Olmesartan medoxomil 40mg film-coated tablets

País: Reino Unido

Língua: inglês

Origem: myHealthbox

Ingredientes ativos:

Olmesartan medoxomil

Disponível em:

Glenmark Pharmaceuticals Europe Limited

Código ATC:

C09CA08

DCI (Denominação Comum Internacional):

Olmesartan medoxomil

Dosagem:

40mg

Forma farmacêutica:

Film-coated tablets

Via de administração:

Oral use

Unidades em pacote:

Packs of 28, 30, 56, 90 and 98 film-coated tablets

Tipo de prescrição:

POM - Prescription Only Medicine

Fabricado por:

Glenmark Pharmaceuticals Europe Limited

Grupo terapêutico:

Angiotensin II antagonists

Indicações terapêuticas:

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

Status de autorização:

Authorised

Data de autorização:

2015-05-19

Folheto informativo - Bula

READ  ALL  OF  THIS  LEAFLET  CAREFULLY  BEFORE  YOU  START 
TAKING  THIS  MEDICINE  BECAUSE  IT  CONTAINS  IMPORTANT 
INFORMATION FOR YOU.
•  Keep this leaflet. You may need to read it again.
•  If you have any further questions, ask your doctor or
pharmacist.
•  This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
•  If  you  get  any  side  effects,  talk  to  your
 doctor  or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Olmesartan medoxomil is and what it is used for
2. What you need to know before you take Olmesartan
medoxomil
3. How to take Olmesartan medoxomil
4. Possible side effects
5. How to store Olmesartan medoxomil
6. Contents of the pack and other information
1.  WHAT  OLMESARTAN  MEDOXOMIL  IS  AND  WHAT  IT  IS 
USED FOR
Olmesartan medoxomil belongs to a group of medicines
called  angiotensin-II  receptor  antagonists.  They  lower
blood pressure by relaxing the blood vessels.
The  tablets  are  used  for  treating  high  blood  pressure
(hypertension) in adults and in children and adolescents
aged  6  to  less  than  18  years.  High  blood  pressure
 can
damage  blood  vessels  in  organs  such  as  the  heart,
kidneys, brain and eyes. In some cases this may lead to a
heart attack, heart or kidney failure, stroke or blindness.
Usually  high  blood  pressure  has  no  symptoms.  It  is
important to have your blood pressure checked to prevent
damage occurring.
High  blood  pressure  can  be  controlled  with  medicines
such  as  Olmesartan  medoxomil  .  Your  doctor  has
probably also recommended that you make some changes
in your lifestyle to help lower your blood pressure (for
example losing weight, giving up smoking, reducing the
amount of alcohol you drink and reducing the amount of
salt in your d

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Olmesartan medoxomil 40 mg film-coated tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Olmesartan medoxomil 
Each film-coated tablet contains 40 mg olmesartan medoxomil 

Excipient with known effect:  
Olmesartan medoxomil 40 mg film-coated tablets: each film-coated
tablet 
contains 301.65mg lactose monohydrate 

For the full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 

Film-coated tablet. 

Olmesartan medoxomil 40 mg are white to off white,
oval-shaped film-coated 
tablets debossed with 438 on one side and plain on the other
side with a 
characteristic odour, approx.15.3 mm in length and 7.2 mm in
breadth. 

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. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 
_ _
_Adults _
The recommended starting dose of olmesartan medoxomil is
10 mg once 
daily. In patients whose blood pressure is not
adequately controlled at this 
dose, the dose of olmesartan medoxomil may be increased to 20
mg once daily 
as the optimal dose. If additional blood pressure reduction
is required, 
olmesartan medoxomil dose may be increased to a maximum of
40 mg daily 
or hydrochlorothiazide therapy may be added.  

The antihypertensive effect of olmesartan medoxomil is
substantially present 
within 2 weeks of initiating therapy and is maximal by about 8
weeks after 
initiating therapy. This should be borne in mind when
considering changing 
the dose regimen for any patient. 
_ _
_Older people (65 years or older) _
No adjustment of dosage is generally required in older people (see
below for 
dose recommendations in patients with renal
impairment). If up-titration to the 
ma