Odrik 0.5mg Hard Capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-11-2020
Summary of Product characteristics
(SPC)
21-11-2020
Active ingredient:
Trandolapril
Available from:
Mylan IRE Healthcare Limited
ATC code:
C09AA; C09AA10
INN (International Name):
Trandolapril
Dosage:
0.5 milligram(s)
Pharmaceutical form:
Capsule, hard
Administration route:
Oral use
Units in package:
7, 28 or 56 capsules
Prescription type:
Product subject to prescription which may be renewed (B)
Manufactured by:
Famar Italia
Therapeutic group:
ACE inhibitors, plain
Therapeutic area:
ACE inhibitors, plain; trandolapril
Therapeutic indications:
All grades of essential hypertension; improves survival following myocardial infarction in patients with left ventricular dysfunction (ejection fraction 35 percent), with or without symptoms of heart failure and/or with or without residual ischaemia; reduces significantly the overall mortality, especially from cardiovascular mortality. It significantly decreases the risk of sudden death and the occurrence of severe or resistant heart failure, and tends to decrease the incidence of fatal and non-fatal reinfarctions.
Authorization status:
Not marketed
Authorization date:
1992-11-25
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ODRIK 0.5 MG HARD CAPSULES
ODRIK 1 MG HARD CAPSULES
ODRIK 2 MG HARD CAPSULES
Trandolapril
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet as you may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
- 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.
WHAT IS IN THIS LEAFLET
1. What Odrik is and what it is used for
2. What you need to know before you take Odrik
3. How to take Odrik
4. Possible Side Effects
5. How to store Odrik
6. Contents of the pack and other information
1. WHAT ODRIK IS AND WHAT IT IS USED FOR
Odrik capsules contain the active ingredient trandolapril which
belongs to a group of medicines
called angiotensin-converting enzyme inhibitors (ACE inhibitors). They
work by relaxing the blood
vessels, making it easier for the heart to pump blood around the body
and lowering blood
pressure.
Odrik Capsules are used to treat hypertension (high blood pressure).
The capsules may also be
prescribed to protect the heart after a heart attack.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ODRIK
DO NOT TAKE ODRIK:
- if you are ALLERGIC (hypersensitive) to trandolapril or any of the
other ingredients in this medicine.
- if you have ever had an ALLERGIC REACTION to any ACE inhibitors such
as swelling of the face,
lips, tongue or throat with difficulty swallowing or breathing.
- if you have ever had the condition known as angioedema or
Quincke’s oedema involving a skin
condition and swelling mainly affecting the face, extremities, tongue,
mouth and throat.
- if you are more than 3 months PREGNANT. (It is also better to avoid
Odrik in early pregnancy -
see section ‘Pregnancy and Bre
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
20 November 2020
CRN00C1LP
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Odrik 0.5mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg of trandolapril.
Excipients: Each hard capsule contains 56mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard Capsule (capsule)
Opaque red/yellow capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION
All grades of essential hypertension. Odrik may be used alone or in
combination with other antihypertensive agents (see
sections 4.3, 4.4, 4.5 and 5.1).
LEFT VENTRICULAR DYSFUNCTION AFTER MYOCARDIAL INFARCTION
It has been demonstrated that Odrik improves survival following
myocardial infarction in patients with left ventricular
dysfunction (ejection fraction ≤35 percent), with or without
symptoms of heart failure and/or with or without residual
ischaemia.
Long-term treatment with Odrik reduces significantly the overall
mortality, especially from cardiovascular mortality. It
significantly decreases the risk of sudden death and the occurrence of
severe or resistant heart failure, and tends to decrease
the incidence of fatal and non-fatal reinfarctions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
FOR ORAL USE
POSOLOGY
_Hypertension_
The starting dose is 1 mg once daily as a single dose. The daily dose
can be adjusted according to patient response up to a
maximum 4 mg given as a single daily dose.
_Left ventricular dysfunction after myocardial infarction_
Following a myocardial infarction, therapy may be initiated as early
as the third day.
Treatment should be initiated as a daily dose of 0.5 mg. The dose
should be progressively increased to a maximum of 4 mg as
a single daily dose. Depending upon the tolerability such as
symptomatic hypotension, this forced titration can be temporarily
suspended.
Health Products Regulatory Authority
20 November 2020
CRN00C1LP
Page 2 of 14
In the event of hypotension, all
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