Valsartan 80mg Hydrochlorothiazide 12.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Valsartan; Hydrochlorothiazide

Available from:

Actavis UK Ltd

ATC code:

C09DA03

INN (International Name):

Valsartan; Hydrochlorothiazide

Dosage:

80mg ; 12.5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502; GTIN: 5012617021526

Patient Information leaflet

1
ACTAVIS LOGO
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALSARTAN/HYDROCHLOROTHIAZIDE 80MG/12.5MG, 160MG/12.5MG AND 160MG/25MG
FILM-COATED TABLETS
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, pharmacist or
nurse.
●
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.

The full name of this medicine is Valsartan/Hydrochlorothiazide
80mg/12.5mg, 160mg/12.5mg and
160mg/25mg Film-coated Tablets but within the leaflet it will be
referred to as Valsartan HCT tablets.
WHAT IS IN THIS LEAFLET:
1.
What Valsartan HCT tablets are and what they are used for
2.
What you need to know before you take
3.
How to take Valsartan HCT tablets
4.
Possible side effects
5.
How to store Valsartan HCT tablets
6.
Contents of the pack and other information
1.
WHAT VALSARTAN HCT TABLETS ARE AND WHAT THEY ARE USED FOR
Valsartan HCT tablets contain two active substances called valsartan
and hydrochlorothiazide. Both of these
substances help to control high blood pressure (hypertension).
●
VALSARTAN belongs to a class of medicines known as “angiotensin II
receptor antagonists”, which help
to control high blood pressure. Angiotensin II is a substance in the
body that causes vessels to tighten,
thus causing your blood pressure to increase. Valsartan works by
blocking the effect of angiotensin II.
As a result, blood vessels relax and blood pressure is lowered.
●
HYDROCHLOROTHIAZIDE belongs to a group of medicines called thiazide
diuretics (also known as “water
tablets”). Hydrochlorothiazide increases urine output, which also
lowers blood pressure.
Valsartan HCT tablets are used to treat high

Summary of Product characteristics

OBJECT 1
VALSARTAN/HYDROCHLOROTHIAZIDE 80MG/12.5MG
FILM-COATED TABLETS
Summary of Product Characteristics Updated 30-Sep-2016 | Accord-UK Ltd
1. Name of the medicinal product
Valsartan/Hydrochlorothiazide 80mg/12.5mg Film-coated Tablets
2. Qualitative and quantitative composition
Each tablet contains 80mg of valsartan and 12.5mg of
hydrochlorothiazide.
Excipients with known effect:
Each Valsartan/Hydrochlorothiazide 80mg/12.5mg film coated tablet
contains 29.72mg lactose monohydrate and 0.25mg lecithin (contains
soya
oil).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Valsartan/Hydrochlorothiazide 80mg/12.5mg: Pink, oval, biconvex
film-coated tablets, 11 x 5.8 mm,
marked 'V' on one side and 'H' on the other.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of essential hypertension in adults.
Valsartan/Hydrochlorothiazide 80mg/12.5mg Film-coated Tablets
fixed-dose combination is indicated in
patients whose blood pressure is not adequately controlled on
valsartan or hydrochlorothiazide
monotherapy.
4.2 Posology and method of administration
_Posology _
The recommended dose of Valsartan/Hydrochlorothiazide 80mg/12.5mg,
Valsartan/Hydrochlorothiazide
160mg/12.5mg and Valsartan/Hydrochlorothiazide 160mg/25mg is one
film-coated tablet once daily.
Dose titration with the individual components is recommended. In each
case, up- titration of individual
components to the next dose should be followed in order to reduce the
risk of hypotension and other
adverse events.
When clinically appropriate direct change from monotherapy to the
fixed combination may be considered
in patients whose blood pressure is not adequately controlled on
valsartan or hydrochlorothiazide
monotherapy, provided the recommended dose titration sequence for the
individual components is
followed.
The clinical response to Valsartan/Hydrochlorothiazide 80mg/12.5mg
Film-coated Tablets
should be evaluated after initiating therapy and if blood pressure
remains uncontrolled, the dose may be
increased b