Irbesartan 300mg Hydrochlorothiazide 12.5mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Irbesartan; Hydrochlorothiazide

MAH:

Mylan

ATC_code:

C09DA04

INN:

Irbesartan; Hydrochlorothiazide

dosage:

300mg ; 12.5mg

pharmaceutical_form:

Tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 02050502; GTIN: 5016695005263

SPC

OBJECT 1
IRBESARTAN/HYDROCHLOROTHIAZIDE MYLAN 300
MG/12.5 MG TABLETS
Summary of Product Characteristics Updated 06-Sep-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Irbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg tablets
2. Qualitative and quantitative composition
300 mg/12.5 mg tablets
Each tablet contains 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect
Each tablet contains 120 mg of lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
300 mg/12.5 mg tablets
A peach, 0.3400” x 0.7350” (8.64 mm x 18.67 mm) oval, biconvex
tablet debossed with “M” on one side
of the tablet and “I34” 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 Mylan can be taken once daily.
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 Mylan 150 mg/12.5 mg may be
administered in patients whose blood
pressure is not adequately controlled with hydrochlorothiazide or
irbesartan 150 mg alone
• Irbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg may be
administered in patients insufficiently
controlled by irbesartan 300 mg or by Irbesartan/Hydrochlorothiazide
Mylan 150 mg/12.5 mg.
• Irbesartan/Hydrochlorothiazide Mylan 300 mg/25 mg may be
administered in patients insufficiently
controlled by Irbesartan/Hydrochlorothiazide Mylan 300 mg/12.5 mg.
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once
daily are not recommended.
When necessary, Irbesartan/Hydrochlorothiazide Mylan may be
administered with a