OLMESARTAN MEDOXOMIL
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
17-02-2018
Summary of Product characteristics
(SPC)
17-02-2018
Active ingredient:
OLMESARTAN MEDOXOMIL
Available from:
Glenmark Pharmaceuticals Europe Limited
ATC code:
C09C
INN (International Name):
OLMESARTAN MEDOXOMIL
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Administration route:
Oral use
Units in package:
Packs of 28, 30, 56, 90 and 98 film-coated tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Manufactured by:
Glenmark Pharmaceuticals Europe Limited
Therapeutic group:
Angiotensin II antagonists
Therapeutic area:
ANGIOTENSIN II ANTAGONISTS, PLAIN
Therapeutic indications:
Treatment of essential hypertension in adults and treatment of hypertension in children and adolescents from 6 to less than 18 years of age
Authorization status:
Authorised
Authorization date:
2015-07-10
Patient Information leaflet
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
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
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 diet). Your doctor may also have urged you to
take regular exercise, such as walking or swimming. It is
important to follow this advice from your doctor.
2.
WHAT
YOU
NEED
TO
KNOW B
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil
Each film-coated tablet contains 10 mg olmesartan medoxomil.
Excipient with known effect:
Olmesartan medoxomil 10 mg film-coated tablets: each film-coated
tablet contains 75.41 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off white, round film-coated tablets, debossed with 476 on
one side and plain on the other side with a
characteristic odour, approx. 6.3 mm in diameter.
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 maximum dose of 40mg 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 dosages i
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