Captopril 50mg tablets tablets

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

captopril

Доступна с:

S.C. Magistra C & C S.R.L.

код АТС:

C09AA01

ИНН (Международная Имя):

captopril

дозировка:

50mg

Фармацевтическая форма:

tablets

Штук в упаковке:

(30/3x10/) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2018-12-10

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CAPTOPRIL 25MG TABLETS
Captopril
CAPTOPRIL 50MG TABLETS
Captopril
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 Captopril is and what it is used for
2.
What you need to know before you take Captopril
3.
How to take Captopril
4.
Possible side effects
5.
How to store Captopril
6.
Contents of the pack and other information
1.
WHAT CAPTOPRIL IS AND WHAT IT IS USED FOR
Captopril tablets contains captopril and belongs to a group of drugs
called angiotensin converting
enzyme inhibitors (ACE inhibitors).
Captopril works by widening the blood vessels (vasodilator effect) and
thus blood pressure is low.
Captopril is indicated in treatment of following disorders:
- hypertension
- heart failure
- myocardial infarction:
- short term treatment (4 weeks) in stable patients with acute
myocardial infarction,
in first 24 hours of an infarction;
- long term prevention of symptomatic heart failure: in clinically
stable patients with
asymptomatic left ventricular dysfunction (ejection fraction ≤ 40%).
- type I diabetic nephropathy: in patients with macroproteinuric
diabetic nephropathy in patients with
type I diabetes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAPTOPRIL
_ _
DO NOT TAKE CAPTOPRIL

you have ever had an allergic reaction to captopril or to any of the
product excipients
(see section 6);

you have more than three months of pregnancy. (also it is better to
avoid Captopril
tablets
in early stages of pregnancy - see section "Pregnancy and lactation");
�

Характеристики продукта

_CAPTOPRIL TABLETS _
APRIL 2016
PAGE 1 OF 14
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_CAPTOPRIL TABLETS _
APRIL 2016
PAGE 2 OF 14
1.
NAME OF THE MEDICINAL PRODUCT
Captopril 25 mg tablets_ _
Captopril 50 mg tablets_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Captopril 25 mg tablets_ _
Each tablet contains captopril 25 mg
Excipient with known effect: lactose monohydrate 39.00 mg.
Captopril 50 mg tablets_ _
_ _
Each tablet contains captopril 50 mg
Excipient with known effect: lactose monohydrate 78,00 mg.
For a complete list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
X 25 mg tablets_ _
Round, flat uncoated tablets, white, with 7mm diameter.
X 50 mg tablets_ _
Round, lenticular uncoated tablets, white, with 9mm diameter and one
median line on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Captopril is indicated in treatment of following disorders:
- hypertension
- heart failure
- myocardial infarction:
- short term treatment (4 weeks) in stable patients with acute
myocardial infarction,
in first 24 hours of an infarction;
- long term prevention of symptomatic heart failure: in clinically
stable patients with
asymptomatic left ventricular dysfunction (ejection fraction ≤ 40%).
- type I diabetic nephropathy: in patients with macroproteinuric
diabetic nephropathy in patients
with type I diabetes.
See sections 4.3, 4.4, 4.5 and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Doses
_CAPTOPRIL TABLETS _
APRIL 2016
PAGE 3 OF 14
_ADULTS _
HYPERTENSION
Dose should be individualised according to patient’s profile (see
section 4.4) and blood pressure
response.

Patients without
prior hydro-saline depletion or renal failure: the recommended
starting
dose is 25-50 mg captopril daily in two divided doses every 12 hours.
The dose may be increased
incrementally, with intervals of at least 2 weeks, to 100mg/day in two
divided doses as needed to
reach target blood pressure.

Severe hypertension: may be necessary, at least at the beginning of
treatment, higher doses
(up to 150 mg capto