PIVMECILLINAM Film-coated tablet Ref.[8310] Active ingredients: Pivmecillinam

• Pseudomembranous colitis caused by Clostridium difficile may occur. If diarrhoea occurs after use, the possibility of pseudomembranous colitis should be considered, and appropriate precaution should be taken.
• Pivmecillinam Aurobindo should not be used by patients suffering from porphyria as pivmecillinam has been connected to acute attacks of porphyria.
• Concurrent treatment with valproic acid, valproate or other medication liberating pivalic acid should be avoided due to increased risk of carnitine depletion.
• Pivmecillinam hydrochloride film-coated tablets should be used with caution for long-term or frequently-repeated treatment, due to the possibility of carnitine depletion. Symptoms of carnitine depletion include muscle aches, fatigue, and confusion.
• The tablets must be taken with at least half a glass of fluid due to the risk of oesophageal ulceration.

• Simultaneous administration of probenecid reduces the excretion of mecillinam and hence increases the blood level of the antibiotic.
• Clearance of methotrexate from the body can be reduced by concurrent use of penicillins.
• Concurrent treatment with valproic acid, valproate or other medication liberating pivalic acid should be avoided due to increased risk of carnitine depletion.
• The bactericidal effect of mecillinam may be hindered by concurrent administration of products with bacteriostatic effect, for instance erythromycin and tetracyclines.

Pregnancy

A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of pivmecillinam/mecillinam. Pivmecillinam can be used during pregnancy if clinically needed.

Lactation

Mecillinam is excreted in human milk, but at therapeutic doses of Pivmecillinam no effects on the breast-fed newborns/infants are anticipated. Pivmecillinam can be used during breast-feeding.

Fertility

There are no clinical studies with Pivmecillinam hydrochloride regarding fertility. A pre-clinical study did not show an effect on fertility in rats.

Pivmecillinam hydrochloride has no or negligible influence on the ability to drive and use machines.

The estimation of the frequency of undesirable effects is based on an analysis of pooled data from clinical studies and spontaneous reporting.

The most frequently reported adverse reactions are nausea and diarrhoea.

Anaphylactic reactions and fatal pseudomembranous colitis (see section 4.4) have been reported.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

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

Infections and infestations

Common: Vulvovaginal mycotic infection

Uncommon: Clostridium difficile colitis

Blood and lymphatic system disorders

Uncommon: Thrombocytopenia

Immune system disorders

Uncommon: Anaphylactic reaction

Metabolism and nutrition disorders

Uncommon: Carnitine decreased

Nervous system disorders

Uncommon: Headache, Dizziness

Ear and labyrinth disorders

Uncommon: Vertigo

Gastrointestinal disorders

Common: Diarrhoea, Nausea

Uncommon: Vomiting, Abdominal pain, Dyspepsia, Oesophageal ulcer, Oesophagitis, Mouth ulceration

Hepatobiliary disorders

Uncommon: Hepatic function abnormal

Skin and subcutaneous tissue disorders

Uncommon: Rash*, Urticaria, Pruritis

General disorders and administration site conditions

Uncommon: Fatigue

* Various types of rash reactions such as erythematous, macular or maculo-papular skin reactions have been reported.

Class adverse reactions of beta-lactam antibiotics:

• Slight reversible increase in aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase, and bilirubin
• Neutropenia
• Eosinophilia

Paediatric population

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults, based on limited data.

Reporting of suspected adverse reactions

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not applicable.