Olmesartan medoxomil 10mg tablets

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Olmesartan medoxomil

Доступно од:

Milpharm Ltd

АТЦ код:

C09CA08

INN (Међународно име):

Olmesartan medoxomil

Дозирање:

10mg

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 02050502; GTIN: 8901175029402

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE
USER
OLMESARTAN 10 MG FILM-COATED
TABLETS
OLMESARTAN 20 MG FILM-COATED
TABLETS
OLMESARTAN 40 MG FILM-COATED
TABLETS
Olmesartanmedoxomil
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 is and what it is used
for
2.
What you need to know before you take
Olmesartan
3.
How to take Olmesartan
4.
Possible side effects
5.
How to store Olmesartan
6.
Contents of the pack and other
information
1.
WHAT OLMESARTAN IS AND WHAT IT IS
USED FOR
Olmesartan belongs to a group of medicines
called angiotensin-II receptor antagonists.
They lower blood pressure by relaxing the
blood vessels.
Olmesartan is used for the treatment of high
blood pressure (also known as “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 tablets. 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 diet). Your doctor may
also have urged you to take regular exercise,
such as wa

Карактеристике производа

OBJECT 1
OLMESARTAN 10 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 10-Nov-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Olmesartan 10 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg of olmesartan medoxomil
Excipient with known effect: Each film-coated tablet contains 65.250
mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Orange coloured, round shaped, biconvex, film-coated tablets debossed
with 'K' on one side and '17' on
the other side. The size is 6.7 mm.
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.
Elderly (65 years or over)
No adjustment of dosage is generally required in 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.
_Renal impairment _
The maximum dose in patients with mild to moderate renal impairment
(creatinine clearance of 20 – 60
mL/min) is 20 mg olmesartan medoxomil once daily, owing to limited
experience of highe