Losartan 100mg / Hydrochlorothiazide 12.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Losartan potassium; Hydrochlorothiazide

Available from:

Accord-UK Ltd

INN (International Name):

Losartan potassium; Hydrochlorothiazide

Dosage:

100mg ; 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: 5012617022578

Patient Information leaflet

LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
100/12.5MG 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 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.
•
The full name of this medicine is Losartan potassium/
Hydrochlorothiazide 100mg/12.5mg Film-coated
Tablets but within the leaflet it will be referred to as
Losartan HCT tablets.
WHAT IS IN THIS LEAFLET
1 WHAT LOSARTAN HCT TABLETS ARE AND WHAT
THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LOSARTAN HCT TABLETS
3
HOW TO TAKE LOSARTAN HCT TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE LOSARTAN HCT TABLETS
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT LOSARTAN HCT TABLETS ARE AND WHAT
THEY ARE USED FOR
Losartan HCT tablets are a combination of an angiotensin
II receptor antagonist (losartan) and a diuretic
(hydrochlorothiazide).
Losartan HCT tablets are indicated for the treatment of
essential hypertension (high blood pressure).
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LOSARTAN HCT TABLETS
DO NOT TAKE LOSARTAN HCT TABLETS IF YOU
• are ALLERGIC to losartan, hydrochlorothiazide or to any of
the other ingredients of this medicine (listed in section 6).
• are ALLERGIC (hypersensitive) to other sulfonamide-
derived substances (e. g. other thiazides, some
antibacterial drugs such as co-trimoxazole, ask your
doctor if you are not sure)
• have severely impaired LIVER function
• are MORE THAN 3 MONTHS PREGNANT (it is also better
to avoid Losartan HCT tablets in early pregnancy - see
pregnancy section)
• have severely impaired KIDNEY function or your kidneys
are not producing any urine
�

Summary of Product characteristics

OBJECT 1
LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
100MG/12.5MG FILM-COATED TABLET
Summary of Product Characteristics Updated 04-Apr-2016 | Accord-UK Ltd
1. Name of the medicinal product
Losartan potassium/Hydrochlorothiazide 100mg/12.5mg Film-coated Tablet
2. Qualitative and quantitative composition
Each Film-coated Tablet contains 100mg losartan potassium and 12.5mg
hydrochlorothiazide.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Losartan potassium/Hydrochlorothiazide 100mg/12.5mg film-coated
tablets: yellow, round, biconvex, 10
mm film-coated tablets. Marked LH3 on one side. The tablets are not
scored.
4. Clinical particulars
4.1 Therapeutic indications
Losartan potassium/Hydrochlorothiazide 100mg/12.5mg Film-coated Tablet
is indicated 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
Posology
_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 one tablet of Losartan
potassium/Hydrochlorothiazide 50mg/12.5mg (losartan 50mg/HCTZ 12.5mg)
once daily. For patients
who do not respond adequately to Losartan
potassium/Hydrochlorothiazide 50mg/12.5mg, the dosage
may be increased to one tablet of Losartan
potassium/Hydrochlorothiazide 100mg/25mg (losartan 100mg/
HCTZ 25mg) once daily. The maximum dose is one tablet of Losartan
potassium/Hydrochlorothiazide
100mg/25mg once daily. In general, the antihypertensive effect is
attained within three to four weeks after