LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE LICONSA 100/25 Milligram Film Coated Tablet

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
10-05-2024
Tabia za bidhaa Tabia za bidhaa (SPC)
10-05-2024

Viambatanisho vya kazi:

LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE

Inapatikana kutoka:

Laboratorios LICONSA, S.A.

INN (Jina la Kimataifa):

LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE

Kipimo:

100/25 Milligram

Dawa fomu:

Film Coated Tablet

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Idhini hali ya:

Authorised

Idhini ya tarehe:

0000-00-00

Taarifa za kipeperushi

                                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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Tabia za bidhaa

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Potassium/Hydrochlorothiazide Liconsa 100 mg/25 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of losartan potassium, equivalent to 91.52 mg of losartan, and 25 mg of
hydrochlorothiazide.
Excipient: 140.61 mg of lactose monohydrate/film-coated tablet
For a full list of excipients, 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 by losartan 50
mg/ hydrochlorothiazide 12.5 mg once daily.
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.
The combination of 100 mg losartan potassium / 25 mg hydrochlorothiazide is not recommended as initial therapy.
One losartan potassium / hydrochlorothiazide tablet once daily is recommended for those patients who do not respond
adequately to a combination of 50 mg losartan potassium / 12.5 mg hydrochlorothiazide given 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 renal impairment
(i.e. creatinine clearance 30-50 ml/min). Losartan potassium/Hydrochlorothiazide is not recommended for patients on
dialysis. It is contraindicated in patients with severe renal impairment (i.e. c
                                
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