Tritace 2.5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ramipril

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

C09AA; C09AA05

INN (International Name):

Ramipril

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain; ramipril

Authorization status:

Marketed

Authorization date:

2003-11-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRITACE
® 1.25MG TABLETS
TRITACE
® 2.5MG TABLETS
TRITACE
® 5MG TABLETS
TRITACE
® 10MG TABLETS
_Ramipril_
IS THIS LEAFLET HARD TO
SEE OR READ?
PHONE [phone] FOR
HELP.
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 TRITACE is and what it is used for
2. What you need to know before you take TRITACE
3. How to take TRITACE
4. Possible side effects
5. How to store TRITACE
6. Contents of the pack and other information
1.
WHAT TRITACE IS AND WHAT IT
IS USED FOR
TRITACE contains a medicine called ramipril. This
belongs to a group of medicines called ACE inhibitors
(Angiotensin Converting Enzyme Inhibitors).
TRITACE 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.
TRITACE 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
TRITACE
DO NOT TAKE TRITACE:
• If you are allergic to ramipril, any other ACE inhibitor
medicine or any of the ingredients of this medicine
listed in section 6.
Sign

Summary of Product characteristics

Health Products Regulatory Authority
22 June 2021
CRN00C2LZ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tritace 2.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets
Each tablet contains ramipril 2.5 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets 2.5 mg
Yellowish to yellow oblong tablet with dimensions of 8 x 4 mm with
score line, upper stamp 2.5 and company logo, lower
stamp HMR and 2.5. 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:
o manifest atherothrombotic cardiovascular disease (history of
coronary heart disease or stroke, or peripheral vascular disease)
or
o diabetes with at least one cardiovascular risk factor (see section
5.1).
- Treatment of renal disease:
o Incipient glomerular diabetic nephropathy as defined by the presence
of microalbuminuria,
o Manifest glomerular diabetic nephropathy as defined by
macroproteinuria in patients with at least one cardiovascular risk
factor (see section 5.1),
o 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
Special populations
o
_Pregnancy_: ACE inhibitors such as ramipril or Angiotensin II
Receptor Antagonists (AIIRAs) should not be initiated
during pregnancy. Unless continued ACE inhibitor/AIIRAs therapy is
considered essential, patients planning
pregnancy should be changed to alternative anti-hypertensive
treatments which have an established safety profile
for use in pregnancy. When pregnancy is diagnosed, treatment with ACE
inhibitors/