Losartan 50mg / Hydrochlorothiazide 12.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Losartan potassium; Hydrochlorothiazide

Available from:

Lupin Healthcare (UK) Ltd

ATC code:

C09DA01

INN (International Name):

Losartan potassium; Hydrochlorothiazide

Dosage:

50mg ; 12.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502; GTIN: 8901107015695

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN POTASSIUM_/_ HYDROCHLOROTHIAZIDE
50MG/12.5MG, 100MG/25MG TABLETS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
READ ALL
OF
THIS LEAFLET
CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE
BEACUSE 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.
WHAT IS IN THIS LEAFLET:
1. What Losartan potassium_ I_ Hydrochlorothiazide Tablets are and
what they
are used for.
2. What
you
need
to
know before
you
take
Losartan
potassium_ I_
Hydrochlorothiazide Tablets.
3. How to take Losartan potassium_ I_ Hydrochlorothiazide Tablets.
4. Possible side effects.
5. How to store Losartan potassium_ I_ Hydrochlorothiazide Tablets.
6. Contents of the pack and other information.
1. WHAT LOSARTAN POTASSIUM /
HYDROCHLOROTHIAZIDE TABLETS
ARE AND WHAT THEY ARE USED FOR
Losartan
potassium /
Hydrochlorothiazide
tablet
contains
two
active
ingredients.
These are Losartan potassium and Hydrochlorothiazide.
Losartan belongs
to a group of
medicines known as angiotensin-ll
receptor
antagonists.
Angiotensin II is a chemical occurring in the body, which tightens
your blood
vessels making it harder for the blood to pass through them and
causing
your blood pressure to increase.
Losartan potassium /
Hydrochlorothiazide
tablets
block
this
effect
of
angiotensin II, causing the blood vessels to relax.
Hydrochlorothiazide works
by making your kidneys pass more water and salt.
Together,
losartan and
hydrochlorothiazide lower high blood pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN POTASSIUM
/ HYDROCHLOROTHIAZIDE TABLETS
_DO NOT TAKE LOSARTAN / HYDROCHLOROTHIAZIDE TABLETS:_
•
if you are allergic t

Summary of Product characteristics

OBJECT 1
LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
50MG/12.5MG TABLETS
Summary of Product Characteristics Updated 08-Oct-2015 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg Tablets.
2. Qualitative and quantitative composition
Each Losartan potassium/Hydrochlorothiazide 50mg/12.5mg Tablet
contains 50 mg of Losartan
potassium and 12.5 mg Hydrochlorothiazide as the active ingredients.
Excipients: Each tablet contains 95.5mg lactose anhydrous.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg Tablets are Yellow,
capsule shaped, biconvex,
film-coated tablets, debossed with '50' on one side and plain on the
other side
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of essential hypertension in patients whose blood
pressure is not adequately controlled
on losartan or hydrochlorothiazide alone.
4.2 Posology and method of administration
Losartan / hydrochlorothiazide tablets may be administered with other
antihypertensive agents (see
sections 4.3, 4.4, 4.5 and 5.1). These tablets should be swallowed
with a glass of water.
Losartan / hydrochlorothiazide tablets may be administered with or
without food.
_Hypertension_
Losartan and hydrochlorothiazide is not for use as initial therapy,
but in patients whose blood pressure is
not adequately controlled by losartan potassium or hydrochlorothiazide
alone.
Dose titration with the individual components (losartan and
hydrochlorothiazide) is recommended.
When clinically appropriate direct change from monotherapy to the
fixed combination may be considered
in patients whose blood pressure is not adequately controlled.
The usual maintenance dose of losartan potassium/hydrochlorothiazide
is 50mg/12.5mg once daily. For
patients who do not respond adequately to 50mg/12.5mg, the dosage may
be increased to one tablet of
100mg/25mg once daily. The maximum dose is 100mg/25mg once daily. In
general, the antihypertensive