LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE MSD 50/12.5 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE

Available from:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC code:

C09DA01

INN (International Name):

LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE

Dosage:

50/12.5 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and diuretics

Authorization status:

Authorised

Authorization date:

2011-06-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE MSD 50MG/12.5MG FILM
‑
COATED
TABLETS
LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE MSD 100MG/12.5MG FILM
‑
COATED
TABLETS
LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE MSD 100MG/25MG FILM
‑
COATED
TABLETS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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, pharmacist, or
nurse.

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, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Losartan Potassium/Hydrochlorothiazide MSD is and what it is used
for
2.
What you need to know before you take Losartan
Potassium/Hydrochlorothiazide MSD
3.
How to take Losartan Potassium/Hydrochlorothiazide MSD
4.
Possible side effects
5.
How to store Losartan Potassium/Hydrochlorothiazide MSD
6.
Contents of the pack and other information
1.
WHAT LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE MSD IS AND WHAT IT IS USED
FOR
Losartan Potassium/Hydrochlorothiazide MSD 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 Potassium/Hydrochlorothiazide MSD is indicated for the
treatment of essential hypertension
(high blood pressure).
2.
WHAT YOU NEED T

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Potassium / Hydrochlorothiazide MSD 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).
Each tablet contains 63.13 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet
Yellow, oval film-coated tablets marked 717 on one side and plain or
scored on the other.
The scoreline is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Losartan Potassium/Hydrochlorothiazide MSD 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
MSD is one tablet of Losartan
Potassium/Hydrochlorothiazide MSD 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 MSD
50 mg/12.5 mg, the dosage may be increased
to one tablet of Losartan Potassium/Hydrochlorothiazide MSD 100 mg/25
mg (losartan 100 mg/ HCTZ 25 mg) once
daily. The maximum dose is one tablet of Losartan
Potassium/Hydrochlorothiazide MSD 100 mg/25 mg once daily. In
general, the antihypertensive effect is attained within three to four
weeks after initiation of therapy. Losartan
Potassium/Hydrochlorothiazide MSD 100/12.5 (losartan 100 m