OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE ACCORD

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OLMESARTAN MEDOXOMIL ; HYDROCHLOROTHIAZIDE EP

Available from:

Accord Healthcare Limited

ATC code:

C09DA08

INN (International Name):

OLMESARTAN MEDOXOMIL ; HYDROCHLOROTHIAZIDE EP

Dosage:

40/12.5 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

olmesartan medoxomil and diuretics

Authorization status:

Authorised

Authorization date:

2017-08-18

Patient Information leaflet

FRONT SIDE
DUMMY
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DUMMY
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Olmesartan Medoxomil/
Hydrochlorothiazide
40 mg/12.5 mg film-coated
tablets
Olmesartan Medoxomil/
Hydrochlorothiazide
40 mg/25 mg film-coated
tablets
Olmesartan Medoxomil/Hydrochlorothiazide
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/Hydrochlorothiazide tablets
are and what they are used for
2. What you need to know before you take Olmesartan
Medoxomil/Hydrochlorothiazide tablets
3. How to take Olmesartan Medoxomil/Hydrochlorothiazide
tablets
4. Possible side effects
5. How to store Olmesartan Medoxomil/Hydrochlorothiazide
tablets
6. Contents of the pack and other information 1.
WHAT OLMESARTAN MEDOXOMIL/
HYDROCHLOROTHIAZIDE TABLETS ARE AND
WHAT THEY ARE USED FOR
Olmesartan Medoxomil/Hydrochlorothiazide tablets contains
two active substances, olmesartan medoxomil and
hydrochlorothiazide, that are used to treat high blood pressure
(hypertension):
•
Olmesartan medoxomil is one of a group of medicines called
angiotensin II-receptor antagonists. It lowers blood pressure
by relaxing the blood vessels.
•
Hydrochlorothiazide is one of a group of medicines called
thiazide diuretics (“water tablets”). It lowers blood pressure by
helping the body to get rid of extra fluid by making your
kidneys produce more urine.
You will only be given Olmesartan Medoxomil/
Hydrochlorothiazide tablets if olmesartan medoxomil alone has
not adequately controlled your blood pressure. When given
together,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Medoxomil/Hydrochlorothiazide 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.
Excipients- with known effect:
Each 40 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide
film-coated tablet contains 234 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Reddish-Yellow, oval film-coated tablets; debossed with “OH2” on
one side and plain on other side.
Approximate dimensions: Length 15.3 mm, width 7.1 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 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 Olmesartan Medoxomil/Hydrochlorothiazide
tablets 40 mg/12.5 mg is 1 tablet per day.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg may be
administered in patients whose blood
pressure is not adequately controlled by olmesartan medoxomil 40 mg
alone.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg /25 mg may be
administered in patients whose blood
pressure is not adequately controlled on Olmesartan
Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg fixed dose
combination.
For convenience, patients receiving olmesartan medoxomil and
hydrochlorothiazide from separate tablets may be
switched to Olmesartan Medoxomil/Hydrochlorothiazide tablets 40
mg/12.5 mg and 40 mg/25 mg tablets containing
the same component doses.
Olmesartan Medoxomil/Hydrochlorothiazide tablets 40 mg/12.5 mg and 40
mg/25 mg can be taken with or without
food.
_Older people (age 65 years or over)_
In older people the same dosage of the combination is recommended as
for adults.
Blood press