Olmesartan medoxomil 20mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Olmesartan medoxomil

Verfügbar ab:

Macleods Pharma UK Ltd

ATC-Code:

C09CA08

INN (Internationale Bezeichnung):

Olmesartan medoxomil

Dosierung:

20mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02050502; GTIN: 8901463122204

Gebrauchsinformation

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

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil 20 mg film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg Olmesartan Medoxomil.
Excipients- with known effect:
Each 10mg tablet contains 123.96 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round, biconvex, film coated tablets, debossed
with “IO3”
on one side and plain on other side. Diameter and thickness of the
film-coated
tablet is 8.5 mm ± 0.1 mm and 3.9 mm ± 0.3 mm respectively.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
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 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 in this patient group.