TRIALIX 5mg/6mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Piretanide; Ramipril

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

C09BA; C09BA05

INN (International Name):

Piretanide; Ramipril

Dosage:

5/6 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors and diuretics; ramipril and diuretics

Authorization status:

Marketed

Authorization date:

1995-05-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IS THIS LEAFLET HARD TO SEE OR READ?
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
WHAT IS IN THIS LEAFLET:
1. What Trialix Tablets are and what they are used for
2. What you need to know before you take Trialix Tablets
3. How to take Trialix Tablets
4. Possible side effects
5. How to store Trialix Tablets
6. Contents of the pack and other information
1. WHAT TRIALIX TABLETS ARE AND WHAT THEY ARE USED FOR
WHAT TRIALIX TABLETS ARE
The name of your medicine is Trialix 5mg/6mg Tablets (called Trialix
Tablets throughout this leaflet). Trialix Tablets contain two
medicines
called ramipril and piretanide.
Trialix is a combination product with one ingredient belonging to
a group of medicines called ACE (Angiotensin Converting Enzyme)
Inhibitors which act on the heart and blood vessels. It also contains
a
diuretic which helps you to pass more water (urine) than you usually
do.
WHAT TRIALIX TABLETS ARE USED FOR
Trialix Tablets can be used:
• To continue treatment of high blood pressure (hypertension) in
those patients who are insufficiently controlled with monotherapy
(treatment with ramipril or piretanide alone).
HOW TRIALIX TABLETS WORK
Trialix Tablets 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
• Helping you to pass more water (urine) than you usually do
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIALIX

Summary of Product characteristics

Health Products Regulatory Authority
20 December 2018
CRN008K0F
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TRIALIX 5mg/6mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Ramipril 5.0 mg
Piretanide 6.0 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Oblong, yellowish-white tablets marked with a score line.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in patients who are insufficiently
controlled with
monotherapy and who have been stabilised on the individual components
given in
the same proportions (see sections 4.3, 4.4, 4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
As a general rule, the treatment of hypertension should be started
with one of the
component substances at a low dosage which is then gradually increased
(see
section 4.3, 4.4, 4.5 and 5.1).
The fixed combination of 5 mg ramipril and 6 mg of piretanide should
only be used
in patients whose blood pressure has already returned to normal
pressure under
treatment with a free combination of ramipril and piretanide in the
same amounts as
those in the combination.
The usual dosage in patients in whom the combination treatment is
indicated is 1
tablet TRIALIX daily. If the blood pressure does not respond
adequately to the
combination, the dosage of TRIALIX must not be increased: instead, the
necessary
Health Products Regulatory Authority
20 December 2018
CRN008K0F
Page 2 of 26
maintenance dose should be determined by further dose titration with
the free
combination.
Dosage in patients with moderate impairment of renal function
(creatinine clearance
30-60 ml/minute) and the elderly; titration with the individual
components should be
done very carefully. The maintenance dose is ½ tablet of TRIALIX
daily and the
maximum dose is 1 tablet of TRIALIX daily.
TRIALIX can be taken independently of meals and should be sw