CAPOZIDE 50/25 Milligram Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

CAPTOPRIL, HYDROCHLOROTHIAZIDE

Disponible des:

Bristol-Myers Squibb Pharmaceuticals uc

Codi ATC:

C09BA01

Designació comuna internacional (DCI):

CAPTOPRIL, HYDROCHLOROTHIAZIDE

Dosis:

50/25 Milligram

formulario farmacéutico:

Tablets

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

ACE inhibitors and diuretics

Estat d'Autorització:

Authorised

Data d'autorització:

1986-05-16

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CAPOZIDE TABLETS
50 mg captopril/ 25 mg 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 Capozide is and what it is used for
2.
What you need to know before you take Capozide
3.
How to take Capozide
4.
Possible side effects
5.
How to store Capozide
6.
Contents of the pack and other information
1.
WHAT CAPOZIDE IS AND WHAT IT IS USED FOR
Capozide is a combination of two active substances, captopril and
hydrochlorothiazide.
Captopril belongs to a group of medicinal products called Angiotensin
Converting Enzyme (ACE)
Inhibitors. ACE inhibitors cause blood vessels to relax and the blood
pressure to lower.
Hydrochlorothiazide is one of a group of medicinal products called
thiazide diuretics (also known as
water tablets). They increase urine output and hence decrease blood
pressure.
The two active substances in Capozide work together to decrease blood
pressure further than if either
was given alone.
Capozide is used in the treatment of high blood pressure (essential
hypertension), if treatment with
captopril or hydrochlorothiazide alone has not led to a sufficient
decrease in blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPOZIDE
Please read the following section attentively. It contains important
information which you and your
doctor should observe prior to taking of Capozide.
DO NOT TAKE CAPOZIDE

if you are allergic to captopril or to any other ACE inhibitors or to
any of the other ingredients of
this medicine (li

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Capozide (Captopril 50mg/ Hydrochlorothiazide 25mg) Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg captopril and 25 mg hydrochlorothiazide.
Excipient with known effect: Each tablet contains 70.20 mg
lactose-monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, oval, biconvex tablet; with a breakbar on one side
and engraved with "C H" on the other side. The
tablet can be divided into equal doses.
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
Posology
Capozide 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 mg/25 mg, once a day, in the
morning. When clinically appropriate a direct change from monotherapy
to the fixed combination may be considered.
_Special populations:_ in salt/volume depleted patients, elderly
patients, and diabetic patients, the usual starting dose is
25 mg/12.5 mg once a day.
_Paediatric population:_ There is no relevant indication for use of
Capozide in children.
Method of administration
For oral use.
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