4.6 Pregnancy and lactation
  Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Limited data on the use of amoxicillin/clavulanic acid during pregnancy in humans do not indicate an increased risk of congenital malformations. In a single study in women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with amoxicillin/clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates. Use should be avoided during pregnancy, unless considered essential by the physician.

Lactation

Both substances are excreted into breast milk (nothing is known of the effects of clavulanic acid on the breast-fed infant). Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant, so that breast-feeding might have to be discontinued. Amoxicillin/clavulanic acid should only be used during breast-feeding after benefit/risk assessment by the physician in charge.
  

4.7 Effects on ability to drive and use machines
  No studies on the effects on the ability to drive and use machines have been performed. However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to drive and use machines (see section 4.8).
  

4.8 Undesirable effects
  The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.

The ADRs derived from clinical studies and post-marketing surveillance with Augmentin, sorted by MedDRA System Organ Class are listed below.

The following terminologies have been used in order to classify the occurrence of undesirable effects.

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
 
Mucocutaneous candidosis
 Common
 
Overgrowth of non-susceptible organisms
 Not known
 
Blood and lymphatic system disorders
 
Reversible leucopenia (including neutropenia)
 Rare
 
Thrombocytopenia
 Rare
 
Reversible agranulocytosis
 Not known
 
Haemolytic anaemia
 Not known
 
Prolongation of bleeding time and prothrombin time1
 Not known
 
Immune system disorders10
 
Angioneurotic oedema
 Not known
 
Anaphylaxis
 Not known
 
Serum sickness-like syndrome
 Not known
 
Hypersensitivity vasculitis
 Not known
 
Nervous system disorders
 
Dizziness
 Uncommon
 
Headache
 Uncommon
 
Reversible hyperactivity
 Not known