Valsotens HCT

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCHLOROTHIAZIDE, VALSARTAN

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

C09DA03

INN (International Name):

HYDROCHLOROTHIAZIDE 12.5 mg VALSARTAN 80 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HYDROCHLOROTHIAZIDE 12.5 mg VALSARTAN 80 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2009-11-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALSOTENS HCT 80 MG/12.5 MG FILM-COATED TABLETS
VALSOTENS HCT 160 MG/12.5 MG FILM-COATED TABLETS
VALSOTENS HCT 160 MG/25 MG FILM-COATED TABLETS
Valsartan/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, 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.
WHAT IS IN THIS LEAFLET
1.
What Valsotens HCT is and what it is used for
2.
What you need to know before you take Valsotens HCT
3.
How to take Valsotens HCT
4.
Possible side effects
5.
How to store Valsotens HCT
6.
Contents of the pack and other information
1.
WHAT
VALSOTENS HCT IS AND WHAT IT IS USED FOR
Valsotens HCT 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.
Valsotens HCT 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 heart and arteries.
If not t

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valsotens HCT 80 mg/12.5 mg film-coated tablets
Valsotens HCT 160 mg/12.5 mg film-coated tablets
Valsotens HCT 160 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Each tablet contains 160 mg of valsartan and 12.5 mg of
hydrochlorothiazide.
Each tablet contains 160 mg of valsartan and 25 mg of
hydrochlorothiazide.
Excipients with known effect:
Each Valsotens HCT 80 mg/12.5 mg film-coated tablet contains 29.72 mg
lactose monohydrate and
0.25 mg lecithin (contains soya oil).
Each Valsotens HCT 160 mg/12.5 mg film-coated tablet contains 71.94 mg
lactose monohydrate,
0.50 mg lecithin (contains soya oil) and 0.56 mg Sunset yellow FCF
(E110).
Each Valsotens HCT 160 mg/25 mg film-coated tablet contains 59.44 mg
lactose monohydrate and
0.50 mg lecithin (contains soya oil).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Valsotens HCT 80 mg/12.5 mg: Pink, oval, biconvex film-coated tablets,
11 x 5.8 mm, marked ‘V’
on one side and ‘H’ on the other.
Valsotens HCT 160 mg/12.5 mg: Red, oval, biconvex film-coated tablets,
15 x 6 mm, marked ‘V’
on one side and ‘H’ on the other.
Valsotens HCT 160 mg/25 mg: Orange, oval, biconvex film-coated
tabelts, 15 x 6 mm, marked ‘V’
on one side and ‘H’ on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Valsotens HCT 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 _
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The recommended dose of Valsotens HCT X mg/Y 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
ris