TOVETOL 50MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

LOSARTAN POTASSIUM

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

C09CA01

INN (Διεθνής Όνομα):

LOSARTAN

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

LOSARTAN POTASSIUM (8000001451) 50MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

LOSARTAN

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 7 TABS IN BLISTER(S) (290036701) 7 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 10 TABS IN BLISTER(S) (290036702) 10 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 14 TABS IN BLISTER(S) (290036703) 14 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (290036704) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 30 TABS IN BLISTER(S) (290036705) 30 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

Tovetol 50 mg Film-coated tablets
Tovetol 100 Film-coated tablets
Losartan potassium
In this leaflet:
1.
What Tovetol is and what it is used for
2.
Before you take Tovetol
3.
How to take Tovetol
4.
Possible side effects
5.
How to store Tovetol
6.
Further information
Losartan belongs to a group of medicines known as 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. Losartan slows
the decrease of kidney function in patients with high blood pressure
and type 2 diabetes
Tovetol is used:
•
to treat patients with high blood pressure (hypertension) in adults
and in children and
adolescents 6-18 years of age.
•
to protect the kidney in hypertensive type 2 diabetic patients with
laboratory evidence of impaired
renal function and proteinuria ≥ 0.5 g per day (a condition in which
urine contains an abnormal amount
of protein).
•
to treat patients with chronic heart failure when therapy with
specific medicines called
angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine
used to lower high blood
pressure) is not considered suitable by your doctor. If your heart
failure has been stabilised with an
ACE inhibitor you should not be switched to losartan.
•
in patients with high blood pressure and a thickening of the left
ventricle, TOVETOL has been
shown to decrease the risk of stroke ("LIFE indication").
1
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE.
•
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. 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 p

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
Tovetol 50 mg Film-coated tablets
Tovetol 100 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 50 mg strength
Each film coated tablet contains 45.76 mg of losartan (as losartan
potassium 50 mg).
Excipient: 53 mg lactose monohydrate per film coated tablet.
For 100 mg strength
Each film coated tablet contains 91.52 mg of losartan (as losartan
potassium 100 mg).
Excipient: 106 mg lactose monohydrate per film coated tablet.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
For 50 mg strength:
White to off white, oval shaped, film coated tablets with break line
on one side.
For 100 mg strength:
White to off white, oval shaped, film coated tables.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Treatment of essential hypertension.in adults and children and
adolescents 6-18 years of age
• Treatment of renal disease in patients with hypertension and type
2 diabetes mellitus with
proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment
(see sections 4.3, 4.4, 4.5 and 5.1).
• Treatment of chronic heart failure (in patients ≥ 60 years),
when treatment with ACE inhibitors is
not considered suitable due to incompatibility, especially cough, or
contraindication. Patients with
heart failure who have been stabilised with an ACE inhibitor should
not be switched to losartan. The
patients should have a left ventricular ejection fraction ≤ 40% and
should be stabilised under the
treatment of the chronic heart failure (see sections 4.3, 4.4, 4.5 and
5.1).
• Reduction in the risk of stroke in hypertensive patients with left
ventricular hypertrophy
documented by ECG (see section 5.1 LIFE study, Race).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Losartan tablets should be swallowed with a glass of water.
1
SUMMARY OF PRODUCT CHARACTERISTICS
Tovetol may be administered with or without food.
Hypertension
The usual starting and maintenance dose is 50 mg once daily for most
patients. The maximal
antihypertensive effect is