Losartan 100mg / Hydrochlorothiazide 25mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Losartan potassium; Hydrochlorothiazide

Boleh didapati daripada:

Arrow Generics Ltd

Kod ATC:

C09DA01

INN (Nama Antarabangsa):

Losartan potassium; Hydrochlorothiazide

Dos:

100mg ; 25mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 02050502; GTIN: 5060034834335

Risalah maklumat

_PACKAGE LEAFLET: INFORMATION FOR THE USER_
_LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE 50 MG/12.5 MG FILM-COATED
TABLETS_
(50 mg losartan potassium and 12.5 mg hydrochlorothiazide)
_LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE 100 MG/25 MG FILM-COATED
TABLETS_
(100 mg losartan potassium and 25 mg hydrochlorothiazide)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
_1.WHAT LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE_
_FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR_
Losartan potassium / hydrochlorothiazide Film-coated Tablets are a
combination of an angiotensin II receptor antagonist (losartan) and a
diuretic (hydrochlorothiazide).
Losartan potassium / hydrochlorothiazide Film-coated Tablets are
indicated
for the treatment of essential hypertension (high blood pressure).
_2.BEFORE YOU TAKE LOSARTAN POTASSIUM /_
_HYDROCHLOROTHIAZIDE FILM-COATED TABLETS _
DO NOT TAKE LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE FILM-
COATED TABLETS
• if you are allergic (hypersensitive) to losartan potassium,
hydrochlorothiazide or to any of the other ingredients in this
medicine
• if you 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)
• if you are more than 3 months pregnant. (It is also better to
avoid
Losartan potassium / hydrochlorothiazide Film-coated Tablets in early
pregnancy - see pregnancy section.)
• if you have severely impaired liver function
• if you have severely impaired kidney function or your kidneys are
not
producing any urine
• if you have low potassium

Ciri produk

OBJECT 1
LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE 100
MG/25 MG FILM-COATED TABLETS (ARROW)
Summary of Product Characteristics Updated 11-Oct-2013 | Accord-UK Ltd
1. Name of the medicinal product
Losartan potassium / hydrochlorothiazide 50 mg/12.5 mg Film-coated
Tablets
2. Qualitative and quantitative composition
Each Tablet contains 50 mg of losartan potassium and 12.5 mg of
hydrochlorothiazide.
Excipients:
Each tablet contains 61.50 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Losartan potassium / hydrochlorothiazide 50 mg/12.5 mg Film-coated
Tablets are white, oblong,
biconvex tablets measuring approximately 13.7 x 6.7 mm with a
scoreline on both sides.
The scoreline is to facilitate breaking for ease of swallowing and not
to divide into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Losartan potassium / hydrochlorothiazide 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
Losartan potassium / Hydrochlorothiazide may be administered with
other antihypertensive agents.
Losartan potassium / hydrochlorothiazide Tablets should be swallowed
with a glass of water.
Losartan potassium / Hydrochlorothiazide may be administered with or
without food.
Hypertension
Losartan and hydrochlorothiazide are not for use as initial therapy,
but should be used 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 is one tablet of Losartan potassium 50 mg /
Hydrochlorothiazide 12.5 mg
once daily. For patients who do not respond adequately to Losartan
pota