Irbesartan 150mg Hydrochlorothiazide 12.5mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Hydrochlorothiazide; Irbesartan

Հասանելի է:

Actavis UK Ltd

ATC կոդը:

C09DA04

INN (Միջազգային անվանումը):

Hydrochlorothiazide; Irbesartan

Դոզան:

12.5mg ; 150mg

Դեղագործական ձեւ:

Tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 02050502; GTIN: 5012617022721

Տեղեկատվական թերթիկ

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IRBESRTAN HCT 150MG/12.5MG, 300MG/12.5MG & 300MG/25MG TABLETS PIL - UK
Black
BBBA1375
S.Anson
20.10.17
21.11.17
S.Anson
190 x 380
8pt
Actavis Bulgaria
Dupnitsa
20.10.17
20.10.17
3
IRBESARTAN HYDROCHLOROTHIAZIDE
150MG/12.5MG, 300MG/12.5MG AND
300MG/25MG FILM-COATED TABLETS
_continued over page_
_continued top of next column_
BBBA1375
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 full name of this product is Irbesartan Hydrochlorothiazide
150mg/12.5mg, 300mg/12.5mg and 300mg/25mg Film-
coated Tablets but within the leaflet it will be referred to as
Irbesartan Hydrochlorothiazide tablets.
WHAT IS IN THIS LEAFLET:
1 WHAT IRBESARTAN HYDROCHLOROTHIAZIDE TABLETS ARE AND
WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRBESARTAN
HYDROCHLOROTHIAZIDE TABLETS
3 HOW TO TAKE IRBESARTAN HYDROCHLOROTHIAZIDE TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE IRBESARTAN HYDROCHLOROTHIAZIDE TABLETS
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT IRBESARTAN HYDROCHLOROTHIAZIDE TABLETS ARE AND
WHAT THEY ARE USED FOR
Irbesartan Hydrochlorothiazide table

Ապրանքի հատկությունները

OBJECT 1
IRBESARTAN HYDROCHLOROTHIAZIDE ACTAVIS
150MG/12.5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 18-Dec-2017 | Accord-UK Ltd
1. Name of the medicinal product
Irbesartan Hydrochlorothiazide Actavis 150mg/12.5mg Film-coated
Tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 150mg of irbesartan and 12.5mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Irbesartan Hydrochlorothiazide Actavis 150mg/12.5mg film-coated
tablets.
Pink, biconvex, oval-shaped, 6.5 x 12.7 mm film-coated tablet with an
H engraved on one side and I on
the other side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of essential hypertension.
This fixed dose combination is indicated in adult patients whose blood
pressure is not adequately
controlled on irbesartan or hydrochlorothiazide alone (see section
5.1).
4.2 Posology and method of administration
Posology
Irbesartan Hydrochlorothiazide Actavis 150mg/12.5mg Film-coated
Tablets can be taken once daily, with
or without food.
Dose titration with the individual components (i.e. irbesartan and
hydrochlorothiazide) may be
recommended.
When clinically appropriate direct change from monotherapy to the
fixed combinations may be
considered:
▪ Irbesartan Hydrochlorothiazide Actavis 150mg/12.5mg may be
administered in patients whose blood
pressure is not adequately controlled with hydrochlorothiazide or
irbesartan 150mg alone;
▪ Irbesartan Hydrochlorothiazide Actavis 300mg/12.5mg may be
administered in patients insufficiently
controlled by irbesartan 300mg or by Irbesartan Hydrochlorothiazide
Actavis 150mg/12.5mg;
▪ Irbesartan Hydrochlorothiazide Actavis 300mg/25mg may be
administered in patients insufficiently
controlled by Irbesartan Hydrochlorothiazide Actavis 300mg/12.5mg.
Doses higher than 300mg irbesartan/25mg hydrochlorothiazide once daily
are not recommended. When
necessary, Irbesartan Hydrochlorothiazide Actavis 150mg/12.5mg
Film-coated Tablets m