Olmetec 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Olmesartan medoxomil

Available from:

Daiichi Sankyo UK Ltd

ATC code:

C09CA08

INN (International Name):

Olmesartan medoxomil

Dosage:

40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502; GTIN: 5015494280406

Patient Information leaflet

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)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Olmetec Plus 40 mg/12.5 mg film-coated tablets
▼
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5
mg
hydrochlorothiazide.
Excipient(s) with known effect:
Each film-coated tablet contains 233.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets.
Reddish-yellow, oval, film-coated tablets of 15 x 7 mm with C23
debossed
on one side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmetec Plus 40 mg/12.5 mg and 40 mg/25 mg fixed dose combinations are
indicated
in adult patients whose blood pressure is not adequately controlled on
olmesartan
medoxomil 40 mg alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended dose of Olmetec Plus 40 mg/12.5 mg or 40 mg/25 mg is 1
tablet
per day.
Olmetec Plus 40 mg/12.5 mg may be administered in patients whose blood
pressure is
not adequately controlled by olmesartan medoxomil 40 mg alone.
Olmetec Plus 40 mg/25 mg may be administered in patients whose blood
pressure is
not adequately controlled on Olmetec Plus 40 mg/12.5 mg fixed dose
combination.
For convenience, patients receiving olmesartan medoxomil and
hydrochlorothiazide
from separate tablets may be switched to Olmetec Plus 40 mg/12.5 mg
and 40 mg/25
mg tablets containing the same component doses.
Olmetec Plus 40 mg/12.5 mg and 40 mg/25 mg can be taken with or
without food.
_Elderly (age 65 years or over) _
In elderly people the same dosage of the combination is recommended as
for adults.
Blood pressure should be closely monitored.
_Renal impairment _
Olmetec Plus is contraindicated in patients with severe renal
impairment (creatinine
clearance < 30 mL/min).
The maximum dose of olmesartan medoxomil in patients with mild to
moderate renal
impairment (creatinine clearance of 30 – 60 mL/min) is 20 mg
olmesartan medoxomil
once daily, owing to limited experience of hig