Valsartan 160mg Hydrochlorothiazide 25mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
19-06-2018
Summary of Product characteristics
(SPC)
19-06-2018
Active ingredient:
Valsartan; Hydrochlorothiazide
Available from:
Consilient Health Ltd
ATC code:
C09DA03
INN (International Name):
Valsartan; Hydrochlorothiazide
Dosage:
160mg ; 25mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02050502; GTIN: 5391512451790
Patient Information leaflet
Read all of this leaflet carefully before you start
taking this medicine.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctoror
pharmacist.
•
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Valsartan/hydrochlorothiazide is and what it is
used for
2. Before you take Valsartan/hydrochlorothiazide
3. How to take Valsartan/hydrochlorothiazide
4. Possible side effects
5. How to store Valsartan/hydrochlorothiazide
6. Further information
PACKAGE LEAFLET: INFORMATION FOR THE
USER
VALSARTAN/HYDROCHLOROTHIAZIDE
80 MG/12.5 MG FILM-COATED TABLETS
VALSARTAN/HYDROCHLOROTHIAZIDE
160 MG/12.5 MG FILM-COATED TABLETS
VALSARTAN/HYDROCHLOROTHIAZIDE
160 MG/25 MG FILM-COATED TABLETS
_Valsartan/Hydrochlorothiazide _
1. WHAT VALSARTAN/HYDROCHLOROTHIAZIDE IS
AND WHAT IT IS USED FOR
Valsartan/hydrochlorothiazide film-coated 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/hydrochlorothiazide is used to treat high
blood pressure which is not adequately controlled by a
single substance alone.
High blood pressure increases the workload of the
hea
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Summary of Product characteristics
OBJECT 1
VALSARTAN/HYDROCHLOROTHIAZIDE 160 MG/25 MG
FILM-COATED TABLETS
Summary of Product Characteristics Updated 21-Nov-2011 | Consilient
Health Ltd
1. Name of the medicinal product
Valsartan/hydrochlorothiazide 160 mg/25 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 160 mg valsartan and 25 mg
hydrochlorothiazide.
Excipient:
One tablet contains 32.54 mg lactose.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
The film-coated tablets are light brown, oval, biconvex.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of essential hypertension in adults.
Valsartan/hydrochlorothiazide 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 160 mg/25 mg 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 dose 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 should be
evaluated after initiating therapy and if
blood pressure remains uncontrolled, the dose may be increased by
increasing either one of the
components to a maximum dose of valsartan/hydrochlorothiazide 320
mg/25 mg.
The antihypertensive effect is substantially present within 2 weeks.
In most patients, maximal effects are observed within 4 weeks.
However, in some patients, 4-8 weeks
treatment may be required. This should be taken into account during
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