Captopril+HCT Denk 50/25 tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

captopril, hydrochlorothiazide

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

C09BA01

INN (International Name):

captopril, hydrochlorothiazide

Dosage:

50mg+ 25mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) and (100/10x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-08-08

Patient Information leaflet

_Captopril+HCT Denk _
_50/25_
Tablet – oral use
Antihypertensive – ACE inhibitor + diuretic
Active substances: captopril + hydrochlorothi-
azide
Package leaflet:
Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CON-
TAINS 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 CAPTOPRIL+HCT DENK IS
AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CAPTOPRIL+HCT DENK
3.
HOW TO TAKE CAPTOPRIL+HCT DENK
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CAPTOPRIL+HCT DENK
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Captopril+HCT Denk is and
what it is used for
Captopril+HCT Denk is a combination medicine
for lowering blood pressure.
Captopril+HCT Denk is used for
non-organ-related
high blood pressure that cannot be sufficiently
reduced by captopril or hydrochlorothiazide
(HCT) alone.
2.
What you need to know before you
take Captopril+HCT Denk
Do not take Captopril+HCT Denk
•
if you are allergic to captopril or any other ACE
inhibitors, to hydrochlorothiazide or other sul-
phonamides, or any of the other ingredients
of this medicine (listed in section 6)
•
if you have previously had swelling of the
tissues (hereditary/idiopathic angioedema,
including after previous treatment with ACE
inhibitors) as a result of treatment with an
ACE inhibitor
•
if you are suffering from severe kidney dys-
function
•
if you are suffering from severe liver dysfunc-
tion
•
if you have diabetes or impaired kidney func-
tion and you are treated with a blood pressure
lowering medicine containing aliskiren
•
if you have tak

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Captopril+HCT Denk 50/25
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: Captopril + Hydrochlorothiazide
Each tablet contains 50 mg of captopril and 25 mg of
hydrochlorothiazide (HCT).
Excipient with known effect: Each tablet contains 68.7 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, biconvex tablet, with break-line and inscription
“DENK | DENK” on one side and
with break-line and inscription “CAPTO+ | HCT 50/25” on the other
side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Captopril+HCT Denk 50/25 is indicated for the treatment of essential
hypertension.
This fixed dose combination is indicated in patients whose blood
pressure cannot be adequately con-
trolled by captopril alone or by hydrochlorothiazide alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Captopril+HCT Denk 50/25 can be administered in a single dose or two
divided doses/day with or
without food in patients whose blood pressure cannot be adequately
controlled by captopril alone or
hydrochlorothiazide alone.
POSOLOGY
A maximum daily dose of 50 mg captopril/25 mg hydrochlorothiazide
should not be exceeded. If hy-
pertension cannot be satisfactorily reduced, additional
antihypertensive medicinal products may be
administered (see sections 4.3, 4.4, 4.5 and 5.1).
Adults
The administration of the fixed combination of captopril and
hydrochlorothiazide is usually recom-
mended after dosage titration with the individual components.
The usual maintenance dose is 50/25 mg, once a day, in the morning.
When clinically appropriate, a
direct change from monotherapy to the fixed combination may be
considered. The 25/25 mg dosage
can be used once daily in patients whose blood pressure cannot be
adequately controlled by monother-
apy with 25 mg hydrochlorothiazide and before the captopril component
is titrated. The 50/25 mg
dosages are intende