Toras-Denk 10 tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

torasemide

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

C03CA04

INN (International Name):

torasemide

Dosage:

10mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-06-19

Patient Information leaflet

SPECIFICATION - DENK PHARMA
product name:
Toras-Denk 10
artwork:
leaflet
language(s):
EN, FR, PT
material number:
6881/003
open format:
168 x 720 mm
fold:
2 x pre-folded (Wickelfalz)
folded format:
168 x 240 mm
pharma code:
21763
paper grammar:
40 g/m
2
printing colours:
 PANTONE YELLOW C
 BLACK
revision/date:
1 / 22.02.2021, KRi
2 / 24.02.2021, KRi
_Toras-Denk 10_
Tablet – oral use
Loop diuretic
Active substance: torasemide
Package leaflet: Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDI-
CINE 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 TORAS-DENK 10 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TORAS-DENK 10
3.
HOW TO TAKE TORAS-DENK 10
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TORAS-DENK 10
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Toras-Denk 10 is and what it is used for
Toras-Denk 10 is a diuretic and anti-hypertensive agent and belongs
to a group of medicines known as loop diuretics.
Toras-Denk 10 is used in the treatment and prevention of recurrent
fluid retention in the tissues (cardiac oedema) and/or body cavities
(effusions) caused by cardiac dysfunction (heart failure).
2.
What you need to know before you take
Toras-Denk 10
Do not take Toras-Denk 10
•
if you are allergic to torasemide, substances with a similar
structure (sulfonyl ureas) or any of the other ingredients of this
medicine (listed in section 6),
•
in cases of renal failure associated with no output of urine
(anuria),
•
in cases of severe liver dysfunction associated with clouding of
cons

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCTS
Toras-Denk 5
Toras-Denk 10
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: torasemide
_Toras-Denk 5_
Each tablet contains 5 mg torasemide.
_Toras-Denk 10_
Each tablet contains 10 mg torasemide.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
_Toras-Denk 5 _
White to off-white, round tablet imprinted with “5” on one side
and a score line on the other side.
The tablet can be divided into equal doses.
_Toras-Denk 10 _
White to off-white, round tablet imprinted with “10” on one side
and a score line on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prevention of recurrent cardiac oedema and/or effusion
in cardiac failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Cardiac oedema and/or effusion in cardiac failure _
Treatment is initiated with 5 mg torasemide daily. This dose is
normally also the maintenance dose.
Treatment with 10 mg torasemide is indicated when the normal dose of 5
mg torasemide daily has
insufficient effect.
In these cases, 10 mg torasemide is taken daily; depending on the
severity of the condition, the dose
may be increased up to 20 mg torasemide.
2
_Paediatric population _
The safety and efficacy of torasemide in children under the age of 12
years has not yet been
established.
_Patients with renal insufficiency _
While clearance is reduced in patients with renal failure, there is no
significant impact on the total
plasma level.
_Patients with hepatic impairment _
Dosage does not have to be adjusted in patients with mild to moderate
hepatic impairment because the
elimination half-live of torasemide and its metabolites is only
slightly increased in these patients.
Torasemide is contraindicated in patients with hepatic coma (see
section 4.3).
Special caution is required in patients with hepatic cirrhosis and
ascites (see section 4.4). Extreme