Lotanos Comp 50 mg/12.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium; Hydrochlorothiazide

Available from:

Rowa Pharmaceuticals Limited

ATC code:

C09DA; C09DA01

INN (International Name):

Losartan potassium; Hydrochlorothiazide

Dosage:

50 /12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

Oral use

Units in package:

7, 28, 30, 50, 56, 50x1

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic group:

Angiotensin II antagonists and diuretics

Therapeutic area:

Angiotensin II antagonists and diuretics; losartan and diuretics

Therapeutic indications:

It is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy

Authorization status:

Marketed

Authorization date:

2008-05-02

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LOTANOS COMP 50 MG/12.5 MG FILM-COATED TABLETS
LOTANOS COMP 100 MG/25 MG FILM-COATED TABLETS
LOSARTAN POTASSIUM / HYDROCHLOROTHIAZIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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 or pharmacist.
•
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lotanos Comp is and what it is used for
2.
What you need to know before you take Lotanos Comp
3.
How to take Lotanos Comp
4.
Possible side effects
5.
How to store Lotanos Comp
6.
Contents of the pack and other information.
1.
WHAT LOTANOS COMP
IS AND WHAT IT IS USED FOR
Lotanos Comp 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 kidney pass more
water and salt. This also helps to reduce blood pressure.
Lotanos Comp is indicated for the treatment of essential hypertension
(high blood pressure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOTANOS COMP
DO NOT TAKE LOTANOS COMP
_• _
If you are allergic to losartan, hydrochlorothiazide or any of the
other ingredients of this
medicine (listed in section 6)
_• _
If you are allergic to other sulphonamide derived substances (e.g.
other thiazides, some
antibacterial drugs such as co-trimoxazole, ask your doctor if you are

Summary of Product characteristics

Health Products Regulatory Authority
03 May 2023
CRN00CR67
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lotanos Comp 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 excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, yellow, film-coated tablet. (diameter 8.1mm)
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lotanos Comp 50 mg/12.5 mg film-coated tablets
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
POSOLOGY
Hypertension
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 maintenance dose is one tablet of Lotanos Comp 50 mg/12.5 mg
(losartan 50 mg/HCTZ 12.5 mg) once daily. For
patients who do not respond adequately to Lotanos Comp 50 mg/12.5 mg,
the dosage may be increased to one tablet of
Lotanos Comp 100 mg/25 mg (losartan 100 mg/ HCTZ 25 mg) once daily.
The maximum dose is one tablet of Lotanos Comp
100 mg/25 mg once daily. In general, the antihypertensive effect is
attained within three to four weeks after initiation of
therapy. Lotanos Comp 100/12.5 (losartan 100 mg/ HCTZ 12.5 mg) is
available for those patients titrated to 100 mg of Losartan
who require additional blood pressure control.
_Special populations_
_Use in the elderly:- Dosage adjustment is not usually necessary for
the elderly _
_ _
_Use in patients with renal impairment and haemodialysis patient_:
No initial dosage adjustment