Olmesartan medoxomil 20mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Olmesartan medoxomil

Prieinama:

Milpharm Ltd

ATC kodas:

C09CA08

INN (Tarptautinis Pavadinimas):

Olmesartan medoxomil

Dozė:

20mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02050502; GTIN: 8901175029419

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
(olmesartan medoxomil)
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.
The name of your medicine is Olmetec 20mg Tablets
but it will be referred to as Olmetec throughout this
leaflet. Please note that the leaflet also contains
information about other strengths Olmetec 10mg and
40mg Tablets.
WHAT IS IN THIS LEAFLET
1.
What Olmetec is and what it is used for
2.
What you need to know before you take Olmetec
3.
How to take Olmetec
4.
Possible side effects
5.
How to store Olmetec
6.
Contents of the pack and other information
1.
WHAT OLMETEC IS AND WHAT IT IS USED
FOR
Olmetec belongs to a group of medicines called
angiotensin-II receptor antagonists. They lower blood
pressure by relaxing the blood vessels.
Olmetec 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 Olmetec. 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

Prekės savybės

OBJECT 1
OLMESARTAN 20MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 10-Nov-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Olmesartan 20 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 20 mg of olmesartan medoxomil
Excipient with known effect: Each film-coated tablet contains 130.500
mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White coloured, round shaped, biconvex, film-coated tablets debossed
with 'K' on one side and '18' on the
other side. The size is 8.6 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 higher