezlocillin, as well as another case, after the combination of methotrexate and amoxicillin.
Probenecid delays the renal excretion of penicillin, which can give higher serum concentrations of phenoxymethylpenicillin for a longer time.
Extensive clinical data suggest that phenoxymethylpenicillin does not increase the risk of foetal harm.
Phenoxymethylpenicillin passes into breast milk, but the risk of affecting the child seems unlikely with therapeutic doses.
Penopen has no effect on the ability to drive and use machines.
Approximately 5% of patients can be expected to experience adverse reactions.
The most common are gastrointestinal problems with loose stools.
The calculated frequencies of the side effects are ranked as follows: Common (>1/100, <1/10); Uncommon (>1/1000, <1/100); Rare (>1/10 000, <1/1000); Very rare (<1/10 000).
| Blood and lymphatic system disorders | Uncommon | Eosinophilia. |
| Gastrointestinal disorders | Common | Loose stools, nausea. |
| Skin and subcutaneous tissue disorders | Common Uncommon Very rare | Rash. Urticaria. Itching. |
| Immune System | Uncommon Rare | Generalised hypersensitivity reaction with fever and/or joint pain. Anaphylactic reaction. |
Fungal overgrowth in the mouth and genital area may occur.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.
None.
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