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:

Accord-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: 5012617017307

Patient Information leaflet

LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE
50/12.5MG AND 100/25MG 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 50/12.5mg and 100/25mg 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
50/12.5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 04-Apr-2016 | Accord-UK Ltd
1. Name of the medicinal product
Losartan potassium/Hydrochlorothiazide 50/12.5mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 50mg losartan potassium and 12.5mg
hydrochlorothiazide
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Film-coated tablet. (Tablets)
Losartan potassium/Hydrochlorothiazide 50mg/12.5mg Film-coated
Tablets: white, round, biconvex, 8
mm film-coated tablets, scored on both sides, with side scores. Marked
LH1 on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Losartan potassium/Hydrochlorothiazide 50/12.5mg Film-coated Tablets
are 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 50 mg/12.5 mg (losartan 50 mg/HCTZ 12.5
mg) once daily. For patients
who do not respond adequately to Losartan
potassium/Hydrochlorothiazide 50 mg/12.5 mg, the dosage
may be increased to one tablet of Losartan
potassium/Hydrochlorothiazide 100 mg/25 mg (losartan 100
mg/ HCTZ 25 mg) once daily. The maximum dose is one tablet of Losartan
potassium/H