Toras-Denk 5 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:

5mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-12-05

Patient Information leaflet

_Toras-Denk 5_
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 MEDICINE BECAUSE IT CONTAINS IMPOR-
TANT 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 5 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE TORAS-DENK 5
3.
HOW TO TAKE TORAS-DENK 5
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TORAS-DENK 5
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Toras-Denk 5 is and what it is
used for
Toras-Denk 5 is a diuretic and anti-hypertensive agent
and belongs to a group of medicines known as loop
diuretics.
Toras-Denk 5 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 5
Do not take Toras-Denk 5
•
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 consciousness (hepatic coma) until this
condition improves or is resolved,
•
in cases of abnormally low blood pressure (hypo-
tension),
•
in cases of lower than normal volume of blood in the
body (hypovolaemia),
•
in cases of sodium or potassium deficiency in the
blood (hyponatraemia, hypokalaemia),
•
in cases of severe urinary outflow obstruction
(caused for ex

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
cauti