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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE

Available from:

Laboratorios LICONSA, S.A.

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)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

                                PACKAGE LEAFLET: INFORMATION FOR THE USER 
 
LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE LICONSA 50
MG/12.5 MG FILM-COATED TABLETS 
LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE LICONSA 100 MG/25
MG FILM-COATED TABLETS 
 
LOSARTAN POTASSIUM / 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 get serious, or if you notice any side
effects not listed in this 
leaflet, please tell your doctor or pharmacist. 
 
 
In this leaflet 
 
1. 
What Losartan Potassium/Hydrochlorothiazide Liconsa is and what it is
used for 
2. 
Before you take Losartan Potassium/Hydrochlorothiazide Liconsa 
3. 
How to take Losartan Potassium/Hydrochlorothiazide Liconsa 
4. 
Possible side effects 
5. 
How to store Losartan Potassium/Hydrochlorothiazide Liconsa 
6. 
Further information 
 
 
1.  WHAT LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE LICONSA IS AND
WHAT IT IS 
USED FOR 
 
Losartan potassium belongs to a group of medicines called
angiotensin-II receptor antagonists. 
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 belongs to a group of drugs called diuretics
(water tablets). 
 
[Losartan Potassium/Hydrochlorothiazide Liconsa 50 mg/12.5 mg]: 
Losartan Potassium/Hydrochlorothiazide Liconsa is used to treat high
blood pressure. Losartan 
Potassium/Hydrochlorothiazide Liconsa is a suitable alternative for
those people who would 
ot
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Potassium/Hydrochlorothiazide Liconsa 50 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of losartan potassium, equivalent to 45.76 mg of losartan, and 12.5 mg of
hydrochlorothiazide.
Excipient: 70.31 mg of lactose monohydrate/film-coated tablet.
For a full list of exipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, yellow, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on
hydrochlorothiazide or losartan monotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration_
The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). Losartan
potassium/Hydrochlorothiazide may be administered with or without food.
Where possible, titration with the individual components (i.e. losartan and hydrochlorothiazide) is recommended.
When clinically appropriate direct change from monotherapy with losartan 50 mg or hydrochlorothiazide 12.5 mg to
the fixed combination may be considered in patients whose blood pressure is not adequately controlled.
The usual starting and maintenance dose is 1 tablet once daily for most patients. For patients who do not respond
adequately, the dosage may be increased to 2 tablets once daily. The maximum dose is 2 tablets once daily. In general,
the antihypertensive effect is attained within three to four weeks after initiation of therapy.
_Use in the elderly: _No initial dose adjustment is necessary. Experience is limited in this population.
_Use in renal impairment_: No initial dosage adjustment is necessary in patients with mild to moderate rena
                                
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