Olmesartan medoxomil 40mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Olmesartan medoxomil

Verfügbar ab:

Torrent Pharma (UK) Ltd

ATC-Code:

C09CA08

INN (Internationale Bezeichnung):

Olmesartan medoxomil

Dosierung:

40mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02050502; GTIN: 5060623370480

Gebrauchsinformation

OLMETEC
® 10 MG TABLETS
OLMESARTAN MEDOXOMIL 10MG TABLETS
OLMETEC
® 40 MG TABLETS
OLMESARTAN MEDOXOMIL 40MG TABLETS
(olmesartan medoxomil)
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.
Your medicine is known by the above names but will be referred to as
Olmetec throughout this leaflet.
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
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)

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil 40 mg film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg Olmesartan Medoxomil.
Excipients- with known effect:
Each 10mg tablet contains 247.92 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 “IO4”
on one side and plain on other side. Diameter and thickness of the
film-coated
tablet is 15.1 mm ± 0.1 mm, 7.0 mm ± 0.1 mm and 5.1 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 t