COTOVETOL 100/25MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Διαθέσιμο από:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

Φαρμακολογική κατηγορία (ATC):

C09DA01

INN (Διεθνής Όνομα):

LOSARTAN AND DIURETICS

Δοσολογία:

100/25MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

HYDROCHLOROTHIAZIDE (0000058935) 25MG; LOSARTAN POTASSIUM (8000001451) 100MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

LOSARTAN AND DIURETICS

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 7 TABS IN BLISTER(S) (300000401) 7 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 10 TABS IN BLISTER(S) (300000402) 10 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 14 TABS IN BLISTER(S) (300000403) 14 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (300000404) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (300000405) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
COTOVETOL 50MG/12.5MG FILM-COATED TABLETS
COTOVETOL 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 or your pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their symptoms 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 CoTovetol is and what it is used for
2. What you need to know before you take CoTovetol
3. How to take CoTovetol
4. Possible side effects
5. How to store CoTovetol
6. Contents of the pack and other information
1. WHAT COTOVETOL IS AND WHAT IT IS USED FOR
CoTovetol 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.
CoTovetol is indicated for the treatment of essential hypertension
(high blood pressure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COTOVETOL
DO NOT TAKE COTOVETOL

if you are allergic to losartan, hydrochlorothiazide or to any of the
other ingredients of
this medicine.

if you are allergic to other sulfonamide-derived substances (e. g.
other thiazides, some
antibacterial drugs such as co-trimoxazole, ask your doctor if you are
not sure)

if you have severely impaired liver function

if you have low po

Αρχείο Π.Χ.Π.

1. NAME OF THE MEDICINAL PRODUCT
CoTovetol 50mg/12.5mg Film-coated tablets
CoTovetol 100mg/25mg Film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
COTOVETOL 50MG/12.5MG
Each tablet contains 50 mg of losartan potassium and 12.5 mg of
hydrochlorothiazide (HCTZ)
COTOVETOL 100MG/25MG
Each tablet contains 100 mg of losartan potassium and 25 mg of
hydrochlorothiazide (HCTZ)
_Excipients with known effects: _
COTOVETOL 50MG/12.5MG:
Each tablet contains 41mg lactose monohydrate.
COTOVETOL 100MG/25MG:
Each tablet contains 82 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
COTOVETOL 50 MG/12.5MG
Yellow, oval shaped Film-coated tablet.
COTOVETOL 100 MG/25MG
Yellow, oval shaped Film-coated tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CoTovetol is indicated for the treatment of essential hypertension in
patients whose blood
pressure is not adequately controlled on losartan or
hydrochlorothiazide alone (see sections
4.3, 4.4, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
1
SUMMARY OF PRODUCT CHARACTERISTICS
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 CoTovetol is one tablet of CoTovetol 50
mg/ 12.5mg (losartan
50 mg/HCTZ 12.5 mg) once daily. For patients who do not respond
adequately to CoTovetol
50 mg/ 12.5mg, the dosage may be increased to one tablet of CoTovetol
100 mg/25 mg
(losartan 100 mg/ HCTZ 25 mg) once daily. The maximum dose is one
tablet of CoTovetol
100 mg/ 25mg once daily. In general, the antihypertensive effect is
attained within thr