Losartan 50mg / Hydrochlorothiazide 12.5mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Losartan potassium; Hydrochlorothiazide

Beszerezhető a:

Milpharm Ltd

ATC-kód:

C09DA01

INN (nemzetközi neve):

Losartan potassium; Hydrochlorothiazide

Adagolás:

50mg ; 12.5mg

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 02050502; GTIN: 8901175013265

Betegtájékoztató

•
if you need to have an anaesthetic (even at
the dentist) or before surgery, or if you are
going to have tests to check your parathyroid
function, you must tell the doctor or medical
staff that you are taking Losartan potassium and
Hydrochlorothiazide tablets.
•
if you suffer from primary hyperaldosteronism (a
syndrome associated with increased secretion of
the hormone aldoesterone by the adrenal gland,
caused by an abnormality within the gland).
•
if you are taking any of the following medicines
used to treat high blood pressure.
-
an ACE-inhibitor (for example enalapril,
lisinopril, ramipril), in particular if you have
diabetes-related kidney problems.
-
aliskiren.
Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.
See also information under the heading “Do not take
Losartan potassium /Hydrochlorothiazide”.
CHILDREN AND ADOLESCENTS
There is no experience with the use of Losartan
potassium/Hydrochlorothiazide in children.
Therefore, Losartan potassium/Hydrochlorothiazide
should not be given to children.
OTHER MEDICINES AND LOSARTAN POTASSIUM /
HYDROCHLOROTHIAZIDE
Tell your doctor or pharmacist if you are taking have
recently taken or might take any other medicines.
Diuretic agents such as the hydrochlorothiazide
contained in Losartan potassium/Hydrochlorothiazide
may interact with other medicines.
Preparations containing lithium should not be taken
with Losartan potassium/Hydrochlorothiazide without
close supervision by your doctor.
Special precautionary measures (e.g. blood
tests) may be appropriate if you take potassium
supplements, potassium-containing salt substitutes
or potassium-sparing medicines, other diuretics
(“water tablets”), some laxatives, medicines for the
treatment of gout, medicines to control heart rhythm
or for diabetes (oral agents or insulins).
It is also important for your doctor to know if you are
taking:
•
other medicines to reduce your blood pressure
•
steroids
•
medicines to

Termékjellemzők

OBJECT 1
LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE 50
MG/12.5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 04-Jun-2018 | Aurobindo
Pharma - Milpharm 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 (HCTZ) as the
active ingredients.
_Excipient _with known effect Each tablet contains 111 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet
Yellow coloured, oval shaped, beveled edge, biconvex film-coated
tablets debossed with 'E' on one side
and '48' on the other side.
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
Hypertension
Losartan potassium 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. (See
Sections 4.3, 4.4, 4.5 and 5.1).
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/Hydrochlorothiazide 100 mg/25