Captor-HCT 50mg/25mg Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Captopril; Hydrochlorothiazide

Verfügbar ab:

Rowex Ltd

ATC-Code:

C09BA; C09BA01

INN (Internationale Bezeichnung):

Captopril; Hydrochlorothiazide

Dosierung:

50/25mg milligram(s)

Darreichungsform:

Tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

ACE inhibitors and diuretics; captopril and diuretics

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

1998-10-16

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
CAPTOR-HCT 25MG/12.5MG & 50MG/25MG TABLETS
CAPTOPRIL & HYDROCHLOROTHIAZIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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 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 Captor-HCT is and what it is used for
2. What you need to know before you take Captor-HCT
3. How to take Captor-HCT
4. Possible side effects
5. How to store Captor-HCT
6. Contents of the pack and other information
1 WHAT CAPTOR-HCT IS AND WHAT IT IS USED FOR
Captor-HCT is used to treat:
• HIGH BLOOD PRESSURE
This medication is made up of two different active substances:
captopril and hydrochlorothiazide.
Captopril belongs to the ACE inhibitors medicine group
(angiotensin-converting enzyme inhibitors).
Captopril expands your blood vessels. This reduces your blood pressure
and makes it easier for your
heart to pump blood to all body parts.
Hydrochlorothiazide is a water pill (diuretic). It increases the
amount of salt and water you lose in
your urine. This also results in a fall in blood pressure.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPTOR-HCT
DO NOT TAKE CAPTOR-HCT:
• if you are ALLERGIC to
- captopril, hydrochlorothiazide or
- any of the other ingredients of this medicine (listed in section 6)
or
- other ACE inhibitors or to any other sulphonamide derivatives
• if during earlier ACE inhibitor use you had SWELLING OF THE FACE,
LIPS, TONGUE and/or THROAT with
difficulty swallowing or breathing
Do not take Captor-HCT if you had any of these reactions
- without a known cause or
- if it has been confirmed that you have a

Fachinformation

Health Products Regulatory Authority
24 November 2019
CRN008X7G
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Captor-HCT 50mg/25mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains captopril 50 mg and hydrochlorothiazide 25 mg.
Excipient(s) with known effect: contains lactose monohydrate 68.7mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White octagonal tablets with a one-sided crossed score notch and the
opposite convex side has the mark ‘Cc’ engraved on it.
The score-notch allows the tablet to be divided into equal halves or
quarters.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension. This fixed dose combination is
indicated in patients whose blood pressure is not
adequately controlled by captopril alone or hydrochlorothiazide alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CAPTOR-HCT can be administered in a single or two divided doses/day
with or without food in patients whose blood pressure
is not adequately controlled by captopril alone or hydrochlorothiazide
alone. A maximum daily dose of 50 mg captopril/25 mg
hydrochlorothiazide should not be exceeded. If satisfactory reduction
of blood pressure has not been achieved, additional
antihypertensive medication may be added (see sections 4.3, 4.4, 4.5
and 5.1).
Adults: the administration of the fixed combination of captopril and
hydrochlorothiazide is usually recommended 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.
Renal impairment: Creatinine clearance between 30 and 80 mL/min: the
initial dose is usually 25/12.5 mg once a day, in the
morning.
The combination captopril/hydrochlorothiazide is contraindicated in
patients with severe renal impairment (creatinine
clearance <30 mL/min).
Special populations: in salt/volume depleted patients, elderly
pati