Lacidipine should only be used during breastfeeding when the potential benefits for the mother outweigh the possibility of adverse effects in the foetus or neonate.

4.7 Effects on ability to drive and use machines
MOTENS may cause dizziness. Patients should be warned not to drive or operate machinery if they experience dizziness or related symptoms.

4.8 Undesirable effects
MOTENS is generally well tolerated. Some individuals may experience minor side effects which are related to its known pharmacological action of peripheral vasodilation. Such effects, indicated by a hash (#), are usually transient and usually disappear with continued administration of MOTENS at the same dosage.

The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, ≤1/100), rare (≥1/10,000, ≤1/1000), very rare (≤1/10,000), not known (cannot be estimated from the available data). Adverse event frequencies have been estimated from spontaneous reports from post-marketing data.

Psychiatric disorders
 
Very rare:
 Depression
 
Nervous system disorders
 
Common:

Very rare:
 Dizziness#, headache#

Tremor
 
Cardiac disorders
 
Common:

Uncommon:
 Palpitations#, tachycardia

Syncope, angina pectoris
 
As with other dihydropyridines aggravation of underlying angina pectoris has been reported in a small number of individuals, especially at the start of treatment. This is more likely to happen in patients with symptomatic ischaemic heart disease. MOTENS should be discontinued under medical supervision in patients who develop unstable angina.

Vascular disorders
 
Common:

Uncommon:
 Flushing#

Hypotension
 
Gastrointestinal disorders
 
Common:

Uncommon:

 Abdominal discomfort, nausea

Gingival hyperplasia
 
Skin and subcutaneous tissue disorders
 
Common:

Rare:
 Rash, erythema, pruritus

Angioedema, urticaria
 
Musculoskeletal and connective tissue disorders
 
Rare:
 Muscle cramps
 
Renal and urinary disorders
 
Common:
 Polyuria
 
General disorders and administration site conditions
 
Common:
 Asthenia, oedema#
 
Investigations
 
Common:
 Blood alkaline phosphatase increased
 

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.

4.9 Overdose
Symptoms:

There have been no recorded cases of MOTENS overdosage. The expected symptoms could comprise prolonged peripheral vasodilation associated with hypotension and tachycardia. Bradycardia or prolonged AV conduction could occur.

Therapy:

There is no specific antidote. Standard general measures for monitoring cardiac function and appropriate supportive an