Updated text highlighted in red.

3. PHARMACEUTICAL FORM

Film-coated tablet.

10mg:
Yellowish brown, round, biconvex film-coated tablet debossed with “LR over 1” on one side of the tablet and with a deep score line on the other side. 
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

20mg:
Pink, round, biconvex film-coated tablets, debossed with “LR over 2” on one side of the tablet and with a deep score line on the other side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4.1 Therapeutic indications

Lercanidipine Mylan is indicated in adults for the treatment of mild to moderate essential hypertension.

4.4 Special warnings and precautions for use

Following headings added:
Sick-sinus syndrome
Left ventricular dysfunction and ischaemic heart disease
Alcohol
Inducers of CYP3A4
Lercanidipine Mylan contains lactose

Section added:
Paediatric population
The safety and efficacy of lercanidipine has not been demonstrated in children.

4.5 Interaction with other medicinal products and other forms of interaction

Following headings added:
Inhibitors of CYP3A4
Ciclosporin
Grapefruit juice
Midazolam
Substrates of CYP3A4
Inducers of CYP3A4
Metoprolol
Fluoxetine
Cimetidine
Digoxin
Simvastatin
Warfarin
Diuretics and ACE inhibitors
Alcohol

Section added:
Paediatric population
Interaction studies have only been performed in adults.

4.6 Fertility, pPregnancy and lactation

Breast-feeding
It is unknown whether lercanidipine/metabolites are excreted in human milk. A risk in the newborns/infants cannot be excluded. Lercanidipine Mylan is contraindicated during breastfeeding (see section 4.3)

Fertility
No clinical data are available with lercanidipine. Reversible biochemical changes in the head of spermatozoa which can impair fecundation have been reported in some patients treated by channel blockers. In cases where repeated in-vitro fertilisation is unsuccessful and where another explanation cannot be found, the possibility of calcium channel blockers as the cause should be considered.

4.7 Effects on ability to drive and use machines

Lercanidipine has minor influence on the ability to drive and use machines.. However, caution should be exercised because dizziness, asthenia, fatigue and rarely somnolence may occur.

4.8 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)
Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness.

Nervous system disorders:
Rare: Somnolence
Very rare: Syncope

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2. Tel: +353 1 6764971; Fax: +353 1 6762517; website: www.hpra.ie; e-mail: medsafety@hpra.ie.

4.9 Overdose

In the post-marketing experience, some cases of overdose were reported (from 40 up to 800 mg of lercanidipine , including reports of suicide attempt).

Symptoms
As with other dihydropyridines, overdosage might be expected to cause excessive peripheral vasodilatation. Symptoms associated to overdose include  marked hypotension and reflex tachycardia.


5.1  Pharmacodynamic properties

following headings added:
Mechanism of action
Pharmacodynamic effects
Clinical efficacy and safety

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for human based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

6.5 Nature and contents of container

Cold form Al/OPA/PVC/Al blister packs containing 7, 14, 28, 35, 50, 56, 98 and 100 tablets.

HDPE bottle with opaque polypropylene cap with dessicant containing 500 and 1000 tablets.

Not all pack sizes may be marketed.

10. DATE OF REVISION OF THE TEXT

July 2015