OLMESARTAN HYDROCHLOROTHIAZIDE ACTAVIS 40mg/12.5 Milligram Film Coated Tablet

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL

Pieejams no:

Actavis Group PTC ehf

ATĶ kods:

C09CA08

SNN (starptautisko nepatentēto nosaukumu):

HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL

Deva:

40mg/12.5 Milligram

Zāļu forma:

Film Coated Tablet

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

Angiotensin II antagonists, plain

Autorizācija statuss:

Authorised

Autorizācija datums:

2016-12-16

Lietošanas instrukcija

29 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

/…/ 20 MG/12.5 MG FILM-COATED TABLETS 
/…/ 20 MG/25 MG FILM-COATED TABLETS 
/…/ 40 MG/12.5 MG FILM-COATED TABLETS 
/…/ 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 /…/ is and what it is used for 
2. 
What you need to know before you take /…/ 
3. 
How to take /…/ 
4. 
Possible side effects 
5. 
How to store /…/ 
6. 
Contents of the pack and other information 

1. 
WHAT /…/ IS AND WHAT IT IS USED FOR 

/…/ 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 /…/ if olmesartan medoxomil alone has not
adequately controlled your blood 
pressure. When given together, the two active substances in /…/ help
to lower blood pressure more 
than if either of them were given alone. 

You may already be taking medicines to treat your high blood
pressure, but your doctor may wa

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan Hydrochlorothiazide Actavis 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 film-coated tablet contains 292.37 mg lactose monohydrate and
0.007 mg sunset yellow FCF (E110).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets.
Olmesartan Hydrochlorothiaizde 40 mg/12.5 mg film-coated tablets are
orange, oval, biconvex, 15 x 7 mm and with
OH 41 debossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan Hydrochlorothiazide Actavis fixed dose combination is
indicated in adult patients whose blood pressure is
not adequately controlled on olmesartan medoxomil alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended dose of Olmesartan Hydrochlorothiaizde 40 mg/12.5 mg
is 1 tablet per day.
Olmesartan Hydrochlorothiaizde 40 mg/12.5 mg may be administered in
patients whose blood pressure is not
adequately controlled by olmesartan medoxomil 40 mg alone.
For convenience, patients receiving olmesartan medoxomil and
hydrochlorothiazide from separate tablets may be
switched to Olmesartan Hydrochlorothiaizde 40 mg/12.5 mg tablets
containing the same component doses.
_Elderly (age 65 years or older)_
In elderly people the same dosage of the combination is recommended as
for adults.
Blood pressure should be closely monitored.
_Renal impairment_
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 higher dosages in this
patient group, and periodic monitoring is advised.
Olmesartan Hydrochlorothiaizde 40 mg/12.5 mg and 40 mg/25 mg is
therefore contraindicated in all stages of renal
impairment (see sections 4.3, 4.4, 5.2).
H
E