Ramipril 2.5mg capsules

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Ramipril

Доступна с:

Genus Pharmaceuticals Ltd

код АТС:

C09AA05

ИНН (Международная Имя):

Ramipril

дозировка:

2.5mg

Фармацевтическая форма:

Oral capsule

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 02050501

тонкая брошюра

Product:
Ramipril 1.25mg, 2.5mg, 5mg
and 10mg capsules (Sovereign)
Item Code:
P1261T
Size:
172 x 540 mm
Min. Point size:
9pt
O. Artwork:
11/12/19
Proof No.
4
Amendment Date
05/02/20
Process Black
Keyline - Does not print
Colours Used
CAPSULES
Ramipril
P1261T
PACKAGE LEAFLET: INFORMATION FOR THE USER
RAMIPRIL 1.25 mg, 2.5 mg, 5 mg and 10 mg
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, PHARMACIST OR
NURSE. THIS INCLUDES ANY POSSIBLE SIDE
EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4.
1. WHAT RAMIPRIL CAPSULES ARE AND WHAT
THEY ARE USED FOR
The full name of your medicine is Ramipril 1.25 mg,
2.5 mg, 5 mg or 10 mg Capsules, but within the
leaflet it will be referred to as Ramipril Capsules.
Ramipril Capsules contain a medicine called
ramipril. This belongs to a group of medicines called
angiotensin-converting enzyme (ACE) inhibitors.
Ramipril Capsules work 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.
Ramipril Capsules 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 RAMIPRIL CAPSULES
DO NOT TAKE RAMIPRIL CAPSULES IF YOU:
• Are allergic to ra

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 2.5 mg Capsules
2
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each capsule contains 2.5 mg of ramipril.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Opaque light orange cap and opaque white body hard gelatin capsules
(No. 4),
printed in black ink 93 and 7210 on opposing cap and body portions of
the
capsule.
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, 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
≥
3g/day (see section 5.1).
-Treatment of symptomatic 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 Ramipril;
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 Ramipril (see section 4.4).
In hypertensive patients in whom the diuretic is not discontinued,
therapy with
Ramipril should be initiated with a 1.25 mg