Olmesartan medoxomil 10mg, 20mg & 40mg Film-coated tablets

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of essential hypertension in adults.
Treatment of hypertension in children and adolescents from 6 to less than 18 years of age.

Elderly (65 years or older)
No adjustment of dosage is generally required in older elderly people (see below for dose recommendations in patients with renal impairment). If up-titration to the maximum dose of 40 mg daily is required, blood pressure should be closely monitored.

Paediatric population

Children and adolescents from 6 to less than 18 years of age
The recommended starting dose of olmesartan medoxomil in children from 6 to less than 18 years of age is 10 mg olmesartan medoxomil once daily. In children whose blood pressure is not adequately controlled at this dose, the dose of olmesartan medoxomil may be increased to 20 mg once daily. If additional blood pressure reduction is required, in children who weigh > 35 kg, the olmesartan medoxomil dose may be increased to a maximum of 40 mg. In children who weigh < 35 kg, the daily dose should not exceed 20 mg.

Other paediatric population
The safety and efficacy of olmesartan in children aged 1 to 5 years old haveand adolescents below 18 years has not yet been established. Currently available data are described in sections 4.8, and 5.1 and 5.2 but no recommendation on a posology can be made.

4.4 Special warnings and precautions for use

Hyperkalaemia:
The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.

The risk, that may be fatal, is increased in olderelderly people, in patients with renal insufficiency and in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/or in patients with intercurrent events.

Sprue-like enteropathy:
In very rare cases severe, chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan few months to years after drug initiation, possibly caused by a localised delayed hypersensitivity reaction. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, and in the absence of other apparent etiologies, olmesartan treatment should be immediately discontinued and should not be restarted. If diarrhoea does not improve during the week after the discontinuation, further specialist (e.g. a gastro-enterologist) advice should be considered.exclude other aetiologies. Consider discontinuation of olmesartan medoxomil in cases where no other aetiology is identified. In cases where symptoms disappear and sprue-like enteropathy is confirmed by biopsy, treatment with olmesartan medoxomil should not be restarted.

4.5 Interaction with other medicinal products and other forms of interaction

Effects of olmesartan medoxomil on other medicinal products:

Paediatric population:
Interaction studies have only been performed in adults.
It is not known if the interactions in children are similar to those in adults.

4.8 Undesirable effects

Additional information on special populations
In olderelderly people the frequency of hypotension is slightly increased from rare to uncommon.

Paediatric population:
The safety of olmesartan was monitored in 361 children and adolescents, aged 1-17 years old during 2 clinical trials. Whilst the nature and severity of the adverse events are similar to that of the adults, the frequency of the following is higher in the children:

• Epistaxis is a common adverse event in children (i.e. ≥ 1/100 to < 1/10) that has not been reported in adults.

• During the 3 weeks of double blind study, the incidence of treatment emergent dizziness and headache nearly doubled in children 6-17 years of age in the high olmesartan dose group.

The overall safety profile for olmesartan medoxomil in paediatric patients does not differ significantly from the safety profile in adults.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Paediatric population:
The antihypertensive effects of olmesartan medoxomil in the paediatric population were evaluated in a randomised, double-blind, placebo-controlled study in 302 hypertensive patients aged 6 to 17 years. The study population consisted of an all black cohort of 112 patients and a mixed racial cohort of 190 patients, including 38 blacks. The aetiology of the hypertension was predominantly essential hypertension (87% of the black cohort and 67% of the mixed cohort). Patients who weighed 20 to <35 kg were randomised to 2.5 mg (low dose) or 20 mg (high dose) of olmesartan medoxomil once daily and patients who weighed ≥35 kg were randomised to 5 mg (low dose) or 40 mg (high dose) of olmesartan medoxomil once daily. Olmesartan medoxomil significantly reduced both systolic and diastolic blood pressure in a weight-adjusted dose-dependent manner. Olmesartan medoxomil at both low and high doses significantly reduced systolic blood pressure by 6.6 and 11.9 mmHg from the baseline, respectively. This effect was also observed during the 2 weeks randomised withdrawal phase, whereby both mean systolic and diastolic blood pressures demonstrated a statistically significant rebound in the placebo group compared to olmesartan medoxomil group. The treatment was effective in both, paediatric patients with primary and secondary hypertension. As observed in adult populations, the blood pressure reductions were smaller in black patients.

5.2 Pharmacokinetic properties

Pharmacokinetics in special populations

Elderly (age 65 years or older):
In hypertensive patients, the AUC at steady state was increased by ca 35% in olderelderly people (65 – 75 years old) and by ca 44% in very oldelderly people (≥ 75 years old) compared with the younger age group. This may be at least in part related to a mean decrease in renal function in this group of patients.

8.       MARKETING AUTHORISATION NUMBER(S)

 

PA0405/065/001

PA0405/065/002

PA0405/065/003

10. DATE OF REVISION OF THE TEXT

August 20167

None provided