Ramic 10 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ramipril

Available from:

Pinewood Laboratories Ltd,

ATC code:

C09AA; C09AA05

INN (International Name):

Ramipril

Dosage:

10 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain; ramipril

Authorization status:

Not marketed

Authorization date:

2005-06-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RAMIC 2.5 MG HARD CAPSULES,
RAMIC 5 MG HARD CAPSULES
RAMIC 10 MG HARD CAPSULES 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. Do not pass it on to
others. It may harm
them, even if their symptoms 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 Ramic capsules are and what they are used for
2.
What you need to know before you take Ramic capsules
3.
How to take Ramic capsules
4.
Possible side effects
5.
How to store Ramic capsules
6.
Contents of the pack and other information
1.
WHAT RAMIC CAPSULES ARE AND WHAT THEY ARE USED FOR
Ramic capsules contain the active ingredient ramipril (belongs to a
group of medicines called
ACE inhibitors [Angiotensin Converting Enzyme inhibitors]) which:

decrease the body’s production of substances that could raise blood
pressure

relax and widen blood vessels

make it easier for the heart to pump blood around the body.
You have been prescribed Ramic capsules for one or more of the
following reasons:

to treat high blood pressure (hypertension)

to help treat your heart when it cannot pump enough blood to the rest
of your
body (heart failure)

to help reduce the risk of having a heart attack or stroke

to help prevent further weakening of your heart if it has been
weakened by a heart
attack

to treat or prevent worsening of some kidney diseases including those
caused by
diabetes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIC CAPSULES
DO NOT TAKE RAMIC CAPSULES:

If you are ALLERGIC (hypersensitive) to ramipril or any of the other
ingredients in
the product (see Section 6). Signs of allergic reaction may inc

Summary of Product characteristics

Health Products Regulatory Authority
04 February 2020
CRN008JZW
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramic 10 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10 mg of ramipril.
Excipient with known effect:
Ponceau 4R: 0.12mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Purple opaque body and purple opaque cap. Dimensions 14.3 x 5 mm. The
body has "RP 10" printed in black containing a
white or almost white powder.
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 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
Oral administration. It is recommended that Ramic is taken each day at
the same time of the day. Ramic capsules should be
taken with plenty of liquid. It must not be chewed or crushed. Ramic
can be taken before, with or after meals, because food
intake does not modify its bioavailability (see section 5.2).
_Adults_
Hypertension:
The dose should be individualised according to the patient profile
(see section 4.4) and blo