Ramitace 10mg Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Ramipril

Доступна с:

Clonmel Healthcare Ltd

код АТС:

C09AA; C09AA05

ИНН (Международная Имя):

Ramipril

дозировка:

10 milligram(s)

Фармацевтическая форма:

Tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

ACE inhibitors, plain; ramipril

Статус Авторизация:

Marketed

Дата Авторизация:

2006-10-13

тонкая брошюра

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
RAMITACE 2.5 MG TABLETS
RAMITACE 5 MG TABLETS
RAMITACE 10 MG TABLETS
ramipril
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 Ramitace is and what it is used for
2.
What you need to know before you take Ramitace
3.
How to take Ramitace
4.
Possible side effects
5.
How to store Ramitace
6.
Contents of the pack and other information
1.
WHAT RAMITACE IS AND WHAT IT IS USED FOR
Ramitace contains a medicine called ramipril. This belongs to a group
of medicines called ACE
inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramitace works by:
•
Decreasing your body’s production of substances that could raise
your blood pressure
•
Making your blood vessels relax and widen
•
Making it easier for your heart to pump blood around your body.
Ramitace can be used:
•
To treat high blood pressure (hypertension)
•
To reduce the risk of you having a heart attack or stroke
•
To reduce the risk or delay the worsening of kidney problems (whether
or not you have diabetes)
•
To treat your heart when it cannot pump enough blood to the rest of
your body (heart failure)
•
As treatment following heart attack (myocardial infarction)
complicated with heart failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMITACE
DO NOT TAKE RAMITACE
•
If you are allergic to ramipril, any other ACE inhibitor medicine or
any of the ingredients of this
medicine (listed in section 6).
Signs of an allergic reaction may include a rash, swallowing or
breathing problems, s

Характеристики продукта

Health Products Regulatory Authority
16 October 2019
CRN00957H
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramitace 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 10 mg ramipril.
Excipient(s) with known effect
Lactose monohydrate 193 mg
3 PHARMACEUTICAL FORM
Tablet
Capsule-shaped, flat, white tablet, scored on one side, printed with
R4. The tablet can be divided into equal doses..
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Treatment of hypertension
- Cardiovascular prevention: reduction of cardiovascular morbidity and
mortality in patients with:
§ manifest atherothrombotic cardiovascular disease (history of
coronary heart disease or stroke, or peripheral vascular disease)
or
§ diabetes with at least one cardiovascular risk factor (see section
5.1).
- Treatment of renal disease:

Incipient glomerular diabetic nephropathy as defined by the presence
of microalbuminuria,

Manifest glomerular diabetic nephropathy as defined by
macroproteinuria in patients with at least one
cardiovascular risk factor (see section 5.1).

Manifest glomerular non diabetic nephropathy as defined by
macroproteinuria ≥ 3 g/day (see section 5.1).
- Treatment of symtomatic heart failure.
- Secondary prevention after acute myocardial infarction: reduction of
mortality from the acute phase of myocardial infarction
in patients with clinical signs of heart failure when started > 48
hours following acute myocardial infarction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Diuretic-Treated patients
Hypotension may occur following initiation of therapy with Ramitace;
this is more likely in patients who are being treated
concurrently with diuretics. Caution is therefore recommended since
these patients may be volume and/or salt depleted. If
possible, the diuretic should be discontinued 2 to 3 days before
beginning therapy with Ramitace (see section 4.4). In
hypertensive patients in whom the diuretic is not discontinued,
therapy with Ramitace should be