LIVAZO Film-coated tablet Ref.[8040] Active ingredients: Pitavastatin

Posology

Patients should be on a cholesterol lowering diet before treatment. It is important that all patients continue dietary control during treatment.

The usual starting dose is 1mg once daily. Adjustment of dose should be made at intervals of 4 weeks or more. Doses should be individualized according to LDL-C levels, the goal of therapy and patient response. The maximum daily dose is 4mg.

Elderly

No dose adjustment necessary in patients older than 70 years (see section 5.1 and section 5.2).

Paediatric population

Children and adolescents aged 6 years and over

Livazo use in children should only be carried out by physicians experienced in the treatment of hyperlipidaemia and progress should be regularly reviewed.

In children and adolescents with heterozygous familial hypercholesterolaemia the usual starting dose is 1mg once daily. Adjustment of dose should be made at intervals of 4 weeks or more. Doses should be individualized according to LDL-C levels, the goal of therapy and patient response. In children 6 to 9 years of age the maximum daily dose is 2mg. In children 10 years or older the maximum daily dose is 4mg (see sections 4.8, 5.1 and 5.2).

Children younger than 6 years of age

The safety and efficacy of Livazo in children below 6 years of age has not been established and no data are available.

Patients with impaired renal function

No dosage adjustment is required in mild renal impairment but pitavastatin should be used with caution. Data with 4mg dose are limited in all grades of impaired renal function. Therefore 4mg dose should ONLY be used with close monitoring after graded dose titration. In those with severe renal impairment 4mg dose is not recommended (see section 4.4 and section 5.2).

Patients with mild to moderate impaired hepatic function

The 4mg dose is not recommended in patients with mild to moderate impaired hepatic function. A maximum daily dose of 2mg may be given with close monitoring (see section 4.4 and section 5.2).

Method of Administration

For oral use only and should be swallowed whole. Livazo can be taken at any time of the day with or without food. It is desirable that the patient takes the tablet at the same time each day. Statin therapy is generally more effective in the evening due to the circadian rhythm of lipid metabolism.

If a child or adolescent is unable to swallow the tablet, where necessary, the tablet may be dispersed in a glass of water and taken immediately. To ensure accurate dosage a second volume of water should be used to rinse the glass and swallowed immediately. Tablets must not be dispersed in either acidic fruit juices or milk.

There is no specific treatment in the event of overdose. The patient should be treated symptomatically and supportive measures instituted as required. Liver function and CK levels should be monitored. Haemodialysis is unlikely to be of benefit.

5 years.

Do not store above 25ºC.

To protect from light keep blister in the outer carton.

1mg: White PVdC coated PVC/AL blisters in cartons of 7, 28, 30, 90 or 100 tablets. Not all pack sizes may be marketed.

2mg: White PVdC coated PVC/AL blisters in cartons of 7, 28, 30, 90 or 100 tablets. Not all pack sizes may be marketed.

4mg: White PVdC coated PVC/AL blisters in cartons of 7, 28 or 30 tablets. Not all pack sizes may be marketed.

To protect the environment, do not dispose of via waste water or household waste.