Losartan/Hydrochlorothiazide Aurobindo 100 mg/12.5 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

C09DA01

INN (International Name):

HYDROCHLOROTHIAZIDE 12.5 mg LOSARTAN POTASSIUM 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HYDROCHLOROTHIAZIDE 12.5 mg LOSARTAN POTASSIUM 100 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2013-08-07

Patient Information leaflet

Package leaflet: Information for the user
LOSARTAN/HYDROCHLOROTHIAZIDE AUROBINDO 50 MG/12.5 MG FILM-COATED
TABLETS
LOSARTAN/HYDROCHLOROTHIAZIDE AUROBINDO 100 MG/12.5 MG FILM-COATED
TABLETS
LOSARTAN/HYDROCHLOROTHIAZIDE AUROBINDO 100 MG/25 MG FILM-COATED
TABLETS
losartan potassium and 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 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/Hydrochlorothiazide Aurobindo
is and what it is used for
2.
What you need to know before you take Losartan/Hydrochlorothiazide
Aurobindo
3.
How to take Losartan/Hydrochlorothiazide Aurobindo
4.
Possible side effects
5.
How to store Losartan/Hydrochlorothiazide Aurobindo
6.
Contents of the pack and other information
1.
WHAT LOSARTAN/HYDROCHLOROTHIAZIDE AUROBINDO IS AND WHAT IT IS USED FOR
Losartan/Hydrochlorothiazide Aurobindo
is a combination of an angiotensin II receptor antagonist
(losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a
substance produced in the body
which binds to receptors in blood vessels, causing them to tighten.
This results in an increase in
blood pressure. Losartan prevents the binding of angiotensin II to
these receptors, causing the blood
vessels to relax which in turn lowers the blood pressure.
Hydrochlorothiazide works by making the
kidneys pass more water and salt. This also helps to reduce blood
pressure.
Losartan/Hydrochlorothiazide Aurobindo
is indicated for the treatment of essential hypertension
(high blood pressure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN/HYDROCHLOROTHIAZIDE
AUROBIN

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Losartan/Hydrochlorothiazide Aurobindo 50 mg/12.5 mg film-coated
tablets
Losartan/Hydrochlorothiazide Aurobindo 100 mg/12.5 mg film-coated
tablets
Losartan/Hydrochlorothiazide Aurobindo 100 mg/25 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Losartan/Hydrochlorothiazide Aurobindo 50 mg/12.5 mg _
Each tablet contains 50 mg of losartan potassium and 12.5 mg of
hydrochlorothiazide as the active
ingredients.
Excipient with known effect
: Each tablet contains 111 mg lactose monohydrate.
_Losartan/Hydrochlorothiazide Aurobindo 100 mg/12.5 mg _
Each tablet contains 100 mg of losartan potassium and 12.5 mg of
hydrochlorothiazide as the active
ingredients.
Excipient with known effect
: Each tablet contains 222 mg lactose monohydrate.
_Losartan/Hydrochlorothiazide Aurobindo 100 mg/25 mg _
Each tablet contains 100 mg of losartan potassium and 25 mg of
hydrochlorothiazide as the active
ingredients.
Excipient with known effect
: Each tablet contains 222 mg lactose monohydrate.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
_Losartan/Hydrochlorothiazide Aurobindo 50 mg/12.5 mg _
Yellow coloured, oval shaped, beveled edge, biconvex film-coated
tablets debossed with ‘E’ on one
side and ‘48’ on the other side. The size is 11.5 mm X 6.5 mm.
_Losartan/Hydrochlorothiazide Aurobindo 100 mg/12.5 mg _
White, Oval shaped, beveled edge, biconvex film-coated tablets
debossed with ‘F’ on one side and
‘74’ on the other side. The size is 17.1 mm X 7.3 mm.
_Losartan/Hydrochlorothiazide Aurobindo 100 mg/25 mg _
Yellow coloured, oval shaped, beveled edge, biconvex film-coated
tablets debossed with ‘E’ on one
side and ‘49’ on the other side. The size is 17.1 mm X 7.3 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Losartan/Hydrochlorothiazide Aurobindo is indicated for the treatment
of essential hypertension in
patients whose blood pressure is not adequately controlled on losa